Enhanced Cognitive Rehabilitation to Treat Comorbid TBI and PTSD

PTSD With a History of Mild to Moderate TBI Clinical Trial

Official title:

Enhanced Cognitive Rehabilitation to Treat Comorbid TBI and PTSD

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01943162
• Other study ID #: W81XWH-11-1-0641
• Status: Completed
• Phase: N/A
• Start date: August 2012
• Est. completion date: September 2017

Study information

• Verified date: May 2018
• Source: San Diego Veterans Healthcare System
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 108
• Est. completion date: September 2017
• Est. primary completion date: September 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• PTSD With a History of Mild to Moderate TBI

Intervention

Behavioral:
• CPT

Locations

Country	Name	City	State
United States	VA San Diego Healthcare System	San Diego	California

Sponsors (2)

Lead Sponsor	Collaborator
San Diego Veterans Healthcare System	Congressionally Directed Medical Research Programs

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PTSD Checklist		change from baseline PTSD Checklist at 12 weeks (post-treatment)