Cognition and Psychotherapy in PTSD

NCT03641924 | Completed Results

• 1 other identifier: D2699-R
• Study Type: observational
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

Posttraumatic stress disorder (PTSD) is prevalent among combat Veterans and is a substantial public health burden. Several psychotherapies, including cognitive processing therapy (CPT) and prolonged exposure therapy, have been recommended as efficacious for the treatment of PTSD and are being disseminated nationally in the VA Healthcare System. Yet many individuals show limited benefit from such treatments. Accumulating evidence indicates that episodic memory deficits may be one factor limiting psychotherapy treatment efficacy in PTSD. The proposed study will determine whether verbal memory is a specific predictor of CPT outcomes in PTSD, including both symptom reductions and functional outcomes. The study will also determine the pathways by which memory functioning affects treatment outcomes by examining relationships between memory functioning, treatment engagement, recall of treatment content, and illness course. More specifically, analyses will examine whether memory for treatment content affects the relationship between memory functioning and treatment outcomes.

Conditions

Posttraumatic Stress Disorder (PTSD)

Keywords

Posttraumatic Stress Disorder; Psychotherapy; Neuropsychology

Outcome Measures

Primary Outcomes (2)

• Change in PTSD Checklist (PCL-5)

  PTSD Symptoms. The range of the scale is from 0 (no symptoms) to 80 (maximal symptoms). Higher scores corresponds to more symptoms.

  Change from baseline to 12 weeks

• Social Adjustment Scale-Self Report (SAS-SR)

  Functional Status. Scored 1-5, with higher scores indicating worse functioning.

  Change from baseline to 12 weeks

Secondary Outcomes (1)

• Veterans RAND 12 Item Health Survey Mental Component Summary (VR-12 MCS)

  Change from baseline to 12 weeks

Study Arms (1)

PTSD

Veterans diagnosed with Diagnostic and Statistical Manual (DSM-V) PTSD

Behavioral: Cognitive Processing Therapy

Interventions

Cognitive Processing Therapy BEHAVIORAL

Cognitive Processing Therapy is an evidence-based psychotherapy for PTSD.

PTSD

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Veterans

You may qualify if:

• DSM-5 criteria for PTSD via the Clinician Administered PTSD Scale (CAPS-5)
• Willing to initiate CPT

You may not qualify if:

• Substance use disorder (moderate or above) not in remission for \>1 mo
• Severe psychiatric illness (e.g., psychosis)
• Significant current suicidal or homicidal intent, including a specific plan
• Dementia, neurological disorder, or severe traumatic brain injury (TBI; i.e., loss of consciousness \> 24h)
• Inability to speak or read English

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

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

Philadelphia, Pennsylvania, 19104-4551, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Results Point of Contact

• Title: Dr. James Cobb Scott
• Organization: Corporal Michael J. Crescenz VAMC

James.Scott2de50a@va.gov

2158235800

Study Officials

• James C. Scott, PhD

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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 20, 2018
• First Posted: August 22, 2018
• Study Start: May 20, 2019
• Primary Completion: September 29, 2023
• Study Completion: September 29, 2023
• Last Updated: May 9, 2025
• Results First Posted: May 9, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ANALYTIC CODE
• Time Frame: Datasets meeting VA standards for disclosure to the public will be made available within one year of publication of primary results.

Locations

US (1)