The Association Between Loneliness and Substance Use

Study Overview
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Brief Summary
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The proposed study will determine if cognitive behavioral therapy will help improve loneliness in people who use opioids.

Detailed Description
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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.

Official Title
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The Association Between Loneliness and Substance Use

Conditions
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Opioid Use, Loneliness

Intervention / Treatment
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* Behavioral: Cognitive Behavioral Therapy for loneliness (CBT-L)
* Behavioral: Physical Health Education Training (PHET)


Participation Criteria
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Eligibility Criteria
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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 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cognitive Behavioral Therapy (CBT)<br>CBT delivered over the course of 6,  45 minute sessions delivered via telehealth. | Behavioral: Cognitive Behavioral Therapy for loneliness (CBT-L)<br>* 6 sessions focused on addressing thoughts, emotions, and behaviors that maintain feeling alone as a way to reduce loneliness and substance use.<br>|
| Active Comparator: Health Education<br>Health education sessions delivered over the course of 6,  45 minute sessions delivered via telehealth. | Behavioral: Physical Health Education Training (PHET)<br>* Health education provides information on the importance and benefits of and guidelines for living a healthy lifestyle.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change in loneliness | 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. | baseline to 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change in number of days of opioid use | Participants will complete a calendar indicating the type and frequency of drug use. | baseline to 2 months | 
| Mean change in percent days abstinent | Participants will complete a calendar indicating the type and frequency of drug use. | baseline to 2 months | 
| Mean change in social interactions | 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. | baseline to 2 months | 
| Mean change in depression | Depression will be measured using the PROMIS tool. The scores range from 4-20 with higher scores indicating worse outcome. | baseline to 2 months | 
| Mean change in anxiety | Anxiety will be measured using the PROMIS tool. The scores range from 4-20 with higher scores indicating worse outcome. | baseline to 2 months |