Cognitive Processing Therapy (CPT) Memory Support (MS) Study

Официальное название

Enhancing Memory and Learning in Cognitive Processing Therapy for Post Traumatic Stress Disorder (PTSD)

Обзор

The efficacy of psychological interventions for posttraumatic stress disorder (PTSD) is likely limited by the difficulty participants have learning and remembering important therapy content. Accordingly, the present study will examine the utility of integrating a Memory Support (MS) intervention into Cognitive Processing Therapy (CPT), an empirically supported and widely disseminated treatment for PTSD. MS was designed to integrate techniques aimed at facilitating encoding, consolidation, and retrieval of new learning into existing treatments, and has been shown to improve outcomes when integrated into cognitive therapy for depression. A pilot randomized controlled trial (n=52) comparing CPT with Memory Support (CPT+MS) to CPT-alone will be conducted. Study participants will be adults diagnosed with PTSD. The primary aim of the trial will be to determine if CPT+MS will lead to greater memory and learning of therapy content relative to CPT-alone, and to establish the acceptability and feasibility of integrating MS into CPT. Secondary aims include a preliminary examination of treatment efficacy, as indicated by the magnitude of changes in PTSD symptoms between conditions, and target validation, as indicated by associations between memory and learning of therapy content and treatment response. Exploratory analyses will examine several indicators of baseline memory-related cognitive functioning as predictors of memory and learning of therapy content, providing preliminary data to inform future research on personalized application of MS. Results of the trial will advance scientific knowledge about methods for optimizing memory and learning as a mechanism for improving PTSD treatment outcomes.

Вмешательства

• Поведенческое CPT
  CPT will be delivered over the course of 12 one-hour weekly sessions (maximum of 18 weeks to complete treatment). Participants will have the option of receiving CPT in-person or via videoconferencing.
• Поведенческое MS
  The MS protocol consists of eight strategies: categorization, evaluation, application, cue-based reminders, practice remembering, attention recruitment, praising recall, and repetitions.

Первичные конечные точки

• Mid-treatment Memory of therapy content assessed by the Therapy Recall Task [Срок оценки: 6 weeks]
• Post-treatment Memory of therapy content assessed by the Therapy Recall Task [Срок оценки: 12 weeks]
• Follow-up Memory of therapy content assessed by the Therapy Recall Task [Срок оценки: 6 months]
• Feasibility assessed by mean CPT Adherence [Срок оценки: 12 weeks]
• Feasibility assessed by mean CPT Competence [Срок оценки: 12 weeks]
• Feasibility assessed by the Memory Support Rating Scale (MSRS) [Срок оценки: 12 weeks]
• Treatment acceptability after Session 1 assessed by the Credibility and Expectancy (CEQ) questionnaire [Срок оценки: 1 week]
• Mid-treatment acceptability assessed by the Working Alliance Inventory Short-Revised (WAI-R) [Срок оценки: 6 weeks]
• Post-treatment acceptability assessed by the Working Alliance Inventory Short-Revised (WAI-R) [Срок оценки: 12 weeks]
• Mid-treatment client satisfaction assessed by the Client Satisfaction Questionnaire (CSQ) [Срок оценки: 6 weeks]

Вторичные конечные точки (12)

• Mid-treatment Memory of Therapy Content assessed by the Treatment Thoughts and Application Task [Срок оценки: 6 weeks]
• Post-treatment Memory of Therapy Content assessed by the Treatment Thoughts and Application Task [Срок оценки: 12 weeks]
• Follow-up Memory of Therapy Content assessed by the Treatment Thoughts and Application Task [Срок оценки: 6 months]
• Mid-treatment Change in Memory of Therapy Content assessed by the Generalization Task [Срок оценки: Baseline, 6 weeks]
• Post-treatment Change in Memory of Therapy Content assessed by the Generalization Task [Срок оценки: Baseline, 12 weeks]
• Follow-up Change in Memory of Therapy Content assessed by the Generalization Task [Срок оценки: Baseline, 6 months]
• Mid-treatment Skills of Cognitive Therapy (SoCT) - Patient [Срок оценки: 6 weeks]
• Post-treatment Skills of Cognitive Therapy (SoCT) - Patient [Срок оценки: 12 weeks]
• Follow-up Skills of Cognitive Therapy (SoCT) - Patient [Срок оценки: 6 months]
• Mid-treatment Skills of Cognitive Therapy (SoCT) - Therapist [Срок оценки: 6 weeks]
• Post-treatment Skills of Cognitive Therapy (SoCT) - Therapist [Срок оценки: 12 weeks]
• Post-treatment Change in PTSD symptoms assessed by the Clinician Administered PTSD Scale for DSM-5 (CAPS-5) [Срок оценки: Baseline, 12 weeks]

Критерии участия

Критерии включения

• Current diagnosis of PTSD as determined by the Clinician Administered PTSD Scale for the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5)
• For potential participants on psychiatric medication, dose must be stable for the past four weeks.
• Veteran status

Критерии исключения

• Current DSM-5 diagnoses of unstable bipolar disorder, past or present psychosis, or organic mental disorder
• Active suicidal or homicidal ideation with plan or intent
• Current moderate or severe substance use disorder, as defined by DSM-5 \[i.e., at least 4 diagnostic symptoms of Substance use disorder (SUD) present\]
• Prior receipt of CPT or concurrent therapy for PTSD
• Significant cognitive impairment as indicated by a score <10th percentile on the Montreal Cognitive Assessment
• History of moderate or severe traumatic brain injury (TBI) based on the Ohio State University TBI Identification Method and Veterans Administration/ Department of Defense (VA/DOD) guidelines
• High verbal memory ability, as indicated by a score >1 standard deviation (SD) above the population mean on the California Verbal Learning Test® Third Edition (CVLT-3) immediate recall task

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• VA Boston Healthcare System — Jamaica Plain

Идентификаторы

NCT: NCT05310097 · H-42343 · 1K23MH129878-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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