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Substance Use and Loneliness

Primary Purpose

Substance Use Disorders

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
CBT for Loneliness
Health Education
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Substance Use Disorders focused on measuring Loneliness, Substance use disorders, social isolation, drug use

Eligibility Criteria

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

Inclusion Criteria:

  • Participants must be ages 18+,
  • understand English,
  • have access to a phone or computer,
  • screen positive for an active, at least moderate SUD. SUD include alcohol, marijuana, opioids, cocaine, other psychomotor stimulants (methamphetamine, amphetamines), and sedative/hypnotic/anxiolytic use disorders.
  • Participants will need to screen positive for loneliness.

Exclusion Criteria:

-Participant with significant cognitive impairment will be excluded.

Sites / Locations

  • VA Finger Lakes Healthcare System, Canandaigua, NYRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

CBT for Loneliness

Health Education

Arm Description

CBT delivered over the course of 8, ~45 minute sessions delivered via telehealth.

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

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 substance use
Participants will complete a calendar indicating the type and frequency of substance use.
Mean change in percent days abstinent
Participants will complete a calendar indicating the type and frequency of substance 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.

Full Information

First Posted
April 13, 2022
Last Updated
September 8, 2023
Sponsor
VA Office of Research and Development
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1. Study Identification

Unique Protocol Identification Number
NCT05338268
Brief Title
Substance Use and Loneliness
Official Title
Addressing Loneliness and Substance Use With Telehealth CBT
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 30, 2022 (Actual)
Primary Completion Date
February 29, 2024 (Anticipated)
Study Completion Date
February 29, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Background: Loneliness-a subjective emotional state characterized by the perception of social isolation-is a psychosocial factor that is associated with increased mortality, substance use, and is associated with precipitants of relapse among individuals with substance use disorders (SUD). Importantly, there are effective interventions that can be used to decrease loneliness; however, these have not been tested on Veterans with SUD who are lonely. Significance/Impact: Individuals with SUD have higher prevalence of loneliness and loneliness exacerbates pain and sleep disturbance, risk factors of relapse. Without effectively intervening on loneliness, Veterans with SUD will continue to be at high risk of relapse and will maintain problems engaging with social support, including healthcare providers-factors critical for recovery. Cognitive-behavioral therapies (CBT) has shown the strongest effects on loneliness, however, there are no interventions that are specifically designed for substance using populations who are lonely. Testing CBT for loneliness and SUD (CBT-L/SUD) has the potential to have a broad impact on addressing a critical, unmet need that commonly affects Veterans with SUD. The investigators approach of national recruitment and telehealth delivery of this intervention highlights how this this study address VHA care priorities including substance use, access to care, and telehealth. Innovation: There are no studies that have tested a loneliness intervention in Veterans with SUD who are lonely, which may neglect a broader impact on mental and physical health. This study is ideally situated to generate new and important knowledge on the association of loneliness and SUD. This study seeks to address a transdiagnostic factor, which may improve engagement with social support thereby reducing substance use. An additional innovative aspect of this study is recruitment being conducted outside the VHA. This may increase access to care among those Veterans who are especially isolated. Specific Aims: the investigators aim to: (1) refine the CBT-L/SUD manual by conducting a one-arm trial among Veterans with a SUD who report loneliness (n = 6), (2) randomize participants to receive either CBT-L/SUD (n = 15) or CBT-SUD (n = 15) to assess feasibility and acceptability among Veterans with a SUD who report loneliness. Methodology: the investigators will elicit feedback on a draft of the CBT-L/SUD manual then conduct a small single-arm trial (n = 6) for further refinement. Specifically, SUD treatment providers and Veterans with SUD will provide feedback on the draft manual, which the research team will integrate to finalize the manual for a small single-arm trial. This trial will allow us to collect feasibility of treatment delivery, and treatment satisfaction and acceptability data to further refine the manual. With the refined manual Veterans with SUD reporting loneliness will be randomized to either CBT-L/SUD (n = 15) or CBT-SUD (n = 15). The investigators will assess: (1) treatment acceptability, (2) participant adherence to treatment, and (3) therapist fidelity. The investigators will also assess outcome measure completion percentage, means and standard deviations, and level of correlation of repeated measurement of primary loneliness outcomes and secondary substance use outcomes. Implementation/Next Steps: Results from this study will provide critical feasibility and acceptability data to inform an HSR&D Merit Award application to conduct a fully-powered randomized controlled trial. The research team will work with the VA Office of Mental Health and Suicide Prevention and the Substance Use Disorder office of the National Mental Health Program to identify implementation and dissemination efforts. For example, the investigators plan to translate findings into applied practice across various settings (e.g., primary care mental health, rehabilitation treatment programs). Additionally, this intervention may be particularly useful for behavioral telehealth centers that deliver evidence-based interventions to rural and other Veterans who have difficulty accessing VHA care.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Substance Use Disorders
Keywords
Loneliness, Substance use disorders, social isolation, drug use

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Model Description
Participants are randomized to one of two interventions.
Masking
InvestigatorOutcomes Assessor
Masking Description
The outcomes assessors will not know what condition that the participant was allocated to, nor will the statistician who is one of the co-investigators.
Allocation
Randomized
Enrollment
36 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CBT for Loneliness
Arm Type
Experimental
Arm Description
CBT delivered over the course of 8, ~45 minute sessions delivered via telehealth.
Arm Title
Health Education
Arm Type
Active Comparator
Arm Description
Health education provides information on the importance and benefits of and guidelines for living a healthy lifestyle.
Intervention Type
Behavioral
Intervention Name(s)
CBT for Loneliness
Intervention Description
CBT delivered over the course of 8, ~45 minute sessions delivered via telehealth.
Intervention Type
Behavioral
Intervention Name(s)
Health Education
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 1-month post-treatment
Secondary Outcome Measure Information:
Title
Mean change in number of days of substance use
Description
Participants will complete a calendar indicating the type and frequency of substance use.
Time Frame
baseline to 1-month post-treatment
Title
Mean change in percent days abstinent
Description
Participants will complete a calendar indicating the type and frequency of substance use
Time Frame
baseline to 1-month post-treatment
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 1-month post-treatment
Other Pre-specified Outcome Measures:
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 1-month post-treatment
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 1-month post-treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Participants must be ages 18+, understand English, have access to a phone or computer, screen positive for an active, at least moderate SUD. SUD include alcohol, marijuana, opioids, cocaine, other psychomotor stimulants (methamphetamine, amphetamines), and sedative/hypnotic/anxiolytic use disorders. Participants will need to screen positive for loneliness. Exclusion Criteria: -Participant with significant cognitive impairment will be excluded.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lisham Ashrafioun, PhD
Phone
(585) 393-7722
Email
lisham.ashrafioun@va.gov
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lisham Ashrafioun, PhD
Organizational Affiliation
VA Finger Lakes Healthcare System, Canandaigua, NY
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Finger Lakes Healthcare System, Canandaigua, NY
City
Canandaigua
State/Province
New York
ZIP/Postal Code
14424-1159
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lisham Ashrafioun, PhD
Phone
585-393-7722
Email
lisham.ashrafioun@va.gov
First Name & Middle Initial & Last Name & Degree
Lisham Ashrafioun, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

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Substance Use and Loneliness

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