VITAL: Friendship Bench Adaptation to Improve Mental Health & HIV Care Engagement Outcomes Among PLWH and PWID in Vietnam

• Sponsor: University of North Carolina, Chapel Hill (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04790201
• Collaborator: Hanoi Medical University (Other), The Friendship Bench Trust (Other), National Institute on Drug Abuse (NIDA) (NIH)
• Enrollment: 75
• Location: 1
• Arms: 3
• Anticipated Duration (Months): 15
• Patients Per Site Per Month: 5

Study Details

Study Description

Brief Summary

This project will adapt and pilot a feasible and effective problem-solving therapy designed for low-resource settings to address common mental disorders like depression and anxiety - the Friendship Bench- in a Vietnamese population of individuals living with HIV who also have opiate use disorder. The Friendship Bench approach has the potential to make an important contribution to address CMDs and reduce barriers to HIV treatment success among people living with HIV (PLWH) with Opioid Use Disorder (OUD), a critical population driving the HIV epidemic in Vietnam and many Southeast Asian countries. This proposal will generate critical evidence for designing a fully powered clinical trial to test the investigation team's adapted FB protocol in improving HIV, mental health, and drug use treatment outcomes for this vulnerable population.

Condition or Disease	Intervention/Treatment	Phase
HIV Infections; Behavioral Symptoms; Depression; Anxiety; Opioid-use Disorder; Virus Infection; Immune System Diseases; Opioid Dependence	Behavioral: Friendship Bench Delivered by Professional Counselor; Behavioral: Friendship Bench Delivered by Lay Counselor; Behavioral: Enhanced Usual Care	N/A

Detailed Description

Injection drug use is the primary driver of the HIV epidemic in Southeast Asia. In 2017, the HIV prevalence among people who inject drugs (PWID) in Southeast Asia was 15%. PWID, most of whom have OUD, who are living with HIV have low rates of retention in care, antiretroviral therapy (ART) initiation, and viral suppression. PWID also experience high rates of HIV-related and all-cause mortality. Common mental disorders (CMDs), including depressive, anxiety, and stress-related illnesses, occur in 40-50% of PLWH and OUD. Despite serious consequences of mental illness on health and HIV progression, mental illness remains under-diagnosed and under-treated in HIV populations, especially in low- and middle-income countries (LMICs), such as many countries in Southeast Asia.

To respond to the great need for mental health treatment in low- and middle-income countries, the global mental health field has focused on developing task-shifting and integration approaches that equip non-specialists to deliver evidence-based mental health interventions at scale. However, such task shifting interventions to address CMDs have received limited attention in Southeast Asia among OUD. Vietnam, with its high prevalence of PLWH and OUD, its integration of methadone maintenance therapy (MMT) with HIV care, and its priority for developing CMD care for this population, is an ideal setting to evaluate task-shifting mental health approaches to address CMDs and improve HIV care outcomes.

The Friendship Bench (FB) is a feasible and effective task-shifting mental health intervention designed for low-resource settings that is a strong candidate to address CMDs in this population. FB is a problem solving therapy-based intervention with demonstrated effectiveness in treating CMDs among primary care patients when delivered by lay counselors. Lay counselors may effectively deliver FB to PLWH with OUD, but CMD may prove more difficult to treat in patients with OUD and require professionally trained counselors to be effective.

The investigators' objective is to complete a pilot randomized trial of 75 patients from 4 MMT clinics in Hanoi. The investigators' specific aims are: 1) To adapt the Friendship Bench (FB) protocol to be optimized for PLWH and OUD in Vietnam; and 2) To evaluate the feasibility, fidelity, and acceptability of the adapted FB as well as preliminary indicators of its impact in improving CMDs and HIV care and drug use treatment outcomes. The Friendship Bench approach has the potential to make an important contribution to address CMDs and reduce barriers to HIV treatment success among PLWH with OUD, a critical population driving the HIV epidemic in Vietnam and many Southeast Asian countries. This proposal will generate critical evidence for designing a fully powered clinical trial to test the adapted FB protocol in improving HIV, mental health, and drug use treatment outcomes for this vulnerable population.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 75 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Three-arm individually randomized trialThree-arm individually randomized trial
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Adaptation of the Friendship Bench Counseling Intervention to Improve Mental Health and HIV Care Engagement Outcomes Among People Living With HIV Who Inject Drugs in Vietnam
• Actual Study Start Date: Feb 28, 2022
• Anticipated Primary Completion Date: Jun 1, 2023
• Anticipated Study Completion Date: Jun 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Friendship Bench Delivered by Professional Counselor 25 participants seeking HIV and/or MMT services at participating clinics in Hanoi, Vietnam will be enrolled in this study arm during study recruitment. Individuals enrolled in this arm will initiate FB with a professional counselor. Individuals enrolled in this arm will receive 6 weekly counseling sessions per the adapted FB protocol (Aim 1).	Behavioral: Friendship Bench Delivered by Professional Counselor; Participants randomized to this arm will receive the Friendship Bench protocol delivered by a professional counselor.
Experimental: Friendship Bench Delivered by Lay Counselor 25 participants seeking HIV and/or MMT services at participating clinics in Hanoi, Vietnam will be enrolled in this study arm during study recruitment. Individuals enrolled in this arm will initiate FB with a trained lay counselor. Individuals enrolled in this arm arm will receive 6 weekly counselling sessions per the adapted FB protocol (Aim 1).	Behavioral: Friendship Bench Delivered by Lay Counselor; Participants randomized to this arm will receive the Friendship Bench protocol delivered by a trained lay counselor.
Active Comparator: Enhanced Usual Care 25 participants seeking HIV and/or MMT services at participating clinics in Hanoi, Vietnam will be enrolled in this study arm during study recruitment. Enhanced usual care will include general training of the HIV providers and clinics about CMD identification and management, and feedback to the HIV provider of the status of their enrolled patient to allow follow-up per the clinic's standard care.	Behavioral: Enhanced Usual Care; Enhanced usual care (EUC) will include general training of the HIV providers and clinics about CMD identification and management, and feedback to the HIV provider of the status of their enrolled patient to allow follow-up per the clinic's standard care. Information will be collected in follow-up interviews to characterize the care that patients receive. These activities will occur in all three arms, but they are the only activities in the EUC arm.

Outcome Measures

Primary Outcome Measures

1. Intervention Feasibility - Recruitment Rate [12th month of the intervention.]

   This measure of feasibility will be measured as the ability to successfully enroll PLWH and OUD with CMDs in the pilot intervention. Feasibility will be evaluated by measuring the recruitment rate (number of patients approached in order to accrue the final sample).

2. Intervention Feasibility - 3 Month Retention Rate [3rd month of intervention]

   This measure of feasibility will be measured as the ability to retain PLWH and OUD with CMDs in the pilot intervention. Feasibility will be evaluated by measuring the retention rate (proportion of patients enrolled at baseline who are still enrolled in the trial).

3. Intervention Feasibility - 6 Month Retention Rate [6th month of intervention]

   This measure of feasibility will be measured as the ability to retain PLWH and OUD with CMDs in the pilot intervention. Feasibility will be evaluated by measuring the retention rate (proportion of patients enrolled at baseline who are still enrolled in the trial).

4. Intervention Feasibility - 12 Month Retention Rate [12th month of intervention]

   This measure of feasibility will be measured as the ability to retain PLWH and OUD with CMDs in the pilot intervention. Feasibility will be evaluated by measuring the retention rate (proportion of patients enrolled at baseline who are still enrolled in the trial).

5. Intervention Feasibility - Proportion of FB Sessions Attended at 3 months [Study baseline through 3rd month of follow-up.]

   The proportion of FB sessions attended by participants out of total FB sessions offered.

6. Intervention Feasibility - Proportion of FB Sessions Attended at 6 months [Study baseline and through the 6th month of follow-up.]

   The proportion of FB sessions attended by participants out of total FB sessions offered.

7. Intervention Feasibility - Proportion of FB Sessions Attended at 12 months [Study baseline and through the 12th month of follow-up.]

   The proportion of FB sessions attended by participants out of total FB sessions offered.

8. Intervention Feasibility - Cumulative Counselor Time Per Session [At treatment exit (6 weeks)]

   Mean duration of counselor time per session (in minutes) including preparation, documentation, and supervision.

9. Intervention Feasibility - Cumulative Counselor Time Per Patient [At treatment exit (6 weeks)]

   Mean duration of counselor time per patient (in minutes) including preparation, documentation, and supervision.

10. Intervention Acceptability - Percent Thematic Dominance across all Key Informant Interviews [Assessed for patient participants when the participant completes the intervention (on average 12 months). Assessed for clinical and administrative participants at the end of the intervention at the participant's intervention site (on average 12 months).]

    A qualitative, applied thematic approach will summarize and report intervention acceptability across key informant interviews (n=84). Acceptability will be defined as the ability to deliver a culturally and resource-appropriate intervention. Acceptability will be measured through brief exit interviews with all patient participants (n=75), HIV providers treating patients in the FB protocol, professional counselors (n=3), lay counselors (n=3), and supervising Master Trainers (n=1 per clinic, n=2 or 3 total). Exit interviews with patients will occur after the final FB session, while exit interviews with other groups will occur after the end of FB activities at each site. Exit interviews will include both closed and open-ended questions and will measure how easy the intervention was to participate in or deliver, the perceived usefulness of the intervention, and suggestions for improvement.

11. Intervention Acceptability - Percent thematic dominance in patient participant key informant interviews [Assessed for patient participants when the participant completes the intervention (on average 12 months).]

    A qualitative, applied thematic approach will measure intervention acceptability. Acceptability will be defined as the ability to deliver a culturally and resource-appropriate intervention. Acceptability will be measured through brief exit interviews with all patient participants (n=75).

12. Intervention Acceptability - Percent thematic dominance in HIV provider key informant interviews [Assessed for clinical participants at the end of the intervention at the participant's intervention site (on average 12 months).]

    A qualitative, applied thematic approach will measure intervention acceptability. Acceptability will be defined as the ability to deliver a culturally and resource-appropriate intervention. Acceptability will be measured through brief exit interviews with HIV providers treating patients in the FB protocol.

13. Intervention Acceptability - Percent thematic dominance in professional counselor key informant interviews [Assessed for clinical participants at the end of the intervention at the participant's intervention site (on average 12 months).]

    A qualitative, applied thematic approach will measure intervention acceptability. Acceptability will be defined as the ability to deliver a culturally and resource-appropriate intervention. Acceptability will be measured through brief exit interviews with professional counselors (n=3).

14. Intervention Acceptability - Percent thematic dominance in lay counselor key informant interviews [Assessed for clinical participants at the end of the intervention at the participant's intervention site (on average 12 months).]

    A qualitative, applied thematic approach will measure intervention acceptability. Acceptability will be defined as the ability to deliver a culturally and resource-appropriate intervention. Acceptability will be measured through brief exit interviews with lay counselors (n=3).

15. Intervention Acceptability - Percent thematic dominance across Master Trainer key informant interviews [Assessed for clinical and administrative participants at the end of the intervention at the participant's intervention site (on average 12 months).]

    A qualitative, applied thematic approach will measure intervention acceptability. Acceptability will be defined as the ability to deliver a culturally and resource-appropriate intervention. Acceptability will be measured through brief exit interviews with supervising Master Trainers (n=1 per clinic, n=2 or 3 total).

16. Intervention Fidelity - Mean Percent of Intervention Checklist Items Followed [12 months]

    This measure of fidelity will be measured as a single mean value: the mean percent of intervention checklist items followed during counseling sessions. Covering at least 80% of checklist items during each session will be considered fidelity to the intervention protocol, as measured by a Master Trainer by using a checklist of counseling session elements either during direct monitoring or using audio recording.

17. Intervention Fidelity - Mean Percent of Sessions Achieving 80% or greater than 80% Fidelity [12 months]

    This measure of fidelity will be measured as a single mean value: the mean percent of intervention checklist items followed during counseling sessions. Covering at least 80% of checklist items during each session will be considered fidelity to the intervention protocol, as measured by a Master Trainer by using a checklist of counseling session elements either during direct monitoring or using audio recording.

Secondary Outcome Measures

1. Proportion of Participants Achieving HIV Viral Suppression [Study baseline through 6 months]

   HIV viral load will be measured from clinical records, or measured and ordered by the study if no viral load is collected in the appropriate window.

2. Proportion of Participants Achieving HIV Viral Suppression [Study baseline through 12 months]

   HIV viral load will be measured from clinical records, or measured and ordered by the study if no viral load is collected in the appropriate window.

3. Proportion of Participants with Consistent ART Use over 12 Months [Assessed during entire study period (Study baseline through 12 months follow-up)]

   Consistent ART use over 12 months as confirmed by clinical records.

4. Proportion of Scheduled HIV Visits Attended vs. Unattended in the 12-Month Follow-Up period. [Study baseline and each study follow-up through 12 months of follow-up.]

   The proportion of scheduled visits in the 12-month follow-up period that are attended vs. no-shows (the "kept visit proportion"). HIV appointment data will be abstracted from clinic records at the end of the study period.

5. Proportion of Participants with Depression Anxiety Stress-Scale (DASS-21) Total Score Indicating Any CMD Symptoms [Study entrance/baseline.]

   The DASS-21 measures self-reported depression, anxiety, and stress with 3 subscales. Responses are ranked on a Likert scale: 0 "Does not apply to me at all (Never)", 1 "Applied to me to some degree, or some of the time (Sometimes)", 2 "Applied to me to a considerable degree, or a good part of time (Often)", and 3 "Applied to me very much, or most of the time (Always)". The sub-scale scores are added ranging 0-126. Higher scores indicate higher emotional stress. A depression sub-scale score ≥14 indicates depressive disorders, anxiety sub-scale score ≥10 indicates anxiety disorders, and stress sub-scale score ≥19 indicates stress disorders. The depression sub-scale is measured as: Normal 0-9, Mild: 10-12, Moderate: 13-20, Severe: 21-27, Extremely Severe: 28-42. The anxiety sub-scale is: Normal: 0-6, Mild: 7-9, Moderate: 10-14, Severe: 15-19, Extremely Severe: 20-42. The stress sub-scale is: Normal: 0-10, Mild: 11-18, Moderate: 19-26, Severe: 27-34, Extremely Severe: 35-42.

6. Proportion of Participants with Depression Anxiety Stress-Scale (DASS-21) Total Score Indicating Any CMD Symptoms [6 weeks after enrollment]

   The DASS-21 measures self-reported depression, anxiety, and stress with 3 subscales. Responses are ranked on a Likert scale: 0 "Does not apply to me at all (Never)", 1 "Applied to me to some degree, or some of the time (Sometimes)", 2 "Applied to me to a considerable degree, or a good part of time (Often)", and 3 "Applied to me very much, or most of the time (Always)". The sub-scale scores are added ranging 0-126. Higher scores indicate higher emotional stress. A depression sub-scale score ≥14 indicates depressive disorders, anxiety sub-scale score ≥10 indicates anxiety disorders, and stress sub-scale score ≥19 indicates stress disorders. The depression sub-scale is measured as: Normal 0-9, Mild: 10-12, Moderate: 13-20, Severe: 21-27, Extremely Severe: 28-42. The anxiety sub-scale is: Normal: 0-6, Mild: 7-9, Moderate: 10-14, Severe: 15-19, Extremely Severe: 20-42. The stress sub-scale is: Normal: 0-10, Mild: 11-18, Moderate: 19-26, Severe: 27-34, Extremely Severe: 35-42.

7. Proportion of Participants with Depression Anxiety Stress-Scale (DASS-21) Total Score Indicating Any CMD Symptoms [3 months after enrollment]

   The DASS-21 measures self-reported depression, anxiety, and stress with 3 subscales. Responses are ranked on a Likert scale: 0 "Does not apply to me at all (Never)", 1 "Applied to me to some degree, or some of the time (Sometimes)", 2 "Applied to me to a considerable degree, or a good part of time (Often)", and 3 "Applied to me very much, or most of the time (Always)". The sub-scale scores are added ranging 0-126. Higher scores indicate higher emotional stress. A depression sub-scale score ≥14 indicates depressive disorders, anxiety sub-scale score ≥10 indicates anxiety disorders, and stress sub-scale score ≥19 indicates stress disorders. The depression sub-scale is measured as: Normal 0-9, Mild: 10-12, Moderate: 13-20, Severe: 21-27, Extremely Severe: 28-42. The anxiety sub-scale is: Normal: 0-6, Mild: 7-9, Moderate: 10-14, Severe: 15-19, Extremely Severe: 20-42. The stress sub-scale is: Normal: 0-10, Mild: 11-18, Moderate: 19-26, Severe: 27-34, Extremely Severe: 35-42.

8. Proportion of Participants with Depression Anxiety Stress-Scale (DASS-21) Total Score Indicating Any CMD Symptoms [6 months after enrollment]

   The DASS-21 measures self-reported depression, anxiety, and stress with 3 subscales. Responses are ranked on a Likert scale: 0 "Does not apply to me at all (Never)", 1 "Applied to me to some degree, or some of the time (Sometimes)", 2 "Applied to me to a considerable degree, or a good part of time (Often)", and 3 "Applied to me very much, or most of the time (Always)". The sub-scale scores are added ranging 0-126. Higher scores indicate higher emotional stress. A depression sub-scale score ≥14 indicates depressive disorders, anxiety sub-scale score ≥10 indicates anxiety disorders, and stress sub-scale score ≥19 indicates stress disorders. The depression sub-scale is measured as: Normal 0-9, Mild: 10-12, Moderate: 13-20, Severe: 21-27, Extremely Severe: 28-42. The anxiety sub-scale is: Normal: 0-6, Mild: 7-9, Moderate: 10-14, Severe: 15-19, Extremely Severe: 20-42. The stress sub-scale is: Normal: 0-10, Mild: 11-18, Moderate: 19-26, Severe: 27-34, Extremely Severe: 35-42.

9. Proportion of Participants with Depression Anxiety Stress-Scale (DASS-21) Total Score Indicating Any CMD Symptoms [12 months after enrollment]

   The DASS-21 measures self-reported depression, anxiety, and stress with 3 subscales. Responses are ranked on a Likert scale: 0 "Does not apply to me at all (Never)", 1 "Applied to me to some degree, or some of the time (Sometimes)", 2 "Applied to me to a considerable degree, or a good part of time (Often)", and 3 "Applied to me very much, or most of the time (Always)". The sub-scale scores are added ranging 0-126. Higher scores indicate higher emotional stress. A depression sub-scale score ≥14 indicates depressive disorders, anxiety sub-scale score ≥10 indicates anxiety disorders, and stress sub-scale score ≥19 indicates stress disorders. The depression sub-scale is measured as: Normal 0-9, Mild: 10-12, Moderate: 13-20, Severe: 21-27, Extremely Severe: 28-42. The anxiety sub-scale is: Normal: 0-6, Mild: 7-9, Moderate: 10-14, Severe: 15-19, Extremely Severe: 20-42. The stress sub-scale is: Normal: 0-10, Mild: 11-18, Moderate: 19-26, Severe: 27-34, Extremely Severe: 35-42.

10. Proportion of Participants with DASS-21 depression subscale score ≥14 indicating a depressive disorder [Study entrance/baseline.]

    The DASS-21 measures self-reported depression, anxiety, and stress using three sub-scales. Questionnaire items ask about experiencing various signs and symptoms over the last week and use a Likert scale with response choices and scoring as follows: 0 indicating "Does not apply to me at all (Never)", 1 indicating "Applied to me to some degree, or some of the time (Sometimes)", 2 indicating "Applied to me to a considerable degree, or a good part of time (Often)", and 3 indicating "Applied to me very much, or most of the time (Always)". A DASS-21 depression sub-scale score ≥14 indicates depressive disorders. Severity on the depression sub-scale is measured as follows: Normal 0-9, Mild: 10-12, Moderate: 13-20, Severe: 21-27, Extremely Severe: 28-42. The proportion of participants with a DASS-21 score indicating a depressive disorder (a depression sub-scale score ≥ 14) will be measured.

11. Proportion of Participants with DASS-21 depression subscale score ≥14 indicating a depressive disorder [6 weeks after enrollment]

    The DASS-21 measures self-reported depression, anxiety, and stress using three sub-scales. Questionnaire items ask about experiencing various signs and symptoms over the last week and use a Likert scale with response choices and scoring as follows: 0 indicating "Does not apply to me at all (Never)", 1 indicating "Applied to me to some degree, or some of the time (Sometimes)", 2 indicating "Applied to me to a considerable degree, or a good part of time (Often)", and 3 indicating "Applied to me very much, or most of the time (Always)". A DASS-21 depression sub-scale score ≥14 indicates depressive disorders. Severity on the depression sub-scale is measured as follows: Normal 0-9, Mild: 10-12, Moderate: 13-20, Severe: 21-27, Extremely Severe: 28-42. The proportion of participants with a DASS-21 score indicating a depressive disorder (a depression sub-scale score ≥ 14) will be measured.

12. Proportion of Participants with DASS-21 depression subscale score ≥14 indicating a depressive disorder [3 months after enrollment]

    The DASS-21 measures self-reported depression, anxiety, and stress using three sub-scales. Questionnaire items ask about experiencing various signs and symptoms over the last week and use a Likert scale with response choices and scoring as follows: 0 indicating "Does not apply to me at all (Never)", 1 indicating "Applied to me to some degree, or some of the time (Sometimes)", 2 indicating "Applied to me to a considerable degree, or a good part of time (Often)", and 3 indicating "Applied to me very much, or most of the time (Always)". A DASS-21 depression sub-scale score ≥14 indicates depressive disorders. Severity on the depression sub-scale is measured as follows: Normal 0-9, Mild: 10-12, Moderate: 13-20, Severe: 21-27, Extremely Severe: 28-42. The proportion of participants with a DASS-21 score indicating a depressive disorder (a depression sub-scale score ≥ 14) will be measured.

13. Proportion of Participants with DASS-21 depression subscale score ≥14 indicating a depressive disorder [6 months]

    The DASS-21 measures self-reported depression, anxiety, and stress using three sub-scales. Questionnaire items ask about experiencing various signs and symptoms over the last week and use a Likert scale with response choices and scoring as follows: 0 indicating "Does not apply to me at all (Never)", 1 indicating "Applied to me to some degree, or some of the time (Sometimes)", 2 indicating "Applied to me to a considerable degree, or a good part of time (Often)", and 3 indicating "Applied to me very much, or most of the time (Always)". A DASS-21 depression sub-scale score ≥14 indicates depressive disorders. Severity on the depression sub-scale is measured as follows: Normal 0-9, Mild: 10-12, Moderate: 13-20, Severe: 21-27, Extremely Severe: 28-42. The proportion of participants with a DASS-21 score indicating a depressive disorder (a depression sub-scale score ≥ 14) will be measured.

14. Proportion of Participants with DASS-21 depression subscale score ≥14 indicating a depressive disorder [12 months after enrollment]

    The DASS-21 measures self-reported depression, anxiety, and stress using three sub-scales. Questionnaire items ask about experiencing various signs and symptoms over the last week and use a Likert scale with response choices and scoring as follows: 0 indicating "Does not apply to me at all (Never)", 1 indicating "Applied to me to some degree, or some of the time (Sometimes)", 2 indicating "Applied to me to a considerable degree, or a good part of time (Often)", and 3 indicating "Applied to me very much, or most of the time (Always)". A DASS-21 depression sub-scale score ≥14 indicates depressive disorders. Severity on the depression sub-scale is measured as follows: Normal 0-9, Mild: 10-12, Moderate: 13-20, Severe: 21-27, Extremely Severe: 28-42. The proportion of participants with a DASS-21 score indicating a depressive disorder (a depression sub-scale score ≥ 14) will be measured.

15. Proportion of participants with a 50 percent decrease in depressive symptom severity as measured using the DASS-21 depression sub-scale [6 weeks after enrollment]

    The DASS-21 measures self-reported depression, anxiety, and stress using three sub-scales. Questionnaire items ask about experiencing various signs and symptoms over the last week and use a Likert scale with response choices and scoring as follows: 0 indicating "Does not apply to me at all (Never)", 1 indicating "Applied to me to some degree, or some of the time (Sometimes)", 2 indicating "Applied to me to a considerable degree, or a good part of time (Often)", and 3 indicating "Applied to me very much, or most of the time (Always)". A DASS-21 depression sub-scale score ≥14 indicates depressive disorders. Severity on the depression sub-scale is measured as follows: Normal 0-9, Mild: 10-12, Moderate: 13-20, Severe: 21-27, Extremely Severe: 28-42. The proportion of participants with a 50% decrease in depressive symptom severity will be measured, as indicated by the proportion of participants with a 50% decrease in depression symptom severity between study follow-up points.

16. Proportion of participants with a 50 percent decrease in depressive symptom severity as measured using the DASS-21 depression sub-scale [3 months after enrollment]

    The DASS-21 measures self-reported depression, anxiety, and stress using three sub-scales. Questionnaire items ask about experiencing various signs and symptoms over the last week and use a Likert scale with response choices and scoring as follows: 0 indicating "Does not apply to me at all (Never)", 1 indicating "Applied to me to some degree, or some of the time (Sometimes)", 2 indicating "Applied to me to a considerable degree, or a good part of time (Often)", and 3 indicating "Applied to me very much, or most of the time (Always)". A DASS-21 depression sub-scale score ≥14 indicates depressive disorders. Severity on the depression sub-scale is measured as follows: Normal 0-9, Mild: 10-12, Moderate: 13-20, Severe: 21-27, Extremely Severe: 28-42. The proportion of participants with a 50% decrease in depressive symptom severity will be measured, as indicated by the proportion of participants with a 50% decrease in depression symptom severity between study follow-up points.

17. Proportion of participants with a 50 percent decrease in depressive symptom severity as measured using the DASS-21 depression sub-scale [6 months after enrollment]

    The DASS-21 measures self-reported depression, anxiety, and stress using three sub-scales. Questionnaire items ask about experiencing various signs and symptoms over the last week and use a Likert scale with response choices and scoring as follows: 0 indicating "Does not apply to me at all (Never)", 1 indicating "Applied to me to some degree, or some of the time (Sometimes)", 2 indicating "Applied to me to a considerable degree, or a good part of time (Often)", and 3 indicating "Applied to me very much, or most of the time (Always)". A DASS-21 depression sub-scale score ≥14 indicates depressive disorders. Severity on the depression sub-scale is measured as follows: Normal 0-9, Mild: 10-12, Moderate: 13-20, Severe: 21-27, Extremely Severe: 28-42. The proportion of participants with a 50% decrease in depressive symptom severity will be measured, as indicated by the proportion of participants with a 50% decrease in depression symptom severity between study follow-up points.

18. Proportion of participants with a 50 percent decrease in depressive symptom severity as measured using the DASS-21 depression sub-scale [12 months after enrollment]

    The DASS-21 measures self-reported depression, anxiety, and stress using three sub-scales. Questionnaire items ask about experiencing various signs and symptoms over the last week and use a Likert scale with response choices and scoring as follows: 0 indicating "Does not apply to me at all (Never)", 1 indicating "Applied to me to some degree, or some of the time (Sometimes)", 2 indicating "Applied to me to a considerable degree, or a good part of time (Often)", and 3 indicating "Applied to me very much, or most of the time (Always)". A DASS-21 depression sub-scale score ≥14 indicates depressive disorders. Severity on the depression sub-scale is measured as follows: Normal 0-9, Mild: 10-12, Moderate: 13-20, Severe: 21-27, Extremely Severe: 28-42. The proportion of participants with a 50% decrease in depressive symptom severity will be measured, as indicated by the proportion of participants with a 50% decrease in depression symptom severity between study follow-up points.

19. Probability of no longer meeting DASS-21 depression diagnostic criteria at follow-up as indicated by a DASS-21 depression sub-scale score ≤ 9 [6 weeks after enrollment]

    The DASS-21 measures self-reported depression, anxiety, and stress using three sub-scales. Questionnaire items ask about experiencing various signs and symptoms over the last week and use a Likert scale with response choices and scoring as follows: 0 indicating "Does not apply to me at all (Never)", 1 indicating "Applied to me to some degree, or some of the time (Sometimes)", 2 indicating "Applied to me to a considerable degree, or a good part of time (Often)", and 3 indicating "Applied to me very much, or most of the time (Always)". A DASS-21 depression sub-scale score ≥14 indicates depressive disorders. Severity on the depression sub-scale is measured as follows: Normal 0-9, Mild: 10-12, Moderate: 13-20, Severe: 21-27, Extremely Severe: 28-42. The probability of no longer meeting DASS-21 depression diagnostic criteria at follow-up is measured by having a score of 0-9 on the DASS-21 depression sub-scale.

20. Probability of no longer meeting DASS-21 depression diagnostic criteria at follow-up as indicated by a DASS-21 depression sub-scale score ≤ 9 [3 months after enrollment]

    The DASS-21 measures self-reported depression, anxiety, and stress using three sub-scales. Questionnaire items ask about experiencing various signs and symptoms over the last week and use a Likert scale with response choices and scoring as follows: 0 indicating "Does not apply to me at all (Never)", 1 indicating "Applied to me to some degree, or some of the time (Sometimes)", 2 indicating "Applied to me to a considerable degree, or a good part of time (Often)", and 3 indicating "Applied to me very much, or most of the time (Always)". A DASS-21 depression sub-scale score ≥14 indicates depressive disorders. Severity on the depression sub-scale is measured as follows: Normal 0-9, Mild: 10-12, Moderate: 13-20, Severe: 21-27, Extremely Severe: 28-42. The probability of no longer meeting DASS-21 depression diagnostic criteria at follow-up is measured by having a score of 0-9 on the DASS-21 depression sub-scale.

21. Probability of no longer meeting DASS-21 depression diagnostic criteria at follow-up as indicated by a DASS-21 depression sub-scale score ≤ 9 [6 months after enrollment]

    The DASS-21 measures self-reported depression, anxiety, and stress using three sub-scales. Questionnaire items ask about experiencing various signs and symptoms over the last week and use a Likert scale with response choices and scoring as follows: 0 indicating "Does not apply to me at all (Never)", 1 indicating "Applied to me to some degree, or some of the time (Sometimes)", 2 indicating "Applied to me to a considerable degree, or a good part of time (Often)", and 3 indicating "Applied to me very much, or most of the time (Always)". A DASS-21 depression sub-scale score ≥14 indicates depressive disorders. Severity on the depression sub-scale is measured as follows: Normal 0-9, Mild: 10-12, Moderate: 13-20, Severe: 21-27, Extremely Severe: 28-42. The probability of no longer meeting DASS-21 depression diagnostic criteria at follow-up is measured by having a score of 0-9 on the DASS-21 depression sub-scale.

22. Probability of no longer meeting DASS-21 depression diagnostic criteria at follow-up as indicated by a DASS-21 depression sub-scale score ≤ 9 [12 months after enrollment]

    The DASS-21 measures self-reported depression, anxiety, and stress using three sub-scales. Questionnaire items ask about experiencing various signs and symptoms over the last week and use a Likert scale with response choices and scoring as follows: 0 indicating "Does not apply to me at all (Never)", 1 indicating "Applied to me to some degree, or some of the time (Sometimes)", 2 indicating "Applied to me to a considerable degree, or a good part of time (Often)", and 3 indicating "Applied to me very much, or most of the time (Always)". A DASS-21 depression sub-scale score ≥14 indicates depressive disorders. Severity on the depression sub-scale is measured as follows: Normal 0-9, Mild: 10-12, Moderate: 13-20, Severe: 21-27, Extremely Severe: 28-42. The probability of no longer meeting DASS-21 depression diagnostic criteria at follow-up is measured by having a score of 0-9 on the DASS-21 depression sub-scale.

23. Proportion of participants with a DASS-21 anxiety subscale score ≥10 indicating an anxiety disorder [Study entrance/baseline.]

    The DASS-21 measures self-reported depression, anxiety, and stress using three sub-scales. Questionnaire items ask about experiencing various signs and symptoms over the last week and use a Likert scale with response choices and scoring as follows: 0 indicating "Does not apply to me at all (Never)", 1 indicating "Applied to me to some degree, or some of the time (Sometimes)", 2 indicating "Applied to me to a considerable degree, or a good part of time (Often)", and 3 indicating "Applied to me very much, or most of the time (Always)". A DASS-21 anxiety sub-scale score ≥6 indicates anxiety disorders. Severity on the anxiety sub-scale is measured as follows: Normal: 0-6, Mild: 7-9, Moderate: 10-14, Severe: 15-19, Extremely Severe: 20-42. The proportion of participants with a Depression Anxiety Stress-Scale (DASS-21) anxiety sub-scale score indicating an anxiety disorder (a score ≥ 10) will be measured.

24. Proportion of participants with a DASS-21 anxiety subscale score ≥10 indicating an anxiety disorder [6 weeks after enrollment]

    The DASS-21 measures self-reported depression, anxiety, and stress using three sub-scales. Questionnaire items ask about experiencing various signs and symptoms over the last week and use a Likert scale with response choices and scoring as follows: 0 indicating "Does not apply to me at all (Never)", 1 indicating "Applied to me to some degree, or some of the time (Sometimes)", 2 indicating "Applied to me to a considerable degree, or a good part of time (Often)", and 3 indicating "Applied to me very much, or most of the time (Always)". A DASS-21 anxiety sub-scale score ≥6 indicates anxiety disorders. Severity on the anxiety sub-scale is measured as follows: Normal: 0-6, Mild: 7-9, Moderate: 10-14, Severe: 15-19, Extremely Severe: 20-42. The proportion of participants with a Depression Anxiety Stress-Scale (DASS-21) anxiety sub-scale score indicating an anxiety disorder (a score ≥ 10) will be measured.

25. Proportion of participants with a DASS-21 anxiety subscale score ≥10 indicating an anxiety disorder [3 months after enrollment]

    The DASS-21 measures self-reported depression, anxiety, and stress using three sub-scales. Questionnaire items ask about experiencing various signs and symptoms over the last week and use a Likert scale with response choices and scoring as follows: 0 indicating "Does not apply to me at all (Never)", 1 indicating "Applied to me to some degree, or some of the time (Sometimes)", 2 indicating "Applied to me to a considerable degree, or a good part of time (Often)", and 3 indicating "Applied to me very much, or most of the time (Always)". A DASS-21 anxiety sub-scale score ≥6 indicates anxiety disorders. Severity on the anxiety sub-scale is measured as follows: Normal: 0-6, Mild: 7-9, Moderate: 10-14, Severe: 15-19, Extremely Severe: 20-42. The proportion of participants with a Depression Anxiety Stress-Scale (DASS-21) anxiety sub-scale score indicating an anxiety disorder (a score ≥ 10) will be measured.

26. Proportion of participants with a DASS-21 anxiety subscale score ≥10 indicating an anxiety disorder [6 months after enrollment]

    The DASS-21 measures self-reported depression, anxiety, and stress using three sub-scales. Questionnaire items ask about experiencing various signs and symptoms over the last week and use a Likert scale with response choices and scoring as follows: 0 indicating "Does not apply to me at all (Never)", 1 indicating "Applied to me to some degree, or some of the time (Sometimes)", 2 indicating "Applied to me to a considerable degree, or a good part of time (Often)", and 3 indicating "Applied to me very much, or most of the time (Always)". A DASS-21 anxiety sub-scale score ≥6 indicates anxiety disorders. Severity on the anxiety sub-scale is measured as follows: Normal: 0-6, Mild: 7-9, Moderate: 10-14, Severe: 15-19, Extremely Severe: 20-42. The proportion of participants with a Depression Anxiety Stress-Scale (DASS-21) anxiety sub-scale score indicating an anxiety disorder (a score ≥ 10) will be measured.

27. Proportion of participants with a DASS-21 anxiety subscale score ≥10 indicating an anxiety disorder [12 months]

    The DASS-21 measures self-reported depression, anxiety, and stress using three sub-scales. Questionnaire items ask about experiencing various signs and symptoms over the last week and use a Likert scale with response choices and scoring as follows: 0 indicating "Does not apply to me at all (Never)", 1 indicating "Applied to me to some degree, or some of the time (Sometimes)", 2 indicating "Applied to me to a considerable degree, or a good part of time (Often)", and 3 indicating "Applied to me very much, or most of the time (Always)". A DASS-21 anxiety sub-scale score ≥6 indicates anxiety disorders. Severity on the anxiety sub-scale is measured as follows: Normal: 0-6, Mild: 7-9, Moderate: 10-14, Severe: 15-19, Extremely Severe: 20-42. The proportion of participants with a Depression Anxiety Stress-Scale (DASS-21) anxiety sub-scale score indicating an anxiety disorder (a score ≥ 10) will be measured.

28. Proportion of participants with a 50 percent decrease in anxiety symptom severity as measured using the DASS-21 anxiety sub-scale [6 weeks]

    The DASS-21 measures self-reported depression, anxiety, and stress using three sub-scales. Questionnaire items ask about experiencing various signs and symptoms over the last week and use a Likert scale with response choices and scoring as follows: 0 indicating "Does not apply to me at all (Never)", 1 indicating "Applied to me to some degree, or some of the time (Sometimes)", 2 indicating "Applied to me to a considerable degree, or a good part of time (Often)", and 3 indicating "Applied to me very much, or most of the time (Always)". A DASS-21 anxiety sub-scale score ≥10 indicates anxiety disorders. Severity on the anxiety sub-scale is measured as follows: Normal: 0-6, Mild: 7-9, Moderate: 10-14, Severe: 15-19, Extremely Severe: 20-42. The proportion of participants with a 50% decrease in depressive symptom severity will be measured, as indicated by the proportion of participants with a 50% decrease in depression symptom severity between study follow-up points.

29. Proportion of participants with a 50 percent decrease in anxiety symptom severity as measured using the DASS-21 anxiety sub-scale [3 months]

    The DASS-21 measures self-reported depression, anxiety, and stress using three sub-scales. Questionnaire items ask about experiencing various signs and symptoms over the last week and use a Likert scale with response choices and scoring as follows: 0 indicating "Does not apply to me at all (Never)", 1 indicating "Applied to me to some degree, or some of the time (Sometimes)", 2 indicating "Applied to me to a considerable degree, or a good part of time (Often)", and 3 indicating "Applied to me very much, or most of the time (Always)". A DASS-21 anxiety sub-scale score ≥10 indicates anxiety disorders. Severity on the anxiety sub-scale is measured as follows: Normal: 0-6, Mild: 7-9, Moderate: 10-14, Severe: 15-19, Extremely Severe: 20-42. The proportion of participants with a 50% decrease in depressive symptom severity will be measured, as indicated by the proportion of participants with a 50% decrease in depression symptom severity between study follow-up points.

30. Proportion of participants with a 50 percent decrease in anxiety symptom severity as measured using the DASS-21 anxiety sub-scale [6 months after enrollment]

    The DASS-21 measures self-reported depression, anxiety, and stress using three sub-scales. Questionnaire items ask about experiencing various signs and symptoms over the last week and use a Likert scale with response choices and scoring as follows: 0 indicating "Does not apply to me at all (Never)", 1 indicating "Applied to me to some degree, or some of the time (Sometimes)", 2 indicating "Applied to me to a considerable degree, or a good part of time (Often)", and 3 indicating "Applied to me very much, or most of the time (Always)". A DASS-21 anxiety sub-scale score ≥10 indicates anxiety disorders. Severity on the anxiety sub-scale is measured as follows: Normal: 0-6, Mild: 7-9, Moderate: 10-14, Severe: 15-19, Extremely Severe: 20-42. The proportion of participants with a 50% decrease in depressive symptom severity will be measured, as indicated by the proportion of participants with a 50% decrease in depression symptom severity between study follow-up points.

31. Proportion of participants with a 50 percent decrease in anxiety symptom severity as measured using the DASS-21 anxiety sub-scale [12 months after enrollment]

    The DASS-21 measures self-reported depression, anxiety, and stress using three sub-scales. Questionnaire items ask about experiencing various signs and symptoms over the last week and use a Likert scale with response choices and scoring as follows: 0 indicating "Does not apply to me at all (Never)", 1 indicating "Applied to me to some degree, or some of the time (Sometimes)", 2 indicating "Applied to me to a considerable degree, or a good part of time (Often)", and 3 indicating "Applied to me very much, or most of the time (Always)". A DASS-21 anxiety sub-scale score ≥10 indicates anxiety disorders. Severity on the anxiety sub-scale is measured as follows: Normal: 0-6, Mild: 7-9, Moderate: 10-14, Severe: 15-19, Extremely Severe: 20-42. The proportion of participants with a 50% decrease in depressive symptom severity will be measured, as indicated by the proportion of participants with a 50% decrease in depression symptom severity between study follow-up points.

32. Probability of no longer meeting DASS-21 anxiety diagnostic criteria at follow-up as indicated by a DASS-21 anxiety sub-scale score ≤6. [6 weeks after enrollment]

    The DASS-21 measures self-reported depression, anxiety, and stress using three sub-scales. Questionnaire items ask about experiencing various signs and symptoms over the last week and use a Likert scale with response choices and scoring as follows: 0 indicating "Does not apply to me at all (Never)", 1 indicating "Applied to me to some degree, or some of the time (Sometimes)", 2 indicating "Applied to me to a considerable degree, or a good part of time (Often)", and 3 indicating "Applied to me very much, or most of the time (Always)". A DASS-21 anxiety sub-scale score ≥6 indicates anxiety disorders. Severity on the anxiety sub-scale is measured as follows: Normal: 0-6, Mild: 7-9, Moderate: 10-14, Severe: 15-19, Extremely Severe: 20-42. The probability of no longer meeting DASS-21 anxiety diagnostic criteria at follow-up will be measured by a DASS-21 anxiety sub-scale score of 0-6.

33. Probability of no longer meeting DASS-21 anxiety diagnostic criteria at follow-up as indicated by a DASS-21 anxiety sub-scale score ≤6. [3 months after enrollment]

    The DASS-21 measures self-reported depression, anxiety, and stress using three sub-scales. Questionnaire items ask about experiencing various signs and symptoms over the last week and use a Likert scale with response choices and scoring as follows: 0 indicating "Does not apply to me at all (Never)", 1 indicating "Applied to me to some degree, or some of the time (Sometimes)", 2 indicating "Applied to me to a considerable degree, or a good part of time (Often)", and 3 indicating "Applied to me very much, or most of the time (Always)". A DASS-21 anxiety sub-scale score ≥6 indicates anxiety disorders. Severity on the anxiety sub-scale is measured as follows: Normal: 0-6, Mild: 7-9, Moderate: 10-14, Severe: 15-19, Extremely Severe: 20-42. The probability of no longer meeting DASS-21 anxiety diagnostic criteria at follow-up will be measured by a DASS-21 anxiety sub-scale score of 0-6.

34. Probability of no longer meeting DASS-21 anxiety diagnostic criteria at follow-up as indicated by a DASS-21 anxiety sub-scale score ≤6. [6 months after enrollment]

    The DASS-21 measures self-reported depression, anxiety, and stress using three sub-scales. Questionnaire items ask about experiencing various signs and symptoms over the last week and use a Likert scale with response choices and scoring as follows: 0 indicating "Does not apply to me at all (Never)", 1 indicating "Applied to me to some degree, or some of the time (Sometimes)", 2 indicating "Applied to me to a considerable degree, or a good part of time (Often)", and 3 indicating "Applied to me very much, or most of the time (Always)". A DASS-21 anxiety sub-scale score ≥6 indicates anxiety disorders. Severity on the anxiety sub-scale is measured as follows: Normal: 0-6, Mild: 7-9, Moderate: 10-14, Severe: 15-19, Extremely Severe: 20-42. The probability of no longer meeting DASS-21 anxiety diagnostic criteria at follow-up will be measured by a DASS-21 anxiety sub-scale score of 0-6.

35. Probability of no longer meeting DASS-21 anxiety diagnostic criteria at follow-up as indicated by a DASS-21 anxiety sub-scale score ≤6. [12 months after enrollment]

    The DASS-21 measures self-reported depression, anxiety, and stress using three sub-scales. Questionnaire items ask about experiencing various signs and symptoms over the last week and use a Likert scale with response choices and scoring as follows: 0 indicating "Does not apply to me at all (Never)", 1 indicating "Applied to me to some degree, or some of the time (Sometimes)", 2 indicating "Applied to me to a considerable degree, or a good part of time (Often)", and 3 indicating "Applied to me very much, or most of the time (Always)". A DASS-21 anxiety sub-scale score ≥6 indicates anxiety disorders. Severity on the anxiety sub-scale is measured as follows: Normal: 0-6, Mild: 7-9, Moderate: 10-14, Severe: 15-19, Extremely Severe: 20-42. The probability of no longer meeting DASS-21 anxiety diagnostic criteria at follow-up will be measured by a DASS-21 anxiety sub-scale score of 0-6.

36. Proportion of participants with a DASS-21 stress sub-scale score ≥19 indicating a stress disorder [Study entrance/baseline.]

    The DASS-21 measures self-reported depression, anxiety, and stress using three sub-scales. Questionnaire items ask about experiencing various signs and symptoms over the last week and use a Likert scale with response choices and scoring as follows: 0 indicating "Does not apply to me at all (Never)", 1 indicating "Applied to me to some degree, or some of the time (Sometimes)", 2 indicating "Applied to me to a considerable degree, or a good part of time (Often)", and 3 indicating "Applied to me very much, or most of the time (Always)". A DASS-21 stress sub-scale score ≥10 indicates stress disorders. Severity on the stress sub-scale is measured as follows: Normal: 0-10, Mild: 11-18, Moderate: 19-26, Severe: 27-34, Extremely Severe: 35-42. The proportion of participants with a Depression Anxiety Stress-Scale (DASS-21) stress sub-scale score indicating a stress disorder (a score ≥ 19) will be measured.

37. Proportion of participants with a DASS-21 stress sub-scale score ≥19 indicating a stress disorder [6 weeks after enrollment]

    The DASS-21 measures self-reported depression, anxiety, and stress using three sub-scales. Questionnaire items ask about experiencing various signs and symptoms over the last week and use a Likert scale with response choices and scoring as follows: 0 indicating "Does not apply to me at all (Never)", 1 indicating "Applied to me to some degree, or some of the time (Sometimes)", 2 indicating "Applied to me to a considerable degree, or a good part of time (Often)", and 3 indicating "Applied to me very much, or most of the time (Always)". A DASS-21 stress sub-scale score ≥10 indicates stress disorders. Severity on the stress sub-scale is measured as follows: Normal: 0-10, Mild: 11-18, Moderate: 19-26, Severe: 27-34, Extremely Severe: 35-42. The proportion of participants with a Depression Anxiety Stress-Scale (DASS-21) stress sub-scale score indicating a stress disorder (a score ≥ 19) will be measured.

38. Proportion of participants with a DASS-21 stress sub-scale score ≥19 indicating a stress disorder [3 months after enrollment]

    The DASS-21 measures self-reported depression, anxiety, and stress using three sub-scales. Questionnaire items ask about experiencing various signs and symptoms over the last week and use a Likert scale with response choices and scoring as follows: 0 indicating "Does not apply to me at all (Never)", 1 indicating "Applied to me to some degree, or some of the time (Sometimes)", 2 indicating "Applied to me to a considerable degree, or a good part of time (Often)", and 3 indicating "Applied to me very much, or most of the time (Always)". A DASS-21 stress sub-scale score ≥10 indicates stress disorders. Severity on the stress sub-scale is measured as follows: Normal: 0-10, Mild: 11-18, Moderate: 19-26, Severe: 27-34, Extremely Severe: 35-42. The proportion of participants with a Depression Anxiety Stress-Scale (DASS-21) stress sub-scale score indicating a stress disorder (a score ≥ 19) will be measured.

39. Proportion of participants with a DASS-21 stress sub-scale score ≥19 indicating a stress disorder [6 months after enrollment]

    The DASS-21 measures self-reported depression, anxiety, and stress using three sub-scales. Questionnaire items ask about experiencing various signs and symptoms over the last week and use a Likert scale with response choices and scoring as follows: 0 indicating "Does not apply to me at all (Never)", 1 indicating "Applied to me to some degree, or some of the time (Sometimes)", 2 indicating "Applied to me to a considerable degree, or a good part of time (Often)", and 3 indicating "Applied to me very much, or most of the time (Always)". A DASS-21 stress sub-scale score ≥10 indicates stress disorders. Severity on the stress sub-scale is measured as follows: Normal: 0-10, Mild: 11-18, Moderate: 19-26, Severe: 27-34, Extremely Severe: 35-42. The proportion of participants with a Depression Anxiety Stress-Scale (DASS-21) stress sub-scale score indicating a stress disorder (a score ≥ 19) will be measured.

40. Proportion of participants with a DASS-21 stress sub-scale score ≥19 indicating a stress disorder [12 months after enrollment]

    The DASS-21 measures self-reported depression, anxiety, and stress using three sub-scales. Questionnaire items ask about experiencing various signs and symptoms over the last week and use a Likert scale with response choices and scoring as follows: 0 indicating "Does not apply to me at all (Never)", 1 indicating "Applied to me to some degree, or some of the time (Sometimes)", 2 indicating "Applied to me to a considerable degree, or a good part of time (Often)", and 3 indicating "Applied to me very much, or most of the time (Always)". A DASS-21 stress sub-scale score ≥10 indicates stress disorders. Severity on the stress sub-scale is measured as follows: Normal: 0-10, Mild: 11-18, Moderate: 19-26, Severe: 27-34, Extremely Severe: 35-42. The proportion of participants with a Depression Anxiety Stress-Scale (DASS-21) stress sub-scale score indicating a stress disorder (a score ≥ 19) will be measured.

41. Proportion of participants with a 50% decrease in stress symptom severity as measured using the DASS-21 stress sub-scale [6 weeks after enrollment]

    The DASS-21 measures self-reported depression, anxiety, and stress using three sub-scales. Questionnaire items ask about experiencing various signs and symptoms over the last week and use a Likert scale with response choices and scoring as follows: 0 indicating "Does not apply to me at all (Never)", 1 indicating "Applied to me to some degree, or some of the time (Sometimes)", 2 indicating "Applied to me to a considerable degree, or a good part of time (Often)", and 3 indicating "Applied to me very much, or most of the time (Always)". A DASS-21 stress sub-scale score ≥19 indicates stress disorders. Severity on the stress sub-scale is measured as follows: Normal: 0-10, Mild: 11-18, Moderate: 19-26, Severe: 27-34, Extremely Severe: 35-42. The proportion of participants with a 50% decrease in stress symptom severity as indicated by Depression Anxiety Stress-Scale (DASS-21) stress sub-scale score will be measured.

42. Proportion of participants with a 50 decrease in stress symptom severity as measured using the DASS-21 stress sub-scale [3 months after enrollment]

    The DASS-21 measures self-reported depression, anxiety, and stress using three sub-scales. Questionnaire items ask about experiencing various signs and symptoms over the last week and use a Likert scale with response choices and scoring as follows: 0 indicating "Does not apply to me at all (Never)", 1 indicating "Applied to me to some degree, or some of the time (Sometimes)", 2 indicating "Applied to me to a considerable degree, or a good part of time (Often)", and 3 indicating "Applied to me very much, or most of the time (Always)". A DASS-21 stress sub-scale score ≥19 indicates stress disorders. Severity on the stress sub-scale is measured as follows: Normal: 0-10, Mild: 11-18, Moderate: 19-26, Severe: 27-34, Extremely Severe: 35-42. The proportion of participants with a 50% decrease in stress symptom severity as indicated by Depression Anxiety Stress-Scale (DASS-21) stress sub-scale score will be measured.

43. Proportion of participants with a 50 percent decrease in stress symptom severity as measured using the DASS-21 stress sub-scale [6 months after enrollment]

    The DASS-21 measures self-reported depression, anxiety, and stress using three sub-scales. Questionnaire items ask about experiencing various signs and symptoms over the last week and use a Likert scale with response choices and scoring as follows: 0 indicating "Does not apply to me at all (Never)", 1 indicating "Applied to me to some degree, or some of the time (Sometimes)", 2 indicating "Applied to me to a considerable degree, or a good part of time (Often)", and 3 indicating "Applied to me very much, or most of the time (Always)". A DASS-21 stress sub-scale score ≥19 indicates stress disorders. Severity on the stress sub-scale is measured as follows: Normal: 0-10, Mild: 11-18, Moderate: 19-26, Severe: 27-34, Extremely Severe: 35-42. The proportion of participants with a 50% decrease in stress symptom severity as indicated by Depression Anxiety Stress-Scale (DASS-21) stress sub-scale score will be measured.

44. Proportion of participants with a 50 percent decrease in stress symptom severity as measured using the DASS-21 stress sub-scale [12 months after enrollment]

    The DASS-21 measures self-reported depression, anxiety, and stress using three sub-scales. Questionnaire items ask about experiencing various signs and symptoms over the last week and use a Likert scale with response choices and scoring as follows: 0 indicating "Does not apply to me at all (Never)", 1 indicating "Applied to me to some degree, or some of the time (Sometimes)", 2 indicating "Applied to me to a considerable degree, or a good part of time (Often)", and 3 indicating "Applied to me very much, or most of the time (Always)". A DASS-21 stress sub-scale score ≥19 indicates stress disorders. Severity on the stress sub-scale is measured as follows: Normal: 0-10, Mild: 11-18, Moderate: 19-26, Severe: 27-34, Extremely Severe: 35-42. The proportion of participants with a 50% decrease in stress symptom severity as indicated by Depression Anxiety Stress-Scale (DASS-21) stress sub-scale score will be measured.

45. Probability of no longer meeting DASS-21 stress related diagnosis diagnostic criteria at follow-up as indicated by a DASS-21 stress sub-scale score ≤ 10. [6 weeks after enrollment]

    The DASS-21 measures self-reported depression, anxiety, and stress using three sub-scales. Questionnaire items ask about experiencing various signs and symptoms over the last week and use a Likert scale with response choices and scoring as follows: 0 indicating "Does not apply to me at all (Never)", 1 indicating "Applied to me to some degree, or some of the time (Sometimes)", 2 indicating "Applied to me to a considerable degree, or a good part of time (Often)", and 3 indicating "Applied to me very much, or most of the time (Always)". A DASS-21 stress sub-scale score ≥10 indicates stress disorders. Severity on the stress sub-scale is measured as follows: Normal: 0-10, Mild: 11-18, Moderate: 19-26, Severe: 27-34, Extremely Severe: 35-42. The probability of no longer meeting DASS-21 stress diagnostic criteria at follow-up will be measured by a DASS-21 stress sub-scale score of ≤ 10.

46. Probability of no longer meeting DASS-21 stress related diagnosis diagnostic criteria at follow-up as indicated by a DASS-21 stress sub-scale score ≤ 10. [3 months after enrollment]

    The DASS-21 measures self-reported depression, anxiety, and stress using three sub-scales. Questionnaire items ask about experiencing various signs and symptoms over the last week and use a Likert scale with response choices and scoring as follows: 0 indicating "Does not apply to me at all (Never)", 1 indicating "Applied to me to some degree, or some of the time (Sometimes)", 2 indicating "Applied to me to a considerable degree, or a good part of time (Often)", and 3 indicating "Applied to me very much, or most of the time (Always)". A DASS-21 stress sub-scale score ≥10 indicates stress disorders. Severity on the stress sub-scale is measured as follows: Normal: 0-10, Mild: 11-18, Moderate: 19-26, Severe: 27-34, Extremely Severe: 35-42. The probability of no longer meeting DASS-21 stress diagnostic criteria at follow-up will be measured by a DASS-21 stress sub-scale score of ≤ 10.

47. Probability of no longer meeting DASS-21 stress related diagnosis diagnostic criteria at follow-up as indicated by a DASS-21 stress sub-scale score ≤ 10. [6 months after enrollment]

    The DASS-21 measures self-reported depression, anxiety, and stress using three sub-scales. Questionnaire items ask about experiencing various signs and symptoms over the last week and use a Likert scale with response choices and scoring as follows: 0 indicating "Does not apply to me at all (Never)", 1 indicating "Applied to me to some degree, or some of the time (Sometimes)", 2 indicating "Applied to me to a considerable degree, or a good part of time (Often)", and 3 indicating "Applied to me very much, or most of the time (Always)". A DASS-21 stress sub-scale score ≥10 indicates stress disorders. Severity on the stress sub-scale is measured as follows: Normal: 0-10, Mild: 11-18, Moderate: 19-26, Severe: 27-34, Extremely Severe: 35-42. The probability of no longer meeting DASS-21 stress diagnostic criteria at follow-up will be measured by a DASS-21 stress sub-scale score of ≤ 10.

48. Probability of no longer meeting DASS-21 stress related diagnosis diagnostic criteria at follow-up as indicated by a DASS-21 stress sub-scale score ≤ 10. [12 months after enrollment]

    The DASS-21 measures self-reported depression, anxiety, and stress using three sub-scales. Questionnaire items ask about experiencing various signs and symptoms over the last week and use a Likert scale with response choices and scoring as follows: 0 indicating "Does not apply to me at all (Never)", 1 indicating "Applied to me to some degree, or some of the time (Sometimes)", 2 indicating "Applied to me to a considerable degree, or a good part of time (Often)", and 3 indicating "Applied to me very much, or most of the time (Always)". A DASS-21 stress sub-scale score ≥10 indicates stress disorders. Severity on the stress sub-scale is measured as follows: Normal: 0-10, Mild: 11-18, Moderate: 19-26, Severe: 27-34, Extremely Severe: 35-42. The probability of no longer meeting DASS-21 stress diagnostic criteria at follow-up will be measured by a DASS-21 stress sub-scale score of ≤ 10.

49. Proportion of Participants with Methadone Maintenance Engagement [Study baseline and each study follow-up through 12 months of follow-up.]

    The proportion of participants engaged in Methadone Maintenance Therapy.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

Eligible individuals will meet the following criteria:

• Adult patients (18 years and older) being treated at the Methadone Maintenance Treatment (MMT) clinic

• Medical record indicates infection with HIV

• Have been screened with the DASS-21 which has been translated, standardized and validated in the Vietnamese population with a positive result indicating a CMD (Henry & Crawford 2005; Le et al. 2017; Tran et al. 2013). The investigators will consider as eligible all patients with a depression subscale score ≥ 7, an anxiety subscale score ≥ 6, and/or a stress subscale score ≥ 10. Elevated depressive symptoms be present for ≥2 weeks and elevated anxiety or post-traumatic stress-related symptoms be present for ≥1 month. The investigators will consider a positive screen for any of the three categories as indicating a CMD.

Exclusion Criteria:

• Those with evidence of psychosis or bipolar disorder per the Mini International Neuropsychiatric Interview (MINI) will be excluded.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CDC Hanoi	Hanoi	Hanoi City	Vietnam

Sponsors and Collaborators

• University of North Carolina, Chapel Hill
• Hanoi Medical University
• The Friendship Bench Trust
• National Institute on Drug Abuse (NIDA)

Investigators

• Principal Investigator: Bradley Gaynes, MD, MPH, University of North Carolina, Chapel Hill

Study Documents (Full-Text)

None provided.

More Information

Publications

• Adams C, Zacharia S, Masters L, Coffey C, Catalan P. Mental health problems in people living with HIV: changes in the last two decades: the London experience 1990-2014. AIDS Care. 2016;28 Suppl 1:56-9. doi: 10.1080/09540121.2016.1146211. Epub 2016 Feb 17.
• Bouhnik AD, Préau M, Vincent E, Carrieri MP, Gallais H, Lepeu G, Gastaut JA, Moatti JP, Spire B; MANIF 2000 Study Group. Depression and clinical progression in HIV-infected drug users treated with highly active antiretroviral therapy. Antivir Ther. 2005;10(1):53-61.
• Chesney MA. Factors affecting adherence to antiretroviral therapy. Clin Infect Dis. 2000 Jun;30 Suppl 2:S171-6. Review.
• Degenhardt L, Peacock A, Colledge S, Leung J, Grebely J, Vickerman P, Stone J, Cunningham EB, Trickey A, Dumchev K, Lynskey M, Griffiths P, Mattick RP, Hickman M, Larney S. Global prevalence of injecting drug use and sociodemographic characteristics and prevalence of HIV, HBV, and HCV in people who inject drugs: a multistage systematic review. Lancet Glob Health. 2017 Dec;5(12):e1192-e1207. doi: 10.1016/S2214-109X(17)30375-3. Epub 2017 Oct 23. Review. Erratum in: Lancet Glob Health. 2017 Nov 15;:.
• Gaynes BN, Pence BW, Eron JJ Jr, Miller WC. Prevalence and comorbidity of psychiatric diagnoses based on reference standard in an HIV+ patient population. Psychosom Med. 2008 May;70(4):505-11. doi: 10.1097/PSY.0b013e31816aa0cc. Epub 2008 Mar 31.
• Henry JD, Crawford JR. The short-form version of the Depression Anxiety Stress Scales (DASS-21): construct validity and normative data in a large non-clinical sample. Br J Clin Psychol. 2005 Jun;44(Pt 2):227-39.
• Jones DL, Waldrop-Valverde D, Gonzalez P, Mack A, Kumar AM, Ownby R, Weiss SM, Kumar M. Mental health in HIV seronegative and seropositive IDUs in South Florida. AIDS Care. 2010 Feb;22(2):152-8. doi: 10.1080/09540120903039851.
• Jordan MR, Obeng-Aduasare Y, Sheehan H, Hong SY, Terrin N, Duong DV, Trung NV, Wanke C, Kinh NV, Tang AM. Correlates of non-adherence to antiretroviral therapy in a cohort of HIV-positive drug users receiving antiretroviral therapy in Hanoi, Vietnam. Int J STD AIDS. 2014 Aug;25(9):662-668. doi: 10.1177/0956462413516301. Epub 2013 Dec 18.
• Lappalainen L, Hayashi K, Dong H, Milloy MJ, Kerr T, Wood E. Ongoing impact of HIV infection on mortality among people who inject drugs despite free antiretroviral therapy. Addiction. 2015 Jan;110(1):111-9. doi: 10.1111/add.12736. Epub 2014 Oct 16.
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• Responsible Party: University of North Carolina, Chapel Hill
• ClinicalTrials.gov Identifier: NCT04790201
• Other Study ID Numbers: 20-1689; R34DA051933; IGHID 12028
• First Posted: Mar 10, 2021
• Last Update Posted: Mar 8, 2022
• Last Verified: Feb 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Infections; Communicable Diseases; Immune System Diseases; Opioid-Related Disorders; Behavioral Symptoms

Study Results

No Results Posted as of Mar 8, 2022