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Enhancing Memory in CPT for PTSD

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ClinicalTrials.gov Identifier: NCT06000475
Recruitment Status : Not yet recruiting
First Posted : August 21, 2023
Last Update Posted : February 23, 2024
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Study Description
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Brief Summary:
Several psychotherapies for posttraumatic stress disorder (PTSD) have a strong evidence base for their efficacy, but nonresponse rates are high, particularly among older Veterans. Accumulating evidence indicates that memory deficits and poor learning of therapy contents adversely affect psychotherapy treatment response in PTSD. However, limited research has examined methods for increasing learning of therapy contents in psychotherapy for PTSD. The proposed study aims to examine the feasibility of integrating an intervention to increase learning and memory of psychotherapy content into the provision of a widely used psychotherapy, cognitive processing therapy (CPT), for older adults with PTSD. The ultimate goal of this line of research is to develop novel rehabilitation interventions to increase functioning for individuals with PTSD.

Condition or disease Intervention/treatment Phase
Stress Disorders, Post-Traumatic Behavioral: Cognitive Processing Therapy Behavioral: Cognitive Processing Therapy (CPT) + Memory Support Not Applicable

Detailed Description:
Posttraumatic stress disorder (PTSD) is prevalent among Veterans and is a substantial public health burden. Several psychotherapies, including cognitive processing therapy (CPT), have a strong evidence base for their efficacy in PTSD. However, many individuals show limited benefit from such treatments, particularly older Veterans. One factor likely affecting treatment response is poor encoding, storage, and retrieval of the skills and treatment points that are learned in psychotherapy. Individuals with PTSD display deficits in learning and memory, and aging is independently associated with declines in memory and executive functioning. Thus, older adults with PTSD may be at heightened risk of cognitive dysfunction that could impact their ability to benefit from frontline PTSD treatments. To this end, pre-treatment memory functioning has been shown to consistently predict treatment response in psychotherapy for PTSD. Inefficient learning and memory for psychotherapy content may be one mechanism explaining this relationship, as poor learning of therapy content is linked with worse treatment adherence and outcomes. The primary aim of this proposal is to examine the feasibility and acceptability of integrating a novel Memory Support intervention into the provision of CPT for older adults with PTSD. The Memory Support intervention was developed such that specific strategies to enhance encoding and retrieval of therapy content and skills can be integrated into manualized psychotherapy. However, no prior studies have integrated this intervention into treatments for PTSD. The proposed project will be guided by a user-centered design framework for treatment development and be conducted in three phases. In the first phase, the investigators will develop a modified CPT treatment manual that systematically integrates Memory Support, with clinician (n=3) and Veteran (n=3) feedback to provide guidance on process and techniques. In the next phase, the investigators will conduct iterative refinement of the modified treatment through a case series in older Veterans (n=3) with an experienced CPT therapist. Finally, the investigators will conduct a small feasibility randomized controlled trial (n=20) in which the investigators will examine accrual, retention, completion, acceptability, and variability in symptom and functional outcomes, as well as all procedures for a larger trial. The proposed project offers substantial conceptual innovations by bridging foundational work from rehabilitation neuropsychology and psychotherapy mechanisms research and will provide valuable pilot data to inform a novel intervention for older Veterans with PTSD that can be tested in future large-scale studies. Such approaches may be especially relevant for Veterans with neurocognitive deficits (e.g., memory), potentially suggesting a target for a personalized approach to mental health care.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description: Blinded to treatment status during feasibility trial
Primary Purpose: Treatment
Official Title: Enhancing Memory in Cognitive Processing Therapy for Older Adults With PTSD
Estimated Study Start Date : July 1, 2024
Estimated Primary Completion Date : September 30, 2025
Estimated Study Completion Date : September 30, 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Cognitive Processing Therapy (CPT)
Standard CPT as described in the treatment manual
 Behavioral: Cognitive Processing Therapy
CPT as described in the treatment manual
Other Name: CPT
Experimental: Cognitive Processing Therapy (CPT) + Memory Support
CPT+Memory support will also incorporate frequent and intentional use of strategies to enhance learning and memory of this content.
 Behavioral: Cognitive Processing Therapy
CPT as described in the treatment manual
Other Name: CPT

Behavioral: Cognitive Processing Therapy (CPT) + Memory Support
CPT+Memory support will also incorporate frequent and intentional use of strategies to enhance learning and memory of this content.


Outcome Measures
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Primary Outcome Measures :
  1. PTSD Checklist-5 (PCL-5) [ Time Frame: Through study completion, weeks 12-16 of treatment ]
    Questionnaire for symptoms of PTSD; the range of the scale is from 0 (no symptoms) to 80 (maximal symptoms).


Other Outcome Measures:
  1. Client Satisfaction Questionnaire (CSQ) [ Time Frame: Through study completion, weeks 12-16 of treatment ]
    8-item patient satisfaction scale; the range of the scale is from 8 to 32, where low scores are indicative of low satisfaction and high scores are indicative of high satisfaction.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Veterans with DSM-5 diagnoses of PTSD via the Clinician Administered PTSD Scale (CAPS-5)
  • Age >59

Exclusion Criteria:

  • daily benzodiazepine use (due to memory impairing effects)
  • bipolar or psychotic disorders
  • current suicidal ideation with plan or intent
  • current moderate or severe substance use disorder not in remission for >1 mo.
  • severe traumatic brain injury
  • a Montreal Cognitive Assessment (MoCA) indicative of dementia
  • or other disorders that would severely limit study participation
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06000475


Contacts
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Contact: James C Scott, PhD (215) 823-5800 ext 7138 James.Scott2de50a@va.gov
Contact: Richard A Moore (215) 823-5800 ext 7916 richard.moore7@va.gov

Locations
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United States, Pennsylvania
Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA
Philadelphia, Pennsylvania, United States, 19104-4551
Contact: Kyong-Mi Chang, MD    215-823-5893    Kyong-Mi.Chang@va.gov   
Contact: Richard A Moore    (215) 823-5800 ext 7916    richard.moore7@va.gov   
Principal Investigator: James C. Scott, PhD         
Sponsors and Collaborators
VA Office of Research and Development
Investigators
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Principal Investigator: James C. Scott, PhD Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA
More Information
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Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT06000475    
Other Study ID Numbers: D4627-P
1I21RX004627 ( U.S. NIH Grant/Contract )
First Posted: August 21, 2023    Key Record Dates
Last Update Posted: February 23, 2024
Last Verified: February 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by VA Office of Research and Development:
Stress Disorders, Post-Traumatic
Psychotherapy
Memory
Additional relevant MeSH terms:
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Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Trauma and Stressor Related Disorders
Mental Disorders