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| ID | Type | Description | Link |
|---|---|---|---|
| R33MH129476-03 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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The purpose of this study is to test whether an individual coaching program helps adults age 60 and older feel more connected to other people in ways that matter to them.
The R33 phase is an RCT (S-ENG+eCAU vs. eCAU only; n=120) with follow-up at 8- and 16 weeks to test target engagement and clinical impact. 10 days of ecological momentary assessment (EMA) will be completed at all assessment points. Participants are 120 adults age 60 and older who report clinically significant loneliness and have access to social activities outside the home. EMA will comprehensively assess indices of social connection. Subjects will complete EMA daily following 3 personally-selected times for prompts (to enhance recall and ease of completion of assessments) for 10-days prior to starting study interventions, beginning the day after the baseline visit. Each EMA instance takes approximately 2-5 minutes to complete. Subjects who successfully complete the smartphone assessment protocol at baseline will be randomly assigned to coaching or waitlist control. Study conditions are Engage Coaching (10 individual coaching sessions) over (up to) 4 month or waitlist control (assessments only for 4 months and then coaching is offered). The follow-up assessments include baseline measures and EMA.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Engage Coaching | Experimental | Engage Coaching |
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| Waitlist Control | No Intervention | Study intervention (coaching) is provided after study completion (assessments) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Social Engage Coaching (S-ENG) | Behavioral | Social Engage Coaching (S-ENG) involves 10 individual coaching sessions focused on increasing social connection. S-ENG is a stepped, modular intervention that was developed to allow personalization to a given subject's needs, preferences, and individualized barriers to social connection. Early sessions include psychoeducation on the importance of social connection; a values clarification exercise on aspects of connection most important to subjects; and assessment of current social networks and social activities. Together, the coach and subject create a conceptualization of reasons for loneliness and identify personalized activities most likely to impact loneliness. The primary activity is 'action planning,' which involves selecting a social goal for the week, brainstorming ways to meet the goal, identifying barriers, and selecting specific actions to take before the next session. The first 8 sessions are offered weekly and the final two are monthly booster sessions. |
| Measure | Description | Time Frame |
|---|---|---|
| Loneliness | PROMIS Social Isolation Short Form 4a assessed by Ecological Momentary Assessment (EMA) for 10 days. | 8-week follow-up |
| Belonging | Interpersonal Needs Questionnaire assessed by Ecological Momentary Assessment (EMA) for 10 days. | 8-week follow-up |
| Time in conversations | Self-report of frequency of conversations with others assessed by Ecological Momentary Assessment (EMA) for 10 days. | 8-week follow-up |
| Time outside the home | Self-report of frequency of time outside the home assessed by Ecological Momentary Assessment (EMA) for 10 days. | 8-week follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Suicide ideation | Geriatric Suicide Ideation Scale Screening version that provides a continuous score of severity of suicide ideation with four items, assessed by Ecological Momentary Assessment (EMA) for 10 days. | 16-week follow-up |
| Depression |
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Inclusion criteria:
Exclusion criteria:
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Data will be shared via the NIMH Data Archive in line with NIMH policies.
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Data will be accessible via the NIMH Data Archive.
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PROMIS Depression Short Form assessed by Ecological Momentary Assessment (EMA) for 10 days.
| 16-week follow-up |