DepressionNCT04319094
PEERS Using Peer Mentors to Deliver Depression Care
A study testing PEERS and Social interaction in people with Depression, run by Massachusetts General Hospital at 2 sites in United States.
Trial summary
Fifteen to twenty percent of older Americans (6 to 8 million people) suffer from depression but more than one-half do not receive any services, a burden disproportionately shared by low-income and minority older adults who receive few or no services. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Depression
- What is being tested?
- PEERS and Social interaction
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 149 participants
- Where
- 2 sitesUnited States
- Study dates
- 17 Feb 2020to 30 May 2023
- 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 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 50 years and older
- depressive symptoms with Patient Health Questionnaire-9 scores ≥ 5
- belong to an underserved population, defined as annual income less than 200% of the federal poverty level ($24,120) and/or self-identified ethnic minority
- able to communicate in English
- willing to give informed consent.
Who cannot join
- meet diagnostic criteria for mania or hypomania
- meet diagnostic criteria for psychotic syndrome
- meet diagnostic criteria for substance abuse or dependence
- acutely suicidal
- a score on the Mini-Mental State Examination (MMSE) ≤ 24
- currently taking an antidepressant medication with dosage change in the past 3 months
- receiving active psychotherapy
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Johns Hopkins University
Baltimore, Maryland, 21287
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: Peer Enhanced Depression Care: Using Peer Mentors to Provide Self Care Support to Low Income and Minority Older Adults
Fifteen to twenty percent of older Americans (6 to 8 million people) suffer from depression but more than one-half do not receive any services, a burden disproportionately shared by low-income and minority older adults who receive few or no services. The investigators propose to test a community-based peer model of depression care called PEERS (a peer support program) that provides self-care support for minority and low-income older adults.
Read the detailed description
Depression is a major burden for minority and low-income older adults who are less likely to use mental health services, and development of new service delivery models is needed to improve the quality of life and address disparities to access for this group. The investigators propose to test the effectiveness of a peer-delivered depression care program that is embedded in the community and linked to the patient's primary care clinic. The investigators will carry out a randomized controlled trial of the PEERS program in which peer mentors who have personal experience of depression meet individually with older adults recruited in the community for 8 weekly meetings focused on relief of depressive symptoms through self-care support and linkages to community resources. This group of low-income and minority older adults in the intervention will be compared to a group that receives non-peer visits that provide social interaction. The PEERS program takes a chronic disease self-management approach and is guided by the conceptual frameworks of social support, peer support, and social learning. The investigators will conduct an analysis of mediation to understand the mechanism of peer support, by measuring factors such as self-efficacy and loneliness that may be responsible for the intervention effect. The investigators' goal is to use peer-delivered depression care to decrease the mental health morbidity of at-risk low-income and minority adults. The potential public health impact is high because the investigators' project seeks to increase access to depression for a vulnerable group of older adults who often do not get care and leverages an existing workforce of peer workers whose services are reimbursed in many states.
- Conditions
- Depression
- Being tested
- PEERS, Social interaction
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEERSBehavioural
Peer mentors deliver depression care that include social support and coping skills, focused on goal setting and small behavioral changes.
Social interactionOther
Study staff will provide a combination of 8 social interaction visits and phone calls to the participants randomized to this condition.
| Study group | Role | What they receive |
|---|---|---|
| PEERS | Experimental | Peer mentors who have experience of depression are trained and supervised to deliver depression care. Peers will meet with depressed older adults for 8 weekly meeting lasting approximately 45 minutes. Peer mentors will provide social support defined as emotional, informational and appraisal support that includes coping strategies. Peers will be supervised by a mental health professional. Receives: Behavioral: PEERS |
| Social interaction | Active comparator | A study staff member will provide eight weekly social interaction visits and phone calls to the depressed older adult. Receives: Other: Social interaction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Health Questionnaire-9
Depression will be assessed with the Patient Health Questionnaire (PHQ)-9. The PHQ-9 score is summed. There are 9 items in the questionnaire and scores range from 0 to 27. A score of 5 indicates mild depressive symptoms, 10 - 14 indicates moderate depression, 15-19 indicates moderately severe depression, 20-27 indicates severe depression.
Measured: Baseline, post-intervention (8-week), 3 months after intervention, 6 months after intervention, 9 months after intervention, 12 months after intervention
Secondary outcomes (11)
Rand Health Survey Short Form 36 - Physical Functioning
The RAND 36-Item Health Survey is a set of generic, coherent, and easily administered quality-of-life measures. Each item is scored on a 0 to 100 range. Higher scores indicate better functioning.The physical functioning subscale was calculated using the average of 10 of the 36 items (item 3, 4, 5, 6, 7, 8, 9, 10, 11, 12)
Measured: Baseline, post-intervention (8-week), 3 months after intervention , 6 months after intervention, 9 months after intervention, 12 months intervention
Rand Health Survey Short Form 36 Item - Social Functioning
The RAND 36-Item Health Survey is a set of generic, coherent, and easily administered quality-of-life measures. Each item is scored on a 0 to 100 range. Higher scores indicate better functioning. The social functioning subscale was calculated using the average of 2 of the 36 items (item 20, 32)
Measured: Baseline, post-intervention (8-week), 3 months after intervention , 6 months after intervention, 9 months after intervention, 12 months intervention
Rand Health Survey Short Form 36 Item - Emotional Functioning
The RAND 36-Item Health Survey is a set of generic, coherent, and easily administered quality-of-life measures. Each item is scored on a 0 to 100 range. Higher scores indicate better functioning. The emotional functioning subscale was calculated using the average of 3 of the 36 items (item 17, 18, 19)
Measured: Baseline, post-intervention (8-week), 3 months after intervention , 6 months after intervention, 9 months after intervention, 12 months intervention
Cornell Health Service Index - ER Service Use
Health service use is measured with the Cornell Service Index, a questionnaire that includes both clinical and informal community-based health services and has been used in depression care studies among older adults. The index asks whether an individual has used a list of services in the 4 months prior, what type of provider was seen, the site of the service, and reasons for service use. Numbers reported indicate the number of participants who reported hospital and emergency service use at specified timepoints.
Measured: Baseline, post-intervention (8-week), 3 months after intervention, 6 months after intervention, 9 months after intervention, 12 months after intervention
Engagement - Adherence
Engagement (adherence) was measured by percentage of attendance of meetings as reported by the peer mentors, with a threshold of 80% of meetings attended.
Measured: Intervention 1-8 weeks
Working Alliance Inventory - Goal
Working alliance was measured on a weekly basis only in the intervention arm with the Working Alliance Inventory-SF. The survey has 12 items with subscales that measure affective bond, and agreement on tasks and goals and are scored using a Likert scale. The goal subscore was calculated by summing items 1, 6, 8, and 11. The subscale ranges from scores of 4-28, with higher scores indicating better agreement on goals.
Measured: Intervention weeks 1-8
Working Alliance Inventory - Bond
Working alliance was measured on a weekly basis only in the intervention arm with the Working Alliance Inventory-SF. The survey has 12 items with subscales that measure affective bond, and agreement on tasks and goals and are scored using a Likert scale. The bond subscore was calculated by summing items 3, 5, 7, and 9. The subscale ranges from 4-28. A higher subscore indicates higher affective bond.
Measured: Intervention weeks 1-8
Working Alliance Inventory - Task
Working alliance was measured on a weekly basis only in the intervention arm with the Working Alliance Inventory-SF. The survey has 12 items with subscales that measure affective bond, and agreement on tasks and goals and are scored using a Likert scale. The task subscore was calculated by summing items 2, 4, 10, and 12. The subscale ranges from 4-28. A higher subscore indicates higher agreement on tasks.
Measured: Intervention weeks 1-8
UCLA Loneliness Scale
The 20-item R-UCLA loneliness scale measures one's subjective feelings of loneliness as well as feelings of social isolation. Items are summed to create a score. The scores range from 20-80 and higher scores indicating higher level of loneliness. A total score of 20-34 represents low degree of loneliness; 35-49 represent moderate degree of loneliness; 50-64 represent moderately high degree of loneliness; and 65 or above represent high degree of loneliness.
Measured: Baseline, post-intervention (8-week), 3 months after intervention, 6 months after intervention, 9 months after intervention, 12 months after intervention
General Self-Efficacy Scale
The General Self-Efficacy Scale assess a general sense of perceived self-efficacy with the aim in mind to predict coping with daily hassles as well as adaptation after experiencing all kinds of stressful life events. GSES score is calculated by summing all item scores. The score ranges from 10-40 and higher scores indicating more self-efficacy.
Measured: Baseline, post-intervention (8-week), 3 months after intervention, 6 months after intervention, 9 months after intervention, 12 months after intervention
Brief COPE - Adaptive Coping
The Brief-COPE is a 28 item self-report questionnaire designed to measure effective and ineffective ways to cope with a stressful life event. Reliance on adaptive coping strategies were calculated as the sum of the following subscales: active coping (item 2, 7), emotional support (item 5, 15), use of informational support (item 10, 23), positive reframing (item 12, 17), planning (item 14,25), acceptance (item 20, 24), religion (item 22, 27). Each of the subscales ranges from 2-8. The range of scores for adaptive coping is 14-56, with higher scores indicating higher adaptive coping.
Measured: Baseline, post-intervention (8-week), 3 months after intervention, 6 months after intervention, 9 months after intervention, 12 months after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2020
- Study start17 Feb 2020
- Primary completion30 May 2023
- Study completion30 May 2023
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 149 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Jin hui Joo, MD, MA, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04319094
- Sponsor's protocol ID
- 2022P001675
- Other IDs
- R01MH123165
- Status last verified
- Oct 2024
- First submitted
- 20 Mar 2020
- Last updated
- 20 Nov 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Joo JH, Xie A, Choi N, Gallo JJ, Zhong Y, Ma M, Locascio JJ, Khemraj U, Mace RA, Solomon P. A Mixed Methods Effectiveness Study of a Peer Support Intervention for Older Adults During the COVID-19 Pandemic: Results of a Randomized Clinical Trial. Am J Geriatr Psychiatry. 2025 Apr;33(4):389-401. doi: 10.1016/j.jagp.2024.09.013. Epub 2024 Oct 10.
PubMed 39438236
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peer Enhanced Depression Care: Using Peer Mentors to Provide Self Care Support to Low Income and Minority Older Adults
- ClinicalTrials.gov ID
- NCT04319094
- Acronym / sponsor ID
- 2022P001675
- Conditions
- Depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 149 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 17 Feb 2020 (actual)
- Primary completion
- 30 May 2023 (actual)
- Study completion
- 30 May 2023 (actual)
- First posted
- 24 Mar 2020 (actual)
- Results
- Posted 20 Nov 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Fifteen to twenty percent of older Americans (6 to 8 million people) suffer from depression but more than one-half do not receive any services, a burden disproportionately shared by low-income and minority older adults who receive few or no services. The investigators propose to test a community-based peer model of depression care called PEERS (a peer support program) that provides self-care support for minority and low-income older adults.
Detailed description
Depression is a major burden for minority and low-income older adults who are less likely to use mental health services, and development of new service delivery models is needed to improve the quality of life and address disparities to access for this group. The investigators propose to test the effectiveness of a peer-delivered depression care program that is embedded in the community and linked to the patient's primary care clinic. The investigators will carry out a randomized controlled trial of the PEERS program in which peer mentors who have personal experience of depression meet individually with older adults recruited in the community for 8 weekly meetings focused on relief of depressive symptoms through self-care support and linkages to community resources. This group of low-income and minority older adults in the intervention will be compared to a group that receives non-peer visits that provide social interaction. The PEERS program takes a chronic disease self-management approach and is guided by the conceptual frameworks of social support, peer support, and social learning. The investigators will conduct an analysis of mediation to understand the mechanism of peer support, by measuring factors such as self-efficacy and loneliness that may be responsible for the intervention effect. The investigators' goal is to use peer-delivered depression care to decrease the mental health morbidity of at-risk low-income and minority adults. The potential public health impact is high because the investigators' project seeks to increase access to depression for a vulnerable group of older adults who often do not get care and leverages an existing workforce of peer workers whose services are reimbursed in many states.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PEERS | Experimental | Behavioral: PEERSPeer mentors who have experience of depression are trained and supervised to deliver depression care. Peers will meet with depressed older adults for 8 weekly meeting lasting approximately 45 minutes. Peer mentors will provide social support defined as emotional, informational and appraisal support that includes coping strategies. Peers will be supervised by a mental health professional. |
| Social interaction | Active comparator | Other: Social interactionA study staff member will provide eight weekly social interaction visits and phone calls to the depressed older adult. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 50 years and older
- depressive symptoms with Patient Health Questionnaire-9 scores ≥ 5
- belong to an underserved population, defined as annual income less than 200% of the federal poverty level ($24,120) and/or self-identified ethnic minority
- able to communicate in English
- willing to give informed consent.
Key exclusion criteria (7 listed)
- meet diagnostic criteria for mania or hypomania
- meet diagnostic criteria for psychotic syndrome
- meet diagnostic criteria for substance abuse or dependence
- acutely suicidal
- a score on the Mini-Mental State Examination (MMSE) ≤ 24
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 |
|---|---|---|
| PEERSPeer mentors deliver depression care that include social support and coping skills, focused on goal setting and small behavioral changes. | Behavioural | PEERS |
| Social interactionStudy staff will provide a combination of 8 social interaction visits and phone calls to the participants randomized to this condition. | Other | Social interaction |
Primary outcome
Patient Health Questionnaire-9
Time frame: Baseline, post-intervention (8-week), 3 months after intervention, 6 months after intervention, 9 months after intervention, 12 months after intervention
Depression will be assessed with the Patient Health Questionnaire (PHQ)-9. The PHQ-9 score is summed. There are 9 items in the questionnaire and scores range from 0 to 27. A score of 5 indicates mild depressive symptoms, 10 - 14 indicates moderate depression, 15-19 indicates moderately severe depression, 20-27 indicates severe depression.
11 secondary outcomes
Rand Health Survey Short Form 36 - Physical Functioning
Time frame: Baseline, post-intervention (8-week), 3 months after intervention , 6 months after intervention, 9 months after intervention, 12 months intervention
Rand Health Survey Short Form 36 Item - Social Functioning
Time frame: Baseline, post-intervention (8-week), 3 months after intervention , 6 months after intervention, 9 months after intervention, 12 months intervention
Rand Health Survey Short Form 36 Item - Emotional Functioning
Time frame: Baseline, post-intervention (8-week), 3 months after intervention , 6 months after intervention, 9 months after intervention, 12 months intervention
Cornell Health Service Index - ER Service Use
Time frame: Baseline, post-intervention (8-week), 3 months after intervention, 6 months after intervention, 9 months after intervention, 12 months after intervention
Engagement - Adherence
Time frame: Intervention 1-8 weeks
Working Alliance Inventory - Goal
Time frame: Intervention weeks 1-8
Working Alliance Inventory - Bond
Time frame: Intervention weeks 1-8
Working Alliance Inventory - Task
Time frame: Intervention weeks 1-8
UCLA Loneliness Scale
Time frame: Baseline, post-intervention (8-week), 3 months after intervention, 6 months after intervention, 9 months after intervention, 12 months after intervention
General Self-Efficacy Scale
Time frame: Baseline, post-intervention (8-week), 3 months after intervention, 6 months after intervention, 9 months after intervention, 12 months after intervention
Brief COPE - Adaptive Coping
Time frame: Baseline, post-intervention (8-week), 3 months after intervention, 6 months after intervention, 9 months after intervention, 12 months after intervention
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39438236Joo JH, Xie A, Choi N, Gallo JJ, Zhong Y, Ma M, Locascio JJ, Khemraj U, Mace RA, Solomon P. A Mixed Methods Effectiveness Study of a Peer Support Intervention for Older Adults During the COVID-19 Pandemic: Results of a Randomized Clinical Trial. Am J Geriatr Psychiatry. 2025 Apr;33(4):389-401. doi: 10.1016/j.jagp.2024.09.013. Epub 2024 Oct 10.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PEERS and Social interaction in people with Depression, run by Massachusetts General Hospital at 2 sites 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 7 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 20 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 20 Nov 2024). 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?
Patient Health Questionnaire-9 (time frame: Baseline, post-intervention (8-week), 3 months after intervention, 6 months after intervention, 9 months after intervention, 12 months after intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04319094, which also lists 1 linked publication.
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 20 Nov 2024.