Enhancing Memory in CPT for PTSD

Stress Disorders, Post-Traumatic Clinical Trial

Official title:

Enhancing Memory in Cognitive Processing Therapy for Older Adults With PTSD

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06000475
• Other study ID #: D4627-P
• Secondary ID: 1I21RX004627
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 1, 2024
• Est. completion date: September 30, 2025

Study information

• Verified date: February 2024
• Source: VA Office of Research and Development
• Contact: James C Scott, PhD
• Phone: (215) 823-5800
• Email: James.Scott2de50a[@]va.gov
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: September 30, 2025
• Est. primary completion date: September 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Behavioral:
• Cognitive Processing Therapy
CPT as described in the treatment manual
• 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.

Locations

Country	Name	City	State
United States	Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Client Satisfaction Questionnaire (CSQ)	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.	Through study completion, weeks 12-16 of treatment
Primary	PTSD Checklist-5 (PCL-5)	Questionnaire for symptoms of PTSD; the range of the scale is from 0 (no symptoms) to 80 (maximal symptoms).	Through study completion, weeks 12-16 of treatment