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Principal Investigator: LISHAM ASHRAFIOUN
Organization: VETERANS AFFAIRS, UNITED STATES DEPARTMENT OF
Fiscal Year: 2024
Funding agency: Veterans Affairs
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. Our 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: We 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: We 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). We will assess: (1) treatment
acceptability, (2) participant adherence to treatment, and (3) therapist fidelity. We 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, we 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.
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