Intensive CBT for PTSD
Trial Summary
What is the purpose of this trial?
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.
Do I have to stop taking my current medications for the trial?
The trial does not specify if you need to stop taking your current medications, but you must be stable on psychotropic medication for 4 weeks before participating. This suggests you can continue your current medications if they have been stable for that period.
What data supports the effectiveness of the treatment Intensive CBT for PTSD?
Research shows that intensive cognitive therapy for PTSD is as effective as weekly treatment, and cognitive-behavioral therapy (CBT) significantly improves PTSD symptoms, especially in those with severe PTSD. Additionally, intensive outpatient programs for PTSD, which include trauma-focused therapies, have high completion rates and effectively reduce PTSD symptoms.12345
Is intensive CBT for PTSD safe for humans?
How is Intensive CBT for PTSD different from other treatments for PTSD?
Intensive CBT for PTSD, including iTCBT-G and iTCBT-I, is unique because it offers a concentrated and focused approach to therapy, often involving multiple sessions over a short period, which can lead to faster symptom reduction and improved treatment retention compared to traditional, less intensive therapies.24679
Eligibility Criteria
This trial is for veterans and service members over 18 with an anxiety disorder like PTSD, panic disorder, or social anxiety. They should have moderate-to-poor life satisfaction and be stable on any psychotropic medication for at least 4 weeks. Participants must be open to random treatment assignment.Inclusion Criteria
Exclusion Criteria
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive iTCBT in either individual or group formats. Individual format involves 12 hours over 2 weeks, while group format involves 12 hours over 2 days.
Enhanced Treatment
For treatment non-responders, 4 additional 90-minute individual therapy sessions are provided over 2 weeks.
Follow-up
Participants are monitored for changes in anxiety and quality of life at 3- and 6-month intervals.
Treatment Details
Interventions
- iTCBT-G (Behavioral Intervention)
- iTCBT-I (Behavioral Intervention)
- TAU (Behavioral Intervention)
- Transdiagnostic Cognitive Behavioral Therapy (Behavioral Intervention)
iTCBT-G is already approved in United States, European Union for the following indications:
- Post-Traumatic Stress Disorder (PTSD)
- Anxiety Disorders
- Post-Traumatic Stress Disorder (PTSD)
- Anxiety Disorders