SMART-CPT for PTSD/Concussion Implementation

NCT ID: NCT06995612

Last Updated: 2025-06-04

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 124 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-01
• Study Completion Date: 2027-06-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

SMART-CPT

Group Type: EXPERIMENTAL

SMART-CPT

Intervention Type: 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

Group Type: ACTIVE_COMPARATOR

CPT

Intervention Type: 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.

Interventions

SMART-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

Intervention Type: BEHAVIORAL

CPT

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

San Diego Veterans Healthcare System

FED

Sponsor Role: lead

Responsible Party

Amy Jak

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

VA San Diego

San Diego, California, United States

Countries

United States

Other Identifiers

TP220123

Identifier Type: -

Identifier Source: org_study_id