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Enhancing Memory in CPT for PTSD

Primary Purpose

Stress Disorders, Post-Traumatic

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cognitive Processing Therapy
Cognitive Processing Therapy (CPT) + Memory Support
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stress Disorders, Post-Traumatic focused on measuring Stress Disorders, Post-Traumatic, Psychotherapy, Memory

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Cognitive Processing Therapy (CPT)

Cognitive Processing Therapy (CPT) + Memory Support

Arm Description

Standard CPT as described in the treatment manual

CPT+Memory support will also incorporate frequent and intentional use of strategies to enhance learning and memory of this content.

Outcomes

Primary Outcome Measures

PTSD Checklist-5 (PCL-5)
Questionnaire for symptoms of PTSD; the range of the scale is from 0 (no symptoms) to 80 (maximal symptoms).

Secondary Outcome Measures

Full Information

First Posted
August 11, 2023
Last Updated
August 30, 2023
Sponsor
VA Office of Research and Development
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1. Study Identification

Unique Protocol Identification Number
NCT06000475
Brief Title
Enhancing Memory in CPT for PTSD
Official Title
Enhancing Memory in Cognitive Processing Therapy for Older Adults With PTSD
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 1, 2024 (Anticipated)
Primary Completion Date
September 30, 2025 (Anticipated)
Study Completion Date
September 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress Disorders, Post-Traumatic
Keywords
Stress Disorders, Post-Traumatic, Psychotherapy, Memory

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
Blinded to treatment status during feasibility trial
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cognitive Processing Therapy (CPT)
Arm Type
Active Comparator
Arm Description
Standard CPT as described in the treatment manual
Arm Title
Cognitive Processing Therapy (CPT) + Memory Support
Arm Type
Experimental
Arm Description
CPT+Memory support will also incorporate frequent and intentional use of strategies to enhance learning and memory of this content.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Processing Therapy
Other Intervention Name(s)
CPT
Intervention Description
CPT as described in the treatment manual
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Processing Therapy (CPT) + Memory Support
Intervention Description
CPT+Memory support will also incorporate frequent and intentional use of strategies to enhance learning and memory of this content.
Primary Outcome Measure Information:
Title
PTSD Checklist-5 (PCL-5)
Description
Questionnaire for symptoms of PTSD; the range of the scale is from 0 (no symptoms) to 80 (maximal symptoms).
Time Frame
Through study completion, weeks 12-16 of treatment
Other Pre-specified Outcome Measures:
Title
Client Satisfaction Questionnaire (CSQ)
Description
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.
Time Frame
Through study completion, weeks 12-16 of treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
James C Scott, PhD
Phone
(215) 823-5800
Ext
7138
Email
James.Scott2de50a@va.gov
First Name & Middle Initial & Last Name or Official Title & Degree
Richard A Moore
Phone
(215) 823-5800
Ext
7916
Email
richard.moore7@va.gov
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James C. Scott, PhD
Organizational Affiliation
Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA
Official's Role
Principal Investigator
Facility Information:
Facility Name
Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104-4551
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kyong-Mi Chang, MD
Phone
215-823-5893
Email
Kyong-Mi.Chang@va.gov
First Name & Middle Initial & Last Name & Degree
Richard A Moore
Phone
(215) 823-5800
Ext
7916
Email
richard.moore7@va.gov
First Name & Middle Initial & Last Name & Degree
James C. Scott, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

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Enhancing Memory in CPT for PTSD

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