NCT05843695 Enhancing Psychotherapy for Veterans and Service Members With PTSD and Anxiety
| NCT ID | NCT05843695 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Baylor College of Medicine |
| Condition | Posttraumatic Stress Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 306 participants |
| Start Date | 2023-09-22 |
| Primary Completion | 2027-03-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 306 participants in total. It began in 2023-09-22 with a primary completion date of 2027-03-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: * Veteran/Service Member at least 18 years old * Current diagnosis of at least one anxiety-based disorder: Posttraumatic Stress Disorder, Panic Disorder, Social Anxiety Disorder, Generalized Anxiety Disorder, Other Specified Trauma- and Stressor-Related Disorder, Other Specified Anxiety Disorder, and Unspecified Anxiety Disorder (based on ADIS-5) * Moderate-to-poor life enjoyment and satisfaction as indicated by a score of 47 or lower on the QLES-Q-SF * Stable on psychotropic medication for 4 weeks before study participation * Willing to be randomized to treatment condition Exclusion Criteria: * Active symptoms of mania or psychosis at baseline (based on ADIS-5) * Depression with active suicidal ideation and intent that would preclude treatment (based on ADIS-5 \& BDI-II) * Moderate-to-severe cognitive impairment as indicated by the SLUMS (a score below 20) * Veterans/Service Members with comorbid substance/alcohol use or dependence are study eligible but must agree to reduce and limit their use of substances during the active course of treatment, particularly during exposure exercises. If they do not agree to this, they will be excluded * Undergoing concurrent transdiagnostic CBT specifically targeting any of the above-mentioned disorders
Contact & Investigator
Ellen Teng, PhD
PRINCIPAL INVESTIGATOR
Michael E. DeBakey VA Medical Center
Frequently Asked Questions
Who can join the NCT05843695 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Posttraumatic Stress Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05843695 currently recruiting?
Yes, NCT05843695 is actively recruiting participants. Contact the research team at eteng@bcm.edu for enrollment information.
Where is the NCT05843695 trial being conducted?
This trial is being conducted at Houston, United States.
Who is sponsoring the NCT05843695 clinical trial?
NCT05843695 is sponsored by Baylor College of Medicine. The principal investigator is Ellen Teng, PhD at Michael E. DeBakey VA Medical Center. The trial plans to enroll 306 participants.