Social ConnectionNCT07488559
Engage Coaching (R33 Phase)
A study testing Social Engage Coaching (S-ENG) in people with Social Connection and Loneliness, run by University of Rochester at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Social Connection, Loneliness, Suicide Ideation
- What is being tested?
- Social Engage Coaching (S-ENG)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jun 2026to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Current problem drinking
- Psychosis
- Significant cognitive impairment
- Hearing problems that preclude engagement with S-ENG and research assessors.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Rochester
Rochester, New York, 14642
Kimberly Van Orden, PhD, (585) 273-1811, hope@urmc.rochester.edu
About this study
Official title: Engage Coaching to Reduce Social Isolation and Loneliness to Prevent Suicide in Later Life
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.
Read the 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.
- Being tested
- Social Engage Coaching (S-ENG)
- Keywords
- Loneliness, Older adults, Ecological momentary assessment, Engage Psychotherapy, Late-life suicide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Social Engage Coaching (S-ENG)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Engage Coaching | Experimental | Engage Coaching Receives: Behavioral: Social Engage Coaching (S-ENG) |
| Waitlist Control | No intervention | Study intervention (coaching) is provided after study completion (assessments) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Loneliness
PROMIS Social Isolation Short Form 4a assessed by Ecological Momentary Assessment (EMA) for 10 days.
Measured: 8-week follow-up
Belonging
Interpersonal Needs Questionnaire assessed by Ecological Momentary Assessment (EMA) for 10 days.
Measured: 8-week follow-up
Time in conversations
Self-report of frequency of conversations with others assessed by Ecological Momentary Assessment (EMA) for 10 days.
Measured: 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.
Measured: 8-week follow-up
Secondary outcomes (2)
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.
Measured: 16-week follow-up
Depression
PROMIS Depression Short Form assessed by Ecological Momentary Assessment (EMA) for 10 days.
Measured: 16-week follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2026
- Study start30 Jun 2026
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Social ConnectionStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Kimberly Van Orden, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07488559
- Sponsor's protocol ID
- STUDY00408657
- Other IDs
- R33MH129476-03
- Status last verified
- Aug 2026
- First submitted
- 17 Mar 2026
- Last updated
- 17 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be shared via the NIMH Data Archive in line with NIMH policies.
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Engage Coaching to Reduce Social Isolation and Loneliness to Prevent Suicide in Later Life
- ClinicalTrials.gov ID
- NCT07488559
- Acronym / sponsor ID
- STUDY00408657
- Keywords
- Loneliness, Older adults, Ecological momentary assessment, Engage Psychotherapy, Late-life suicide
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 30 Jun 2026 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 23 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Engage Coaching | Experimental | Behavioral: Social Engage Coaching (S-ENG)Engage Coaching |
| Waitlist Control | No intervention | –Study intervention (coaching) is provided after study completion (assessments) |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- Current problem drinking
- Psychosis
- Significant cognitive impairment
- Hearing problems that preclude engagement with S-ENG and research assessors.
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 |
|---|---|---|
| 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 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. | Behavioural | Engage Coaching |
Primary outcome
Loneliness
Time frame: 8-week follow-up
PROMIS Social Isolation Short Form 4a assessed by Ecological Momentary Assessment (EMA) for 10 days.
Belonging
Time frame: 8-week follow-up
Interpersonal Needs Questionnaire assessed by Ecological Momentary Assessment (EMA) for 10 days.
Time in conversations
Time frame: 8-week follow-up
Self-report of frequency of conversations with others assessed by Ecological Momentary Assessment (EMA) for 10 days.
Time outside the home
Time frame: 8-week follow-up
Self-report of frequency of time outside the home assessed by Ecological Momentary Assessment (EMA) for 10 days.
2 secondary outcomes
Suicide ideation
Time frame: 16-week follow-up
Depression
Time frame: 16-week follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2026.
- Individual participant dataSharing planned: Yes. Data will be shared via the NIMH Data Archive in line with NIMH policies.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Social Engage Coaching (S-ENG) in people with Social Connection and Loneliness, run by University of Rochester 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 3 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 17 Aug 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Loneliness (time frame: 8-week follow-up). The study lists 4 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 17 Aug 2026.