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The Association Between Loneliness and Substance Use

Primary Purpose

Opioid Use, Loneliness

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cognitive Behavioral Therapy for loneliness (CBT-L)
Physical Health Education Training (PHET)
Sponsored by
University of Rochester
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Opioid Use

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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 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

Sites / Locations

  • University of Rochester Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Cognitive Behavioral Therapy (CBT)

Health Education

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Mean change in number of days of opioid use
Participants will complete a calendar indicating the type and frequency of drug use.
Mean change in percent days abstinent
Participants will complete a calendar indicating the type and frequency of drug use.
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.
Mean change in depression
Depression will be measured using the PROMIS tool. The scores range from 4-20 with higher scores indicating worse outcome.
Mean change in anxiety
Anxiety will be measured using the PROMIS tool. The scores range from 4-20 with higher scores indicating worse outcome.

Full Information

First Posted
June 16, 2021
Last Updated
August 7, 2023
Sponsor
University of Rochester
Collaborators
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT04938492
Brief Title
The Association Between Loneliness and Substance Use
Official Title
The Association Between Loneliness and Substance Use
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
August 12, 2021 (Actual)
Primary Completion Date
July 1, 2023 (Actual)
Study Completion Date
July 1, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Rochester
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opioid Use, Loneliness

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
125 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cognitive Behavioral Therapy (CBT)
Arm Type
Experimental
Arm Description
CBT delivered over the course of 6, ~45 minute sessions delivered via telehealth.
Arm Title
Health Education
Arm Type
Active Comparator
Arm Description
Health education sessions delivered over the course of 6, ~45 minute sessions delivered via telehealth.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Behavioral Therapy for loneliness (CBT-L)
Intervention Description
6 sessions focused on addressing thoughts, emotions, and behaviors that maintain feeling alone as a way to reduce loneliness and substance use.
Intervention Type
Behavioral
Intervention Name(s)
Physical Health Education Training (PHET)
Intervention Description
Health education provides information on the importance and benefits of and guidelines for living a healthy lifestyle.
Primary Outcome Measure Information:
Title
Mean change in loneliness
Description
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.
Time Frame
baseline to 2 months
Secondary Outcome Measure Information:
Title
Mean change in number of days of opioid use
Description
Participants will complete a calendar indicating the type and frequency of drug use.
Time Frame
baseline to 2 months
Title
Mean change in percent days abstinent
Description
Participants will complete a calendar indicating the type and frequency of drug use.
Time Frame
baseline to 2 months
Title
Mean change in social interactions
Description
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.
Time Frame
baseline to 2 months
Title
Mean change in depression
Description
Depression will be measured using the PROMIS tool. The scores range from 4-20 with higher scores indicating worse outcome.
Time Frame
baseline to 2 months
Title
Mean change in anxiety
Description
Anxiety will be measured using the PROMIS tool. The scores range from 4-20 with higher scores indicating worse outcome.
Time Frame
baseline to 2 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
University of Rochester Medical Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Participant data is available upon request as part of scientific collaboration.

Learn more about this trial

The Association Between Loneliness and Substance Use

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