SMART-CPT for PTSD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: San Diego Veterans Healthcare System

Must be taking: Psychiatric medications

Disqualifiers: Severe TBI, Neurological conditions, Substance use, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 12

Duration: 12 weeks

124 Participants Needed

Trial Summary

What is the purpose of this trial?

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).

Eligibility Criteria

This trial is for Veterans who are experiencing post-concussive headaches, PTSD, or traumatic brain injury. It aims to help those struggling with the main factors that lead to poor outcomes after a concussion.

Inclusion Criteria

I have been diagnosed with PTSD.

I had a mild brain injury more than three months ago.

I have been stable on my psychiatric medication for at least 6 weeks with no changes expected.

Exclusion Criteria

current homicidal ideation

concurrent participation in other intervention studies for PTSD or TBI

inability to read

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive SMART-CPT or standard CPT for PTSD and concussion over a period of 3 months

12 weeks

Weekly visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

Assessments at week 12 and week 24

Treatment Details

Interventions

• CPT
• SMART-CPT

Trial Overview The study is testing SMART-CPT against standard Cognitive Processing Therapy (CPT) to see which is more effective and feasible for broad implementation in treating veterans with concussion-related issues.

Participant Groups

Group I: SMART-CPT Experimental Treatment 1 Intervention

Group II: CPT Active Control 1 Intervention

Who Is Running the Clinical Trial?

San Diego Veterans Healthcare System

Lead Sponsor

Trials

38

Recruited

5,500+