Trial Outcomes & Findings for Cognition and Psychotherapy in PTSD (NCT NCT03641924)

NCT ID: NCT03641924

Last Updated: 2025-05-09

Results Overview

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

• Recruitment status: COMPLETED
• Target enrollment: 110 participants
• Primary outcome timeframe: Change from baseline to 12 weeks
• Results posted on: 2025-05-09

Participant Flow

28 participants either did not meet criteria for PTSD after a structured assessment (n=19), met criteria for a comorbid disorder that was exclusionary (n=4), or were lost to follow-up before completing baseline assessments.

Participant milestones

Measure	Posttraumatic Stress Disorder (PTSD) Veterans diagnosed with DSM-V PTSD Cognitive Processing Therapy: Cognitive Processing Therapy is an evidence-based psychotherapy for PTSD.
Overall Study STARTED	110
Overall Study Received Intervention	94
Overall Study COMPLETED	58
Overall Study NOT COMPLETED	52

Reasons for withdrawal

Measure	Posttraumatic Stress Disorder (PTSD) Veterans diagnosed with DSM-V PTSD Cognitive Processing Therapy: Cognitive Processing Therapy is an evidence-based psychotherapy for PTSD.
Overall Study Withdrawal by Subject	26
Overall Study Lost to Follow-up	16
Overall Study Protocol Violation	10

Baseline Characteristics

Cognition and Psychotherapy in PTSD

Baseline characteristics by cohort

Measure	Veterans With PTSD n=94 Participants Veterans with DSM-5 PTSD as assessed with the Clinician Administered PTSD Scale
Age, Continuous	45 years STANDARD_DEVIATION 12 • n=5 Participants
Sex: Female, Male Female	30 Participants n=5 Participants
Sex: Female, Male Male	64 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants
Race (NIH/OMB) Asian	4 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	2 Participants n=5 Participants
Race (NIH/OMB) Black or African American	40 Participants n=5 Participants
Race (NIH/OMB) White	45 Participants n=5 Participants
Race (NIH/OMB) More than one race	2 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	94 Participants n=5 Participants
Mild Traumatic Brain Injury (TBI)	49 Participants n=5 Participants
Moderate TBI	7 Participants n=5 Participants
PTSD Checklist (PCL-5)	45 units on a scale STANDARD_DEVIATION 11 • n=5 Participants

PRIMARY outcome

Timeframe: Change from baseline to 12 weeks

Population: Based on baseline memory scores

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

Outcome measures

Measure	Low Memory n=31 Participants Bottom tertile of memory performance	Medium Memory n=32 Participants Middle tertile of memory performance	High Memory n=31 Participants Top tertile of memory performance
Change in PTSD Checklist (PCL-5)	9.25 change in units on a scale Standard Deviation 20.37	11.94 change in units on a scale Standard Deviation 15.93	15.91 change in units on a scale Standard Deviation 15.10

PRIMARY outcome

Timeframe: Change from baseline to 12 weeks

Population: Groups based on baseline memory scores

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

Outcome measures

Measure	Low Memory n=30 Participants Bottom tertile of memory performance	Medium Memory n=31 Participants Middle tertile of memory performance	High Memory n=30 Participants Top tertile of memory performance
Social Adjustment Scale-Self Report (SAS-SR)	0.14 change in units on a scale Standard Deviation 0.56	0.10 change in units on a scale Standard Deviation 0.41	0.38 change in units on a scale Standard Deviation 0.42

SECONDARY outcome

Timeframe: Change from baseline to 12 weeks

Population: Based on baseline memory scores

Mental Health-Related Quality of Life. Scores range from 0-100; higher values indicate better mental health-related quality of life.

Outcome measures

Measure	Low Memory n=30 Participants Bottom tertile of memory performance	Medium Memory n=31 Participants Middle tertile of memory performance	High Memory n=30 Participants Top tertile of memory performance
Veterans RAND 12 Item Health Survey Mental Component Summary (VR-12 MCS)	1.26 change in units on a scale Standard Deviation 7.95	0.32 change in units on a scale Standard Deviation 9.05	0.39 change in units on a scale Standard Deviation 6.11

Adverse Events

PTSD

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. James Cobb Scott

Corporal Michael J. Crescenz VAMC

Phone: 2158235800

Email: James.Scott2de50a@va.gov

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place