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

Trial Summary

What is the purpose of this trial?

Individual with anxiety and post-traumatic stress disorder often use alcohol in ways that could cause them harm. Treating both mental health concerns and alcohol use at the same time can help reduce difficulties engaging in multiple treatments. The investigators are evaluating how a cognitive behavioral therapy program that helps Veterans with anxiety, posttraumatic stress disorder, and alcohol use at the same time can help improve the participants lives.

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.

What data supports the effectiveness of the treatment Problem Solving Therapy and Unified Protocol for Transdiagnostic Treatment of Emotional Disorders - Alcohol Focus for anxiety and substance use in veterans?

Research shows that Problem Solving Therapy (PST) is effective in reducing depression and managing suicide risk, which suggests it could help with anxiety and substance use. The Unified Protocol (UP) has been shown to be a promising treatment for emotional disorders, including in trauma-exposed veterans, indicating potential benefits for anxiety and substance use. ^{1 2 3 4 5}

Is CBT for Anxiety and Substance Use in Veterans safe?

Problem-Solving Therapy (PST), a form of cognitive-behavioral therapy, has been used safely in various groups, including older adults with anxiety and active duty military personnel, showing promise in reducing distress and suicide risk without reported safety concerns. ^{1 4 5 6 7}

How is the CBT treatment for anxiety and substance use in veterans unique?

This treatment is unique because it combines Problem Solving Therapy (PST) with the Unified Protocol (UP), which is a transdiagnostic approach focusing on emotional disorders. It aims to address both anxiety and substance use by increasing emotional awareness, encouraging repeated practice, and providing corrective experiences, making it more comprehensive than treatments targeting only one disorder. ^{1 2 7 8 9}

Research Team

Anthony Ecker, PhD

Principal Investigator

Michael E. DeBakey VA Medical Center, Houston, TX

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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]

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 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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

A pilot randomized effectiveness trial of the unified protocol in trauma-exposed veterans. [2023]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Transdiagnostic versus Diagnosis-Specific Group Cognitive Behavioral Therapy for Anxiety Disorders and Depression: A Randomized Controlled Trial. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

The Development of the Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders: A Case Study. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Problem-solving therapy for depression: a meta-analysis. [2022]

5. England 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. [2020]

6. United States pubmed.ncbi.nlm.nih.gov

A Case Report of Problem Solving Therapy for Reducing Suicide Risk in Older Adults with Anxiety Disorders. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

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

8. England 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. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Demographic and clinical characteristics of UK military veterans attending a psychological therapies service. [2020]