RECRUITING

Enhancing Psychotherapy for Veterans and Service Members with PTSD and Anxiety

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Enhancing Intensive Transdiagnostic Cognitive Behavioral Therapy for Veterans with PTSD and Anxiety Disorders

Quick Facts

Study Start:2023-09-22
Study Completion:2026-09
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05843695

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Veteran/Service Member at least 18 years old
  2. * 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)
  3. * Moderate-to-poor life enjoyment and satisfaction as indicated by a score of 47 or lower on the QLES-Q-SF
  4. * Stable on psychotropic medication for 4 weeks before study participation
  5. * Willing to be randomized to treatment condition
  1. * Active symptoms of mania or psychosis at baseline (based on ADIS-5)
  2. * Depression with active suicidal ideation and intent that would preclude treatment (based on ADIS-5 \& BDI-II)
  3. * Moderate-to-severe cognitive impairment as indicated by the SLUMS (a score below 20)
  4. * 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
  5. * Undergoing concurrent transdiagnostic CBT specifically targeting any of the above-mentioned disorders

Contacts and Locations

Study Contact

Ellen Teng, PhD
CONTACT
(713) 791-1414
eteng@bcm.edu
Keri Bayley, PhD
CONTACT
(713) 791-1414
Keri.Bayley@bcm.edu

Principal Investigator

Ellen Teng, PhD
PRINCIPAL_INVESTIGATOR
Michael E. DeBakey VA Medical Center

Study Locations (Sites)

Michael E. DeBakey VA Medical Center
Houston, Texas, 77030
United States

Collaborators and Investigators

Sponsor: Baylor College of Medicine

  • Ellen Teng, PhD, PRINCIPAL_INVESTIGATOR, Michael E. DeBakey VA Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-09-22
Study Completion Date2026-09

Study Record Updates

Study Start Date2023-09-22
Study Completion Date2026-09

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

  • Posttraumatic Stress Disorder
  • Anxiety Disorders