Recruiting

PTSD Therapy

Sponsor:

United States Department of Defense

Code:

NCT06957067

Conditions

Post Traumatic Stress Disorder

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

CPT Skills

Cognitive Processing Therapy

Present Centered Therapy

Shared Decision Making

Measurement Based Care

Study Details

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.

Conditions

Post Traumatic Stress Disorder

Study ID

NCT06957067

Start date

Mar 17, 2025

Status verified date

Apr, 2025

Completion date

Aug 31, 2028

Anticipated

Primary completion date

May 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

280 participants

Anticipated

Allocation

Randomized

Intervention Model

Factorial

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

Interventions

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.

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.

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.

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.

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).

Primary outcome measure

  • PTSD severity (via structured clinical interview) [ Time Frame: Baseline, through six-months after treatment completion. Treatment completion takes an average of 4 months. ]

Central Contacts and Locations

Central contacts

Emily M Hudson, PhD

612-629-7262emily.hudson@va.gov

Donald Lemon

(612) 467-1957donald.lemon2@va.gov

Locations

VA Phoenix Health Care System

Recruiting

Phoenix, Arizona, United States, 85012

Contacts

Donald Lemon

(612) 467-1957donald.lemon2@va.gov

New Orleans VA Medical Center

Recruiting

New Orleans, Louisiana, United States, 70119

Contacts

Jessica Chambliss

1-800-935-8387Jessica.chambliss@va.gov

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

Recruiting

Charleston, South Carolina, United States, 29401

Contacts

Sarah Szafranski

843-543-0482Sarah.Szafranski@va.gov

VA Houston Healthcare System

Recruiting

Houston, Texas, United States, 77030

Contacts

Ashley Rogers

(713) 794-7920Ashley.Rogers6@va.gov

More Information

Sponsor

United States Department of Defense

Last update posted

Nov 14, 2025

Last verified

Apr, 2025

Keywords

  • Cognitive Processing Therapy
  • Post Traumatic Stress Disorder
  • Trauma-focused treatments
  • Veterans

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by United States Department of Defense on 2025-11-14.