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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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The goal of this intervention study is to design and learn whether peer support that is delivered through video chats and texts can decrease depression among older adults. Participants will be assigned to a peer support program where they will receive 8 video chats with a peer mentor who provide social support and supportive texts over 8 weeks.
PEERS plus is a psychosocial intervention being developed to reduce depression among older adults. In this intervention peer mentors who are also 50 years of age and older and who have experiential knowledge of depression provide depression care. Older adults with depression will be recruited and assigned to the peer support program. This will consist of 8 weekly peer mentor - older adult video chats that provide emotional support and sharing of self-care skills for depression. Supportive texts will be sent on a weekly basis to older adults by peer mentors. These texts will provide encouragement, affirmations and information about mental health resources. Peer mentors are trained and supervised by a mental health professional during the 8 week period. We will assess at baseline, post study and 3 months after the intervention.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Peer support | Other | Peer mentors who have experienced depression provide social support through video chats and texts for 8 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Peers plus | Behavioral | Peer support intervention in which peer mentors who have experiential knowledge of depression deliver social support through video chats and texts to older adults with depression. |
| Measure | Description | Time Frame |
|---|---|---|
| Intervention Feasibility | Proportion of the participants who complete 80% of their weekly meetings with the peer coach. | 18 months |
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| Measure | Description | Time Frame |
|---|---|---|
| Patient Health Questionnaire-9 | Depression will be assessed with the Patient Health Questionnaire (PHQ-9). The PHQ-9 score is summed from 9 items in the questionnaire, and scores range from 0 to 27. A higher score indicates a worse outcome in depression. A score of 5 indicates mild depressive symptoms, 10 - 14 indicates moderate depression, 15-19 indicates moderately severe depression, and 20-27 indicates severe depression. |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Peer Support | Older adults who are experiencing depression receive peer support. Peer support consists of emotional and self care support delivered by a peer mentor. Peer mentors are the interventionists and do not receive the intervention. We did not collect any data about peer mentors in the study. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Peer mentors who have experienced depression provide social support through video chats and texts for 8 weeks.
Peers plus: Peer support intervention in which peer mentors who have experiential knowledge of depression deliver social support through video chats and texts to older adults with depression.
Baseline data were not collected from peer mentors participants and peer mentors were not assessed for adverse events.
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| ID | Title | Description |
|---|---|---|
| BG000 | Peer Support | Peer mentors who have experienced depression provide social support through video chats and texts for 8 weeks. Peers plus: Peer support intervention in which peer mentors who have experiential knowledge of depression deliver social support through video chats and texts to older adults with depression. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 34 participants started the intervention, 28 finished the intervention and 6 dropped during the intervention. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Intervention Feasibility | Proportion of the participants who complete 80% of their weekly meetings with the peer coach. | Peer mentors who have experienced depression provide social support through video chats and texts for 8 weeks. Peers plus: Peer support intervention in which peer mentors who have experiential knowledge of depression deliver social support through video chats and texts to older adults with depression. | Posted | Count of Participants | Participants | 18 months |
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Adverse event data is collected through study completion, an average of 18 months.
Baseline data were not collected from peer mentors and peer mentors were not assessed for adverse events.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Peer Support | Peer mentors who have experienced depression provide social support through video chats and texts for 8 weeks. Peers plus: Peer support intervention in which peer mentors who have experiential knowledge of depression deliver social support through video chats and texts to older adults with depression. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jin Hui Joo | Massachusetts General Hospital | 6177245317 | jhjoo@mgh.harvard.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 7, 2022 | May 5, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 1, 2025 | May 5, 2025 | SAP_001.pdf |
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A cohort of 20 older adults will be assigned to the Peer plus program for 8 weeks, without a comparison group.
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| We assessed PHQ-9 scores as changes across three timepoints: baseline, post study and 3 month follow up. We ran a mixed-effects longitudinal model to examine how PHQ-9 scores changed over 5 months (8 week intervention and 3 month follow up). |
| Mean |
| Full Range |
| years |
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| Sex: Female, Male | 34 participants started the intervention, 28 finished the intervention and 6 dropped during the intervention. | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | 34 participants started the intervention, 28 finished the intervention and 6 dropped during the intervention. | Count of Participants | Participants |
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| Race/Ethnicity, Customized | 34 participants started the intervention, 28 finished the intervention and 6 dropped during the intervention. | Count of Participants | Participants |
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| Region of Enrollment | 34 participants started the intervention, 28 finished the intervention and 6 dropped during the intervention. | Count of Participants | Participants |
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| Patient Health Questionnaire-9 | Depression will be assessed with the Patient Health Questionnaire (PHQ-9). The PHQ-9 score is summed from 9 items in the questionnaire, and scores range from 0 to 27. A higher score indicates a worse outcome in depression. A score of 5 indicates mild depressive symptoms, 10 - 14 indicates moderate depression, 15-19 indicates moderately severe depression, and 20-27 indicates severe depression. | 34 participants started the intervention, 28 finished the intervention and 6 dropped during the intervention. | Mean | Standard Deviation | units on a scale |
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| Units | Counts |
|---|---|
| Participants |
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| Other Pre-specified | Patient Health Questionnaire-9 | Depression will be assessed with the Patient Health Questionnaire (PHQ-9). The PHQ-9 score is summed from 9 items in the questionnaire, and scores range from 0 to 27. A higher score indicates a worse outcome in depression. A score of 5 indicates mild depressive symptoms, 10 - 14 indicates moderate depression, 15-19 indicates moderately severe depression, and 20-27 indicates severe depression. | Sample sizes varied across the three timepoints due to participant attrition. Some individuals chose not to proceed with the intervention after completing the baseline assessment, while others were lost to follow-up by the post-intervention or 3-month follow-up assessments. | Posted | Mean | Standard Deviation | score on a scale | We assessed PHQ-9 scores as changes across three timepoints: baseline, post study and 3 month follow up. We ran a mixed-effects longitudinal model to examine how PHQ-9 scores changed over 5 months (8 week intervention and 3 month follow up). |
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| 34 |
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| 34 |
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| 34 |
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| 3 Month Follow Up |
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| Null hypothesis: there is no difference in the mean Patient Health Questionnaire-9 (PHQ-9) scores from baseline to 3-month for all study participants. | Mixed Models Analysis | 0.005 | The a priori threshold for statistical significance is p=0.05. | Mean Difference (Net) | -2.420 | Standard Error of the Mean | 0.814 | 2-Sided | 95 | -4.057 | -0.784 | Score difference = 3-month - Baseline | Superiority |
| Null hypothesis: There is no difference in the mean Patient Health Questionnaire-9 (PHQ-9) scores over time for all study participants. | Mixed Models Analysis | 0.0040 | The a priori threshold for statistical significance is p=0.05. | Mean Difference (Net) | -0.5468 | Standard Error of the Mean | 0.1744 | 2-Sided | 95 | -0.9039 | -0.1897 | The mean difference of the PHQ-9 score by each unit increase of the time(each week increase) | Superiority |