The clinical implementation trial will evaluate effectiveness and feasibility, acceptability, appropriateness, barriers, and facilitators of implementing SMART-CPT, a treatment targeting the two primary factors leading to poor outcomes following concussion, in Veterans. It will test effectiveness and broad implementation feasibility of SMART-CPT compared to standard Cognitive Processing Therapy (CPT).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
124
SMART-CPT T is a psychotherapy that combines Cognitive Processing Therapy (CPT) for Posttraumatic Stress Disorder (PTSD) and Cognitive Symptom Management and Rehabilitation Training (CogSMART) for neurobehavioral and neurocognitive symptoms to simultaneously target persistent postconcussive symptoms and PTSD
CPT is a cognitive behavioral treatment specifically targeting PTSD and other corollary symptoms following traumatic events (Resick \& Schnicke, 1992). Based on a social cognitive theory of PTSD and trauma, CPT focuses on identifying the content of trauma-related thoughts, examining whether these thoughts are consistent or inconsistent with a patient's prior beliefs about the world, and addressing the impact these thoughts have on emotions and behaviors. Patients are taught to recognize and challenge thought patterns such as, assimilation (distorting the memory of the traumatic event to fit prior world beliefs), over-accommodation (excessively altering world beliefs to be consistent with the trauma), or the reinforcement of previously held distorted world beliefs.
VA San Diego
San Diego, California, United States
PTSD Checklist (PCL5)
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
Time frame: weekly through treatment completion, an average of 3 months
Neurobehavioral Symptom Inventory (NSI)
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.
Time frame: weekly through treatment completion, an average of 3 months
The Patient Global Impression of Change (PGIC)
A single-item measure of activity limitations, symptoms, and overall quality of life
Time frame: at treatment completion, an average of three months
Brief Inventory of Psychosocial Functioning (B-IPF)
7-item measure of PTSD psychosocial functional impairment
Time frame: at 3 primary assessment timepoints, week 0, week 12, week 24
World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0)
will measure function in the following areas: life activities (work, school, domestic responsibilities), cognition, mobility, self-care, social, and community participation
Time frame: at 3 primary assessment timepoints; week 0, week 12, week 24
Traumatic Brain Injury Quality of Life Scale (TBI-QOL)
provides comprehensive patient-reported outcomes specific to TBI.
Time frame: at 3 primary assessment timepoints; week 0, week 12, week 24
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