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NCT04871100 Clinical Trial

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

Posttraumatic Stress Disorder Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04871100
Other study ID # D3520-W
Secondary ID 1IK2RX003520-01A
Status Recruiting
Phase N/A
First received
Last updated
Start date March 1, 2023
Est. completion date October 1, 2026

Study information
Verified date February 2024
Source VA Office of Research and Development
Contact Anthony Ecker, PhD
Phone (713) 440-4400
Email anthony.ecker@va.gov
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 40
Est. completion date October 1, 2026
Est. primary completion date October 1, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Behavioral:
• Unified Protocol- Alcohol
Transdiagnostic cognitive behavior therapy for emotional disorders modified to include CBT for alcohol use.
• Problem Solving therapy
Skills based approach for managing negative moods and stress.

Locations
Country Name City State
United States Michael E. DeBakey VA Medical Center, Houston, TX Houston Texas

Sponsors (1)
Lead Sponsor Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Social Adjustment Scale- Self Report Evaluates individuals' satisfaction with social situation. Greater scores reflect greater social/occupational impairment (range 42-210). 2-weeks
Primary Beck Anxiety Inventory Evaluates levels of anxiety in past month. Higher scores reflect greater anxiety (range 0-63). past 30 days
Primary 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
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