Primary-Care Based Mindfulness Intervention

Sponsor

Emory University (Other)

Overall Status

Recruiting

CT.gov ID

NCT03922581

Collaborator

National Center for Complementary and Integrative Health (NCCIH) (NIH)

Enrollment

Location

Arms

45.5

Anticipated Duration (Months)

1.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to pilot a primary-care based mindfulness intervention for chronically traumatized African Americans screening positive for posttraumatic stress disorder (PTSD) and major depressive disorder (MDD) in primary care clinics within an urban public hospital. The study will utilize a randomized controlled trial (RCT) design along with a multi-method psychological and physiological assessment approach to establish the feasibility and acceptability of a mindfulness-based cognitive therapy (MBCT) intervention for primary care versus wait-list control in African Americans with chronic trauma exposure and comorbid PTSD and MDD. Preliminary mechanisms of action associated with MBCT including emotion dysregulation and autonomic function will be evaluated. The data collection and 8-session group intervention will take place in primary care clinics within an urban public hospital serving primarily low-income, minority individuals (>80% African American).

Condition or Disease	Intervention/Treatment	Phase
Post Traumatic Stress Disorder Major Depressive Disorder	Behavioral: Mindfulness-Based Cognitive Therapy	N/A

Detailed Description

There is significant public health burden of chronic trauma exposure in low income, predominantly ethnic minority, urban communities, which is reflected in the extraordinarily high levels of trauma-related psychiatric disorders, particularly PTSD and MDD. Despite this, limited access to behavioral health treatment and significant barriers to treatment engagement and success remain and integrating mind-body approaches in medical settings could be a critical next step in treating chronically traumatized individuals in these urban settings. This study will utilize a randomized controlled trial design along with a multi-method assessment approach to ascertain the feasibility, acceptability, and preliminary mechanisms of action and outcomes of mindfulness-based cognitive therapy versus wait-list control in 80 African Americans with chronic trauma exposure and comorbid PTSD and MDD symptoms.

Participants will be randomized to an 8-session (90 minutes each) group intervention or wait-list control. The researchers will examine the retention and follow-up rates, participants' report of acceptability and interest in the intervention, and examine barriers to treatment engagement through self-report measures and exit interviews. This study will also investigate preliminary mechanisms of action and outcomes of the mindfulness intervention in targeting emotion regulation and autonomic processes by measuring self-report of emotion dysregulation using the Difficulties in Emotion Regulation Scale and autonomic arousal to trauma cues using eSense technology to assess skin conductance during administration of Standardized Trauma Interview. Latent growth modeling will assess relative changes in emotion dysregulation and autonomic function over time through intervention and 1 month follow-up.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

80 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Participants will be randomized with block stratified randomization (in blocks of 20) to ensure variability in PTSD and MDD diagnosis in the two groups.Participants will be randomized with block stratified randomization (in blocks of 20) to ensure variability in PTSD and MDD diagnosis in the two groups.

Masking:

Single (Outcomes Assessor)

Masking Description:

Staff members conducting the Clinician Administered PTSD Scale and the Mini-International Neuropsychiatric Interview will be blind to study arm assignment.

Primary Purpose:

Treatment

Official Title:

Primary-Care Based Mindfulness Intervention for Chronically Traumatized Individuals

Actual Study Start Date :

Sep 14, 2018

Anticipated Primary Completion Date :

Jun 30, 2022

Anticipated Study Completion Date :

Jun 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Mindfulness-Based Cognitive Therapy Participants randomized to this study arm will receive Mindfulness-Based Cognitive Therapy (MBCT) for 8 weeks.	Behavioral: Mindfulness-Based Cognitive Therapy The intervention consists of MBCT for the prevention of depression relapse with adaptations for discussing trauma and PTSD. Participants attend eight, weekly 90-minute group sessions involving skills training and in-class practice. Participants will return one month after the intervention has ended for a follow-up assessment.
No Intervention: Wait-list Control Group Participants randomized to the wait-list control study arm will be administered the study assessments while not receiving active treatment. Participants will be given the opportunity to participate in the MBCT intervention following completion of the study assessments.

Arm

Intervention/Treatment

Experimental: Mindfulness-Based Cognitive Therapy

Participants randomized to this study arm will receive Mindfulness-Based Cognitive Therapy (MBCT) for 8 weeks.

Behavioral: Mindfulness-Based Cognitive Therapy

The intervention consists of MBCT for the prevention of depression relapse with adaptations for discussing trauma and PTSD. Participants attend eight, weekly 90-minute group sessions involving skills training and in-class practice. Participants will return one month after the intervention has ended for a follow-up assessment.

No Intervention: Wait-list Control Group

Participants randomized to the wait-list control study arm will be administered the study assessments while not receiving active treatment. Participants will be given the opportunity to participate in the MBCT intervention following completion of the study assessments.

Outcome Measures

Primary Outcome Measures

Retention rate [Baseline through Follow-up (1 month after the end of the 8-week intervention)]
Retention rates will be assessed using session attendance. Previous mindfulness-based stress reduction (MBSR) interventions among low-income minority populations have yielded completion rates of 53-80%. Based on 80% completion rates of MBSR in primary care and 75% completion rates of MBCT both in combat vet samples and the anticipated improved accessibility through primary care, it is expected that subjects in the intervention group will evidence at least 75% retention and follow-up rates.
Client Satisfaction Questionnaire (CSQ) Score [Week 8]
Feasibility and acceptability will be assessed using the Client Satisfaction Questionnaire (CSQ). The CSQ is an 8-item questionnaire asking respondents to rate the quality of care they received on a scale from 1 to 4 where 1 = poor and 4 = excellent. Total raw scores range from 8 to 24 where higher values indicate greater satisfaction.
Perceived Barriers to Psychological Treatment (PBPT) Scale Score [Week 8]
Barriers to treatment will be assessed using the Perceived Barriers to Psychological Treatment (PBPT) scale. The PBPT is a 25-item scale asking respondents about factors that interfere with attending weekly therapy. Items are rated on a 5-point scale where 1 = impossible to attend and 5 = not a problem. Total raw scores range from 25 to 125 where higher scores indicate low barriers regarding attending psychotherapy.
Change in Difficulties in Emotion Regulation Scale (DERS) Score [Baseline, Weeks 3, 5, 7, 8, and Follow-up (1 month after the end of the intervention)]
The Difficulties in Emotion Regulation Scale (DERS) is a 36-item instrument assessing emotion dysregulation and includes six subscales (non-acceptance of emotions, difficulty with goal-directed behavior in the presence of negative emotions, difficulty controlling impulses in the presence of negative emotions, lack of awareness of emotions, limited use of effective emotion regulation strategies, and lack of understanding of emotions). Responses are scaled from 1 (almost never) to 5 (almost always). Total raw scores range from 36 to 180; certain items are reverse scored so that higher scores indicate increased difficulty with emotion regulation.
Post-group Follow-up Questionnaire [Week 8]
Participants randomized to the MBCT intervention will complete an open-ended, follow-up questionnaire designed to assess feelings and changes experienced from participation in the intervention. The 10 questions include "how did you feel about the group?" and "what barriers came up for you in participating in the group?". Responses are in text form rather than on a pre-set scale.
Change in skin conductance [Baseline, Week 8, Follow-up (3 months after the end of the intervention)]
Skin conductance (SC) response will be measured using a mobile SC device, eSense (Mindfield Biosystems). Continuous recording of SC is measured with electrodes on hands and data is transmitted through the eSense app. Using the PhenX Toolkit protocol, a two minute baseline measure of SC will be obtained and then SC levels will be measured during administration of the Standardized Trauma Interview immediately following to determine physiological reactivity to trauma stimuli. SC response is calculated by subtracting SC level at the end of baseline recording (average of last 30 seconds) from the maximum SC level value during the trauma interview.

Secondary Outcome Measures

Change in Primary Care PTSD Screen (PC-PTSD) Determination [Baseline, Week 8, Follow-up (1 month after the end of the intervention)]
The Primary Care PTSD Screen (PC-PTSD) is a 4-item screen designed for use in primary care will assess for presence of PTSD symptoms and serve as PTSD screener. Respondents answer "yes" or "no" to each question and an individual is considered to have PTSD if they respond with "yes" to at least 3 of the 4 questions.
Change in Patient Health Questionnaire-9 (PHQ-9) Score [Baseline, Week 8, Follow-up (1 month after the end of the intervention)]
The Patient Health Questionnaire-9 (PHQ-9) will assess for presence of depressive symptoms and serve as MDD screening tool. The PHQ-9 is a 9-item tool that asks respondents to indicate how frequently they have felt symptoms of depression on a scale of 0 to 3 where 0 = not at all and 3 = nearly every day. Total scores range from 0 to 27, where higher scores indicate worse depression.
Change in PTSD Checklist for Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 (PCL-5) Score [Baseline, Week 8]
The PCL-5 is a 20-item questionnaire asking respondents to report how much they have been bothered by problems in the past month on a scale of 0 (not at all) to 4 (extremely). Total scores range from 0 to 80 where higher scores indicate increased difficulty with responses to stressful experiences.
Change in Beck Depression Inventory-II (BDI-II) Score [Baseline, Week 8]
The BDI-II is a 21-item instrument asking respondents to indicate how much they are bothered by negative feelings. Responses are on a scale of 0 to 3 where 0 = the problematic feeling is not present and 3 = the feeling is very strong. Total scores range from 0 to 63, where high scores indicate worse problems with negative feelings.
Change in Clinician Administered PTSD Scale PTSD Determination [Baseline, Week 8]
The Clinician Administered PTSD Scale is a semi-structured interview used for diagnosing PTSD. The number of participants diagnosed with PTSD pre- and post-intervention will be compared between study arms.
Change in Mini International Neuropsychiatric Interview (MINI) MDD Determination [Baseline, Week 8]
The Mini International Neuropsychiatric Interview (MINI) is a semi-structured interview used for diagnosing MDD. The number of participants diagnosed with MDD pre- and post-intervention will be compared between study arms.
Change in Five Facet Mindfulness Questionnaire Score [Baseline, Week 8, Follow-up (1 month after the end of the intervention)]
The Five Facet Mindfulness Questionnaire is a 39-item instrument assessing mindfulness, and includes five facets (observing, describing, acting with awareness, non-judging of inner experience, and non-reactivity to inner experience). Participants respond to each item on a scale of 1 to 5 where 1 = the statement is never or very rarely true for them and 5 = the statement is very often or always true. Total raw scores range from 39 to 195; certain items are reverse scored so that higher scores indicate increased mindfulness.
Change in Self Compassion Scale, Short Form Score [Baseline, Week 8, Follow-up (1 month after the end of the intervention)]
The Self Compassion Scale is a 12-item instrument assessing how respondents typically act towards themselves during difficult times. Items are answered on a scale of 1 to 5 where 1 = almost never and 5 = almost always. Total scores range from 12 to 60; certain items are reversed scored so that higher scores indicate increased self compassion.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

ability to provide informed consent
willingness to participate in study
self-identity as African American
history of childhood and/or adult trauma exposure (3 total criterion A traumas)
positive PTSD screen (PC-PTSD ≥ 3)
positive MDD screen (PHQ-9 ≥ 5)

Exclusion Criteria:

presence of intellectual disability, bipolar, or psychotic disorder
presence of current substance use disorder (past 1 month; see cut off scores in psychological measures below)
active suicidality