Concussion, Mild, PTSD
Conditions
Brief summary
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).
Interventions
BEHAVIORALSMART-CPT
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
BEHAVIORALCPT
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.
Sponsors
San Diego Veterans Healthcare System
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
* 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 criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Outcome results
None listed