Social Prescribing and Relationship Cognitive Strategies (SPARCS)

University of Michigan

Status: Active, not recruiting

Conditions: Suicidal Ideation; Social Isolation

Treatments: Other: Enhanced Usual Care; Behavioral: Social Prescribing; Behavioral: Brief Cognitive Therapy

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06656975

5R34MH132808-02 (U.S. NIH Grant/Contract)

HUM00258121

Details and patient eligibility

About

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.

Full description

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

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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 design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 3 patient groups

Enhanced Usual Care control group

Other group

Description:

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.

Treatment:

Other: Enhanced Usual Care

Brief Cognitive Therapy then Social Prescribing

Experimental group

Description:

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.

Treatment:

Behavioral: Brief Cognitive Therapy

Behavioral: Social Prescribing

Social Prescribing then Brief Cognitive Therapy

Experimental group

Description:

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.

Treatment:

Behavioral: Brief Cognitive Therapy

Behavioral: Social Prescribing