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Enhancing Psychotherapy for Veterans and Service Members With PTSD and Anxiety

RecruitingNAAges 18 Years - anyAllBaylor College of Medicine
NCT05843695 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 individ

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📋 Eligibility rules (as published)
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
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What it tests

  • iTCBT-I
  • iTCBT-G
  • TAU
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Where

1 site
Michael E. DeBakey VA Medical Center
Houston, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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