Cognitive Processing Therapy (CPT) Memory Support (MS) Study
NCT ID: NCT05310097
Last Updated: 2025-03-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
100 participants
INTERVENTIONAL
2023-01-04
2027-04-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Cognitive Processing Therapy + Memory Support (CPT + MS)
CPT + MS will involve the same treatment strategies as CPT while incorporating deliberate and frequent use of memory and learning support strategies. MS strategies are designed to enhance the memory of specific treatment points, defined as any insight, skill or strategy determined to be important for the patient to remember and/or implement. MS is not designed to enhance memory functioning generally, but rather improve the encoding, consolidation and retrieval of specific components of therapeutic learning.
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.
MS
The MS protocol consists of eight strategies: categorization, evaluation, application, cue-based reminders, practice remembering, attention recruitment, praising recall, and repetitions.
Cognitive Processing Therapy (CPT)
CPT is a manualized, trauma-focused therapy for PTSD. Treatment consists of psychoeducation on the cognitive model of PTSD, identification of trauma-related stuck points (i.e. dysfunctional beliefs), and cognitive challenging techniques to help participants identify more realistic and adaptive ways of viewing their trauma, themselves, and the world.
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.
Interventions
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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.
MS
The MS protocol consists of eight strategies: categorization, evaluation, application, cue-based reminders, practice remembering, attention recruitment, praising recall, and repetitions.
Eligibility Criteria
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Inclusion Criteria
* For potential participants on psychiatric medication, dose must be stable for the past four weeks.
* Veteran status
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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National Institute of Mental Health (NIMH)
NIH
VA Boston Healthcare System
FED
Boston University
OTHER
Responsible Party
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Principal Investigators
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Joseph Carpenter, PhD MA
Role: PRINCIPAL_INVESTIGATOR
VA Boston Healthcare System, BUSM Psychiatry Dept.
Locations
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VA Boston Healthcare System
Jamaica Plain, Massachusetts, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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H-42343
Identifier Type: -
Identifier Source: org_study_id
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