The Association Between Loneliness and Substance Use
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Rochester
- Enrollment
- 125
- Locations
- 1
- Primary Endpoint
- Mean Change in Loneliness
Study Overview
Brief Summary
The proposed study will determine if cognitive behavioral therapy will help improve loneliness in people who use opioids.
Detailed Description
The proposed study will be the first to assess the cognitive, affective, and behavioral pathways by which loneliness impacts opioid use. Individuals with an opioid use disorder (OUD) reporting loneliness will be randomized to either a 6-session Cognitive- Behavioral Therapy for loneliness (CBT-L) or a 6-session education control condition, both delivered via telehealth. Telehealth delivery can be easily implemented and can increase reach and access to individuals not engaged in treatment. We will use an established brief CBT manual to address loneliness. We will assess loneliness, negative affect (i.e., depression and anxiety), and the quality and quantity of social interactions prior to, during, and after the intervention to evaluate the subsequent impact on opioid use trajectories. Participant will complete questionnaires pre-treatment, post-treatment, and at 1- and 2-months posttreatment.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Must be ages 18+
- •Understand English
- •Have internet access
- •Screen positive for an active OUD on the OUD Module of the Structured Clinical Interview for DSM-5 (Diagnostic & Statistical Manual of Mental Disorder, 5th edition) Research Version (SCID-5-RV)
- •Screen positive for loneliness by scoring at least a T-score > 60 on the NIH Toolbox Loneliness Scale
Exclusion Criteria
- •Consistent with previously used telehealth-delivered assessments, we will exclude any participant with cognitive impairment as measured by the Blessed Orientation-Memory-Concentration Test (BOMC)
- •Potential participants who are in the process of detoxifying as measured by the Subjective Opiate Withdrawal Scale will also be excluded
Arms & Interventions
Cognitive Behavioral Therapy (CBT)
CBT delivered over the course of 6, ~45 minute sessions delivered via telehealth.
Intervention: Cognitive Behavioral Therapy for loneliness (CBT-L) (Behavioral)
Health Education
Health education sessions delivered over the course of 6, ~45 minute sessions delivered via telehealth.
Intervention: Physical Health Education Training (PHET) (Behavioral)
Outcomes
Primary Outcomes
Mean Change in Loneliness
Time Frame: baseline to 2 months post-treatment
Loneliness will be measured using the University of California-Los Angeles (UCLA) Loneliness Scale. A 20-item scale designed to measure one's subjective feelings of loneliness as well as feelings of social isolation. Participants rate each item as 1 (never), 2 (rarely), 3 (sometimes) or 4 (often). The scores range from 20-80 with higher scores indicating worse outcome.
Secondary Outcomes
- Mean Change in Percent Days Abstinent From Opioids(baseline to 2 months post-treatment)
- Mean Change in Percent Days Abstinent From Other Drugs(baseline to 2 months)
- Mean Change in Social Support(baseline to 2 months post-treatment)
Investigators
Lisham Ashrafioun
Assistant Professor
University of Rochester