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Intensive CBT for PTSD

Q: Are there any vacancies within this experiment for research participants?

<p>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.</p>

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 below

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I have been diagnosed with an anxiety disorder.

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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3- and 6-month follow-ups for reporting.

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.

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Secondary 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.

0 / 2Eligibility criteria met

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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

iTCBT-G Clinical Trial Eligibility Overview. Trial Name: NCT05843695 — N/A

Anxiety Disorders Research Study Groups: iTCBT-I (Intensive Transdiagnostic Cognitive Behavioral Therapy-Individual), iTCBT-G (Intensive Transdiagnostic Cognitive Behavioral Therapy-Group), Treatment as Usual (TAU)

Anxiety Disorders Clinical Trial 2023: iTCBT-G Highlights & Side Effects. Trial Name: NCT05843695 — N/A

iTCBT-G 2023 Treatment Timeline for Medical Study. Trial Name: NCT05843695 — N/A

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."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Enhancing Psychotherapy for Veterans and Service Members With PTSD and Anxiety

Ellen Teng 2023. "Enhancing Psychotherapy for Veterans and Service Members With PTSD and Anxiety". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05843695.

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