CBT for Substance Use Disorders

No longer recruiting at 1 trial location

Overseen By Lisham Ashrafioun, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Disqualifiers: Cognitive impairment

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 8

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if cognitive-behavioral therapy (CBT) can assist Veterans with substance use disorders (SUD) who also experience loneliness. Researchers are comparing two approaches: CBT specifically targeting loneliness and general health education. The goal is to identify which approach more effectively reduces loneliness and potentially aids with substance use issues. Veterans who may be suitable participants have an active SUD, frequently feel lonely, and need access to a phone or computer for telehealth sessions. As an unphased trial, this study provides Veterans with a unique opportunity to contribute to research that could enhance mental health support for others facing similar challenges.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your healthcare provider.

What prior data suggests that CBT for Loneliness is safe for Veterans with SUD?

Research has shown that cognitive-behavioral therapy (CBT) is generally safe for treating substance use problems. Studies have found that people with various substance use issues usually respond well to CBT. Some mild side effects, such as fatigue or temporary stress, might occur, but these are uncommon and not serious.

In this trial, researchers are adjusting CBT to also address feelings of loneliness alongside substance use issues. Although this specific combination hasn't been widely tested, CBT itself is known to be safe and effective. This suggests that using CBT to address loneliness in people with substance use problems should also be safe.

Overall, existing research supports the safety of CBT, making it a promising option for those considering this trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about CBT for Loneliness because it offers a fresh approach to tackling substance use disorders by addressing loneliness, a common underlying issue. Unlike traditional treatments that focus primarily on the addiction itself, this therapy uses cognitive-behavioral techniques delivered via telehealth to help individuals reshape their thoughts and behaviors around loneliness. This method not only makes treatment more accessible but also targets a root cause that can contribute to substance misuse, potentially leading to more sustainable recovery outcomes.

What evidence suggests that CBT for Loneliness might be an effective treatment for substance use disorders?

Research has shown that cognitive-behavioral therapy (CBT) effectively treats loneliness and substance use disorders (SUD). Many studies have found that CBT can reduce loneliness and assist individuals with various substance use problems. In this trial, one group of participants will receive CBT for Loneliness, delivered over eight approximately 45-minute sessions via telehealth. Another group will receive Health Education, which provides information on the importance and benefits of a healthy lifestyle. One study found that a specific type of CBT, called CBT for perceived social isolation (CBT-PSI), helped address loneliness and opioid use. Additionally, CBT has improved social interactions, which is important for recovering from substance use. Thus, using CBT to address loneliness could be a useful approach for individuals with SUD who also feel lonely. ^{1 3 4 6 7}

Who Is on the Research Team?

Lisham Ashrafioun, PhD

Principal Investigator

VA Finger Lakes Healthcare System, Canandaigua, NY

Are You a Good Fit for This Trial?

This trial is for Veterans aged 18+ with substance use disorders who feel lonely. They must have access to a phone or computer, understand English, and screen positive for loneliness and an active moderate SUD including alcohol, marijuana, opioids, cocaine, stimulants like methamphetamine/amphetamines, or sedatives. Those with significant cognitive impairment cannot participate.

Inclusion Criteria

Participants must screen positive for an active, at least moderate Substance Use Disorder (SUD) including alcohol, marijuana, opioids, cocaine, other psychomotor stimulants (methamphetamine, amphetamines), and sedative/hypnotic/anxiolytic use disorders

Participants must understand English

Participants must have access to a phone or computer

Exclusion Criteria

Participants with significant cognitive impairment will be excluded.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive CBT for Loneliness or CBT-SUD over 8 sessions via telehealth

8 weeks

8 sessions (telehealth)

Follow-up

Participants are monitored for changes in loneliness, social interactions, anxiety, substance use, and depression

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• CBT for Loneliness
• Health Education

Trial Overview The study tests Cognitive-Behavioral Therapy (CBT) tailored for loneliness in individuals with substance use disorders (SUD), comparing it against standard health education. Participants will be randomly assigned to either the specialized CBT for Loneliness/SUD or regular CBT-SUD to evaluate the treatment's feasibility and acceptability.

How Is the Trial Designed?

Group I: CBT for Loneliness Experimental Treatment 1 Intervention

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

Group II: Health Education Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11088495/

A randomized clinical trial to assess feasibility ... These results indicate that CBT-PSI is a feasible, acceptable, and promising intervention to address loneliness and opioid use among individuals with OUD.

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0376871624001893

A randomized clinical trial to assess feasibility ... The purpose of this study was to report on feasibility, acceptability, and initial efficacy data cognitive-behavioral therapy for perceived isolation (CBT-PSI)

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5714654/

Cognitive Behavioral Interventions for Alcohol and Drug ... Multiple meta analyses and reviews over the past 30 years have concluded that CBT is an effective treatment across a range of substance use disorders (Carroll & ...

4. ascpjournal.biomedcentral.com ascpjournal.biomedcentral.com/articles/10.1186/s13722-024-00498-y

Comparing cognitive behavioral therapy and social ... Cognitive behavioral therapy and social prescribing have been shown to be efficacious in reducing loneliness and improving outcomes in other ...

5. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/92/NCT04938492/Prot_SAP_001.pdf

The association between loneliness and substance use Hypothesis: CBT-L will reduce loneliness and negative affect (i.e., depression and anxiety) and will increase the quality and quantity of social interactions ...

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0376871625002091

Cognitive-behavioral interventions for co-occurring ... The current meta-analysis provides an overview of cognitive-behaviorally-based interventions (CBI) that treat co-occurring alcohol and other drug use (AOD)

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11389301/

Comparing cognitive behavioral therapy and social ... The CBT intervention will include education about the connections between loneliness and substance use, practice of behavioral skills for effectively ...