NCT06957067 Reducing Dropout and Improving Outcomes From PTSD Therapy: When to Switch Therapies or Stay the Course
| NCT ID | NCT06957067 |
| Status | Recruiting |
| Phase | — |
| Sponsor | United States Department of Defense |
| Condition | Post Traumatic Stress Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 280 participants |
| Start Date | 2025-03-17 |
| Primary Completion | 2028-05-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 280 participants in total. It began in 2025-03-17 with a primary completion date of 2028-05-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * Veterans interested in outpatient VA psychotherapy for PTSD * Meets DSM-5 criteria for PTSD * Be able to provide informed consent * Be willing to be randomized * Agree to not receive non-study psychotherapy for PTSD during study treatment (case management, supportive therapy/group, and concurrent substance use treatment are allowable) Exclusion Criteria: * Severe cognitive impairment * Current suicidal or homicidal intent with a specific plan * Uncontrolled psychotic or manic symptoms * A psychiatric medication change in the past month * A severe SUD as diagnosed by the DSM-5
Contact & Investigator
Laura Meis, PhD
PRINCIPAL INVESTIGATOR
Women's Health Sciences Division of the National Center for PTSD; University of Minnesota
Frequently Asked Questions
Who can join the NCT06957067 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Post Traumatic Stress Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06957067 currently recruiting?
Yes, NCT06957067 is actively recruiting participants. Contact the research team at emily.hudson@va.gov for enrollment information.
Where is the NCT06957067 trial being conducted?
This trial is being conducted at Phoenix, United States, New Orleans, United States, Charleston, United States, Houston, United States.
Who is sponsoring the NCT06957067 clinical trial?
NCT06957067 is sponsored by United States Department of Defense. The principal investigator is Laura Meis, PhD at Women's Health Sciences Division of the National Center for PTSD; University of Minnesota. The trial plans to enroll 280 participants.