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Social IsolationNCT06656975

Social Prescribing and Relationship Cognitive Strategies (SPARCS)

A study testing Brief Cognitive Therapy and Social Prescribing in people with Social Isolation and Suicidal Ideation, run by University of Michigan at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Social Isolation, Suicidal Ideation
What is being tested?
Brief Cognitive Therapy and Social Prescribing
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
2 sitesUnited States
Study dates
30 Dec 2024to 26 May 2026
Phase
Interventional
Are there results?
None posted in the registry

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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Screen positive for either or both of the following during routine clinic screening:
  • Social isolation in the past 6 months, according to the screening question "How often do you feel isolated from others?"
  • Suicidal ideation in the past 12 months, according to the 9th item of the Patient Health Questionnaire (HQ-9) (per protocol)
  • Loneliness, according to the 3-item version of the University of California, Los Angeles (UCLA) Loneliness Scale (per protocol)
  • Are currently receiving or are able to initiate Collaborative Care Management at to participant's study site

Who cannot join

  • Currently receiving or have an active referral for specialty mental health or substance use disorder treatment outside of primary care
  • Neurocognitively impaired according to chart diagnosis, self-report on the Eligibility Screening Survey, or inability to answer comprehension check questions during the Informed Consent process (per protocol)
  • Unable to participate in the interventions and research assessments due to planned travel or limited phone access (e.g., does not own phone)
  • Terminally ill or receiving of palliative care with less than 6 months life expectancy

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • University of Michigan (Michigan Medicine)-Brighton Health Center

    Brighton, Michigan, 48116

  • University of Michigan (Michigan Medicine)-Canton Center

    Canton, Michigan, 48187

Other trials in United States

About this study

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.

Read the detailed description

The study will take place at 2 University of Michigan sites.

Being tested
Brief Cognitive Therapy, Social Prescribing, Enhanced Usual Care
Keywords
Collaborative Care Management, Social Prescribing, Relationship Cognitive Strategies
Medical subject headings
Social Isolation, Suicidal Ideation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Brief Cognitive TherapyBehavioural

    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.

  • Social PrescribingBehavioural

    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.

  • Enhanced Usual CareOther

    Participants will receive an informational booklet on improving loneliness. Participants may initiate or continue Collaborative Care for other conditions on a not research basis.

Study groups in NCT06656975
Study groupRoleWhat they receive
Enhanced Usual Care control groupOtherParticipants 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.
Receives: Other: Enhanced Usual Care
Brief Cognitive Therapy then Social PrescribingExperimentalBesides 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.
Receives: Behavioral: Brief Cognitive Therapy; Behavioral: Social Prescribing
Social Prescribing then Brief Cognitive TherapyExperimentalBesides 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.
Receives: Behavioral: Brief Cognitive Therapy; Behavioral: Social Prescribing

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 3 and 6 months

  2. 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.

    Measured: 6 months

  3. 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.

    Measured: Baseline, 3 and 6 months

  4. 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.

    Measured: Baseline, 3 and 6 months

  5. Feasibility will be measured by the recruitment goal of 60 participants

    Measured: 15 months (recruitment period)

  6. Feasibility will be measured by completion rates of follow-up assessments at 3 and 6 months

    The target for this goal = 75%.

    Measured: 3 and 6 months

Secondary outcomes (7)

  1. 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.

    Measured: Baseline, 12 and 24 weeks

  2. 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.

    Measured: Baseline, 12 and 24 weeks

  3. 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.

    Measured: Baseline, 12 and 24 weeks

  4. 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.

    Measured: Baseline, 12 and 24 weeks

  5. 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.

    Measured: Baseline, 12 and 24 weeks

  6. 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.

    Measured: Baseline, 12 and 24 weeks

  7. 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.

    Measured: Baseline, 12 and 24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Oct 2024
  2. Study start30 Dec 2024
  3. Primary completion26 May 2026
  4. Study completion26 May 2026

Resources

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
Model description
Participants will be randomized into 1 of 3 arms in a 1:1:1 ratio (see Protocol for detailed descriptions).
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06656975
Sponsor's protocol ID
HUM00258121
Other IDs
5R34MH132808-02
Status last verified
Jun 2026
First submitted
22 Oct 2024
Last updated
23 Jun 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
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.

Questions about this trial

What is this clinical trial studying?

A study testing Brief Cognitive Therapy and Social Prescribing in people with Social Isolation and Suicidal Ideation, run by University of Michigan at 2 sites 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 5 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: finished, as of the sponsor's last update on 23 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adapted Client Satisfaction Questionnaire - Intervention arms only (time frame: 3 and 6 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06656975.

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 23 Jun 2026.

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