SMART-CPT for PTSD/Concussion Implementation

San Diego Veterans Healthcare System

Status

Invitation-only

Conditions

PTSD

Concussion, Mild

Treatments

Behavioral: SMART-CPT

Behavioral: CPT

Study type

Interventional

Funder types

Other U.S. Federal agency

Identifiers

NCT06995612

TP220123

Details and patient eligibility

About

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).

Enrollment

124 estimated patients

Sex

All

Ages

18 to 55 years old

Volunteers

No Healthy Volunteers

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