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

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.

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).

Sponsors & Collaborators

• University of Minnesota

  collaborator OTHER

• Lowcountry Center for Veterans Research

  collaborator UNKNOWN

• Baylor College of Medicine

  collaborator OTHER

• Louisiana Veterans Research and Education Corporation

  collaborator UNKNOWN

• Mayo Clinic

  collaborator OTHER

• Veterans Education and Research Association of Michigan

  collaborator UNKNOWN

• Minneapolis Veterans Affairs Medical Center

  collaborator FED

• Center for Veterans Research and Education

  collaborator OTHER

• New Orleans VA Medical Center

  collaborator UNKNOWN

• Boston VA Research Institute, Inc.

  collaborator OTHER

• Arizona Veterans Research and Education Foundation

  collaborator UNKNOWN

• Ocean State Research Institute, Inc.

  collaborator OTHER

• Veterans Education and Research Association of Northern New England, Inc

  collaborator UNKNOWN

• Michael E. DeBakey VA Medical Center

  collaborator FED

• Phoenix VA Health Care System

  collaborator FED

• Charleston VA Medical Center

  collaborator UNKNOWN

• United States Department of Defense

  lead FED

Principal Investigators

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

• Princess Ackland, PhD · University of Minnesota

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

FACTORIAL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-03-17

Primary Completion

2028-05-31

Completion

2028-08-31

Countries

• United States

Study Locations