Clinical trial NCT06656975: Social Prescribing and Relationship Cognitive Strategies (SPARCS)
Official title: Social Prescribing and Relationship Cognitive Strategies (SPARCS)
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Social Isolation
Suicidal Ideation
Keywords: Collaborative Care Management
Social Prescribing
Relationship Cognitive Strategies
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2024-10-24
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomized into 1 of 3 arms in a 1:1:1 ratio (see Protocol for detailed descriptions).
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Adapted Client Satisfaction Questionnaire - Intervention arms only
timeFrame: 3 and 6 months
measure: Intervention Helpfulness - Intervention Arms Only
timeFrame: 6 months
measure: UCLA Loneliness Scale
timeFrame: Baseline, 3 and 6 months
measure: Computer Adaptive Testing - Suicide Scale (CAT-SS)
timeFrame: Baseline, 3 and 6 months
measure: Feasibility will be measured by the recruitment goal of 60 participants
timeFrame: 15 months (recruitment period)
measure: Feasibility will be measured by completion rates of follow-up assessments at 3 and 6 months
timeFrame: 3 and 6 months
Secondary outcomes:
measure: Beck Scale for Suicidal Ideation (BSS)
timeFrame: Baseline, 12 and 24 weeks
measure: Interpersonal Needs Questionnaire (INQ)
timeFrame: Baseline, 12 and 24 weeks
measure: Interpersonal Support Evaluation List (ISEL)
timeFrame: Baseline, 12 and 24 weeks
measure: Patient Health Questionnaire (PHQ-9)
timeFrame: Baseline, 12 and 24 weeks
measure: Generalized Anxiety Disorder 7 (GAD-7)
timeFrame: Baseline, 12 and 24 weeks
measure: Short Form Survey (SF-12)
timeFrame: Baseline, 12 and 24 weeks
measure: Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q-SF)
timeFrame: Baseline, 12 and 24 weeks
Other outcomes:
measure: Percentage of eligible patients that agree to participate in the study
timeFrame: Approximately 15 months (recruitment study period)
measure: Percentage of participants assigned to either intervention arm that complete any intervention session
timeFrame: 6 months
measure: Percentage of participants assigned to either intervention arm that complete at least 3 of 4 sessions of the initially (first) assigned intervention
timeFrame: 3 months
measure: Percentage of participants that complete 3 of 4 sessions of the second intervention
timeFrame: 3 months
measure: Percentage of participants that complete any sessions of the second intervention
timeFrame: 3 months
Locations:
city: Brighton
country: United States
facility: University of Michigan (Michigan Medicine)-Brighton Health Center
state: Michigan
city: Canton
country: United States
facility: University of Michigan (Michigan Medicine)-Canton Center
state: Michigan
Study officials:
affiliation: University of Michigan
name: Paul Pfeiffer, MD
role: PRINCIPAL_INVESTIGATOR
References: