SMART-CPT for PTSD/Concussion Implementation

Official title

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

Overview

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

• Behavioral 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
• 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 chal

Primary outcome measures

• PTSD Checklist (PCL5) [Time frame: weekly through treatment completion, an average of 3 months]
• Neurobehavioral Symptom Inventory (NSI) [Time frame: weekly through treatment completion, an average of 3 months]
• The Patient Global Impression of Change (PGIC) [Time frame: at treatment completion, an average of three months]
• Brief Inventory of Psychosocial Functioning (B-IPF) [Time frame: at 3 primary assessment timepoints, week 0, week 12, week 24]
• World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0) [Time frame: at 3 primary assessment timepoints; week 0, week 12, week 24]
• Traumatic Brain Injury Quality of Life Scale (TBI-QOL) [Time frame: at 3 primary assessment timepoints; week 0, week 12, week 24]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

United States · 1 center

• VA San Diego — San Diego

Identifiers

NCT: NCT06995612 · TP220123

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗