Enhancing Psychotherapy for Veterans and Service Members With PTSD and Anxiety

Conditions

• Anxiety Disorders
• Posttraumatic Stress Disorder

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• iTCBT-I — BEHAVIORAL
  Individual format over 2 weeks
• iTCBT-G — BEHAVIORAL
  Group format over 2 days
• TAU — BEHAVIORAL
  Standard care

Study Details

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.

Key Dates

Start date

Sep 22, 2023

Status verified

Jan 2026

Primary completion

Mar 30, 2027

Completion

Mar 30, 2027

Study Design

Enrollment

306 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: iTCBT-I (Intensive Transdiagnostic Cognitive Behavioral Therapy-Individual)
  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.
• Active Comparator: iTCBT-G (Intensive Transdiagnostic Cognitive Behavioral Therapy-Group)
  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.
• Active Comparator: Treatment as Usual (TAU)
  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.

Primary Outcome Measure

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 conditions (Individual & Group) and TAU. [ Time Frame: 6-Month Follow-Up ]

Central Contacts

• Ellen Teng, PhD
  (713) 791-1414
  [email protected]
• Keri Bayley, PhD
  (713) 791-1414
  [email protected]

Locations (1)

Find similar trials in Houston, TX

Related Studies

• Respiratory Training in the Treatment of Transdiagnostic Pathological Anxiety
  Recruiting · University of Texas at Austin · Austin, Texas
• Integration of Cognitive Processing Therapy and Relapse Prevention for Alcohol Use Disorder and PTSD
  PHASE2 · Recruiting · Texas A&M University · Charleston, South Carolina
• Mitigating PTSD-CUD After Sexual Assault
  PHASE1/PHASE2 · Recruiting · University of Nevada, Las Vegas · Minneapolis, Minnesota
• Intensive Multi-Couple Therapy for PTSD Versus Relationship Education in Military Couples
  Recruiting · Penn State University · San Antonio, Texas