CBT for Anxiety and Substance Use in Veterans

Overseen By Anthony Ecker, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Disqualifiers: High-risk suicidality, psychotic symptoms, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 8-12 weeks

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to help veterans who struggle with anxiety and PTSD (post-traumatic stress disorder) and use alcohol in potentially harmful ways. The study tests a special kind of talk therapy, called cognitive behavioral therapy (CBT), to address both anxiety and alcohol use simultaneously. Participants will receive either referrals for usual care or a new therapy program, called Problem Solving Therapy, which combines emotional support with strategies to manage alcohol use. Veterans with an anxiety disorder who drink alcohol in risky ways might be a good fit for this trial. As an unphased trial, this study offers veterans a unique opportunity to explore innovative therapy options that could improve their quality of life.

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 doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that the Unified Protocol (UP), a type of cognitive-behavioral therapy, is generally easy for patients to handle. In studies with adults, this therapy reduced symptoms of anxiety and other emotional issues, indicating its safe use for anxiety and alcohol use problems.

A review of the Unified Protocol found it effective for treating various anxiety disorders. No major side effects were reported, suggesting it is safe for most people. The treatment targets common issues across different emotional disorders, making it versatile and helpful for those facing multiple challenges.

Overall, evidence indicates that the Unified Protocol is a safe and effective treatment option for those dealing with anxiety and alcohol use issues. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the CBT treatments being tested for anxiety and substance use in veterans because they take a unique approach by integrating mental health and substance abuse care. Unlike standard treatments that often address anxiety and substance use separately, the Unified Protocol - Alcohol (UP-A) combines cognitive behavioral therapy techniques with specialized modules for alcohol use, aiming to treat both conditions simultaneously. This comprehensive method could offer more cohesive and effective care, potentially leading to improved outcomes for veterans struggling with these intertwined challenges.

What evidence suggests that this trial's treatments could be effective for anxiety and substance use in veterans?

Research has shown that the Unified Protocol, a type of talk therapy, effectively treats emotional problems. In this trial, participants may receive the Unified Protocol for Emotional Disorders with supplemental skills-based alcohol modules (UP-A). Studies have found that it reduces symptoms like anxiety and depression. Recipients of this therapy reported significant overall improvement. The therapy aids in managing emotions, which can also foster healthier habits around alcohol use. By addressing both emotional issues and alcohol use, it aims to support long-term improvements in well-being. ^{1 2 4 5 6}

Who Is on the Research Team?

Anthony Ecker, PhD

Principal Investigator

Michael E. DeBakey VA Medical Center, Houston, TX

Are You a Good Fit for This Trial?

This trial is for Veterans who have an anxiety disorder and engage in hazardous alcohol use but don't need immediate detox. It's not suitable for those at high risk of suicide, with cognitive impairments that affect therapy participation, or experiencing psychotic symptoms.

Inclusion Criteria

I have been diagnosed with an anxiety disorder and I use alcohol in a way that may be harmful.

Exclusion Criteria

My thinking or memory problems do not prevent me from participating in weekly therapy.

I have experienced symptoms like hallucinations or delusions.

-need for acute medically-supervised detoxification with exclusionary criteria of high-risk suicidality

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive cognitive behavioral therapy using the Unified Protocol for Emotional Disorders with supplemental skills-based alcohol modules

8-12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Problem Solving therapy
• Unified Protocol- Alcohol

Trial Overview The study tests a cognitive behavioral therapy program called the Unified Protocol-Alcohol alongside Problem Solving Therapy to see if it can improve functioning in Veterans by addressing anxiety, PTSD, and problem drinking together.

How Is the Trial Designed?

Group I: UP-A Experimental Treatment 1 Intervention

Cognitive behavior therapy using the Unified Protocol for Emotional Disorders with supplemental skills-based alcohol modules.

Group II: Enhanced Usual Care Active Control 1 Intervention

referrals to VA care for SUD and anxiety

Problem Solving therapy is already approved in United States, European Union for the following indications:

Approved in United States as Problem Solving Therapy for:

• Anxiety disorders
• Post-traumatic stress disorder (PTSD)
• Substance use disorders

Approved in European Union as Problem Solving Therapy for:

• Anxiety disorders
• Depression
• Substance use disorders

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Published Research Related to This Trial

Problem-Solving Therapy (PST) is as effective as other psychosocial therapies and medications for reducing depressive symptoms, based on a meta-analysis of 21 independent studies.

PST shows greater effectiveness when it includes training in a positive problem orientation and all four major problem-solving skills, suggesting that a comprehensive approach enhances its therapeutic impact.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Problem-solving therapy for depression: a meta-analysis. Bell, AC., D'Zurilla, TJ.[2022]

In a study involving 291 patients with various anxiety and depression disorders, the group-delivered Unified Protocol (UP) showed non-inferior efficacy compared to diagnosis-specific cognitive behavioral therapy (dCBT) at the end of treatment, indicating it can be an effective alternative.

Both treatment approaches resulted in similar client satisfaction and outcomes regarding response, remission, and attrition rates, suggesting that UP could be a practical option for outpatient mental health services, although further research is needed on its long-term effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transdiagnostic versus Diagnosis-Specific Group Cognitive Behavioral Therapy for Anxiety Disorders and Depression: A Randomized Controlled Trial. Reinholt, N., Hvenegaard, M., Christensen, AB., et al.[2022]

The pilot program training for Department of Defense providers in problem-solving training (PST) significantly increased their self-efficacy in delivering the intervention, indicating that they felt more confident in their ability to help service members manage distress (p < 0.001).

Service members who participated in the PST intervention (n = 435) reported significant reductions in distress and improvements in resilience and coping skills, as evidenced by declines in Outcome Questionnaire-30 and Patient Health Questionnaire-9 scores, and increases in Brief Resilience Scale and Social Problem Solving Inventory scores (all p < 0.001).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Military Health Provider Training and Evaluation of a Problem-Solving Intervention to Reduce Distress and Enhance Readiness Among Service Members. Cooper, DC., Bates, MJ.[2020]

Problem-solving therapy (PST) was effective in reducing suicide risk in two older adults with anxiety disorders, demonstrating its potential as a treatment option for this population.

Both individuals showed significant decreases in anxiety, worry, and depressive symptoms after completing six sessions of PST, suggesting that this therapy can improve overall mental health in older adults at risk for suicide.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Case Report of Problem Solving Therapy for Reducing Suicide Risk in Older Adults with Anxiety Disorders. Lutz, J., Mashal, N., Kramer, A., et al.[2022]

The study found that early service leavers among UK veterans showed the most significant improvement in anxiety and depression symptoms after receiving psychological therapy, indicating that this subgroup may respond better to treatment.

In contrast, veterans with physical disabilities or substance/alcohol misuse issues experienced less improvement, suggesting that tailored therapeutic approaches may be necessary for these groups to enhance treatment efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Demographic and clinical characteristics of UK military veterans attending a psychological therapies service. Giebel, CM., Clarkson, P., Challis, D.[2020]

The Unified Protocol (UP) is a transdiagnostic cognitive-behavioral therapy designed to address various anxiety and mood disorders by focusing on common emotional components.

Key strategies in the UP include increasing emotional awareness, encouraging repeated practice, and providing corrective experiences, all of which are supported by research to facilitate effective treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intervention strategies and clinical process in transdiagnostic cognitive-behavioral therapy. Boswell, JF.[2019]

The Unified Protocol (UP) showed the greatest effectiveness in reducing anxiety and depression symptoms among trauma-exposed veterans, with significant decreases in self-reported measures and a notable reduction in the number of comorbid diagnoses.

In a study involving 37 veterans, the UP outperformed both Presented Centered Therapy (PCT) and Treatment as Usual (TAU), demonstrating large effect sizes for improvements in psychosocial functioning and emotional disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A pilot randomized effectiveness trial of the unified protocol in trauma-exposed veterans. Gutner, CA., Song, J., Canale, CA., et al.[2023]

The Unified Protocol (UP) is an emotion-focused cognitive-behavioral treatment that is being tested in an ongoing randomized controlled trial, showcasing its potential as a transdiagnostic approach for various emotional disorders.

The case example demonstrates how the UP's modular structure allows for tailored treatment, applying specific principles to address the individual needs of the patient, which may enhance its effectiveness across different diagnoses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Development of the Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders: A Case Study. Boisseau, CL., Farchione, TJ., Fairholme, CP., et al.[2022]

A new integrated treatment combining Motivational Interviewing and Cognitive Behaviour Therapy for individuals with both Social Anxiety Disorder and Alcohol Use Disorder is being tested in a randomized controlled trial, which aims to improve outcomes compared to standard treatment for alcohol use alone.

The trial will assess the effectiveness of this integrated approach over 9 sessions, with follow-up evaluations at 3 and 6 months to measure changes in alcohol consumption and social anxiety symptoms, addressing a significant gap in existing treatment options.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An investigator-blinded, randomized study to compare the efficacy of combined CBT for alcohol use disorders and social anxiety disorder versus CBT focused on alcohol alone in adults with comorbid disorders: the Combined Alcohol Social Phobia (CASP) trial protocol. Baillie, AJ., Sannibale, C., Stapinski, LA., et al.[2022]

Citations

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The Unified Protocol for Transdiagnostic Treatment ... In this randomized clinical equivalence trial of 223 adults, treatment with the Unified Protocol produced reductions in symptom severity for 4 ...

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A systematic review and meta-analysis of the Unified ... This current systematic review and meta-analysis evaluated the treatment efficacy of the Unified Protocol for Transdiagnostic Treatment of Emotional Disorders ...

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