Mental DisordersPhotovoiceNCT02508480
Testing Effectiveness of a Peer-Led Intervention to Enhance Community Integration
A study testing Photovoice in people with Mental Disorders, run by Boston University Charles River Campus at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mental Disorders
- What is being tested?
- Photovoice
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 192 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Mar 2015to 15 Feb 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Prior exposure to Photovoice
- Cognitive disability
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Mental Disorders
- Being tested
- Photovoice, Enhanced Control
- Keywords
- Stigma, Community Integration
- Medical subject headings
- Mental Disorders, Social Stigma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PhotovoiceBehavioural
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.
Enhanced ControlBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Photovoice | Experimental | Participants in this arm will attend a 10-week peer-led Photovoice program conducted in group format. Receives: 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. Receives: Behavioral: Enhanced Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, post-treatment, 3 months post-treatment, 6 months post-treatment
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, post-treatment, 3 months post-treatment, 6 months post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2015 (estimated)
- Study start5 Mar 2015
- Primary completion15 Feb 2019
- Study completion15 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Mental DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 192 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston University Charles River Campus
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zlatka Russinova, Boston University Charles River Campus
- Investigators
- Zlatka Russinova, PhD, Principal investigator, Boston University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02508480
- Sponsor's protocol ID
- 2014-22
- Acronym
- Photovoice
- Status last verified
- Mar 2020
- First submitted
- 23 Jul 2015
- Last updated
- 10 Apr 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing Effectiveness of a Peer-Led Intervention to Enhance Community Integration
- ClinicalTrials.gov ID
- NCT02508480
- Acronym / sponsor ID
- Photovoice / 2014-22
- Conditions
- Mental Disorders
- Keywords
- Stigma, Community Integration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 192 participants (actual)
- Lead sponsor
- Boston University Charles River CampusUniversity, hospital or other
- Study start
- 5 Mar 2015 (actual)
- Primary completion
- 15 Feb 2019 (actual)
- Study completion
- 15 Feb 2019 (actual)
- First posted
- 27 Jul 2015 (estimated)
- Results
- Posted 10 Apr 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Photovoice | Experimental | Behavioral: PhotovoiceParticipants in this arm will attend a 10-week peer-led Photovoice program conducted in group format. |
| Enhanced Control | Active comparator | Behavioral: Enhanced ControlParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- Prior exposure to Photovoice
- Cognitive disability
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PhotovoiceThe 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. | Behavioural | Photovoice |
| Enhanced ControlThe 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. | Behavioural | Enhanced Control |
Primary outcome
Internalized Stigma of Mental Illness Scale, Change in Internalized Stigma
Time frame: Baseline, post-treatment, 3 months post-treatment, 6 months post-treatment
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.
Approaches to Coping With Stigma, Change in Coping With Stigma
Time frame: Baseline, post-treatment, 3 months post-treatment, 6 months post-treatment
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.
The Stigma Scale, Change in Perceptions of Stigma
Time frame: Baseline, post-treatment, 3 months post-treatment, 6 months post-treatment
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.
Heinrich's Quality of Life Scale-Client Version, Change in Quality of Life
Time frame: Baseline, post-treatment, 3 months post-treatment, 6 months post-treatment
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.
Temple University Community Participation Scale, Change in Community Participation
Time frame: Baseline, post-treatment, 3 months post-treatment, 6 months post-treatment
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.
4 secondary outcomes
Brief Psychiatric Rating Scale, Change in Psychiatric Symptoms
Time frame: Baseline, post-treatment, 3 months post-treatment, 6 months post-treatment
Scales of Psychological Well-Being, Change in Well-being
Time frame: Baseline, post-treatment, 3 months post-treatment, 6 months post-treatment
Maryland Assessment of Recovery, Change in Perceptions of Recovery
Time frame: Baseline, post-treatment, 3 months post-treatment, 6 months post-treatment
Personal Growth and Recovery Scale, Change in Perceptions of Growth and Recovery
Time frame: Baseline, post-treatment, 3 months post-treatment, 6 months post-treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zlatka Russinova, PhD principal investigator
Boston University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Photovoice in people with Mental Disorders, run by Boston University Charles River Campus at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Apr 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Internalized Stigma of Mental Illness Scale, Change in Internalized Stigma (time frame: Baseline, post-treatment, 3 months post-treatment, 6 months post-treatment). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2020; AzTrials last refreshed its copy on 6 Nov 2026.