Engage Coaching (R33 Phase)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Social Engage Coaching (S-ENG).
- Who it may be relevant to
- Registry conditions: Social Connection, Loneliness, Suicide Ideation, Social-emotional Quality of Life. Basic parameters: from 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Engage Coaching to Reduce Social Isolation and Loneliness to Prevent Suicide in Later Life
Overview
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.
Detailed description
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.
Interventions
- Behavioral Social Engage Coaching (S-ENG)
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 s
Primary outcome measures
- Loneliness [Time frame: 8-week follow-up]
- Belonging [Time frame: 8-week follow-up]
- Time in conversations [Time frame: 8-week follow-up]
- Time outside the home [Time frame: 8-week follow-up]
Secondary outcome measures (2)
- Suicide ideation [Time frame: 16-week follow-up]
- Depression [Time frame: 16-week follow-up]
Eligibility criteria
Inclusion criteria
- Age 60 or older
- Access to social activities outside the home, including through living in senior living communities
- Clinically-significant loneliness over the prior month.
Exclusion criteria
- Current problem drinking
- Psychosis
- Significant cognitive impairment
- Hearing problems that preclude engagement with S-ENG and research assessors.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07488559 · STUDY00408657 · R33MH129476-03