SMART-CPT for PTSD/Concussion Implementation

NCT06995612 | Enrolling By Invitation

• 1 other identifier: TP220123
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 1

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).

Conditions

PTSD; Concussion, Mild

Outcome Measures

Primary Outcomes (6)

• 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

  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.

  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

  at treatment completion, an average of three months

• Brief Inventory of Psychosocial Functioning (B-IPF)

  7-item measure of PTSD psychosocial functional impairment

  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

  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.

  at 3 primary assessment timepoints; week 0, week 12, week 24

Study Arms (2)

SMART-CPT

EXPERIMENTAL

Behavioral: SMART-CPT

CPT

ACTIVE COMPARATOR

Behavioral: CPT

Interventions

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

SMART-CPT

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.

CPT

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• San Diego Veterans Healthcare System: lead

Study Sites (1)

VA San Diego

San Diego, California, 92161, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Brain Concussion

Interventions

2-cyclohexylidenhydrazo-4-phenyl-thiazole

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Brain Injuries, Traumatic; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds and Injuries; Wounds, Nonpenetrating

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 5, 2024
• First Posted: May 29, 2025
• Study Start: December 1, 2024
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: June 4, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: at study completion
• Access Criteria: FITBIR is publicly available researchers at fitbir.nih.gov

Locations

US (1)