The Association Between Loneliness and Substance Use

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

Study Overview

• Status: Completed
• Conditions: Loneliness; Opioid Use
• Intervention / Treatment: Behavioral: Cognitive Behavioral Therapy for loneliness (CBT-L); Behavioral: Physical Health Education Training (PHET)

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 Type: Interventional
• Enrollment (Actual): 125
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Rochester, New York, United States, 14642
      • University of Rochester Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Rochester
• Collaborators: National Institute on Drug Abuse (NIDA)

Study record dates

Study Major Dates

• Study Start (Actual): August 12, 2021
• Primary Completion (Actual): July 1, 2023
• Study Completion (Actual): July 1, 2023

Study Registration Dates

• First Submitted: June 16, 2021
• First Submitted That Met QC Criteria: June 16, 2021
• First Posted (Actual): June 24, 2021

Study Record Updates

• Last Update Posted (Actual): August 14, 2023
• Last Update Submitted That Met QC Criteria: August 7, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders
• Other Study ID Numbers: STUDY00005387

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Participant data is available upon request as part of scientific collaboration.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No