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CompletedNCT01943162Updated May 9, 2018

Enhanced Cognitive Rehabilitation to Treat Comorbid TBI and PTSD

An interventional study of CPT in PTSD With a History of Mild to Moderate TBI, sponsored by San Diego Veterans Healthcare System. Completed at 1 site in United States. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2018-05-09.

Sponsored by San Diego Veterans Healthcare System · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
108
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study 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.

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Conditions studied

  • PTSD With a History of Mild to Moderate TBI
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In context

Lead sponsor

San Diego Veterans Healthcare System is the lead sponsor of 10 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility 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.

-

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
108 participants (actual)

Study arms

  • Experimental
    SMART-CPT

    CPT with additional elements of cognitive rehabilitation

    Behavioral: CPT

  • Active comparator
    CPT

    Standard Cognitive Processing Therapy

    Behavioral: CPT

Interventions

  • BehavioralCPT
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What researchers measure

Primary outcomes

  1. PTSD Checklist

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

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Study locations

1 site
  • VA San Diego Healthcare System
    San Diego, California 92161, United States
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 9, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01943162
Lead sponsor
San Diego Veterans Healthcare System
Collaborators
Congressionally Directed Medical Research Programs
Responsible party
Amy Jak (Staff Neuropsychologist, San Diego Veterans Healthcare System) — Principal investigator
First posted
Sep 16, 2013
Start date
Aug 2012
Primary completion
Sep 2017
Completion
Sep 2017
Last update
May 9, 2018

Study contacts

Amy Jak, Ph.D.
principal investigator · VA San Diego

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2018. You cannot join it, but the record below documents what was studied.

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