Testing Effectiveness of a Peer-Led Intervention to Enhance Community Integration

Study Overview
=================
Brief Summary
-----------------
We are conducting a randomized clinical trial (RCT) comparing the 10-week peer-led Photovoice program to services as usual (SAU) at a large publicly funded community mental health agency in Massachusetts. The control SAU condition will be enhanced with a 60-minute peer-led group educational session about understanding and coping with prejudice and discrimination. The 10-session, peer-led Photovoice program, designed to empower individuals with serious mental illness (SMI) to confront public prejudice and discrimination and reduce personal stigma (self-stigma and perceived stigma), was developed and pilot tested at our Center, with primary contributions from staff with a lived experience of mental illness. Development of the Photovoice program was guided by an adaptation of the stress-coping model, informed by recent research and conceptualizations of the effects of stigma on people with SMI. The stress-coping model explicates the mechanisms by which public stigma about mental illness can lead to personal stigma, which in turn has a negative impact on the person's mental health and psychosocial functioning. This model also identifies critical factors that contribute to personal stigma or protect against it, as well as more vs. less adaptive coping responses, that are the primary focus of the Photovoice program.

Detailed Description
-----------------
We are conducting a RCT comparing the 10-week peer-led Photovoice program to services as usual (SAU) enhanced with a 60-minute peer-led group discussion session. The RCT will be at a large publicly funded community mental health agency in Massachusetts. A total of 192 participants or 96 participants per group will be recruited over a period of 36 months across the three clubhouses of the agency where the intervention will take place. We plan to have randomization cohorts of 16 individuals per delivery of the Photovoice program at each of the three clubhouses. Given the projected sample size of 192 participants, we will have 12 randomization cohorts - 4 at each clubhouse implemented at 6-month intervals. Participants will be randomized to either the Photovoice program (plus usual services) or the enhanced SAU. Participants will be assessed by a blinded rater at baseline, post-treatment, 3-month and 6-month follow-ups on a range of primary and secondary outcomes related to personal stigma, coping, and functioning. Primary analyses will test the hypotheses that the Photovoice program will lead to significantly greater reductions in self-stigma and perceived stigma, greater improvements in proactive coping with psychiatric prejudice and discrimination, and greater improvements in community functioning and integration than the enhanced SAU. Secondary analyses will evaluate whether the Photovoice program leads to greater gains than SAU in psychological adjustment, including wellbeing, personal growth and recovery. Individuals randomized to the enhanced SAU will be able to join the 10-week Photovoice program once they complete their 6-month follow up for the study.

Official Title
-----------------
Testing Effectiveness of a Peer-Led Intervention to Enhance Community Integration

Conditions
-----------------
Mental Disorders

Intervention / Treatment
-----------------
* Behavioral: Photovoice
* Behavioral: Enhanced Control


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18years and older Diagnosis of serious mental illness Receiving services at agency where study is taking place Willing and able to give written consent Conversant in English Exclusion Criteria: Prior exposure to Photovoice Cognitive disability

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Photovoice<br>Participants in this arm will attend a 10-week peer-led Photovoice program conducted in group format. | Behavioral: Photovoice<br>* The 10-session, peer-led Photovoice program, designed to empower individuals with SMI to confront public prejudice and discrimination and reduce personal stigma (self-stigma and perceived stigma), was developed and pilot tested at our Center, with primary contributions from staff with a lived experience of mental illness. In the Photovoice sessions, participants will be given a workbook titled Combating Prejudice and Discrimination through Photovoice Empowerment. Peer leaders will facilitate discussions based on topics in the workbook. Participants will be given cameras and guidance on taking pictures and writing narratives descriptions about the pictures, specifically the ways in which the pictures relate to experiences of prejudice and discrimination.<br>|
| Active Comparator: Enhanced Control<br>Participants in this arm will attend a 60-minute peer-led group discussion on stigma and discrimination, and be eligible to participate in the 10-week Photovoice program after completing all study assessments. | Behavioral: Enhanced Control<br>* The control SAU condition will be enhanced with a 60-minute peer-led manualized educational group session (Leaders' Guidelines and Handout for Participants are attached). It will provide participants with information about the nature of stigma and the laws in the U.S. that protect people with disabilities from discrimination. Participants will be engaged in a discussion about their use of different strategies for proactive coping with psychiatric stigma. This session will be co-led by the same peers who will be delivering the Photovoice program to the experimental group at relevant wave and study sites. Participants randomized to the enhanced Services as Usual control condition will be invited to join a Photovoice group once they complete the final 6-month follow-up assessment.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Internalized Stigma of Mental Illness Scale, Change in Internalized Stigma | a 29-item, 4-point scale (strongly disagree to strongly agree) assesses behaviors, thoughts and feelings that are self-stigmatizing and includes alienation, stereotype endorsement, discriminatory experiences, social withdrawal, and stigma resistance subscales. Internal consistency is .9 and test-retest reliability is .92. Lower scores are better. The scale score is the average score on the 29 items, which are scored from 1-4. Lower scores signify less internalized stigma. | Baseline, post-treatment, 3 months post-treatment, 6 months post-treatment | 
| Approaches to Coping With Stigma, Change in Coping With Stigma | is a 27-item, 4-point scale ranging from 1-4 (strongly disagree to strongly agree) measuring strategies to cope with stigma: secrecy, withdrawal, distancing, educating others, and challenging others. The average score of the items in the first three subscales will represent the index for Avoidant Coping and the average score of the items in the last two subscales - the index for Proactive Coping with Stigma. Internal consistency for subscales range: .63-.84. Lower scores are better on Avoidant Coping and higher scores are better on Proactive Coping. | Baseline, post-treatment, 3 months post-treatment, 6 months post-treatment | 
| The Stigma Scale, Change in Perceptions of Stigma | is a 28 item, 5 point scale ranging from 0-4 (strongly disagree to strongly agree) measuring experienced and anticipated stigma. Internal consistency ranges from .85-.87 and test-retest reliability from .4 to .7. The scale score is the average score on all items. Lower scores are better. | Baseline, post-treatment, 3 months post-treatment, 6 months post-treatment | 
| Heinrich's Quality of Life Scale-Client Version, Change in Quality of Life | This is a 21 item, semi-structured interview-based, rating of an individual's psycho-social functioning and satisfaction with various life domains. The score on each item ranges from 0-6 with higher scores indicating better functioning. The subscale scores are computed based on the average score of items included. We report below on the interpersonal functioning and intrapsychic foundations subscales. | Baseline, post-treatment, 3 months post-treatment, 6 months post-treatment | 
| Temple University Community Participation Scale, Change in Community Participation | is a 26 item instrument measuring frequency of participation and importance of various community activities (e.g., movies, library). Test-retest reliability is .7 and internal consistency is .9. Higher scores are better. We provide below the results for cumulative days of participation in the last 30 days across the 26 activities included in the measure (tcpm_days_participated). The possible range for this measure is 0-780. | Baseline, post-treatment, 3 months post-treatment, 6 months post-treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Brief Psychiatric Rating Scale, Change in Psychiatric Symptoms | This is a 24-item scale that rates the severity of a variety of psychiatric psychotic symptoms, positive and negative symptoms on a 7-point scale of 1 (absent) to 7 (severe). The scale score is the mean of the score on all items, ranging from 1 to 7. | Baseline, post-treatment, 3 months post-treatment, 6 months post-treatment | 
| Scales of Psychological Well-Being, Change in Well-being | This is a 54-item, 6-point (1 to 6) measure rating wellbeing (from strongly disagree to strongly agree) including subscales of mastery, personal growth, purpose in life, self-acceptance, autonomy and positive relations with others. Internal consistency is .94. It has been successfully used with individuals with SMI. Higher scores indicate greater well-being. Each subscale score is the average of the scores on included items. We present below the scores on the self-acceptance subscale. | Baseline, post-treatment, 3 months post-treatment, 6 months post-treatment | 
| Maryland Assessment of Recovery, Change in Perceptions of Recovery | is a 25-item, 5-point (1 to 5) scale that assesses a person's sense of recovery from mental illness across a variety of dimensions. Internal consistency is.95 and test-retest reliability is .89). The scale score is the average score on each item with higher scores indicating higher levels of recovery. | Baseline, post-treatment, 3 months post-treatment, 6 months post-treatment | 
| Personal Growth and Recovery Scale, Change in Perceptions of Growth and Recovery | This is a 16-item, 4 point scale (1 to 4) developed for a previous Photovoice study. Items tap aspects of a person's psychosocial functioning and recovery. Internal consistency is 0.94 and retest reliability is .79. The scale score is the average of scores on each item with higher scores indicating higher levels of recovery. | Baseline, post-treatment, 3 months post-treatment, 6 months post-treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Stigma, Community Integration