The Association Between Loneliness and Substance Use
- Conditions
- Opioid UseLoneliness
- Interventions
- Behavioral: Physical Health Education Training (PHET)Behavioral: Cognitive Behavioral Therapy for loneliness (CBT-L)
- Registration Number
- NCT04938492
- Lead Sponsor
- University of Rochester
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 125
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Health Education Physical Health Education Training (PHET) Health education sessions delivered over the course of 6, \~45 minute sessions delivered via telehealth. Cognitive Behavioral Therapy (CBT) Cognitive Behavioral Therapy for loneliness (CBT-L) CBT delivered over the course of 6, \~45 minute sessions delivered via telehealth.
- Primary Outcome Measures
Name Time Method Mean Change in Loneliness 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 Outcome Measures
Name Time Method Mean Change in Percent Days Abstinent From Opioids baseline to 2 months post-treatment Participants will complete a calendar indicating the type and frequency of drug use.
Mean Change in Percent Days Abstinent From Other Drugs baseline to 2 months Participants will complete a calendar indicating the type and frequency of drug use.
Mean Change in Social Support baseline to 2 months post-treatment Duke Social Support Index assesses several domains of perceived social support, including social network size, social interaction, social satisfaction, and instrumental social support. Higher scores indicate a higher quality of social interactions or perceived social support. Scores range from 6 to 18.
Trial Locations
- Locations (1)
University of Rochester Medical Center
🇺🇸Rochester, New York, United States