Digital Mental Health Service for Non-Treatment Seeking Young Adults

Sponsor

Northwestern University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT04948268

Collaborator

(none)

120

Enrollment

Location

Arms

Anticipated Duration (Months)

9.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a feasibility trial of a personalized 8-week text messaging intervention aimed at young adults (ages 18-25) with depression and anxiety who are not interested in -- or experience barriers to -- receiving traditional face-to-face psychological treatments.

The trial will consist of a pilot test of (1) an 8-week adaptive (personalized) messaging intervention relative to (2) a static digital mental health intervention, or (3) an active control which will send weekly psychoeducation information by way of URLs. The adaptive intervention will uses machine learning to tailor SMS messages to an individual's needs and preferences, and URL links to provide access to psychoeducational content to contextualize messages, when the length of that content exceeds the limitations of messages.

The primary goals of the project are to conduct a feasibility trial using a sequential multiple assignment randomized treatment (SMART) design, which will evaluate (a) the effectiveness of an adaptive, personalized messaging intervention in reducing engagement relative to a static version; and (b) whether human coaching results in greater symptom reduction and engagement, relative an unguided implementation.

Condition or Disease	Intervention/Treatment	Phase
Depression Anxiety Suicidal Ideation	Behavioral: Adaptive messaging intervention Behavioral: Static messaging intervention Behavioral: Coaching Behavioral: Psychoeducational links	N/A

Detailed Description

The primary purpose of this trial is to test the feasibility of conducting a randomized controlled trial of digital mental health intervention (DMHI) for non-treatment seeking young adults with symptoms of depression or anxiety, comparing an 8-week adaptive (personalized) messaging intervention, an 8-week static digital mental health intervention, or an active control which will deliver psychoeducational content via clickable URLs. The adaptive intervention will be powered by reinforcement learning to deliver tailored SMS messages based on user profiles and the ways in which a user interacts with the intervention system, along with links to longer psychoeducational content. The static intervention arm will not personalize the messages, but will still be an active treatment. The active control condition will receive the adaptive treatment after an 8-week waiting period. This study will examine the adaptive intervention's ability to engage users and effectiveness in decreasing psychological distress relative to a static intervention. Participants who become disengaged (5 continuous days of not clicking on content URL links or message ratings, or completing symptom assessments) from the adaptive or static intervention arms at any point in the first two weeks of treatment will be randomized to receive low-intensity human coaching or continue without coaching for the remainder of the intervention period.

Recruitment till take place via Mental Health America's (MHA) website. MHA is a large mental health advocacy organization that hosts online screeners and has large number of visitors the majority of whom meet clinical cutoffs for depressive or anxiety disorder symptoms. This study will enroll individuals who have completed a depression or anxiety disorder screener on MHA's website, and meet clinical cut-offs on the PHQ-9 or GAD-7 (min. score of 10).

Initial randomization will be generated in permuted blocks of 5 using a computer program. To prevent allocation bias, randomization will be conducted by the biostatistician, who will not inform the study team of the treatment arms until the baseline assessment has been completed and the patient has been enrolled. Second randomization of disengaged participants will occur as disengagement is detected during the first two weeks. Half (50%) of disengaged individuals will be randomized to receive additional human coaching throughout the remainder of the study while remaining in either the adaptive or static treatment arms. The disengaged participants not randomized to receive additional human coaching will continue to receive either the static or adaptive automated treatment the participants were randomized to initially.

Coaching will consist providing users with support and accountability via positive reinforcement, goal and expectation setting, and monitoring. Coaching outreach will focus on adherence to the treatment but will not provide treatment advice. Coaches will provide a brief (15-minute phone call or equivalent depending on the medium) engagement session over the phone, SMS, or email, depending user preference. Thereafter, coaches will check in with participants via messaging, phone call, or email, twice per week and respond to patient texts. Additional outreach will be made available to participants who continue demonstrate low engagement (defined as <50% response to ratings or URL psychoeducational content).

Participants will be assessed using self-report measures at baseline, weeks 1, 4, 8, 12, and 16 weeks (note: week 1 assessment comprises a usability questionnaire and a measure of subjective engagement). The primary outcomes are feasibility markers, including meeting recruitment goals (120 participants), obtaining 80% of follow-up self-report data, and having an overall study dropout rate of <30%.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

120 participants

Allocation:

Randomized

Intervention Model:

Sequential Assignment

Intervention Model Description:

This study uses a sequential multiple assignment randomized trial (SMART) design. The first level of randomization is to one of the three treatment conditions: self-guided static intervention, self-guided adaptive intervention, or active control. The second level of randomization occurs during the first two weeks of intervention. Participants who meet criteria for disengagement from either the static or adaptive intervention (defined as 5 days with no engagement) are then randomized to receive coaching or continue as self-guided. This will provide the investigators with preliminary information on the need for and value of coaching. Participants will receive the assigned intervention from baseline to week 8, followed by an 8 week follow-up periodThis study uses a sequential multiple assignment randomized trial (SMART) design. The first level of randomization is to one of the three treatment conditions: self-guided static intervention, self-guided adaptive intervention, or active control. The second level of randomization occurs during the first two weeks of intervention. Participants who meet criteria for disengagement from either the static or adaptive intervention (defined as 5 days with no engagement) are then randomized to receive coaching or continue as self-guided. This will provide the investigators with preliminary information on the need for and value of coaching. Participants will receive the assigned intervention from baseline to week 8, followed by an 8 week follow-up period

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Digital Mental Health Service for Non-Treatment Seeking Young Adults

Anticipated Study Start Date :

Dec 1, 2022

Anticipated Primary Completion Date :

Sep 1, 2023

Anticipated Study Completion Date :

Jan 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Adaptive digital mental health intervention without coaching The adaptive intervention will consist of SMS messages, symptom tracking, and psychological content that centers on evidence-based psychological strategies. Psychoeducational content will be delivered via a URL in an SMS message. Machine learning will be used to tailor messages and to prioritize psychological strategies to meet participant preferences.	Behavioral: Adaptive messaging intervention Psychological content and messages delivered regularly over an 8-week period via SMS. Psychological content will center on a single psychological strategy each week. Content and messages will be tailored using machine learning.
Experimental: Static digital Mental Health intervention without coaching The static intervention will consist of SMS messages, symptom tracking, and psychological content that centers on evidence-based psychological strategies. Messages and content will not be tailored based on participants profile or usage.	Behavioral: Static messaging intervention Psychological content and messages delivered regularly over an 8-week period via SMS. Psychological content will center on a single psychological strategy each week. There will not be any tailoring of messaging and content based on group or individual level data.
Experimental: Adaptive digital mental health intervention with coaching The adaptive intervention will consist of SMS messages, symptom tracking, and psychological content that centers on evidence-based psychological strategies. Psychoeducational content will be delivered via a URL in an SMS message. Machine learning will be used to tailor messages and to prioritize psychological strategies to meet participant preferences. Coaching will be provided to support engagement and intervention use via medium of participants choice (texts, calls, or emails).	Behavioral: Adaptive messaging intervention Psychological content and messages delivered regularly over an 8-week period via SMS. Psychological content will center on a single psychological strategy each week. Content and messages will be tailored using machine learning. Behavioral: Coaching Human coaching to support intervention use and engagement via telephone calls, text or email
Experimental: Static digital Mental Health intervention with coaching The static intervention will consist of SMS messages, symptom tracking, and psychological content that centers on evidence-based psychological strategies. Message content, timing, and number, as well as the ordering of psychological content, will not be tailored based on participants profile or usage. Coaching will be provided to support engagement and intervention use via medium of participants choice (texts, calls, or emails).	Behavioral: Static messaging intervention Psychological content and messages delivered regularly over an 8-week period via SMS. Psychological content will center on a single psychological strategy each week. There will not be any tailoring of messaging and content based on group or individual level data. Behavioral: Coaching Human coaching to support intervention use and engagement via telephone calls, text or email
Active Comparator: Active control The active control condition will provide a brief text message that includes a URL link to psychoeducational content, but will not include the messaging component described in experimental arms.	Behavioral: Psychoeducational links URLs containing brief psychoeducational information (one link per week).

Outcome Measures

Primary Outcome Measures

Kessler Psychological Distress Scale [16 weeks]
10-item self-report measure of transdiagnostic distress, used as outcome measure across diagnostic categories. Higher scores mean greater distress. Minimum score: 10; maximum score: 50
Engagement length [Up to 16 weeks]
Last message/content rating or click on content URL link received from participant.

Secondary Outcome Measures

Patient Health Questionnaire-9 [16 weeks]
10-item self-report measure assessing depression symptom severity. Higher scores mean greater symptom severity. Minimum score: 0; maximum score: 27
Generalized Anxiety Disorder-7 [16 weeks]
8-item self-report measure assessing generalized anxiety disorder symptom severity Higher scores mean greater symptom severity. Minimum score: 0; maximum score: 21

Other Outcome Measures

Objective engagement markers [16 weeks]
Number of message & content ratings, and content URL clicks.
Cognitive Behavioral Response to Stress Scale [16 weeks]
9-item self-report measure of behavioral and cognitive coping related skills. Higher scores indicate greater adaptive cognitive and behavioral skills use. Two domains: Use and usefulness. For each domain, minimum score: 0; maximum score: 54
Depression Symptom Inventory - Suicidality Subscale [16 weeks]
4-item self-report questionnaire assessing the frequency and intensity of suicidal thoughts over previous two weeks. Higher scores signal greater frequency and severity of suicidal thoughts. Minimum score: 0; maximum score: 12

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 25 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Ages 18 to 25 *The age to provide consent in Nebraska is 19. Individuals recruited from the state of Nebraska must be 19 or older.
A positive screen on an MHA screen for depression (Patient Health Questionnaire - 9 [PHQ-9]) or anxiety (Generalized Anxiety Disorder - 7 [GAD-7]);
Resident of the United States.

Exclusion Criteria:

History of treatment with psychotherapy or psychiatric medication management;
Seeking traditional mental health treatment;
Serious mental illness for which intervention would be contraindicated (e.g., psychotic disorder, manic episode, etc.)
Severe suicidality (i.e., experiencing suicidal ideation with a plan and intent to act);
English insufficient to engage in design activities.