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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

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3- and 6-month follow-ups

Awards & highlights

No Placebo-Only Group

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.

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.

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.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 more

Secondary study objectives

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.

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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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