RECRUITING

Reducing Dropout and Improving Outcomes From PTSD Therapy: When to Switch Therapies or Stay the Course

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

Investigators' overall objective is to compare methods of identifying individuals who may be experiencing challenges in Cognitive Processing Therapy (CPT) and compare methods of intervening to optimize treatment retention and outcomes. Investigators' specific aims are: 1. to determine whether the use of CPT skills versus collaboratively considering switching to Present Centered Therapy (PCT) is more effective in improving outcomes for individuals experiencing challenges with CPT. Outcomes include post-traumatic stress disorder (PTSD) severity \[primary\], depression, functioning, and treatment retention; 2. to compare two approaches to identifying individuals in CPT in need of additional support during treatment; 3. to study the barriers and facilitators of implementing these intervention strategies. Finally, exploratory aims will examine the stability of differences between treatment conditions, compare combinations of interventions tested, and examine moderators of intervention effects.

Official Title

Reducing Dropout and Improving Outcomes From PTSD Therapy: When to Switch Therapies or Stay the Course

Quick Facts

Study Start:2025-03-17
Study Completion:2028-08-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06957067

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. * Veterans interested in outpatient VA psychotherapy for PTSD
  2. * Meets DSM-5 criteria for PTSD
  3. * Be able to provide informed consent
  4. * Be willing to be randomized
  5. * Agree to not receive non-study psychotherapy for PTSD during study treatment (case management, supportive therapy/group, and concurrent substance use treatment are allowable)
  1. * Severe cognitive impairment
  2. * Current suicidal or homicidal intent with a specific plan
  3. * Uncontrolled psychotic or manic symptoms
  4. * A psychiatric medication change in the past month
  5. * A severe SUD as diagnosed by the DSM-5

Contacts and Locations

Study Contact

Erin Linden
CONTACT
612-670-6451
Erin.linden@va.gov
Donald Lemon
CONTACT
(612) 467-1957
donald.lemon2@va.gov

Principal Investigator

Laura Meis, PhD
PRINCIPAL_INVESTIGATOR
Women's Health Sciences Division of the National Center for PTSD; University of Minnesota
Princess Ackland, PhD
PRINCIPAL_INVESTIGATOR
University of Minnesota

Study Locations (Sites)

VA Phoenix Health Care System
Phoenix, Arizona, 85012
United States
New Orleans VA Medical Center
New Orleans, Louisiana, 70119
United States
Ralph H. Johnson VA Health Care System (Charleston VA)
Charleston, South Carolina, 29401
United States
VA Houston Healthcare System
Houston, Texas, 77030
United States

Collaborators and Investigators

Sponsor: United States Department of Defense

  • Laura Meis, PhD, PRINCIPAL_INVESTIGATOR, Women's Health Sciences Division of the National Center for PTSD; University of Minnesota
  • Princess Ackland, PhD, PRINCIPAL_INVESTIGATOR, University of Minnesota

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 Date2025-03-17
Study Completion Date2028-08-31

Study Record Updates

Study Start Date2025-03-17
Study Completion Date2028-08-31

Terms related to this study

Keywords Provided by Researchers

  • Cognitive Processing Therapy
  • Post Traumatic Stress Disorder
  • Trauma-focused treatments
  • Veterans

Additional Relevant MeSH Terms

  • Post Traumatic Stress Disorder