CBT for Loneliness for Substance Use Disorders (SUD)

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Canandaigua VA Medical Center, Canandaigua, NY, Canandaigua, NY
Substance Use Disorders (SUD)+1 More
CBT for Loneliness - Behavioral
Eligibility
18+
All Sexes
What conditions do you have?
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Study 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.

Eligible Conditions

  • Substance Use Disorders (SUD)

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 3 Secondary · Reporting Duration: baseline to 1-month post-treatment

baseline to 1-month post-treatment
Mean change in anxiety
Mean change in depression
Mean change in loneliness
Mean change in number of days of substance use
Mean change in percent days abstinent
Mean change in social interactions

Trial Safety

Safety Progress

1 of 3

Trial Design

2 Treatment Groups

Health Education
1 of 2
CBT for Loneliness
1 of 2
Active Control
Experimental Treatment

36 Total Participants · 2 Treatment Groups

Primary Treatment: CBT for Loneliness · No Placebo Group · Phase 1

CBT for Loneliness
Behavioral
Experimental Group · 1 Intervention: CBT for Loneliness · Intervention Types: Behavioral
Health Education
Behavioral
ActiveComparator Group · 1 Intervention: Health Education · Intervention Types: Behavioral

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline to 1-month post-treatment
Closest Location: Canandaigua VA Medical Center, Canandaigua, NY · Canandaigua, NY
Photo of new york 1Photo of new york 2Photo of new york 3
2016First Recorded Clinical Trial
1 TrialsResearching Substance Use Disorders (SUD)
3 CompletedClinical Trials

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor
1,459 Previous Clinical Trials
2,748,877 Total Patients Enrolled
20 Trials studying Substance Use Disorders (SUD)
4,498 Patients Enrolled for Substance Use Disorders (SUD)
Lisham Ashrafioun, PhDPrincipal InvestigatorCanandaigua VA Medical Center, Canandaigua, NY
2 Previous Clinical Trials
348 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 5 Total Inclusion Criteria

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About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.