RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2023-01-04
Study Completion:2026-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05310097

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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)
  2. * For potential participants on psychiatric medication, dose must be stable for the past four weeks.
  3. * Veteran status
  1. * Current DSM-5 diagnoses of unstable bipolar disorder, past or present psychosis, or organic mental disorder
  2. * Active suicidal or homicidal ideation with plan or intent
  3. * Current moderate or severe substance use disorder, as defined by DSM-5 \[i.e., at least 4 diagnostic symptoms of Substance use disorder (SUD) present\]
  4. * Prior receipt of CPT or concurrent therapy for PTSD
  5. * Significant cognitive impairment as indicated by a score \<10th percentile on the Montreal Cognitive Assessment
  6. * 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
  7. * 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

Contacts and Locations

Study Contact

Joseph Carpenter, PhD MA
CONTACT
617-435-5319
jcarpen@bu.edu

Principal Investigator

Joseph Carpenter, PhD MA
PRINCIPAL_INVESTIGATOR
VA Boston Healthcare System, BUSM Psychiatry Dept.

Study Locations (Sites)

VA Boston Healthcare System
Jamaica Plain, Massachusetts, 02130
United States

Collaborators and Investigators

Sponsor: Boston University

  • Joseph Carpenter, PhD MA, PRINCIPAL_INVESTIGATOR, VA Boston Healthcare System, BUSM Psychiatry Dept.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-01-04
Study Completion Date2026-12

Study Record Updates

Study Start Date2023-01-04
Study Completion Date2026-12

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

  • PTSD