Clinical trial NCT06957067: Reducing Dropout and Improving Outcomes From PTSD Therapy: When to Switch Therapies or Stay the Course
Official title: Reducing Dropout and Improving Outcomes From PTSD Therapy: When to Switch Therapies or Stay the Course
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Post Traumatic Stress Disorder
Keywords: Cognitive Processing Therapy
Post Traumatic Stress Disorder
Trauma-focused treatments
Veterans
Lead sponsor: United States Department of Defense
Sponsor class: FED
Collaborators: name: University of Minnesota
name: Lowcountry Center for Veterans Research
name: Baylor College of Medicine
name: Louisiana Veterans Research and Education Corporation
name: Mayo Clinic
name: Veterans Education and Research Association of Michigan
name: Minneapolis Veterans Affairs Medical Center
name: Center for Veterans Research and Education
name: New Orleans VA Medical Center
name: Boston VA Research Institute, Inc.
name: Arizona Veterans Research and Education Foundation
name: Ocean State Research Institute, Inc.
name: Veterans Education and Research Association of Northern New England, Inc
name: Michael E. DeBakey VA Medical Center
name: Phoenix VA Health Care System
name: Charleston VA Medical Center
First posted: 2025-05-04
Enrollment: 280
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: Investigators will use a two-stage sequential, multiple assignment, randomized trial design (SMART) in which all participants beginning CPT are randomized to a first-stage intervention. In this first-stage, providers use one of two approaches to decision rules to identify patients who may be experiencing challenges in CPT (Catchall vs Targeted). The tailoring variables used in these decision rules will include weekly self-report measures and behavioral indicators. Investigators will evaluate if a participant meets criteria for their assigned decision rules every week during treatment. If individuals meet their decision rule criteria, participants will be randomized again to a second-stage intervention. For the second stage, providers will meet with their patients to either collaboratively consider switching to Present Centered Therapy or to discuss any problems they may be having with treatment using existing CPT skills, per randomization.
Primary purpose: TREATMENT

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.

Detailed description: Background: Trauma-focused treatments (TFTs) for PTSD, including Cognitive Processing Therapy (CPT), result in clinically significant symptom relief for many. However, they are not equally effective for everyone, and an important subgroup will discontinue before fully completing therapy. Identifying this subgroup is an important, but elusive, first step. In their prior work, investigators found Veterans were often unlikely to tell providers about the nature and extent of the challenges they experienced while trying to effectively participate in TFTs. Use of behavioral and attitudinal indices that do not rely on individuals' willingness to speak up in session may help providers identify with whom to intervene. Using weekly measures, investigators will compare two approaches to cut scores to classify individuals as "in need of intervention." One will liberally classify many individuals (Catchall); the other will take a more targeted approach (Targeted). For the present study, investigators will focus on CPT, as it is the most widely disseminated TFT in VA and DoD.

Once investigators have used the above approaches to identify individuals who may need additional support and help with CPT, an important next question is what is the most effective way to intervene with these individuals. TFTs have built in strategies for flexing the treatments to help patients who are experiencing challenges in treatment. These strategies are of unknown efficacy. Alternatively, patients and their therapists could consider switching to a different form of therapy besides TFTs. Present Centered Therapy (PCT) may be a well-suited alternative. While PCT is somewhat less effective than TFTs, it has solid evidence of efficacy. There is no reflection on past trauma, homework demands are modest, and it has superior completion rates to TFTs. Starting with CPT and then considering switching to PCT, is a potentially promising pathway to ensure individuals who are challenged by CPT complete an effective treatment. Given the efficacy differences between CPT and PCT, switching should be done collaboratively between patients and providers (versus forcing all participants to PCT). This ensures the choice to switch is patient-centered, relevant to real-world care, and consistent with Veteran end-users' recommendations.

Objectives/Aims: Investigators overall objective is to compare methods of identifying individuals who may be experiencing difficulties with CPT and compare methods of intervening to optimize treatment retention and outcomes. Investigators will use weekly measures developed with Veteran end-users to identify individuals who could benefit from intervention. When identified, providers will either use CPT skills to address participants' treatment challenges or collaboratively consider switching to PCT.

Investigators' specific aims are:

1. to determine whether the use of CPT skills versus collaboratively considering switching to PCT is more effective in improving outcomes for individuals experiencing challenges with CPT. Outcomes include PTSD severity \[primary\], depression, functioning, and treatment retention;
2. to compare two approaches (Catchall versus Targeted) to identifying individuals in CPT in need of additional support;
3. to study the barriers/facilitators of implementing these intervention strategies.

Finally, exploratory aims will examine the stability of differences, compare combinations of interventions tested, and examine moderators of intervention effects.

Study Design: Investigators propose a sequential multiple assignment randomized trial (SMART) where investigators first randomize 280 CPT patients to one of the two approaches to identify who needs extra support in CPT (Catchall vs Targeted). Participants deemed "in need of intervention" will then be randomized again to either (a) CPT skills or (b) to collaboratively consider switching. Outcomes will be assessed using structured clinical interviews (PTSD severity) and self-report (functioning and depression) at baseline, posttreatment, 3-, and 6-months posttreatment. Investigators will also study the implementation of their interventions through a mixed methods process evaluation. The study treatment with Veteran participants will take place across four VAs (Houston, Charleston, New Orleans, and Phoenix) over 4-years.

Clinical Impact: Investigators expect to learn an optimal approach to identifying individuals who need extra support during CPT and an optimal approach for addressing their needs. This will help ensure all individuals reach their maximal potential in PTSD treatment. The proposed work addresses multiple sub-areas within FY23 TBIPHRP CTA Focus Area 3 (Treat) through adapting or combining interventions so they can achieve their greatest impact on the lives and functioning on Service Members and Veterans, promoting sustained functional recovery, and enhancing the relevance of research to practice via hybrid effectiveness implementation studies.

Relevance to Military Health: The influence of a successful course of PTSD treatment on an individual's life is considerable. In addition to reducing PTSD and associated mental health symptoms (e.g., depression), successful PTSD treatment reduces suicidal ideation and improves, reduces, and may even reverse the negative physical health effects associated with the disorder. Yet, abundant heterogeneity remains in therapy response. Investigators propose using rigorous methods to alter CPT mid-stream to ensure that PTSD treatment promotes recovery from PTSD for more Service Members. Investigators will also explore differences for women, an important priority for the DoD. This work is essential for moving the science of therapy forward. To investigators' knowledge, this will be the first to study to test a strategy for considering switching from trauma to non-trauma focused therapies. Such research is critical to military service retention and to the health of the entire military. Findings from this work will yield an evidence base for personalizing PTSD treatment to make it more tolerable and more effective for more people.

Eligibility criteria: 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

Primary outcomes:
measure: PTSD severity (via structured clinical interview)
timeFrame: Baseline, through six-months after treatment completion. Treatment completion takes an average of 4 months.
Secondary outcomes:
measure: Depression severity
timeFrame: Baseline, through six-months after treatment completion. Treatment completion takes an average of 4 months.
measure: PTSD severity (via self report)
timeFrame: Baseline, through six-months after treatment completion. Treatment completion takes an average of 4 months.
measure: Psychosocial functioning (IPF scores)
timeFrame: Baseline, through six-months after treatment completion. Treatment completion takes an average of 4 months.
measure: Treatment completion
timeFrame: At the end of treatment. Treatment takes an average of 4 months.
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: VA Phoenix Health Care System
state: Arizona
city: New Orleans
country: United States
facility: New Orleans VA Medical Center
state: Louisiana
city: Charleston
country: United States
facility: Ralph H. Johnson VA Health Care System (Charleston VA)
state: South Carolina
city: Houston
country: United States
facility: VA Houston Healthcare System
state: Texas
Study officials:
affiliation: Women's Health Sciences Division of the National Center for PTSD; University of Minnesota
name: Laura Meis, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Minnesota
name: Princess Ackland, PhD
role: PRINCIPAL_INVESTIGATOR
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