NCT06000475

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
2mo left

Started Oct 2024

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress91%
Oct 2024Jun 2026

First Submitted

Initial submission to the registry

August 11, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

August 21, 2023

Completed
1.2 years until next milestone

Study Start

First participant enrolled

October 15, 2024

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2026

Last Updated

October 14, 2025

Status Verified

October 1, 2025

Enrollment Period

1.7 years

First QC Date

August 11, 2023

Last Update Submit

October 9, 2025

Conditions

Keywords

Stress Disorders, Post-TraumaticPsychotherapyMemory

Outcome Measures

Primary Outcomes (1)

  • 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

Other Outcomes (1)

  • Client Satisfaction Questionnaire (CSQ)

    Through study completion, weeks 12-16 of treatment

Study Arms (2)

Cognitive Processing Therapy (CPT)

ACTIVE COMPARATOR

Standard CPT as described in the treatment manual

Behavioral: Cognitive Processing Therapy

Cognitive Processing Therapy (CPT) + Memory Support

EXPERIMENTAL

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

Behavioral: Cognitive Processing TherapyBehavioral: Cognitive Processing Therapy (CPT) + Memory Support

Interventions

CPT as described in the treatment manual

Also known as: CPT
Cognitive Processing Therapy (CPT)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.

Cognitive Processing Therapy (CPT) + Memory Support

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Philadelphia, Pennsylvania, 19104-4551, United States

RECRUITING

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Interventions

2-cyclohexylidenhydrazo-4-phenyl-thiazole

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Study Officials

  • James C. Scott, PhD

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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Blinded to treatment status during feasibility trial
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 11, 2023

First Posted

August 21, 2023

Study Start

October 15, 2024

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

June 30, 2026

Last Updated

October 14, 2025

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will not share

Locations