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

Boston University

Status: Enrolling

Conditions: PTSD

Treatments: Behavioral: MS; Behavioral: CPT

Study type: Interventional

Funder types: Other; Other U.S. Federal agency; NIH

Identifiers

NCT05310097

1K23MH129878-01 (U.S. NIH Grant/Contract)

H-42343

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups

Cognitive Processing Therapy + Memory Support (CPT + MS)

Experimental group

Description:

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.

Treatment:

Behavioral: CPT

Behavioral: MS

Cognitive Processing Therapy (CPT)

Active Comparator group

Description:

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.

Treatment:

Behavioral: CPT