Post-Traumatic Stress Disorder (PTSD) Clinical Trials

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

Status: Recruiting
Location: See all (4) locations...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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)

Locations
United States
Arizona
VA Phoenix Health Care System
RECRUITING
Phoenix
Louisiana
New Orleans VA Medical Center
RECRUITING
New Orleans
South Carolina
Ralph H. Johnson VA Health Care System (Charleston VA)
RECRUITING
Charleston
Texas
VA Houston Healthcare System
RECRUITING
Houston
Contact Information
Primary
Emily M Hudson, PhD
emily.hudson@va.gov
612-629-7262
Backup
Donald Lemon
donald.lemon2@va.gov
(612) 467-1957
Time Frame
Start Date: 2025-03-17
Estimated Completion Date: 2028-08-31
Participants
Target number of participants: 280
Treatments
Active_comparator: Catchall
The Catchall approach to identifying individuals in need of intervention is intended to provide a generous, all-inclusive approach to identifying anyone who might have some concerns about their experiences with Cognitive Processing Therapy (CPT) and may benefit from discussing these concerns. The goal of this approach is to err on the side of intervening within anyone who may be experiencing challenges with the therapy. This approach assumes that spending a session talking about any concerns or struggles patients are having will help with patient-provider communication, improve attitudes about treatment, and improve treatment retention and outcomes.
Active_comparator: Targeted
The Targeted approach to identifying individuals is intended to capture a narrower band of participants with clearer concerns about Cognitive Processing Therapy (e.g., at least one of their self-report scale scores is similar to or worse than patients who ultimately dropped out of CPT treatment in investigators' pilot data). Providers are more likely to miss some participants who may benefit from intervention through this approach but are less likely to unintentionally undermine CPT for participants who did not need intervention.
Active_comparator: CPT Skills
Cognitive Processing Therapy is a 12-session, cognitive-behavioral treatment for PTSD that focuses on challenging and modifying maladaptive beliefs related to prior trauma. The goal is to build a new understanding of prior trauma in order to limit the negative influence trauma and it's reminders have on individuals' daily lives. CPT has built in strategies to address any challenges patients participating in the therapy. The degree to which these strategies are more effective than other approaches to addressing treatment challenges (e.g., switching to another therapy) are unknown.
Active_comparator: Consider Switching
When patients are experiencing challenges with PTSD therapy, providers and their patients will consider switching from CPT to Present Centered Therapy. While PCT is somewhat less effective than CPT, it has solid evidence that it improves symptoms of PTSD. There is also no reflection on past trauma, homework demands are modest, and it has superior completion rates to CPT. Starting with a CPT and then considering switching to PCT, is a promising pathway to ensure individuals struggling in CPT complete an effective treatment. Given the efficacy differences between CPT and PCT, switching will be done collaboratively between patients and providers using shared decision making (versus requiring all patients to switch to PCT). This ensures the choice to switch is patient-centered and relevant to how these decisions would be made in real-world care.
Related Therapeutic Areas
Sponsors
Collaborators: Mayo Clinic, Veterans Education and Research Association of Michigan, Lowcountry Center for Veterans Research, Charleston VA Medical Center, Center for Veterans Research and Education, Arizona Veterans Research and Education Foundation, Phoenix VA Health Care System, Louisiana Veterans Research and Education Corporation, Veterans Education and Research Association of Northern New England, Inc, University of Minnesota, Michael E. DeBakey VA Medical Center, Minneapolis Veterans Affairs Medical Center, Boston VA Research Institute, Inc., Baylor College of Medicine, New Orleans VA Medical Center, Ocean State Research Institute, Inc.
Leads: United States Department of Defense

This content was sourced from clinicaltrials.gov