The Association Between Loneliness and Substance Use

University of Rochester

Status: Completed

Conditions: Loneliness; Opioid Use

Treatments: Behavioral: Cognitive Behavioral Therapy for loneliness (CBT-L); Behavioral: Physical Health Education Training (PHET)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04938492

STUDY00005387

Details and patient eligibility

About

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

Full 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.

Enrollment: 125 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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125 participants in 2 patient groups

Cognitive Behavioral Therapy (CBT)

Experimental group

Description:

CBT delivered over the course of 6, \~45 minute sessions delivered via telehealth.

Treatment:

Behavioral: Cognitive Behavioral Therapy for loneliness (CBT-L)

Health Education

Active Comparator group

Description:

Health education sessions delivered over the course of 6, \~45 minute sessions delivered via telehealth.

Treatment:

Behavioral: Physical Health Education Training (PHET)