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

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое 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 atti
• Поведенческое 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 t
• Поведенческое 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 val
• Поведенческое 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 misalig
• Поведенческое 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 attend

Первичные конечные точки

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

Вторичные конечные точки (4)

• Depression severity [Срок оценки: Baseline, through six-months after treatment completion. Treatment completion takes an average of 4 months.]
• PTSD severity (via self report) [Срок оценки: Baseline, through six-months after treatment completion. Treatment completion takes an average of 4 months.]
• Psychosocial functioning (IPF scores) [Срок оценки: Baseline, through six-months after treatment completion. Treatment completion takes an average of 4 months.]
• Treatment completion [Срок оценки: At the end of treatment. Treatment takes an average of 4 months.]

Критерии участия

Критерии включения

• 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)

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Факторный дизайн

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

США · 4 центра

• VA Phoenix Health Care System — Phoenix
• New Orleans VA Medical Center — New Orleans
• Ralph H. Johnson VA Health Care System (Charleston VA) — Charleston
• VA Houston Healthcare System — Houston

Публикации

• Bradley R, Greene J, Russ E, Dutra L, Westen D. A multidimensional meta-analysis of psychotherapy for PTSD. Am J Psychiatry. 2005 Feb;162(2):214-27. doi: 10.1176/appi.ajp.162.2.214. PMID 15677582
• Steenkamp MM, Litz BT, Hoge CW, Marmar CR. Psychotherapy for Military-Related PTSD: A Review of Randomized Clinical Trials. JAMA. 2015 Aug 4;314(5):489-500. doi: 10.1001/jama.2015.8370. PMID 26241600
• Maguen S, Li Y, Madden E, Seal KH, Neylan TC, Patterson OV, DuVall SL, Lujan C, Shiner B. Factors associated with completing evidence-based psychotherapy for PTSD among veterans in a national healthcare system. Psychiatry Res. 2019 Apr;274:112-128. doi: 10.1016/j.psychres.2019.02.027. Epub 2019 Feb 11. PMID 30784780
• Nahum-Shani I, Almirall D, Yap JRT, McKay JR, Lynch KG, Freiheit EA, Dziak JJ. SMART longitudinal analysis: A tutorial for using repeated outcome measures from SMART studies to compare adaptive interventions. Psychol Methods. 2020 Feb;25(1):1-29. doi: 10.1037/met0000219. Epub 2019 Jul 18. PMID 31318231
• Meis LA, Polusny MA, Kehle-Forbes SM, Erbes CR, O'Dougherty M, Erickson EPG, Orazem RJ, Burmeister LB, Spoont MR. Making sense of poor adherence in PTSD treatment from the perspectives of veterans and their therapists. Psychol Trauma. 2023 May;15(4):715-725. doi: 10.1037/tra0001199. Epub 2022 Mar 24. PMID 35324228
• Lei H, Nahum-Shani I, Lynch K, Oslin D, Murphy SA. A "SMART" design for building individualized treatment sequences. Annu Rev Clin Psychol. 2012;8:21-48. doi: 10.1146/annurev-clinpsy-032511-143152. Epub 2011 Dec 12. PMID 22224838
• Maguen S, Holder N, Madden E, Li Y, Seal KH, Neylan TC, Lujan C, Patterson OV, DuVall SL, Shiner B. Evidence-based psychotherapy trends among posttraumatic stress disorder patients in a national healthcare system, 2001-2014. Depress Anxiety. 2020 Apr;37(4):356-364. doi: 10.1002/da.22983. Epub 2019 Dec 18. PMID 31850650
• Kehle-Forbes SM, Ackland PE, Spoont MR, Meis LA, Orazem RJ, Lyon A, Valenstein-Mah HR, Schnurr PP, Zickmund SL, Foa EB, Chard KM, Alpert E, Polusny MA. Divergent experiences of U.S. veterans who did and did not complete trauma-focused therapies for PTSD: A national qualitative study of treatment dropout. Behav Res Ther. 2022 Jul;154:104123. doi: 10.1016/j.brat.2022.104123. Epub 2022 May 21. PMID 35644083

Идентификаторы

NCT: NCT06957067 · 1806524-49 · HT94252410639

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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