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

NCT ID: NCT04871100

Last Updated: 2025-10-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-01

Study Completion Date

2026-10-01

Brief Summary

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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

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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.

Conditions

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Anxiety Disorder Posttraumatic Stress Disorder Hazardous Drinking

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

TREATMENT

Blinding Strategy

NONE

Study Groups

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UP-A

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

Group Type EXPERIMENTAL

Unified Protocol- Alcohol

Intervention Type BEHAVIORAL

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

Enhanced Usual Care

referrals to VA care for SUD and anxiety

Group Type ACTIVE_COMPARATOR

Usual care

Intervention Type BEHAVIORAL

referrals to VA care for SUD and anxiety

Interventions

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Unified Protocol- Alcohol

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

Intervention Type BEHAVIORAL

Usual care

referrals to VA care for SUD and anxiety

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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VA Office of Research and Development

FED

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Anthony Ecker, PhD

Role: PRINCIPAL_INVESTIGATOR

Michael E. DeBakey VA Medical Center, Houston, TX

Locations

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Michael E. DeBakey VA Medical Center, Houston, TX

Houston, Texas, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Anthony Ecker, PhD

Role: CONTACT

(713) 440-4400

Facility Contacts

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Anthony Ecker, PhD

Role: primary

713-440-4400

References

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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.

Reference Type RESULT
PMID: 37347915 (View on PubMed)

Ecker AH, Cucciare MA, Lindsay JA. Overcoming barriers to care for Alcohol Use Disorder: Pathways for change. J Hosp Med. 2025 May;20(5):528-529. doi: 10.1002/jhm.13554. Epub 2024 Nov 14. No abstract available.

Reference Type RESULT
PMID: 39542875 (View on PubMed)

Haskins C, Amspoker AB, Walder A, Hogan J, Ecker A, Lindsay J, Shore J. Telehealth Buprenorphine Initiation for Opioid Use Disorder Among American Indian and Alaska Native Veterans, April 2017-March 2023. Telemed J E Health. 2025 Jul 10. doi: 10.1089/tmj.2025.0038. Online ahead of print.

Reference Type RESULT
PMID: 40637596 (View on PubMed)

Other Identifiers

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1IK2RX003520-01A2

Identifier Type: NIH

Identifier Source: secondary_id

View Link

D3520-W

Identifier Type: -

Identifier Source: org_study_id

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