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

NARecruitingINTERVENTIONAL
Enrollment

280

Participants

Timeline

Start Date

March 17, 2025

Primary Completion Date

May 31, 2028

Study Completion Date

August 31, 2028

Conditions
Post Traumatic Stress Disorder
Interventions
BEHAVIORAL

CPT Skills

CPT trainings recommend that if an individual is experiencing challenges with the CPT protocol (e.g., ambivalence about continuing treatment or struggling with completing homework), the provider can apply the skills of CPT to that particular problem. Those skills include problem solving and cognitive restructuring to identify and alter maladaptive underlying beliefs. The purpose of this work is to address the individual's underlying problem or problematic beliefs to improve the individual's attitudes about CPT and/or improve the individual's compliance with treatment activities. The therapist's end-goal is to keep the individual moving forward in the CPT protocol.

BEHAVIORAL

Cognitive Processing Therapy

"CPT 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. The treatment involves education about PTSD and skill building to identify and challenge maladaptive, trauma-related thinking through Socratic questioning and worksheets that teach individuals to challenge this thinking themselves. Later sessions focus on specific themes that are difficult for individuals with PTSD and can keep individuals stuck in their symptoms. Themes include safety, trust, control, self-esteem, and intimacy.~Although the skills utilized in CPT may be used to respond to challenges individuals have with participating in CPT, the effectiveness of these strategies has not been explicitly tested."

BEHAVIORAL

Present Centered Therapy

"PCT was developed as a comparator for active TFT, so protocol length typically matches the comparator. PCT focuses on current life problems as manifestations of PTSD in weekly 60-minute sessions. It includes psychoeducation and normalization of responses to trauma, problem solving related to life difficulties and stress, and emotional support and validation. Its hypothesized mechanisms are increased interpersonal connection and mastery in managing life stressors. Therapist skills include validation, support, and reflective listening. The first 2 sessions provide an overview and rationale for PCT. Subsequent sessions focus on topics participants choose and are less structured. Participants use a daily diary to record any concerning problems or issues they experience during the week. These diaries are used to select session topics."

BEHAVIORAL

Shared Decision Making

Shared decision making (SDM) is widely considered the best model for achieving patient-provider agreement on treatment plans and an ethical imperative for decision making. SDM is a communicative process in which patients and their provider personalize treatment approaches to the individual, their situation, and the problems that they are experiencing. Providers and patients engage in a shared deliberation of meaningful treatment alternatives, including pros and cons, how choices align or misalign with values, and patients' abilities to complete the plans under consideration.

BEHAVIORAL

Measurement Based Care

"Investigators will compare methods of identifying individuals experiencing challenges in CPT. Investigators will use self-report measures administered each week during treatment to identify individuals who may be struggling in during CPT and compare two approaches to cut scores on these measures to classify individuals as in need of intervention. Investigators will also use behavioral indices to determine if veterans are in need of intervention, including homework compliance and session attendance. One approach will liberally classify many individuals as in need of intervention (Catchall), while the other will take a more targeted approach (Targeted)."

Trial Locations (4)

29401

RECRUITING

Ralph H. Johnson VA Health Care System (Charleston VA), Charleston

70119

RECRUITING

New Orleans VA Medical Center, New Orleans

77030

RECRUITING

VA Houston Healthcare System, Houston

85012

RECRUITING

VA Phoenix Health Care System, Phoenix

All Listed Sponsors
collaborator

University of Minnesota

OTHER

collaborator

Lowcountry Center for Veterans Research

UNKNOWN

collaborator

Baylor College of Medicine

OTHER

collaborator

Louisiana Veterans Research and Education Corporation

UNKNOWN

collaborator

Mayo Clinic

OTHER

collaborator

Veterans Education and Research Association of Michigan

UNKNOWN

collaborator

Minneapolis Veterans Affairs Medical Center

FED

collaborator

Center for Veterans Research and Education

OTHER

collaborator

New Orleans VA Medical Center

UNKNOWN

collaborator

Boston VA Research Institute, Inc.

OTHER

collaborator

Arizona Veterans Research and Education Foundation

UNKNOWN

collaborator

Ocean State Research Institute, Inc.

OTHER

collaborator

Veterans Education and Research Association of Northern New England, Inc

UNKNOWN

collaborator

Michael E. DeBakey VA Medical Center

FED

collaborator

Phoenix VA Health Care System

FED

collaborator

Charleston VA Medical Center

UNKNOWN

lead

United States Department of Defense

FED

NCT06957067 - Reducing Dropout and Improving Outcomes From PTSD Therapy: When to Switch Therapies or Stay the Course | Biotech Hunter | Biotech Hunter