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

NCT02508480 | Completed Results DMC

• 1 other identifier: 2014-22
• Study Type: interventional
• Target: 192
• Locations: 1 country
• Sites: 1

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.

Conditions

Mental Disorders

Keywords

Stigma; Community Integration

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (4)

• Brief Psychiatric Rating Scale, Change in Psychiatric Symptoms

  Baseline, post-treatment, 3 months post-treatment, 6 months post-treatment

• Scales of Psychological Well-Being, Change in Well-being

  Baseline, post-treatment, 3 months post-treatment, 6 months post-treatment

• Maryland Assessment of Recovery, Change in Perceptions 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

  Baseline, post-treatment, 3 months post-treatment, 6 months post-treatment

Study Arms (2)

Photovoice

EXPERIMENTAL

Participants in this arm will attend a 10-week peer-led Photovoice program conducted in group format.

Behavioral: Photovoice

Enhanced Control

ACTIVE COMPARATOR

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

Interventions

Photovoice BEHAVIORAL

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.

Photovoice

Enhanced Control BEHAVIORAL

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.

Enhanced Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Prior exposure to Photovoice
• Cognitive disability

Sponsors & Collaborators

• Boston University Charles River Campus: lead

Study Sites (1)

Boston University

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Mental Disorders; Social Stigma

Condition Hierarchy (Ancestors)

Social Behavior; Behavior

Results Point of Contact

• Title: Dr. Zlatka Russinova
• Organization: Boston University

zlatka@bu.edu

617-353-3549

Study Officials

• Zlatka Russinova, PhD

  Boston University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Associate Professor

Study Record Dates

• First Submitted: July 23, 2015
• First Posted: July 27, 2015
• Study Start: March 5, 2015
• Primary Completion: February 15, 2019
• Study Completion: February 15, 2019
• Last Updated: April 10, 2020
• Results First Posted: April 10, 2020

Record last verified: 2020-03

Locations

US (1)