NCT04871100

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
5mo left

Started Mar 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress89%
Mar 2023Oct 2026

First Submitted

Initial submission to the registry

April 28, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 4, 2021

Completed
1.8 years until next milestone

Study Start

First participant enrolled

March 1, 2023

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 29, 2026

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2026

Last Updated

October 9, 2025

Status Verified

October 1, 2025

Enrollment Period

3.2 years

First QC Date

April 28, 2021

Last Update Submit

October 7, 2025

Conditions

Anxiety DisorderPosttraumatic Stress DisorderHazardous Drinking

Keywords

VeteransanxietyStress Disorders, Post-TraumaticAlcohol Drinkingpsychosocial functioning

Outcome Measures

Primary Outcomes (3)

  • Social Adjustment Scale- Self Report

    Evaluates individuals' satisfaction with social situation. Greater scores reflect greater social/occupational impairment (range 42-210).

    2-weeks

  • Beck Anxiety Inventory

    Evaluates levels of anxiety in past month. Higher scores reflect greater anxiety (range 0-63).

    past 30 days

  • 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

Study Arms (2)

UP-A

EXPERIMENTAL

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

Behavioral: Unified Protocol- Alcohol

Enhanced Usual Care

ACTIVE COMPARATOR

referrals to VA care for SUD and anxiety

Behavioral: Usual care

Interventions

Unified Protocol- AlcoholBEHAVIORAL

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

UP-A
Usual careBEHAVIORAL

referrals to VA care for SUD and anxiety

Enhanced Usual Care

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • meeting diagnostic criteria for current anxiety disorder and
  • endorsing hazardous alcohol use

You may not qualify if:

  • high-risk suicidality
  • psychotic symptoms, or
  • cognitive impairment that could interfere with engagement in weekly psychotherapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Michael E. DeBakey VA Medical Center, Houston, TX

Houston, Texas, 77030-4211, United States

RECRUITING

Related Publications (3)

  • 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.

    PMID: 37347915RESULT

  • 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.

    PMID: 39542875RESULT

  • 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 Nov;31(11):1333-1341. doi: 10.1089/tmj.2025.0038. Epub 2025 Jul 10.

    PMID: 40637596RESULT

MeSH Terms

Conditions

Anxiety DisordersStress Disorders, Post-TraumaticAlcohol Drinking

Interventions

Ethanol

Condition Hierarchy (Ancestors)

Mental DisordersStress Disorders, TraumaticTrauma and Stressor Related DisordersDrinking BehaviorBehavior

Intervention Hierarchy (Ancestors)

AlcoholsOrganic Chemicals

Study Officials

  • Anthony Ecker, PhD

    Michael E. DeBakey VA Medical Center, Houston, TX

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Anthony Ecker, PhD

CONTACT

(713) 440-4400anthony.ecker@va.gov

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants will be randomized to receive the intervention or a control intervention.
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 28, 2021

First Posted

May 4, 2021

Study Start

March 1, 2023

Primary Completion (Estimated)

May 29, 2026

Study Completion (Estimated)

October 1, 2026

Last Updated

October 9, 2025

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)