Enhanced Cognitive Rehabilitation to Treat Comorbid TBI and PTSD

NCT ID: NCT01943162

Last Updated: 2018-05-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

108 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-08-31

Study Completion Date

2017-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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PTSD With a History of Mild to Moderate TBI

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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SMART-CPT

CPT with additional elements of cognitive rehabilitation

Group Type EXPERIMENTAL

CPT

Intervention Type BEHAVIORAL

CPT

Standard Cognitive Processing Therapy

Group Type ACTIVE_COMPARATOR

CPT

Intervention Type BEHAVIORAL

Interventions

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CPT

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

\-
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Congressionally Directed Medical Research Programs

FED

Sponsor Role collaborator

San Diego Veterans Healthcare System

FED

Sponsor Role lead

Responsible Party

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Amy Jak

Staff Neuropsychologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Amy Jak, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

VA San Diego

Locations

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VA San Diego Healthcare System

San Diego, California, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 36204974 (View on PubMed)

Other Identifiers

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W81XWH-11-1-0641

Identifier Type: -

Identifier Source: org_study_id

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