Social Prescribing and Relationship Cognitive Strategies (SPARCS)

Not Applicable

• Conditions: Social Isolation; Suicidal Ideation

• Registration Number: NCT06656975
• Lead Sponsor: University of Michigan

Brief 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 that might use them.

Detailed Description

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

Study Timeline

• Study First Submitted: 2024-10-22
• Study First Submitted QC: 2024-10-22
• Study First Posted: 2024-10-24
• Study Start: 2024-12-30
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-14
• Last Update Posted: 2025-01-16
• Primary Completion: 2026-07
• Study Completion: 2026-07

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Adapted Client Satisfaction Questionnaire - Intervention arms only	3 and 6 months	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.
Intervention Helpfulness - Intervention Arms Only	6 months	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.
UCLA Loneliness Scale	Baseline, 3 and 6 months	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.
Computer Adaptive Testing - Suicide Scale (CAT-SS)	Baseline, 3 and 6 months	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.
Feasibility will be measured by the recruitment goal of 60 participants	15 months (recruitment period)
Feasibility will be measured by completion rates of follow-up assessments at 3 and 6 months	3 and 6 months	The target for this goal = 75%.

Secondary Outcome Measures

Name	Time	Method
Beck Scale for Suicidal Ideation (BSS)	Baseline, 12 and 24 weeks	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.
Interpersonal Needs Questionnaire (INQ)	Baseline, 12 and 24 weeks	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.
Interpersonal Support Evaluation List (ISEL)	Baseline, 12 and 24 weeks	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.
Patient Health Questionnaire (PHQ-9)	Baseline, 12 and 24 weeks	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.
Generalized Anxiety Disorder 7 (GAD-7)	Baseline, 12 and 24 weeks	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.
Short Form Survey (SF-12)	Baseline, 12 and 24 weeks	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.
Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q-SF)	Baseline, 12 and 24 weeks	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.

Trial Locations

Locations (2)

University of Michigan (Michigan Medicine)-Brighton Health Center; 🇺🇸 Brighton, Michigan, United States

University of Michigan (Michigan Medicine)-Canton Center; 🇺🇸 Canton, Michigan, United States