Clinical trial NCT04871100: 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
Overall status: RECRUITING
Phase: NA
Conditions: Anxiety Disorder
Posttraumatic Stress Disorder
Hazardous Drinking
Keywords: Veterans
anxiety
Stress Disorders, Post-Traumatic
Alcohol Drinking
psychosocial functioning
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2021-05-04
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomized to receive the intervention or a control intervention.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Social Adjustment Scale- Self Report
timeFrame: 2-weeks
measure: Beck Anxiety Inventory
timeFrame: past 30 days
measure: Addiction Severity Index
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: Michael E. DeBakey VA Medical Center, Houston, TX
state: Texas
Study officials:
affiliation: Michael E. DeBakey VA Medical Center, Houston, TX
name: Anthony Ecker, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ecker AH, Amspoker AB, Johnston W, Walder A, Lindsay JA, Hogan JB. The role of depression and anxiety symptom severity in remotely delivered mental health care. Psychol Serv. 2024 Feb;21(1):42-49. doi: 10.1037/ser0000775. Epub 2023 Jun 22.