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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new therapy called SMART-CPT to assist Veterans with PTSD and past mild concussions. The goal is to determine if this therapy is more effective than the standard treatment, Cognitive Processing Therapy (CPT). Researchers aim to assess the ease of implementing this new therapy on a wider scale. Candidates are a good fit for this trial if they experienced PTSD and a mild concussion over three months ago, have difficulties with memory or thinking, and are stable on any prescribed psychiatric medications. As an unphased trial, this study offers the chance to contribute to groundbreaking research that could enhance treatment options for Veterans.

Will I have to stop taking my current medications?

You can continue taking your current psychiatric medications if you have been stable on them for at least 6 weeks before joining the study, and there are no planned changes to your medication.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that SMART-CPT, a therapy for PTSD (post-traumatic stress disorder) and concussion symptoms, may improve patient outcomes. Earlier studies found that both SMART-CPT and traditional CPT (Cognitive Processing Therapy) significantly reduced PTSD symptoms and issues related to concussions. Patients also reported an improved quality of life.

Regarding safety, studies on CPT, which is similar to SMART-CPT, provide useful information. These studies suggest that CPT is generally well-tolerated. For example, one study found that only a small number of patients discontinued CPT due to side effects or discomfort. Although SMART-CPT is newer and has less specific safety data, its foundation in CPT suggests it could be similarly well-tolerated.

In summary, while direct safety data for SMART-CPT is limited, its connection to CPT suggests it is likely safe and well-tolerated for most people. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about SMART-CPT for PTSD because it introduces a novel approach by integrating technology with cognitive processing therapy (CPT). Unlike traditional CPT, which relies solely on in-person sessions with a therapist, SMART-CPT incorporates digital tools to enhance therapy accessibility and engagement. This innovative method aims to make treatment more flexible and personalized, potentially improving outcomes for those struggling with PTSD. Additionally, SMART-CPT could provide valuable data on therapy progress through its digital platform, offering insights for tailoring future treatments.

What evidence suggests that this trial's treatments could be effective for PTSD?

Research has shown that SMART-CPT, one of the treatments in this trial, effectively reduces PTSD (post-traumatic stress disorder) symptoms and improves quality of life. Studies have found that veterans using SMART-CPT experienced significant reductions in both PTSD and postconcussive symptoms. This trial will compare SMART-CPT with standard Cognitive Processing Therapy (CPT) to evaluate their effectiveness. While both SMART-CPT and CPT reduce PTSD symptoms, SMART-CPT offers additional benefits in other areas. Overall, SMART-CPT is a promising option for helping veterans with PTSD, providing similar effectiveness to traditional therapies with some extra advantages. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/30554135/

SMART-CPT for veterans with comorbid post-traumatic stress ... Results: Both CPT and SMART-CPT resulted in clinically significant reductions in PTSD and postconcussive symptomatology and improvements in quality of life.

2. blastinjuryresearch.health.mil blastinjuryresearch.health.mil/assets/docs/reset/fy17/neurocognitive_psychological_treatment/SMART_CPT_Therapy.pdf

SMART-CPT Therapy Improves Both Posttraumatic Stress ... Findings indicate that individuals in the SMART-CPT group experienced the same PTSD symptom reduction as those in the CPT group, but also showed additional ...

3. ptsd.va.gov ptsd.va.gov/professional/treat/txessentials/cpt_for_ptsd_pro.asp

Cognitive Processing Therapy for PTSD Participants in the active treatment conditions (both CPT and PE) demonstrated significant improvement in PTSD and depression over the course of treatment as ...

4. clinicaltrials.ucsd.edu clinicaltrials.ucsd.edu/trial/NCT06995612

SMART-CPT for PTSD/Concussion Implementation It will test effectiveness and broad implementation feasibility of SMART-CPT compared to standard Cognitive Processing Therapy (CPT). SHOW MORE ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S088761852500012X

A meta-analytic review of cognitive processing therapy with ... Meta-analyses have consistently reported that CPT has a strong effect on PTSD symptoms (e.g., Asmundson et al., 2018; Haagen et al., 2015; Lewis et al., 2020; ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S1077722922001377

Clinician Concerns About Cognitive Processing Therapy A secondary analysis of randomized clinical trial data showed that 14.7% of patients receiving CPT and 28.6% of clients receiving CPT with a written trauma ...

7. jnnp.bmj.com jnnp.bmj.com/content/90/3/333.abstract

SMART-CPT for veterans with comorbid post-traumatic ... Results Both CPT and SMART-CPT resulted in clinically significant reductions in PTSD and postconcussive symptomatology and improvements in quality of life.

8. clinicaltrials.gov clinicaltrials.gov/study/NCT06957067

Reducing Dropout and Improving Outcomes From PTSD ... Outcomes include post-traumatic stress disorder (PTSD) severity [primary], depression, functioning, and treatment retention;; to compare two approaches to ...