An interventional study of CBT for Loneliness and CBT for Substance Use Disorder in Substance Use Disorders, sponsored by VA Office of Research and Development. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-18.
Sponsored by VA Office of Research and Development · Not applicable, Interventional, and Treatment
Among 61 studies in Substance-Related Disorders by VA Office of Research and Development — 14 open to participants now, 17 under way, none of them phase 3. Substance-Related Disorders · VA Office of Research and Development.
Among the 61 studies in Substance-Related Disorders by VA Office of Research and Development, this one is the 49th largest by enrollment of the 59 interventional ones that give a count, is one of 5 that started in 2022, is one of 52 with no phase, and was the 45th registered.
2,238 studies on the registry are indexed under Substance-Related Disorders; 409 are open to participants now.
This study's enrollment of 36 is below the median of 108 across 1,840 interventional studies indexed under Substance-Related Disorders.
Browse Substance-Related Disorders studies →14 of the 61 studies in Substance-Related Disorders by VA Office of Research and Development are open now, in 1 country. Each count lists the studies.
Of the 266 Substance-Related Disorders studies recruiting now, 130 (49%) set no upper age limit and 118 (44%) stop at 75 or younger; 56 take children under 18; 89 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →61 studies; the count open now beside each. This study's row is marked.
First in 2000; this study’s year is marked. 5 started in 2022.
Median enrollment 138 across the 59 interventional studies, 247 across the 2 observational. Of the 43 that completed or were terminated, 38 (88%) have results posted.
VA Office of Research and Development is the lead sponsor of 1,771 studies on the registry; 392 are open to participants now.
Of its 213 completed or terminated interventional studies of FDA-regulated products, 185 (87%) have results posted.
5 of the studies in Substance-Related Disorders by VA Office of Research and Development that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05812131VA Office of Research and DevelopmentCOPEWeb Training for Providers | 2027-01-01 |
| NCT04366531VA Office of Research and DevelopmentSuccessful Transitions and Reintegration Tools for Veterans (START-VETS) | 2027-02-05 |
| NCT05327504VA Office of Research and DevelopmentWritten Exposure Therapy for Veterans With SUD and PTSD | 2027-05-12 |
| NCT05156112VA Office of Research and DevelopmentOSA PAP Treatment for Veterans With SUD and PTSD on Residential Treatment Unit | 2027-05-31 |
| NCT05348317VA Office of Research and DevelopmentDeveloping a Telehealth Model to Improve Treatment Access for Rural Veterans With Substance Use Disorders | 2027-09-30 |
Among the 61 studies in Substance-Related Disorders by VA Office of Research and Development, from their registry updates:
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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 substance use disorders delivered over the course of 8, \~45 minute sessions delivered via telehealth.
Behavioral: CBT for Substance Use Disorder
CBT focused on social relationships and loneliness delivered over the course of 8, \~45 minute sessions delivered via telehealth.
CBT focused on substance use disorders delivered over the course of 8, \~45 minute sessions delivered via telehealth.
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.
Time frame: baseline to 1-month post-treatment follow-up
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.
Time frame: 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
Time frame: 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.
Time frame: baseline to 1-month post-treatment follow-up
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.
Time frame: 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.
Time frame: baseline to 1-month post-treatment follow-up
Potential participants were recruited through a case finding procedure of VHA medical records.
| Milestone | CBT for Loneliness | CBT for Substance Use Disorder |
|---|---|---|
| Started | 20 | 16 |
| Completed | 9 | 5 |
| Not completed | 11 | 11 |
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.
| score on a scale | CBT for Loneliness | CBT for Substance Use Disorder |
|---|---|---|
| Mean Change in Loneliness From Baseline to 1-month Post-treatment Follow-up | -1.38 ± 17.82 | -5.40 ± 3.58 |
Participants will complete a calendar indicating the type and frequency of substance use.
| percentage of days (used/total) | CBT for Loneliness | CBT for Substance Use Disorder |
|---|---|---|
| Mean Change in Number of Days of Substance Use From Baseline to 1-month Post-treatment Follow-up | -1.79 ± 3.74 | -1.75 ± 1.26 |
Participants will complete a calendar indicating the type and frequency of substance use
| percentage of days (abstinent/total) | CBT for Loneliness | CBT for Substance Use Disorder |
|---|---|---|
| Mean Change in Percent Days Abstinent From Baseline to 1-month Post-treatment Follow-up | 5.95 ± 12.74 | 5.83 ± 4.19 |
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.
| units on a scale | CBT for Loneliness | CBT for Substance Use Disorder |
|---|---|---|
| Mean Change in Social Interactions Baseline to 1-month Post-treatment Follow-up | .38 ± 6.05 | 4.00 ± 1.73 |
Depression will be measured using the PROMIS tool. The scores range from 4-20 with higher scores indicating worse outcome.
| units on a scale | CBT for Loneliness | CBT for Substance Use Disorder |
|---|---|---|
| Mean Change in Depression Baseline to 1-month Post-treatment Follow-up | -2.00 ± 6.95 | -2.80 ± 2.17 |
Anxiety will be measured using the PROMIS tool. The scores range from 4-20 with higher scores indicating worse outcome.
| units on a scale | CBT for Loneliness | CBT for Substance Use Disorder |
|---|---|---|
| Mean Change in Anxiety Baseline to 1-month Post-treatment Follow-up | .13 ± 4.45 | -5.80 ± 3.11 |
Collected over from enrollment until end of follow-up (baseline assessment, post-treatment assessment, 1-month follow-up; 8 intervention session; ~3 months). Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| CBT for Loneliness | 0/20 (0%) | 1/20 (5%) | 3/20 (15%) |
| CBT for Substance Use Disorder | 0/16 (0%) | 0/16 (0%) | 1/16 (6.3%) |
| Event | CBT for Loneliness | CBT for Substance Use Disorder |
|---|---|---|
| hospitalization - detoxificationPsychiatric disorders | 1/20 | 0/16 |
| hospitalization - GI issuesGastrointestinal disorders | 1/20 | 0/16 |
| Event | CBT for Loneliness | CBT for Substance Use Disorder |
|---|---|---|
| Increased psychiatric distress/substance usePsychiatric disorders | 3/20 | 1/16 |
| Age, Continuous(Years) | CBT for Loneliness | CBT for Substance Use Disorder | Total |
|---|---|---|---|
| Mean | 44.45 ± 14.0 | 39.81 ± 11.55 | 42.39 ± 13.0 |
| Sex: Female, Male(Participants) | CBT for Loneliness | CBT for Substance Use Disorder | Total |
|---|---|---|---|
| Female | 4 | 4 | 8 |
| Male | 16 | 12 | 28 |
| Race (NIH/OMB)(Participants) | CBT for Loneliness | CBT for Substance Use Disorder | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 1 | 0 | 1 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 6 | 3 | 9 |
| White | 13 | 13 | 26 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Ethnicity (NIH/OMB)(Participants) | CBT for Loneliness | CBT for Substance Use Disorder | Total |
|---|---|---|---|
| Hispanic or Latino | 2 | 2 | 4 |
| Not Hispanic or Latino | 18 | 14 | 32 |
| Unknown or Not Reported | 0 | 0 | 0 |
| UCLA Loneliness Scale(units on a scale) | CBT for Loneliness | CBT for Substance Use Disorder | Total |
|---|---|---|---|
| Mean | 51.3 ± 13.4 | 59.5 ± 9.4 | 55.7 ± 11.7 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Sep 2022 to primary completion in Dec 2024, 27 months.
Results were first posted in Jan 2026, 1 year after primary completion.
Of 814 non-industry interventional studies with no phase under Substance-Related Disorders, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 53. This study's 27 months is below that.
Counting every sponsor, half of 854 studies reached it within 34 months; a quarter within 17 and three quarters within 53.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.
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