Social Prescribing and Relationship Cognitive Strategies (SPARCS)

NCT06656975 | Active Not Recruiting

• 2 other identifiers: HUM002581215R34MH132808-02
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

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.

Conditions

Social Isolation; Suicidal Ideation

Keywords

Collaborative Care Management; Social Prescribing; Relationship Cognitive Strategies

Outcome Measures

Primary Outcomes (6)

• 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.

  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.

  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.

  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.

  Baseline, 3 and 6 months

• 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

  The target for this goal = 75%.

  3 and 6 months

Secondary Outcomes (7)

• Beck Scale for Suicidal Ideation (BSS)

  Baseline, 12 and 24 weeks

• Interpersonal Needs Questionnaire (INQ)

  Baseline, 12 and 24 weeks

• Interpersonal Support Evaluation List (ISEL)

  Baseline, 12 and 24 weeks

• Patient Health Questionnaire (PHQ-9)

  Baseline, 12 and 24 weeks

• Generalized Anxiety Disorder 7 (GAD-7)

  Baseline, 12 and 24 weeks

Other Outcomes (5)

• Percentage of eligible patients that agree to participate in the study

  Approximately 15 months (recruitment study period)

• Percentage of participants assigned to either intervention arm that complete any intervention session

  6 months

• Percentage of participants assigned to either intervention arm that complete at least 3 of 4 sessions of the initially (first) assigned intervention

  3 months

Study Arms (3)

Enhanced Usual Care control group

OTHER

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

Brief Cognitive Therapy then Social Prescribing

EXPERIMENTAL

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

Social Prescribing then Brief Cognitive Therapy

EXPERIMENTAL

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

Interventions

Brief Cognitive Therapy BEHAVIORAL

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.

Brief Cognitive Therapy then Social Prescribing; Social Prescribing then Brief Cognitive Therapy

Social Prescribing BEHAVIORAL

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.

Brief Cognitive Therapy then Social Prescribing; Social Prescribing then Brief Cognitive Therapy

Enhanced Usual Care OTHER

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

Enhanced Usual Care control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Michigan: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (2)

University of Michigan (Michigan Medicine)-Brighton Health Center

Brighton, Michigan, 48116, United States

Location

University of Michigan (Michigan Medicine)-Canton Center

Canton, Michigan, 48187, United States

Location

MeSH Terms

Conditions

Social Isolation; Suicidal Ideation

Condition Hierarchy (Ancestors)

Social Behavior; Behavior; Suicide; Self-Injurious Behavior; Behavioral Symptoms

Study Officials

• Paul Pfeiffer, MD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: To the extent possible, the assessor will be blinded. The study team will track any instances where an assessor becomes unblinded to a participant's arm assignment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Psychiatry

Model Details: Participants will be randomized into 1 of 3 arms in a 1:1:1 ratio (see Protocol for detailed descriptions).

Study Record Dates

• First Submitted: October 22, 2024
• First Posted: October 24, 2024
• Study Start: December 30, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: February 6, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• 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.

Locations

US (2)