An interventional study of Social Engage (S-ENGAGE) and The Healthy Lifestyles Education Program in Social Isolation, Loneliness and Suicidal Ideation, sponsored by University of Rochester. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-30.
Sponsored by University of Rochester · Not applicable, Interventional, and Treatment
Among 97 studies in Social Isolation with a site in United States — 26 open to participants now, 29 under way, none of them phase 3. Social Isolation · United States.
Among the 97 studies in Social Isolation with a site in United States, this one is the 60th largest by enrollment of the 92 interventional ones that give a count, is one of 9 that started in 2022, is one of 89 with no phase, and was the 51st registered.
236 studies on the registry are indexed under Social Isolation; 61 are open to participants now.
This study's enrollment of 54 is below the median of 80 across 198 interventional studies indexed under Social Isolation.
Browse Social Isolation studies →26 of the 97 studies in Social Isolation with a site in United States are open now.
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 34 Social Isolation studies recruiting now, 22 (65%) set no upper age limit and 6 (18%) stop at 75 or younger; 4 take children under 18; 18 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →97 studies; the count open now beside each. This study's row is marked.
First in 2009; this study’s year is marked. 9 started in 2022.
Median enrollment 79 across the 92 interventional studies, 650 across the 5 observational. Of the 65 that completed or were terminated, 22 (34%) have results posted.
1 of 97 have an industry lead sponsor. The 10 most frequent:
University of Rochester is the lead sponsor of 729 studies on the registry; 116 are open to participants now.
Of its 56 completed or terminated interventional studies of FDA-regulated products, 44 (79%) have results posted.
University of Rochester has 9 studies filed under Social Isolation — fewer than ten, so there is no comparison to draw.
8 of the studies in Social Isolation with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06721559University of MichiganEmpower@Home: Community Implementation for Older Adults With Ambulatory Disabilities | 2026-12 |
| NCT04391816National Institute on Alcohol Abuse and Alcoholism (NIAAA)COVID-19 Pandemic Impact on Alcohol (PIA) - A Natural History Study | 2026-12-31 |
| NCT06817993University of PittsburghTeen Brain Online II: Understanding How Social Media Affects the Teen Brain | 2027-03-30 |
| NCT07863583Johns Hopkins UniversitySocial Connection Collective for Older Adults in Subsidized Housing | 2027-04 |
| NCT07123298Johns Hopkins UniversityCAPABLE Care + Connect | 2027-05 |
Among the 97 studies in Social Isolation with a site in United States, from their registry updates:
The proposed K23 study is an intervention study using an experimental therapeutics approach. This pilot RCT asks: "Does SOCIAL-ENGAGE increase cultural-social engagement and decrease suicide risk among Spanish-speaking adults?" We will first optimize a behavioral intervention - SOCIAL ENGAGE (S-ENGAGE) - for target engagement using human-centered design approaches with Spanish-speaking adults at risk for suicide (n=5) and then conduct a pilot RCT (n=60) to test target engagement (cultural-social engagement) and clinical impact (suicide risk) of S-ENGAGE with this population. The ultimate goal is for S-ENGAGE to be offered as a suicide prevention program for Hispanics at risk for suicide.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
S-ENGAGE is a skills-based psychotherapy that focuses on helping patients engage in meaningful rewarding social activities. Subjects will receive 10 one-hour individual sessions of S-ENGAGE over 10 weeks.
Behavioral: Social Engage (S-ENGAGE)
The healthy lifestyles education program consists of a notebook containing evidence-based educational material on mental health, physical activity, and information on community resources. Study staff meet with participants once, individually, for 1 hour to review each section and answer questions participants might have.
Behavioral: The Healthy Lifestyles Education Program
S-ENGAGE uses the process of action planning to foster sustained behavior change. Action planning involves: 1) select a goal; 2) develop ideas to meet this goal; 3) choose one or more of these ideas; 4) identify concrete steps to implement the goal (i.e., form an action plan); 5) identify and address barriers if needed.
The healthy lifestyles education program is a self-guided psychoeducational program, including a notebook containing evidence-based educational material on mental health, physical activity, and information on community resources.
Change in Cultural-Social Engagement (A)
Average number of cultural-social interactions (measured via EMA), with greater number indicating greater cultural-social engagement (i.e., better outcome).
Time frame: Baseline and 10 weeks
Change in Cultural-Social Engagement (B)
Time spent in positive Spanish-language conversations (measured via passive monitoring of conversations), with more time indicating greater cultural-social engagement (i.e., better outcome).
Time frame: Baseline and 10 weeks
Change in Cultural-Social Engagement (C)
Number of visits to cultural-social settings outside the home (measured via GPS), with greater number indicating greater cultural-social engagement (i.e., better outcome).
Time frame: Baseline and 10 weeks
Change in Cultural-Social Engagement (D)
Self-reported feelings of belonging to Hispanic cultural groups (measured via EMA with the Interpersonal Needs Questionnaire), with greater scores indicating greater cultural-social engagement (i.e., better outcome).
Time frame: Baseline and 10 weeks
Change in Suicide Risk (A)
Reasons for living total score, measured by the Reasons for Living Inventory, with 48 items rated from 1 to 6, with greater scores indicating greater importance for reasons for living (i.e., better outcome).
Time frame: Baseline and 10 weeks
Change in Suicide Risk (B)
Suicide ideation total score, measured by the Beck Scale for Suicide Ideation, with scores ranging from 0 to 38, with greater scores indicating greater suicide ideation (i.e., worse outcome).
Time frame: Baseline and 10 weeks
Plan to share: No
No publications or documents are linked to this record.
Ran from Jun 2022 to primary completion in Sep 2025, 39 months.
Of 155 non-industry interventional studies with no phase under Social Isolation, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 36. This study's 39 months is above that.
Counting every sponsor, half of 156 studies reached it within 18 months; a quarter within 10 and three quarters within 36.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.