Enhancing Psychotherapy for Veterans and Service Members With PTSD and Anxiety

NCT05843695 | Recruiting DMC

• 1 other identifier: H-52390
• Study Type: interventional
• Target: 306
• Locations: 1 country
• Sites: 1

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

Keywords

PTSD; Anxiety; Veterans; Service Members; Reservists; Treatment

Outcome Measures

Primary Outcomes (4)

• 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.

  The QLES-Q-SF measures subjective functioning and satisfaction across a range of life domains including work, leisure activities, social relationships, and physical health. Satisfaction scores on this measure range from 14 (very poor) to 70 (very good). Higher scores indicate greater overall life satisfaction and functioning.

  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.

  The BAI assesses the severity of anxiety symptoms across 21 items, minimizing those that overlap with depression. Two components of anxiety are measured: The cognitive subscale provides a measure of fearful thoughts and impaired cognitive functioning, whereas the somatic subscale measures the symptoms of physiological arousal. The total score on the BAI ranges from 0-63, with higher scores reflecting higher levels of anxiety.

  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.

  The QLES-Q-SF measures subjective functioning and satisfaction across a range of life domains including work, leisure activities, social relationships, and physical health. Satisfaction scores on this measure range from 14 (very poor) to 70 (very good). Higher scores indicate greater overall life satisfaction and functioning.

  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.

  The BAI assesses the severity of anxiety symptoms across 21 items, minimizing those that overlap with depression. Two components of anxiety are measured: The cognitive subscale provides a measure of fearful thoughts and impaired cognitive functioning, whereas the somatic subscale measures the symptoms of physiological arousal. The total score on the BAI ranges from 0-63, with higher scores reflecting higher levels of anxiety.

  6-Month Follow-Up

Secondary Outcomes (2)

• 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.

  3- and 6-Month Follow-Ups

• 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.

  3- and 6-Month Follow-Ups

Study Arms (3)

iTCBT-I (Intensive Transdiagnostic Cognitive Behavioral Therapy-Individual)

EXPERIMENTAL

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.

Behavioral: iTCBT-I

iTCBT-G (Intensive Transdiagnostic Cognitive Behavioral Therapy-Group)

ACTIVE COMPARATOR

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.

Behavioral: iTCBT-G

Treatment as Usual (TAU)

ACTIVE COMPARATOR

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.

Behavioral: TAU

Interventions

iTCBT-I BEHAVIORAL

Individual format over 2 weeks

iTCBT-I (Intensive Transdiagnostic Cognitive Behavioral Therapy-Individual)

iTCBT-G BEHAVIORAL

Group format over 2 days

iTCBT-G (Intensive Transdiagnostic Cognitive Behavioral Therapy-Group)

TAU BEHAVIORAL

Standard care

Treatment as Usual (TAU)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Baylor College of Medicine: lead
• United States Department of Defense: collaborator

Study Sites (1)

Michael E. DeBakey VA Medical Center

Houston, Texas, 77030, United States

RECRUITING

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Anxiety Disorders

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Officials

• Ellen Teng, PhD

  Michael E. DeBakey VA Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ellen Teng, PhD

CONTACT

(713) 791-1414; eteng@bcm.edu

Keri Bayley, PhD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Assessors who conduct 3- and 6- months follow-up evaluations will be masked to participant treatment assignment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 3 treatment arms: iTCBT Individual; iTCBT Group; TAU

Study Record Dates

• First Submitted: April 25, 2023
• First Posted: May 6, 2023
• Study Start: September 22, 2023
• Primary Completion (Estimated): March 30, 2027
• Study Completion (Estimated): March 30, 2027
• Last Updated: February 3, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data requests can be submitted 12 months following manuscript publication.
• Access Criteria: Access to data from this clinical trial can be requested by qualified investigators conducting independent scientific research. Data will be provided via a data sharing agreement, following review and approval of a research proposal and analytic plan.

Locations

US (1)