NCT01943162

Brief Summary

This study will test a modification of Cognitive Processing Therapy (CPT) for Post-Traumatic Stress Disorder, (PTSD) in which CPT is augmented with compensatory cognitive rehabilitation principles from the Cognitive Symptom Management and Rehabilitation Therapy (CogSMART) intervention to create a hybrid treatment, SMART-CPT. This study investigates the efficacy of SMART-CPT in improving PTSD and post-concussive symptoms, cognition, quality of life, and treatment compliance in those with a history of mild to moderate TBI and persistent cognitive complaints.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
108

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2012

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

September 6, 2013

Completed
10 days until next milestone

First Posted

Study publicly available on registry

September 16, 2013

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed
Last Updated

May 9, 2018

Status Verified

May 1, 2018

Enrollment Period

5.1 years

First QC Date

September 6, 2013

Last Update Submit

May 8, 2018

Conditions

PTSD With a History of Mild to Moderate TBI

Outcome Measures

Primary Outcomes (1)

  • PTSD Checklist

    change from baseline PTSD Checklist at 12 weeks (post-treatment)

Study Arms (2)

SMART-CPT

EXPERIMENTAL

CPT with additional elements of cognitive rehabilitation

Behavioral: CPT

CPT

ACTIVE COMPARATOR

Standard Cognitive Processing Therapy

Behavioral: CPT

Interventions

CPTBEHAVIORAL
CPTSMART-CPT

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • \) OEF/OIF veteran; 2) Current diagnosis of PTSD; 3) History of mild-to-moderate TBI; 4) Subjective cognitive complaints; 5) No anticipated/pending medication changes; 6) Written informed consent to participate in the study. -

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA San Diego Healthcare System

San Diego, California, 92161, United States

Location

Related Publications (1)

  • Crocker LD, Sullan MJ, Jurick SM, Thomas KR, Davey DK, Hoffman SN, Twamley EW, Jak AJ. Baseline executive functioning moderates treatment-related changes in quality of life in veterans with posttraumatic stress disorder and comorbid traumatic brain injury. J Trauma Stress. 2023 Feb;36(1):94-105. doi: 10.1002/jts.22883. Epub 2022 Oct 6.

    PMID: 36204974DERIVED

MeSH Terms

Interventions

2-cyclohexylidenhydrazo-4-phenyl-thiazole

Study Officials

  • Amy Jak, Ph.D.

    VA San Diego

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Staff Neuropsychologist

Study Record Dates

First Submitted

September 6, 2013

First Posted

September 16, 2013

Study Start

August 1, 2012

Primary Completion

September 1, 2017

Study Completion

September 1, 2017

Last Updated

May 9, 2018

Record last verified: 2018-05

Locations

US(1)