Enhanced Cognitive Rehabilitation to Treat Comorbid TBI and PTSD

San Diego Veterans Healthcare System

Status: Completed

Conditions: PTSD With a History of Mild to Moderate TBI

Treatments: Behavioral: CPT

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT01943162

W81XWH-11-1-0641

Details and patient eligibility

About

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.

Enrollment: 108 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

1. 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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108 participants in 2 patient groups

SMART-CPT

Experimental group

Description:

CPT with additional elements of cognitive rehabilitation

Treatment:

Behavioral: CPT

CPT

Active Comparator group

Description:

Standard Cognitive Processing Therapy

Treatment:

Behavioral: CPT