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NCT06995612

SMART-CPT for PTSD/Concussion Implementation

Enrolling by Invitation
NAAges 18–55InterventionalTreatment
San Diego Veterans Healthcare System
~124 participants
Updated 2025-06-04 on ClinicalTrials.gov
What's tested:SMART-CPTCPT

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
PTSD Checklist (PCL5)
Measured over weekly through treatment completion, an average of 3 months
+5 more outcomes measured

Conditions

PTSD
Concussion, Mild

Explore related trials

ConcussionPost-Traumatic Stress Disorder

Where it's being run

1 sites across 1 states
California1

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

PTSD diagnosis;
mild TBI sustained greater than three months prior to enrollment;
cognitive complaints;
not medicated or stable on prescribed psychiatric medication for at least 6 weeks prior to study enrollment with no anticipated/pending medication changes;
English literacy.

Exclusion

mTBI sustained less than 3 months previously;
history of moderate, severe, or penetrating TBI;
history of other significant neurological condition unrelated to TBI;
severe psychiatric disturbance expected to interfere with successful completion of the study;
current severe alcohol or other substance use disorder;
suicidal intent or attempt within the previous month;
current homicidal ideation;
impaired decision making capacity;
prior completion of five or more sessions of CPT or cognitive rehabilitation; -concurrent participation in other intervention studies for PTSD or TBI;
life threatening or unstable medical illness;
inability to read;
dementia

What this trial measures

  • PTSD Checklist (PCL5)weekly through treatment completion, an average of 3 months

    A brief self-report instrument to measure PTSD symptom severity. It consists of 20 items, scored on a 5-point scale (0 = not at all to 5 = extremely), that correspond to the DSM-5 symptoms of PTSD. It will be used to track PTSD symptom reporting weekly as well as at comprehensive assessments

  • Neurobehavioral Symptom Inventory (NSI)weekly through treatment completion, an average of 3 months

    A 22 item self-report measure of neurobehavioral symptoms commonly experienced following a mTBI that will be utilized to assess inclusionary cognitive complaints as well as monitor overall neurobehavioral symptoms weekly and at comprehensive assessments.

  • The Patient Global Impression of Change (PGIC)at treatment completion, an average of three months

    A single-item measure of activity limitations, symptoms, and overall quality of life

  • Brief Inventory of Psychosocial Functioning (B-IPF)at 3 primary assessment timepoints, week 0, week 12, week 24

    7-item measure of PTSD psychosocial functional impairment

  • World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0)at 3 primary assessment timepoints; week 0, week 12, week 24

    will measure function in the following areas: life activities (work, school, domestic responsibilities), cognition, mobility, self-care, social, and community participation

  • Traumatic Brain Injury Quality of Life Scale (TBI-QOL)at 3 primary assessment timepoints; week 0, week 12, week 24

    provides comprehensive patient-reported outcomes specific to TBI.