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OpenTrials
Completed

NCT Number: NCT04938492

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.

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Key information

Conditions

Opioid Use Loneliness

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Rochester Medical Center

Rochester, New York, 14642, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cognitive Behavioral Therapy for loneliness (CBT-L)

Behavioral

6 sessions focused on addressing thoughts, emotions, and behaviors that maintain feeling alone as a way to reduce loneliness and substance use.

Physical Health Education Training (PHET)

Behavioral

Health education provides information on the importance and benefits of and guidelines for living a healthy lifestyle.

Primary outcomes

  1. Mean Change in Loneliness

    Time frame: 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 outcomes

  1. Mean Change in Percent Days Abstinent From Opioids

    Time frame: baseline to 2 months post-treatment

    Participants will complete a calendar indicating the type and frequency of drug use.

  2. Mean Change in Percent Days Abstinent From Other Drugs

    Time frame: baseline to 2 months

    Participants will complete a calendar indicating the type and frequency of drug use.

  3. Mean Change in Social Support

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Rochester

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Jun 24, 2021
Registry last updated
Feb 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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