Substance Use and Loneliness

Addressing Loneliness and Substance Use With Telehealth CBT

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.

Study Overview

• Status: Completed
• Conditions: Substance Use Disorders
• Intervention / Treatment: Behavioral: CBT for Loneliness; Behavioral: CBT for Substance Use Disorder

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Canandaigua, New York, United States, 14424-1159
      • VA Finger Lakes Healthcare System, Canandaigua, NY

Participation Criteria

Eligibility Criteria

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

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CBT for Loneliness; CBT focused on social relationships and loneliness delivered over the course of 8, ~45 minute sessions delivered via telehealth.	Behavioral: CBT for Loneliness; CBT focused on social relationships and loneliness delivered over the course of 8, ~45 minute sessions delivered via telehealth.
Active Comparator: CBT for Substance Use Disorder; CBT focused on substance use disorders delivered over the course of 8, ~45 minute sessions delivered via telehealth.	Behavioral: CBT for Substance Use Disorder; CBT focused on substance use disorders delivered over the course of 8, ~45 minute sessions delivered via telehealth.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Change in Loneliness From Baseline to 1-month Post-treatment Follow-up	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 1-month post-treatment follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Change in Number of Days of Substance Use From Baseline to 1-month Post-treatment Follow-up	Participants will complete a calendar indicating the type and frequency of substance use.	baseline to 1-month post-treatment follow-up
Mean Change in Percent Days Abstinent From Baseline to 1-month Post-treatment Follow-up	Participants will complete a calendar indicating the type and frequency of substance use	baseline to 1-month post-treatment follow-up
Mean Change in Social Interactions Baseline to 1-month Post-treatment Follow-up	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 1-month post-treatment follow-up

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Change in Depression Baseline to 1-month Post-treatment Follow-up	Depression will be measured using the PROMIS tool. The scores range from 4-20 with higher scores indicating worse outcome.	baseline to 1-month post-treatment follow-up
Mean Change in Anxiety Baseline to 1-month Post-treatment Follow-up	Anxiety will be measured using the PROMIS tool. The scores range from 4-20 with higher scores indicating worse outcome.	baseline to 1-month post-treatment follow-up

Collaborators and Investigators

• Sponsor: VA Office of Research and Development
• Investigators: Principal Investigator: Lisham Ashrafioun, PhD, VA Finger Lakes Healthcare System, Canandaigua, NY

Study record dates

Study Major Dates

• Study Start (Actual): September 30, 2022
• Primary Completion (Actual): December 31, 2024
• Study Completion (Actual): December 31, 2024

Study Registration Dates

• First Submitted: April 13, 2022
• First Submitted That Met QC Criteria: April 13, 2022
• First Posted (Actual): April 21, 2022

Study Record Updates

• Last Update Posted (Actual): February 18, 2026
• Last Update Submitted That Met QC Criteria: February 4, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Loneliness; drug use; Substance use disorders; social isolation
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Behavior; Social Behavior; Substance-Related Disorders; Social Isolation
• Other Study ID Numbers: PPO 21-074

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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