An interventional study of Brief Cognitive Therapy and Social Prescribing in Social Isolation and Suicidal Ideation, sponsored by University of Michigan. Completed at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-23.
Sponsored by University of Michigan · 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 56th largest by enrollment of the 92 interventional ones that give a count, is one of 9 that started in 2024, is one of 89 with no phase, and was the 78th registered.
236 studies on the registry are indexed under Social Isolation; 61 are open to participants now.
This study's enrollment of 60 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 2024.
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 Michigan is the lead sponsor of 1,506 studies on the registry; 192 are open to participants now.
Of its 169 completed or terminated interventional studies of FDA-regulated products, 133 (79%) have results posted.
University of Michigan has 7 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 study team is testing the acceptability and feasibility of two treatments for improving loneliness: Social Prescribing and Brief Cognitive Therapy.
For this pilot study, the study team have adapted these treatments for Collaborative Care and are studying whether these are practical and well-received by patients that might use them.
The study will take place at 2 University of Michigan sites.
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.
Screen positive for either or both of the following during routine clinic screening:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive an informational booklet on improving loneliness and may initiate or continue Collaborative Care for other conditions on a not research basis. Besides the baseline survey participants will also take 2 more surveys, 3-months and 6-months from the first survey. Those surveys will ask similar questions and will take about 45 minutes to complete. These can be done online or over the phone with a researcher that will not know the treatment arm assignment.
Other: Enhanced Usual Care
Besides the baseline survey participants will also take 2 more surveys, 3-months and 6-months from the first survey. Those surveys will ask similar questions and will take about 45 minutes to complete. These can be done online or over the phone with a researcher that will not know the treatment arm assignment.
Behavioral: Brief Cognitive Therapy · Behavioral: Social Prescribing
Besides the baseline survey participants will also take 2 more surveys, 3-months and 6-months from the first survey. Those surveys will ask similar questions and will take about 45 minutes to complete. These can be done online or over the phone with a researcher that will not know the treatment arm assignment.
Behavioral: Brief Cognitive Therapy · Behavioral: Social Prescribing
This intervention will be delivered by participants Behavioral Health Care Manager during Collaborative Care Management appointments. These appointments typically take place over video call (telehealth). Each intervention consists of 4 sessions (approximately 20 minutes each), delivered over 3 months. Participants will also receive a one-time introductory session before starting the first intervention. Between sessions, there will be "homework" tasks, such as filling out worksheets or completing goals that are set with the provider. The therapy portion of the appointment only will be audio recorded using a voice recorder or secure meeting software. Audio recordings will be reviewed by study staff for training and compliance purposes.
This intervention will be delivered by participants Behavioral Health Care Manager during Collaborative Care Management appointments. These appointments typically take place over video call (telehealth). Each intervention consists of 4 sessions (approximately 20 minutes each), delivered over 3 months. Participants will also receive a one-time introductory session before starting the first intervention. Between sessions, there will be "homework" tasks, such as filling out worksheets or completing goals that are set with the provider. The therapy portion of the appointment only will be audio recorded using a voice recorder or secure meeting software. Audio recordings will be reviewed by study staff for training and compliance purposes.
Participants will receive an informational booklet on improving loneliness. Participants may initiate or continue Collaborative Care for other conditions on a not research basis.
Adapted Client Satisfaction Questionnaire - Intervention arms only
This is an 8-item self-report survey which assesses participant satisfaction with services received. SCORING: Items 2, 4, 5, and 8 are reverse scored. Total scores range from 8 to 32, with the higher number indicating greater satisfaction.
Time frame: 3 and 6 months
Intervention Helpfulness - Intervention Arms Only
This is a 9-item, self-report study-specific questionnaire that assesses how much participants were helped by the combined study interventions on various cognitive and behavioral factors that impact loneliness. Questions use a 6-point Likert scale where 0 = "Not applicable/Did not work on this" and 6 = "Made things a lot better." SCORING: Scores will range from 0 to 45, with higher scores indicating greater helpfulness.
Time frame: 6 months
UCLA Loneliness Scale
This consists of 20 items using 4-point Likert-type response anchors from never feel this way (0) - often feel this way (3) (9 items are reverse coded) for a score range from 10 to 80.
Time frame: Baseline, 3 and 6 months
Computer Adaptive Testing - Suicide Scale (CAT-SS)
The CAT-SS is based on multidimensional item response theory (MIRT). Within computer adaptive testing, an individuals' initial item responses are used to determine a provisional estimate of their standing on the measured trait to be used for subsequent item selection. MIRT weighs more severe items more heavily than less severe items in deriving a test score, and provides an estimate of uncertainty that can be used to assess the significance of change for an individual. The measure adaptively selects an average of 10 items per administration from a large bank of approximately 1,000 items. Instead of fixing the items and allowing the precision of measurement to vary, this measure fixes the precision of measurement and allow the items to vary. As a result, measurement is more precise and less burdensome compared with fixed-item standardized measures of suicidal ideation.
Time frame: Baseline, 3 and 6 months
Feasibility will be measured by the recruitment goal of 60 participants
Time frame: 15 months (recruitment period)
Feasibility will be measured by completion rates of follow-up assessments at 3 and 6 months
The target for this goal = 75%.
Time frame: 3 and 6 months
Beck Scale for Suicidal Ideation (BSS)
The Beck Scale for Suicidal Ideation (BSS) is a self-report 21-item scale that assesses thoughts, plans and intent to commit suicide. All items are rated on a three-point scale (0 to 2). Total scores could range from 0 to 42. No specific cut-off scores exist to classify severity. Higher scores reflect greater suicide risk.
Time frame: Baseline, 12 and 24 weeks
Interpersonal Needs Questionnaire (INQ)
This is a 15-item questionnaire that participants answer from not at all (1) to very true (7). There is a score range from 15-105 with a higher score indicating higher perceived burdensomeness. There are 6 items that are reverse coded.
Time frame: Baseline, 12 and 24 weeks
Interpersonal Support Evaluation List (ISEL)
This is a 12-item measure that assesses the perceived availability of social support from family, friends, and others. Each statement is scored using a 4-point scale (definitely false, probably false, probably true, definitely true) to measure subscales of appraisal, belonging, and tangible support. All items are summed to a total score ranging from 0 to 36 with higher scores indicating greater perceived social support.
Time frame: Baseline, 12 and 24 weeks
Patient Health Questionnaire (PHQ-9)
The PHQ-9 is a 9-item self-report measure that assesses the frequency of symptoms of major depressive disorder. Response options range from 0 ("not at all") to 3 (nearly every day). Total scores on the PHQ-9 range from 0-27 with greater scores indicating greater frequency of depressive symptoms.
Time frame: Baseline, 12 and 24 weeks
Generalized Anxiety Disorder 7 (GAD-7)
The 7-item GAD-7 will measure symptoms of anxiety. Items are scored 0-3, resulting in a total score of 0-21. Higher scores indicate more symptoms of anxiety.
Time frame: Baseline, 12 and 24 weeks
Short Form Survey (SF-12)
The SF-12 covers domains including: (1) physical functioning; (2) role-physical; (3) bodily pain; (4) general health; (5) vitality; (6) social functioning; (7) role emotional; and (8) mental health. Summary scores are calculated by summing factor-weighted scores across all 8 subscales, with factor weights derived from a US-based general population sample. Physical and Mental Health Composite Scores (PCS \& MCS) are computed using the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health.
Time frame: Baseline, 12 and 24 weeks
Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q-SF)
Quality of Life Enjoyment and Satisfaction Questionnaire Short Form (Q-LES-Q-SF) consists of 14 items, assesses satisfaction with a variety of life domains such as physical health, work, and social relationships. The scoring of the Q-LES-Q-SF involves summing only the first 14 items to yield a raw total score. The last two items are not included in the total score but are standalone items. The raw total score ranges from 14 to 70. Higher level of enjoyment and satisfaction with life are reflected in higher scores.
Time frame: Baseline, 12 and 24 weeks
Percentage of eligible patients that agree to participate in the study
This will be done for acceptability with a target = 60%
Time frame: Approximately 15 months (recruitment study period)
Percentage of participants assigned to either intervention arm that complete any intervention session
The percentage of participants assigned to either intervention arm that complete any intervention session (target = 90%)
Time frame: 6 months
Percentage of participants assigned to either intervention arm that complete at least 3 of 4 sessions of the initially (first) assigned intervention
This will be done for acceptability with a target = 75%.
Time frame: 3 months
Percentage of participants that complete 3 of 4 sessions of the second intervention
This will be done for acceptability with a target = 50%.
Time frame: 3 months
Percentage of participants that complete any sessions of the second intervention
This will be done for acceptability with a target = 65%.
Time frame: 3 months
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — The Principal investigator (PI) will share information about this/these trial(s) via timely registration, updates, and results reporting in ClinicalTrials.gov in accordance with NIH policy. The PI will also upload data gathered in this proposal to an National Institute of Mental Health (NIMH)-designated central data, NIMH Data Archive (NDA), as prescribed by NOT-MH-15-012, working with NIMH program to determine the timing and extent of data sharing. This includes formulation of an enrollment strategy that will obtain the information necessary to generate a Global Unique Identifier (GUID) for each participant.
Supporting information: Study protocol, Informed consent form
Time frame: De-identified data will be entered into the NDA within 1 year of the conclusion of the study.
Access criteria: No additional access restrictions will be placed on the de-identified data beyond those that are standard for the NDA.
Data sharing details ↗ · nda.nih.gov
Ran from Dec 2024 to primary completion in May 2026, 16 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 16 months is below 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 Jun 2026. You cannot join it, but the record below documents what was studied.
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