Clinical trial NCT02508480: Testing Effectiveness of a Peer-Led Intervention to Enhance Community Integration
Official title: Testing Effectiveness of a Peer-Led Intervention to Enhance Community Integration
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mental Disorders
Keywords: Stigma
Community Integration
Lead sponsor: Boston University Charles River Campus
Sponsor class: OTHER
First posted: 2015-07-27
Enrollment: 192
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Internalized Stigma of Mental Illness Scale, Change in Internalized Stigma
timeFrame: Baseline, post-treatment, 3 months post-treatment, 6 months post-treatment
measure: Approaches to Coping With Stigma, Change in Coping With Stigma
timeFrame: Baseline, post-treatment, 3 months post-treatment, 6 months post-treatment
measure: The Stigma Scale, Change in Perceptions of Stigma
timeFrame: Baseline, post-treatment, 3 months post-treatment, 6 months post-treatment
measure: Heinrich's Quality of Life Scale-Client Version, Change in Quality of Life
timeFrame: Baseline, post-treatment, 3 months post-treatment, 6 months post-treatment
measure: Temple University Community Participation Scale, Change in Community Participation
timeFrame: Baseline, post-treatment, 3 months post-treatment, 6 months post-treatment
Secondary outcomes:
measure: Brief Psychiatric Rating Scale, Change in Psychiatric Symptoms
timeFrame: Baseline, post-treatment, 3 months post-treatment, 6 months post-treatment
measure: Scales of Psychological Well-Being, Change in Well-being
timeFrame: Baseline, post-treatment, 3 months post-treatment, 6 months post-treatment
measure: Maryland Assessment of Recovery, Change in Perceptions of Recovery
timeFrame: Baseline, post-treatment, 3 months post-treatment, 6 months post-treatment
measure: Personal Growth and Recovery Scale, Change in Perceptions of Growth and Recovery
timeFrame: Baseline, post-treatment, 3 months post-treatment, 6 months post-treatment
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston University
state: Massachusetts
Study officials:
affiliation: Boston University
name: Zlatka Russinova, PhD
role: PRINCIPAL_INVESTIGATOR
References: