Clinical trial NCT05310097: Cognitive Processing Therapy (CPT) Memory Support (MS) Study
Official title: Enhancing Memory and Learning in Cognitive Processing Therapy for Post Traumatic Stress Disorder (PTSD)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: PTSD
Keywords: Cognitive Processing Therapy (CPT)
Memory Support (MS)
CPT + MS
Lead sponsor: Boston University
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
name: VA Boston Healthcare System
First posted: 2022-04-04
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Mid-treatment Memory of therapy content assessed by the Therapy Recall Task
timeFrame: 6 weeks
measure: Post-treatment Memory of therapy content assessed by the Therapy Recall Task
timeFrame: 12 weeks
measure: Follow-up Memory of therapy content assessed by the Therapy Recall Task
timeFrame: 6 months
measure: Feasibility assessed by mean CPT Adherence
timeFrame: 12 weeks
measure: Feasibility assessed by mean CPT Competence
timeFrame: 12 weeks
measure: Feasibility assessed by the Memory Support Rating Scale (MSRS)
timeFrame: 12 weeks
measure: Treatment acceptability after Session 1 assessed by the Credibility and Expectancy (CEQ) questionnaire
timeFrame: 1 week
measure: Mid-treatment acceptability assessed by the Working Alliance Inventory Short-Revised (WAI-R)
timeFrame: 6 weeks
measure: Post-treatment acceptability assessed by the Working Alliance Inventory Short-Revised (WAI-R)
timeFrame: 12 weeks
measure: Mid-treatment client satisfaction assessed by the Client Satisfaction Questionnaire (CSQ)
timeFrame: 6 weeks
measure: Post-treatment client satisfaction assessed by the Client Satisfaction Questionnaire (CSQ)
timeFrame: 12 weeks
Secondary outcomes:
measure: Mid-treatment Memory of Therapy Content assessed by the Treatment Thoughts and Application Task
timeFrame: 6 weeks
measure: Post-treatment Memory of Therapy Content assessed by the Treatment Thoughts and Application Task
timeFrame: 12 weeks
measure: Follow-up Memory of Therapy Content assessed by the Treatment Thoughts and Application Task
timeFrame: 6 months
measure: Mid-treatment Change in Memory of Therapy Content assessed by the Generalization Task
timeFrame: Baseline, 6 weeks
measure: Post-treatment Change in Memory of Therapy Content assessed by the Generalization Task
timeFrame: Baseline, 12 weeks
measure: Follow-up Change in Memory of Therapy Content assessed by the Generalization Task
timeFrame: Baseline, 6 months
measure: Mid-treatment Skills of Cognitive Therapy (SoCT) - Patient
timeFrame: 6 weeks
measure: Post-treatment Skills of Cognitive Therapy (SoCT) - Patient
timeFrame: 12 weeks
measure: Follow-up Skills of Cognitive Therapy (SoCT) - Patient
timeFrame: 6 months
measure: Mid-treatment Skills of Cognitive Therapy (SoCT) - Therapist
timeFrame: 6 weeks
measure: Post-treatment Skills of Cognitive Therapy (SoCT) - Therapist
timeFrame: 12 weeks
measure: Post-treatment Change in PTSD symptoms assessed by the Clinician Administered PTSD Scale for DSM-5 (CAPS-5)
timeFrame: Baseline, 12 weeks
measure: Follow-up Change in PTSD symptoms assessed by the Clinician Administered PTSD Scale for DSM-5 (CAPS-5)
timeFrame: Baseline, 6 months
measure: Post-treatment Change in PTSD symptoms assessed by the PTSD Checklist for DSM-5 (PCL-5)
timeFrame: Baseline, 12 weeks
measure: Follow-up Change in PTSD symptoms assessed by the PTSD Checklist for DSM-5 (PCL-5)
timeFrame: Baseline, 6 months
measure: Post-treatment Change in Depression symptoms assessed by the Patient Health Questionnaire 9-item (PHQ-9)
timeFrame: Baseline, 12 weeks
measure: Follow-up Change in Depression symptoms assessed by the Patient Health Questionnaire 9-item (PHQ-9)
timeFrame: Baseline, 6 months
measure: Post-treatment Change in general functioning assessed by the WHO Disability Assessment Scale-II (WHODAS-II)
timeFrame: Baseline, 12 weeks
measure: Follow-up Change in general functioning assessed by the WHO Disability Assessment Scale-II (WHODAS-II)
timeFrame: Baseline, 6 months
Other outcomes:
measure: Post-treatment Change in cognitive complaints assessed by the Cognitive Self-Report Questionnaire - Cognitive subscale (CSRQ-C)
timeFrame: Baseline, 12 weeks
measure: Follow-up Change in cognitive complaints assessed by the Cognitive Self-Report Questionnaire - Cognitive subscale (CSRQ-C)
timeFrame: Baseline, 6 months
measure: Post-treatment Change in PTSD-related cognitions assessed by the Posttraumatic Cognitions Inventory - 9-item (PTCI-9)
timeFrame: Baseline, 12 weeks
measure: Follow-up Change in PTSD-related cognitions assessed by the Posttraumatic Cognitions Inventory - 9-item (PTCI-9)
timeFrame: Baseline, 6 months
measure: Post-treatment Change in PTSD-related coping self-efficacy assessed by the Trauma Coping Self Efficacy Scale (CSE-T)
timeFrame: Baseline, 12 weeks
measure: Follow-up Change in PTSD-related coping self-efficacy assessed by the Trauma Coping Self Efficacy Scale (CSE-T)
timeFrame: Baseline, 6 months
measure: Post-treatment Change in sleep difficulties assessed by the Pittsburgh Sleep Quality Index - Brief (PSQI)
timeFrame: Baseline, 12 weeks
measure: Follow-up Change in sleep difficulties assessed by the Pittsburgh Sleep Quality Index - Brief (PSQI)
timeFrame: Baseline, 6 months
Locations:
city: Jamaica Plain
country: United States
facility: VA Boston Healthcare System
state: Massachusetts
Study officials:
affiliation: VA Boston Healthcare System, BUSM Psychiatry Dept.
name: Joseph Carpenter, PhD MA
role: PRINCIPAL_INVESTIGATOR
References: