Back to resultsIntegrated CBT to Improve Functioning in Veterans With Anxiety and Substance Use
Primary Purpose
Anxiety Disorder, Posttraumatic Stress Disorder, Hazardous Drinking
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Unified Protocol- Alcohol
Problem Solving therapy
Sponsored by
About this trial
This is an interventional treatment trial for Anxiety Disorder focused on measuring Veterans, anxiety, Stress Disorders, Post-Traumatic, Alcohol Drinking, psychosocial functioning
Eligibility Criteria
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
Sites / Locations
- Michael E. DeBakey VA Medical Center, Houston, TXRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
UP-A
Problem Solving therapy
Arm Description
Cognitive behavior therapy using the Unified Protocol for Emotional Disorders with supplemental skills-based alcohol modules.
Skills based approach for managing negative moods and stress.
Outcomes
Primary Outcome Measures
Social Adjustment Scale- Self Report
Evaluates individuals' satisfaction with social situation. Greater scores reflect greater social/occupational impairment (range 42-210).
Beck Anxiety Inventory
Evaluates levels of anxiety in past month. Higher scores reflect greater anxiety (range 0-63).
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).
Secondary Outcome Measures
Full Information
NCT ID
NCT04871100
First Posted
April 28, 2021
Last Updated
March 8, 2023
Sponsor
VA Office of Research and Development
1. Study Identification
Unique Protocol Identification Number
NCT04871100
Brief Title
Integrated CBT to Improve Functioning in Veterans With Anxiety and Substance Use
Official Title
Addressing Mental Health Comorbidities: Integrated CBT to Improve Functioning in Veterans With Co-Occurring Anxiety and Substance Use
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2023 (Actual)
Primary Completion Date
October 1, 2025 (Anticipated)
Study Completion Date
October 1, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety Disorder, Posttraumatic Stress Disorder, Hazardous Drinking
Keywords
Veterans, anxiety, Stress Disorders, Post-Traumatic, Alcohol Drinking, psychosocial functioning
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants will be randomized to receive the intervention or a control intervention.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
UP-A
Arm Type
Experimental
Arm Description
Cognitive behavior therapy using the Unified Protocol for Emotional Disorders with supplemental skills-based alcohol modules.
Arm Title
Problem Solving therapy
Arm Type
Active Comparator
Arm Description
Skills based approach for managing negative moods and stress.
Intervention Type
Behavioral
Intervention Name(s)
Unified Protocol- Alcohol
Intervention Description
Transdiagnostic cognitive behavior therapy for emotional disorders modified to include CBT for alcohol use.
Intervention Type
Behavioral
Intervention Name(s)
Problem Solving therapy
Intervention Description
Skills based approach for managing negative moods and stress.
Primary Outcome Measure Information:
Title
Social Adjustment Scale- Self Report
Description
Evaluates individuals' satisfaction with social situation. Greater scores reflect greater social/occupational impairment (range 42-210).
Time Frame
2-weeks
Title
Beck Anxiety Inventory
Description
Evaluates levels of anxiety in past month. Higher scores reflect greater anxiety (range 0-63).
Time Frame
past 30 days
Title
Addiction Severity Index
Description
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).
Time Frame
30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anthony Ecker, PhD
Phone
(713) 440-4400
Email
anthony.ecker@va.gov
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anthony Ecker, PhD
Organizational Affiliation
Michael E. DeBakey VA Medical Center, Houston, TX
Official's Role
Principal Investigator
Facility Information:
Facility Name
Michael E. DeBakey VA Medical Center, Houston, TX
City
Houston
State/Province
Texas
ZIP/Postal Code
77030-4211
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anthony Ecker, PhD
Phone
713-440-4400
Email
anthony.ecker@va.gov
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Integrated CBT to Improve Functioning in Veterans With Anxiety and Substance Use
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