Enhancing Psychotherapy for Veterans and Service Members With PTSD and Anxiety
NCT05843695 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 306
Last updated 2026-02-03
Summary
The goal of this clinical trial is to compare two different intensive formats of delivering cognitive-behavioral treatment for people with PTSD and anxiety disorders. The main questions it aims to answer are:
* Is iTCBT delivered in individual and group formats more effective than TAU in improving anxiety symptoms and quality of life?
* For treatment non-responders, is iTCBT-Enhanced more effective than TAU improving anxiety symptoms and quality of life?
* Does iTCBT-Individual produce a larger improvement in anxiety and quality of life compared with iTCBT-Group?
Participants will undergo several assessments throughout the course of the study. Based on randomization, they will receive: (1) iTCBT in an individual format over a 2-week period, (2) iTCBT in a group format over a 2-day period, or (3) usual care. Those who do not show a response to treatment will receive 4 additional individual therapy sessions.
Conditions
- Posttraumatic Stress Disorder
- Anxiety Disorders
Interventions
- BEHAVIORAL
-
iTCBT-I
Individual format over 2 weeks
- BEHAVIORAL
-
iTCBT-G
Group format over 2 days
- BEHAVIORAL
-
TAU
Standard care
Sponsors & Collaborators
-
United States Department of Defense
collaborator FED -
Baylor College of Medicine
lead OTHER
Principal Investigators
-
Ellen Teng, PhD · Michael E. DeBakey VA Medical Center
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-09-22
- Primary Completion
- 2027-03-30
- Completion
- 2027-03-30
Countries
- United States
Study Locations
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