Recruiting

CPT with MS

Sponsor:

Boston University

Code:

NCT05310097

Conditions

PTSD

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

CPT

MS

Study Details

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.

Conditions

PTSD

Study ID

NCT05310097

Start date

Jan 4, 2023

Status verified date

Mar, 2026

Completion date

Apr, 2027

Anticipated

Primary completion date

Jan, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 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.

active comparator: 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.

Interventions

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.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Joseph Carpenter, PhD MA

617-435-5319jcarpen@bu.edu

Locations

VA Boston Healthcare System

Recruiting

Jamaica Plain, Massachusetts, United States, 02130

Contacts

Joseph Carpenter, PhD MA

617-435-5319jcarpen@bu.edu

More Information

Sponsor

Boston University

Last update posted

Apr 1, 2026

Last verified

Mar, 2026

Keywords

  • Cognitive Processing Therapy (CPT)
  • Memory Support (MS)
  • CPT + MS

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Boston University on 2026-04-01.