Recruiting

Psychotherapy

Sponsor:

Baylor College of Medicine

Code:

NCT05843695

Conditions

Posttraumatic Stress Disorder

Anxiety Disorders

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

iTCBT-I

iTCBT-G

TAU

Study Details

Brief summary:

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.

Conditions

Posttraumatic Stress Disorder

Anxiety Disorders

Study ID

NCT05843695

Start date

Sep 22, 2023

Status verified date

Jan, 2026

Completion date

Mar 30, 2027

Anticipated

Primary completion date

Mar 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Veteran/Service Member at least 18 years old
  • 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
  • Stable on psychotropic medication for 4 weeks before study participation
  • Willing to be randomized to treatment condition

Exclusion Criteria:

  • Active symptoms of mania or psychosis at baseline (based on ADIS-5)
  • Depression with active suicidal ideation and intent that would preclude treatment (based on ADIS-5 \& BDI-II)
  • Moderate-to-severe cognitive impairment as indicated by the SLUMS (a score below 20)
  • Veterans/Service Members with comorbid substance/alcohol use or dependence are study eligible but must agree to reduce and limit their use of substances during the active course of treatment, particularly during exposure exercises. If they do not agree to this, they will be excluded
  • Undergoing concurrent transdiagnostic CBT specifically targeting any of the above-mentioned disorders

Study Design

Enrollment

306 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

iTCBT-I

Individual format over 2 weeks

iTCBT-G

Group format over 2 days

TAU

Standard care

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 ]
  • 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. [ Time Frame: 6-Month Follow-Up ]
  • 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. [ Time Frame: 6-Month Follow-Up ]
  • 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. [ Time Frame: 6-Month Follow-Up ]

Central Contacts and Locations

Central contacts

Ellen Teng, PhD

(713) 791-1414eteng@bcm.edu

Keri Bayley, PhD

(713) 791-1414Keri.Bayley@bcm.edu

Locations

Michael E. DeBakey VA Medical Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Ellen Teng, PhD

(713) 791-1414eteng@bcm.edu

Keri Bayley, PhD

(713) 791-1414Keri.Bayley@bcm.edu

More Information

Sponsor

Baylor College of Medicine

Last update posted

Feb 3, 2026

Last verified

Jan, 2026

Keywords

  • PTSD
  • Anxiety
  • Veterans
  • Service Members
  • Reservists
  • Treatment

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Baylor College of Medicine on 2026-02-03.