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OpenTrials
Completed

NCT Number: NCT06656975

Social Prescribing and Relationship Cognitive Strategies (SPARCS)

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

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.

Primary outcomes

  1. Adapted Client Satisfaction Questionnaire - Intervention arms only

    Time frame: 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.

  2. Intervention Helpfulness - Intervention Arms Only

    Time frame: 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.

  3. UCLA Loneliness Scale

    Time frame: 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.

  4. Computer Adaptive Testing - Suicide Scale (CAT-SS)

    Time frame: 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.

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

    Time frame: 15 months (recruitment period)

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

    Time frame: 3 and 6 months

    The target for this goal = 75%.

Secondary outcomes

  1. Beck Scale for Suicidal Ideation (BSS)

    Time frame: 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.

  2. Interpersonal Needs Questionnaire (INQ)

    Time frame: 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.

  3. Interpersonal Support Evaluation List (ISEL)

    Time frame: 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.

  4. Patient Health Questionnaire (PHQ-9)

    Time frame: 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.

  5. Generalized Anxiety Disorder 7 (GAD-7)

    Time frame: 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.

  6. Short Form Survey (SF-12)

    Time frame: 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.

  7. Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q-SF)

    Time frame: 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.

Other outcomes

  1. Percentage of eligible patients that agree to participate in the study

    Time frame: Approximately 15 months (recruitment study period)

    This will be done for acceptability with a target = 60%

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

    Time frame: 6 months

    The percentage of participants assigned to either intervention arm that complete any intervention session (target = 90%)

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

    Time frame: 3 months

    This will be done for acceptability with a target = 75%.

  4. Percentage of participants that complete 3 of 4 sessions of the second intervention

    Time frame: 3 months

    This will be done for acceptability with a target = 50%.

  5. Percentage of participants that complete any sessions of the second intervention

    Time frame: 3 months

    This will be done for acceptability with a target = 65%.

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Oct 24, 2024
Registry last updated
Jun 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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