The Association Between Loneliness and Substance Use
Study Details
Study Description
Brief Summary
The proposed study will determine if cognitive behavioral therapy will help improve loneliness in people who use opioids.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Cognitive Behavioral Therapy (CBT) CBT delivered over the course of 6, ~45 minute sessions delivered via telehealth. |
Behavioral: Cognitive Behavioral Therapy for loneliness (CBT-L)
6 sessions focused on addressing thoughts, emotions, and behaviors that maintain feeling alone as a way to reduce loneliness and substance use.
|
| Active Comparator: Health Education Health education sessions delivered over the course of 6, ~45 minute sessions delivered via telehealth. |
Behavioral: Physical Health Education Training (PHET)
Health education provides information on the importance and benefits of and guidelines for living a healthy lifestyle.
|
Outcome Measures
Primary Outcome Measures
- Mean change in loneliness [baseline to 2 months]
Loneliness will be measured using the 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
- Mean change in number of days of opioid use [baseline to 2 months]
Participants will complete a calendar indicating the type and frequency of drug use.
- Mean change in percent days abstinent [baseline to 2 months]
Participants will complete a calendar indicating the type and frequency of drug use.
- Mean change in social interactions [baseline to 2 months]
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. Scores range from 0 to 37.
- Mean change in depression [baseline to 2 months]
Depression will be measured using the PROMIS tool. The scores range from 4-20 with higher scores indicating worse outcome.
- Mean change in anxiety [baseline to 2 months]
Anxiety will be measured using the PROMIS tool. The scores range from 4-20 with higher scores indicating worse outcome.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Must be ages 18+
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Understand English
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Have internet access
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Screen positive for an active OUD on the OUD Module of the Structured Clinical Interview for DSM-5 Research Version (SCID-5-RV)
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Screen positive for loneliness by scoring at least a T-score > 60 on the NIH Toolbox Loneliness Scale
Exclusion Criteria:
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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)
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Potential participants who are in the process of detoxifying as measured by the Subjective Opiate Withdrawal Scale will also be excluded
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Rochester Medical Center | Rochester | New York | United States | 14642 |
Sponsors and Collaborators
- University of Rochester
- National Institute on Drug Abuse (NIDA)
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- STUDY00005387