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

Not Applicable

Recruiting

• Conditions: Anxiety Disorder; Posttraumatic Stress Disorder; Hazardous Drinking
• Interventions: Behavioral: Unified Protocol- Alcohol; Behavioral: Problem Solving therapy

• Registration Number: NCT04871100
• Lead Sponsor: VA Office of Research and Development

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2021-04-28
• Study First Submitted QC: 2021-04-28
• Study First Posted: 2021-05-04
• Study Start: 2023-03-01
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-08
• Last Update Posted: 2025-01-10
• Primary Completion: 2025-10-01
• Study Completion: 2026-10-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
UP-A	Unified Protocol- Alcohol	Cognitive behavior therapy using the Unified Protocol for Emotional Disorders with supplemental skills-based alcohol modules.
Problem Solving therapy	Problem Solving therapy	Skills based approach for managing negative moods and stress.

Primary Outcome Measures

Name	Time	Method
Addiction Severity Index	30 days	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).
Social Adjustment Scale- Self Report	2-weeks	Evaluates individuals' satisfaction with social situation. Greater scores reflect greater social/occupational impairment (range 42-210).
Beck Anxiety Inventory	past 30 days	Evaluates levels of anxiety in past month. Higher scores reflect greater anxiety (range 0-63).

Trial Locations

Locations (1)

Michael E. DeBakey VA Medical Center, Houston, TX; 🇺🇸 Houston, Texas, United States