Integrated CBT to Improve Functioning in Veterans With Anxiety and Substance Use

Study Overview
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Brief Summary
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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.

Detailed Description
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Co-occurring hazardous drinking, anxiety disorders, and PTSD are problematic combinations of mental health concerns experienced by deployed Veterans. Veterans who have been deployed are at particular risk for experiencing problems in functioning and reintegration related to mental health disorders and hazardous drinking. Co-occurring anxiety and hazardous drinking heavily impact psychosocial functioning and quality of life. Although cognitive behavior therapy (CBT) can promote psychological recovery through improvements in functioning and quality of life, most CBT protocols do not address co-occurring disorders, leading to inefficient and disjointed treatment. The current research seeks to adapt and test the Unified Protocol (UP) for deployed Veterans with hazardous drinking. The use of combined CBT for both anxiety disorders and hazardous drinking has the potential to more efficiently and effectively improve functioning, reduce symptoms, and promote psychosocial recovery.

Official Title
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Addressing Mental Health Comorbidities: Integrated CBT to Improve Functioning in Veterans With Co-Occurring Anxiety and Substance Use

Conditions
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Anxiety Disorder, Posttraumatic Stress Disorder, Hazardous Drinking

Intervention / Treatment
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* Behavioral: Unified Protocol- Alcohol
* Behavioral: Problem Solving therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: meeting diagnostic criteria for current anxiety disorder and endorsing hazardous alcohol use Exclusion Criteria: -need for acute medically-supervised detoxification with exclusionary criteria of high-risk suicidality psychotic symptoms, or cognitive impairment that could interfere with engagement in weekly psychotherapy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants will be randomized to receive the intervention or a control intervention.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: UP-A<br>Cognitive behavior therapy using the Unified Protocol for Emotional Disorders with supplemental skills-based alcohol modules. | Behavioral: Unified Protocol- Alcohol<br>* Transdiagnostic cognitive behavior therapy for emotional disorders modified to include CBT for alcohol use.<br>|
| Active Comparator: Problem Solving therapy<br>Skills based approach for managing negative moods and stress. | Behavioral: Problem Solving therapy<br>* Skills based approach for managing negative moods and stress.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Social Adjustment Scale- Self Report | Evaluates individuals' satisfaction with social situation. Greater scores reflect greater social/occupational impairment (range 42-210). | 2-weeks | 
| Beck Anxiety Inventory | Evaluates levels of anxiety in past month. Higher scores reflect greater anxiety (range 0-63). | past 30 days | 
| Addiction Severity Index | Assessment of substance use and related problems. Higher scores in each domain indicate problems related to substance use in that domain (range for each domain 0-1). | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Veterans, anxiety, Stress Disorders, Post-Traumatic, Alcohol Drinking, psychosocial functioning