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Intensive CBT for PTSD
N/A
Recruiting
Led By Ellen Teng, PhD
Research Sponsored by Baylor College of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3- and 6-month follow-ups
Awards & highlights
Study Summary
This trial is testing two intensive formats of CBT for people with PTSD & anxiety to compare effectiveness in improving symptoms & quality of life.
Who is the study for?
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.Check my eligibility
What is being tested?
The study compares two intensive cognitive-behavioral therapies (iTCBT) in individual (over 2 weeks) and group formats (over 2 days), against usual care (TAU). It checks which method better improves symptoms of anxiety and quality of life. Non-responders get extra individual sessions.See study design
What are the potential side effects?
While not explicitly listed, side effects may include discomfort from discussing traumatic events, emotional distress during therapy sessions, fatigue after intensive therapy work, potential temporary increase in anxiety levels due to exposure techniques used in CBT.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with an anxiety disorder.
Select...
I score below 47 on a life satisfaction survey.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3- and 6-month follow-ups
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3- and 6-month follow-ups
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Anxiety score on the Beck Anxiety Inventory (BAI) from Baseline to 6-Month Follow-Up between the iTCBT Enhanced (iTCBT-E) condition and TAU.
Change in Anxiety score on the Beck Anxiety Inventory (BAI) from Baseline to 6-Month Follow-Up between the iTCBT conditions (Individual & Group) and TAU.
Change in Quality of Life score on the Quality of Life Enjoyment & Satisfaction Questionnaire Short-Form (QLES-Q-SF) from Baseline to 6-Month Follow-Up between the iTCBT Enhanced (iTCBT-E) condition and TAU.
+1 moreSecondary outcome measures
Magnitude of Change in Anxiety score on the Beck Anxiety Inventory (BAI) from Baseline to 3- and 6-Month Follow-Ups between the iTCBT Individual and Group Conditions.
Magnitude of Change in Quality of Life score on Quality of Life Enjoyment & Satisfaction Questionnaire Short-Form (QLES-Q-SF) from Baseline to 3- and 6-Month Follow-Ups between the iTCBT Individual and Group Conditions.
Trial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: iTCBT-I (Intensive Transdiagnostic Cognitive Behavioral Therapy-Individual)Experimental Treatment1 Intervention
Patients in this arm will receive transdiagnostic CBT delivered in an intensive individual format over 2 weeks. Intensive Transdiagnostic Cognitive Behavior Therapy-Individual (iTCBT-I): Participants randomized to this condition will receive 12 hours of treatment in four 3 hour sessions, over a 2-week period. Treatment consists of psychoeducation, cognitive restructuring, and exposure exercises.
For treatment non-responders (i.e., BAI score decrease < 10), patients will receive 4 additional 90 minute sessions of individual therapy over a 2-week period (iTCBT-Enhanced). These sessions will identify areas where participants might benefit from more in-depth focus on specific concepts taught in the treatment.
Group II: iTCBT-G (Intensive Transdiagnostic Cognitive Behavioral Therapy-Group)Active Control1 Intervention
Patients in this arm will receive transdiagnostic CBT delivered in an intensive group format over 2 weeks. Intensive Transdiagnostic Cognitive Behavior Therapy-Group (iTCBT-G): Participants randomized to this condition will receive 12 hours of treatment over a 2-day period (6 hrs each day). Treatment consists of psychoeducation, cognitive restructuring, and exposure exercises.
For treatment non-responders (i.e., BAI score decrease < 10), patients will receive 4 additional 90 minute sessions of individual therapy over a 2-week period (iTCBT-Enhanced). These sessions will identify areas where participants might benefit from more in-depth focus on specific concepts taught in the treatment.
Group III: Treatment as Usual (TAU)Active Control1 Intervention
Patients in this arm will not receive transdiagnostic CBT but will receive treatment as usual, which may include other forms of psychotherapy and/or medication.
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Who is running the clinical trial?
Baylor College of MedicineLead Sponsor
1,001 Previous Clinical Trials
6,001,646 Total Patients Enrolled
15 Trials studying Anxiety Disorders
1,682 Patients Enrolled for Anxiety Disorders
United States Department of DefenseFED
861 Previous Clinical Trials
226,888 Total Patients Enrolled
5 Trials studying Anxiety Disorders
584 Patients Enrolled for Anxiety Disorders
Ellen Teng, PhDPrincipal InvestigatorMichael E. DeBakey VA Medical Center
5 Previous Clinical Trials
529 Total Patients Enrolled
2 Trials studying Anxiety Disorders
406 Patients Enrolled for Anxiety Disorders
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have severe depression or thoughts of harming myself that would stop me from receiving treatment.I am currently experiencing symptoms of mania or psychosis.I am willing to be assigned to a treatment group by chance.I have been diagnosed with an anxiety disorder.I have been on stable mental health medication for at least 4 weeks.I am currently receiving CBT for my mental health condition.I am a veteran or service member over 18.I score below 47 on a life satisfaction survey.
Research Study Groups:
This trial has the following groups:- Group 1: iTCBT-I (Intensive Transdiagnostic Cognitive Behavioral Therapy-Individual)
- Group 2: iTCBT-G (Intensive Transdiagnostic Cognitive Behavioral Therapy-Group)
- Group 3: Treatment as Usual (TAU)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any vacancies within this experiment for research participants?
"Clinicaltrials.gov confirms that this study, which was inaugurated on May 1st 2023 and recently edited April 25th of the same year, is not presently recruiting patients. Nevertheless, there are over 1500 other clinical trials actively calling for participants to sign up at the moment."
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