Therapy Options for Post-Traumatic Stress Disorder

Overseen By Sarah Pridgen, MA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Rush University Medical Center

Must not be taking: Psychotropics

Disqualifiers: Suicidal, Psychosis, Substance use, others

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

Compensation: Varies

Number of Visits: Unknown

400 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests different therapy options for people with PTSD who did not improve after their initial treatment. It aims to assess the practicality of offering another round of therapy and to determine which options are most effective. Researchers aim to develop a simple tool to quickly identify individuals who might benefit from a different treatment approach. Suitable candidates have a PTSD diagnosis, have experienced a traumatic event, and are prepared to attend therapy sessions. As an unphased trial, this study provides an opportunity to contribute to the development of more effective PTSD treatments for those requiring alternative options.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you must have been on a stable dose of any psychotropic medication for at least one month before starting the study.

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

Studies have shown that Cognitive Processing Therapy (CPT) is safe and well-tolerated for people with PTSD. Research indicates its effectiveness in various settings, such as in-person and online sessions, without requiring extra preparation. Most people can begin treatment immediately, and it is often tailored to individual needs.

Program evaluations, particularly with military and veteran patients, have demonstrated that CPT can help reduce PTSD symptoms and depression. This supports its safety and effectiveness across different groups.

These studies have reported no serious safety concerns. While CPT works well for many, individual responses may vary. Discussing any concerns with healthcare providers is important to find the best treatment fit. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Skills Training for Affective and Interpersonal Regulation (STAIR) because it offers a fresh approach to treating PTSD by focusing on emotional and interpersonal skills rather than just processing traumatic memories. Unlike traditional treatments like Cognitive Behavioral Therapy (CBT) or Eye Movement Desensitization and Reprocessing (EMDR), STAIR emphasizes building emotional regulation and improving relationships, which are often affected by PTSD. This approach could be particularly beneficial for those who haven't found relief with standard therapies, providing a more comprehensive way to manage PTSD symptoms. By addressing the emotional and social aspects of PTSD, STAIR has the potential to enhance overall well-being and recovery.

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

Research has shown that Cognitive Processing Therapy (CPT), which all participants in this trial will initially receive, helps reduce PTSD symptoms. Studies have found that CPT can lead to significant improvements, with patients noticing a clear decrease in their symptoms. In one study, PTSD scores dropped by an average of 14 points, and few people discontinued the treatment early. Another study demonstrated that CPT was more effective than other treatments for easing PTSD symptoms. This evidence suggests that CPT is a dependable option for managing PTSD. ^{2 4 6 7 8}

Are You a Good Fit for This Trial?

This trial is for English-speaking individuals who have experienced a traumatic event and are diagnosed with PTSD. Participants must be willing to undergo 10 therapy sessions over two weeks, with the possibility of an additional 10 sessions. They should also agree to complete various assessments throughout the study.

Inclusion Criteria

I am fluent in English.

I have experienced a significant traumatic event in my life.

I am willing and able to complete surveys and assessments during the study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Initial Treatment

Participants receive 10 sessions of Cognitive Processing Therapy

10 weeks

Subsequent Treatment

Participants with high PTSD scores are offered a subsequent course of treatment

Varies

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Cognitive Processing Therapy
• Prolonged Exposure
• Skills Training for Affective and Interpersonal Regulation

Trial Overview

The study tests how practical and effective it is to offer another round of proven therapies for PTSD patients who didn't improve after initial treatment. It compares Skills Training, Cognitive Processing Therapy, and Prolonged Exposure to find personalized care approaches.

How Is the Trial Designed?

Group I: Initial Course of Cognitive Processing Therapy Experimental Treatment 1 Intervention

All participants will start in Arm 1 where they receive 10-sessions of Cognitive Processing Therapy.

Group II: Subsequent Treatment Active Control 3 Interventions

At one-week follow up after initial Cognitive Processing Therapy, participants whose scores are 28 or above on the PTSD Checklist for DSM-5 will be offered a subsequent course of treatment.

Who Is Running the Clinical Trial?

Rush University Medical Center

Lead Sponsor

Trials

448

Recruited

247,000+

Citations

1.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/39908018/

Cognitive Processing Therapy for Posttraumatic Stress ...

The CPT-TAU group showed a mean (SE) reduction in CAPS-5 scores of 14.00 (1.92) points, with a low dropout rate (2 of 29 [6.9%]). Patients in ...

2.

jamanetwork.com

jamanetwork.com/journals/jamanetworkopen/fullarticle/2829857

Cognitive Processing Therapy for Posttraumatic Stress ...

In this randomized clinical trial of CPT-TAU vs WL-TAU, CPT was superior in reducing PTSD symptoms. These results strengthen the evidence for use of CPT in ...

3.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S2589979124000027

Effectiveness of Cognitive Processing Therapy for PTSD in ...

This study provides promising data on the outcomes associated with a modified CPT protocol for treating PTSD in a high need but under-treated SMI population.

4.

ptsd.va.gov

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

Cognitive Processing Therapy for PTSD

Program evaluation data from intensive treatment programs serving military and Veteran patients receiving CPT have shown improvements in PTSD and depression ...

5.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/30332919/

A meta-analytic review of cognitive processing therapy for ...

These meta-analytic findings indicate that CPT is an effective PTSD treatment with lasting benefits across a range of outcomes.

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC3467002/

Cognitive and Affective Predictors of Treatment Outcome in ...

This study examined cognitive and affective predictors of treatment dropout and treatment efficacy in Cognitive Processing Therapy (CPT) and Prolonged Exposure ...

7.

sciencedirect.com

sciencedirect.com/science/article/pii/S1077722922001377

Clinician Concerns About Cognitive Processing Therapy

The research literature indicates that CPT is effective without preparatory treatment across a range of outcomes, settings, and populations.

8.

bmcpsychiatry.biomedcentral.com

bmcpsychiatry.biomedcentral.com/articles/10.1186/s12888-022-03699-4

In-office, in-home, and telehealth cognitive processing therapy ...

CPT delivered by telehealth is an efficient and effective treatment modality for PTSD, especially considering in-person restrictions resulting from COVID-19.