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.
The study will take place at 2 University of Michigan sites.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
60
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.
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.
University of Michigan (Michigan Medicine)-Brighton Health Center
Brighton, Michigan, United States
University of Michigan (Michigan Medicine)-Canton Center
Canton, Michigan, United States
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline, 3 and 6 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Participants will receive an informational booklet on improving loneliness. Participants may initiate or continue Collaborative Care for other conditions on a not research basis.
Feasibility will be measured by the recruitment goal of 60 participants
Time frame: 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%.
Time frame: 3 and 6 months
Beck Scale for Suicidal Ideation (BSS)
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.
Time frame: Baseline, 12 and 24 weeks
Interpersonal Needs Questionnaire (INQ)
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.
Time frame: Baseline, 12 and 24 weeks
Interpersonal Support Evaluation List (ISEL)
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.
Time frame: Baseline, 12 and 24 weeks
Patient Health Questionnaire (PHQ-9)
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.
Time frame: Baseline, 12 and 24 weeks
Generalized Anxiety Disorder 7 (GAD-7)
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.
Time frame: Baseline, 12 and 24 weeks
Short Form Survey (SF-12)
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.
Time frame: Baseline, 12 and 24 weeks
Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q-SF)
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.
Time frame: Baseline, 12 and 24 weeks