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Enrolling by Invitation

NCT Number: NCT06995612

SMART-CPT for PTSD/Concussion Implementation

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).

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Key information

Conditions

PTSD Brain Concussion Brain Diseases Brain Injuries Brain Injuries, Traumatic Central Nervous System Diseases Concussion, Mild Craniocerebral Trauma Head Injuries, Closed Mental Disorders Nervous System Diseases Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma and Stressor Related Disorders Trauma, Nervous System Wounds and Injuries Wounds, Nonpenetrating

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

VA San Diego

San Diego, California, 92161, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SMART-CPT

Behavioral

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

Behavioral

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.

Primary outcomes

  1. PTSD Checklist (PCL5)

    Time frame: 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

  2. Neurobehavioral Symptom Inventory (NSI)

    Time frame: 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.

  3. The Patient Global Impression of Change (PGIC)

    Time frame: at treatment completion, an average of three months

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

  4. Brief Inventory of Psychosocial Functioning (B-IPF)

    Time frame: at 3 primary assessment timepoints, week 0, week 12, week 24

    7-item measure of PTSD psychosocial functional impairment

  5. World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0)

    Time frame: 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

  6. Traumatic Brain Injury Quality of Life Scale (TBI-QOL)

    Time frame: at 3 primary assessment timepoints; week 0, week 12, week 24

    provides comprehensive patient-reported outcomes specific to TBI.

Sponsors and collaborators

Lead sponsor

San Diego Veterans Healthcare System

Fed

Registry information

Official study title

SMART-CPT for PTSD and History of Concussion: A Pragmatic Implementation Trial

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
May 29, 2025
Registry last updated
Jun 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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