Completed

NCT Number: NCT01943162

Enhanced Cognitive Rehabilitation to Treat Comorbid TBI and PTSD

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.

Completed

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Key information

Conditions

PTSD With a History of Mild to Moderate TBI

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

VA San Diego Healthcare System

San Diego, California, 92161, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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. -

Exclusion criteria

1) Active substance dependence, 2) Suicidal intent or attempt within the previous month; 3) Current psychotic disorder; 4) Dementia; 5) Non-English speaking; 6) Participation in other intervention studies.

Treatment and study plan

CPT

Behavioral

Primary outcomes

PTSD Checklist

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

Sponsors and collaborators

Lead sponsor

San Diego Veterans Healthcare System

Fed

Collaborators

Congressionally Directed Medical Research Programs

Registry information

Important dates

Study start: 2012
Primary completion: 2017
Study completion: 2017
First posted: Sep 16, 2013
Registry last updated: May 9, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.