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OpenTrials
Active, Not Recruiting

NCT Number: NCT04871100

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Anxiety Disorder Alcohol Drinking Anxiety Disorders Behavior Drinking Behavior Hazardous Drinking Mental Disorders Posttraumatic Stress Disorder Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma and Stressor Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Michael E. DeBakey VA Medical Center, Houston, TX

Houston, Texas, 77030-4211, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Unified Protocol- Alcohol

Behavioral

Transdiagnostic cognitive behavior therapy for emotional disorders modified to include CBT for alcohol use.

Usual Care

Behavioral

referrals to VA care for SUD and anxiety

Primary outcomes

  1. Social Adjustment Scale- Self Report

    Time frame: 2-weeks

    Evaluates individuals' satisfaction with social situation. Greater scores reflect greater social/occupational impairment (range 42-210).

  2. Beck Anxiety Inventory

    Time frame: past 30 days

    Evaluates levels of anxiety in past month. Higher scores reflect greater anxiety (range 0-63).

  3. Addiction Severity Index

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

VA Office of Research and Development

Fed

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
May 4, 2021
Registry last updated
Jun 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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