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.
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
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
Factorial
CPT Skills
BehavioralCPT 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.
Cognitive Processing Therapy
BehavioralCPT 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.
Present Centered Therapy
BehavioralPCT 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.
Shared Decision Making
BehavioralShared 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.
Measurement Based Care
BehavioralInvestigators 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).
PTSD severity (via structured clinical interview)
Measured using the Clinician-Administered PTSD Scale for the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (CAPS-5). This standardized interview is conducted by an evaluator blinded to study condition, via telehealth.
Depression severity
Self-report surveys using established, validated instruments will be used to assess secondary outcomes. In routine care, CPT response is typically evaluated through repeated PHQ-9 administration, rather than through structured clinical interview. Thus, these self-reports will be administered to facilitate comparisons with outcomes in real-world care. They will also be used by clinicians for monitoring treatment response and determining treatment end-date.
PTSD severity (via self report)
Self-report surveys using established, validated instruments will be used to assess secondary outcomes. In routine care, CPT response is typically evaluated through repeated PCL-5 administration, rather than through structured clinical interview. Thus, these self-reports will be administered to facilitate comparisons with outcomes in real-world care. They will also be used by clinicians for monitoring treatment response and determining treatment end-date.
Psychosocial functioning (IPF scores)
Self-report surveys using established, validated instruments will be used to assess secondary outcomes. For psychosocial functioning, investigators will assess individuals' self-reported functioning on the Inventory of Psychosocial Functioning (IPF). The IPF is a self-report instrument developed specifically for assessing PTSD-related functional impairment. The instrument measures each of the PTSD-related functional domains determined to matter most to individuals with PTSD: relationships with intimate partners, family relationships, work performance, friend relationships, parenting, educational performance, and self-care functioning (e.g., maintaining personal hygiene, exercising, household chores, healthy eating). The total scale will be used, which is the average of the total number of subscales of relevance to the respondent (i.e., respondent skips employment functioning items if they are not employed).
Treatment completion
Participants will be considered to have completed treatment if they complete the final session of their treatment protocol.
Click on the lead sponsor to view all of their trials.
United States Department of Defense
Lead sponsor
University of Minnesota
Sponsor institution
University of Minnesota
Collaborator
Lowcountry Center for Veterans Research
Collaborator
Baylor College of Medicine
Collaborator
Louisiana Veterans Research and Education Corporation
Collaborator
Mayo Clinic
Collaborator
Veterans Education and Research Association of Michigan
Collaborator
Minneapolis Veterans Affairs Medical Center
Collaborator
Center for Veterans Research and Education
Collaborator
New Orleans VA Medical Center
Collaborator
Boston VA Research Institute, Inc.
Collaborator
Ocean State Research Institute, Inc.
Collaborator
Michael E. DeBakey VA Medical Center
Collaborator
Phoenix VA Health Care System
Collaborator
Ralph H. Johnson VA Medical Center
Collaborator
Veterans Education and Research Association of Northern New England, Inc
Collaborator
Arizona Veterans Research and Education Foundation
Collaborator
