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Recruiting NCT05843695

Enhancing Psychotherapy for Veterans and Service Members With PTSD and Anxiety

Trial Parameters

Condition Posttraumatic Stress Disorder
Sponsor Baylor College of Medicine
Study Type INTERVENTIONAL
Phase N/A
Enrollment 306
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2023-09-22
Completion 2027-03-30
Interventions
iTCBT-IiTCBT-GTAU

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

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