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

Sponsor

VA Office of Research and Development (U.S. Fed)

Overall Status

Not yet recruiting

CT.gov ID

NCT04871100

Collaborator

(none)

Enrollment

Location

Arms

47.9

Anticipated Duration (Months)

0.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Anxiety Disorder Posttraumatic Stress Disorder Hazardous Drinking	Behavioral: Unified Protocol- Alcohol Behavioral: Problem Solving therapy	Early Phase 1

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 Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Participants will be randomized to receive the intervention or a control intervention.Participants will be randomized to receive the intervention or a control intervention.

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Oct 3, 2022

Anticipated Primary Completion Date :

Oct 1, 2025

Anticipated Study Completion Date :

Oct 1, 2026

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: UP-A

Cognitive behavior therapy using the Unified Protocol for Emotional Disorders with supplemental skills-based alcohol modules.

Behavioral: Unified Protocol- Alcohol

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

Active Comparator: Problem Solving therapy

Skills based approach for managing negative moods and stress.

Behavioral: Problem Solving therapy

Skills based approach for managing negative moods and stress.

Outcome Measures

Primary Outcome Measures

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).
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).