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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
280
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.
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.
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 (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.
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).
VA Phoenix Health Care System
Phoenix, Arizona, United States
RECRUITINGNew Orleans VA Medical Center
New Orleans, Louisiana, United States
RECRUITINGRalph H. Johnson VA Health Care System (Charleston VA)
Charleston, South Carolina, United States
RECRUITINGVA Houston Healthcare System
Houston, Texas, United States
RECRUITINGPTSD 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.
Time frame: Baseline, through six-months after treatment completion. Treatment completion takes an average of 4 months.
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.
Time frame: Baseline, through six-months after treatment completion. Treatment completion takes an average of 4 months.
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.
Time frame: Baseline, through six-months after treatment completion. Treatment completion takes an average of 4 months.
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).
Time frame: Baseline, through six-months after treatment completion. Treatment completion takes an average of 4 months.
Treatment completion
Participants will be considered to have completed treatment if they complete the final session of their treatment protocol.
Time frame: At the end of treatment. Treatment takes an average of 4 months.
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