Interventions for Post-Traumatic Stress Disorder

(MIRROR Trial)

Overseen By Madelyn Olis, BA

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Icahn School of Medicine at Mount Sinai

Disqualifiers: High suicide risk, Active psychosis, Problematic substance use

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

Compensation: Varies

Number of Visits: 13

Duration: 10 weeks

136 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two treatments to assist female Veterans who have experienced military sexual trauma (MST) or intimate partner violence (IPV) and also have a brain injury. The goal is to determine which treatment better manages emotions and reduces symptoms of post-traumatic stress disorder (PTSD). Participants will either use a web-based program called webSTAIR followed by exposure therapy (ExpoTx, a type of talk therapy focused on facing fears) or receive psycho-education sessions followed by exposure therapy. Female Veterans who have experienced MST or IPV and struggle with managing emotions might be a good fit. As an unphased trial, this study provides a unique opportunity to contribute to research that could lead to better treatment options for others in similar situations.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

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

Studies have shown that webSTAIR helps people with PTSD and depression symptoms. It also improves how veterans manage their emotions and interact socially. So far, webSTAIR appears well-tolerated, with no major side effects reported in the studies.

Exposure therapy (ExpoTx) is a well-known treatment for PTSD and has been used safely for many years. Research shows that while exposure therapy can be intense, most patients manage it well. Some might feel anxious or uncomfortable during sessions, but these feelings usually lessen over time.

Overall, both treatments show promise in managing PTSD symptoms, and past research suggests they are safe to use. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the treatments for PTSD in this trial because they combine innovative digital tools with established therapy methods. webSTAIR is unique as it leverages a web-based platform to teach important skills for managing emotions and relationships, offering flexibility and accessibility to Female Veterans. By pairing webSTAIR with ExpoTx, a traditional exposure therapy, participants may receive a more comprehensive treatment experience addressing both emotional regulation and trauma processing. Additionally, the digital nature of webSTAIR allows for scalable and potentially cost-effective delivery, making it a promising option for reaching more individuals in need.

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

Research has shown that webSTAIR, a treatment in this trial, effectively reduces PTSD symptoms and helps individuals manage their emotions better. Studies indicate that webSTAIR benefits veterans with PTSD and depression by improving emotional and social well-being. Similarly, exposure therapy (ExpoTx), another treatment option in this trial, has significantly reduced PTSD symptoms. Reviews of multiple studies confirm that exposure therapy is highly effective for PTSD, with many patients experiencing improvements. Both treatments have strong evidence supporting their effectiveness in treating PTSD symptoms and enhancing emotional health. ^{6 7 8 9 10}

Who Is on the Research Team?

Maria Kajankova, PhD

Principal Investigator

Icahn School of Medicine at Mount Sinai

Are You a Good Fit for This Trial?

This trial is for female Veterans who have experienced military sexual trauma (MST) or intimate partner violence (IPV), and also have a brain injury. They should show signs of PTSD but not full-blown PTSD, and struggle with managing their emotions.

Inclusion Criteria

I have been exposed to intimate partner violence or military sexual trauma.

I have had at least one brain injury assessed.

My PTSD score is above 33, indicating sub-threshold PTSD.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either webSTAIR+ExpoTx or PsychoEd+ExpoTx interventions

10 weeks

10 online sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 months

Follow-up assessments at month 3

What Are the Treatments Tested in This Trial?

Interventions

• ExpoTx
• webSTAIR

Trial Overview The MIRROR study is testing two different treatments: ExpoTx and webSTAIR, along with PsychoEd. The goal is to see which one better helps participants manage their emotions and reduce symptoms related to PTSD from MST or IPV.

How Is the Trial Designed?

Group I: webSTAIR+ExpoTx Experimental Treatment 2 Interventions

Web-based technology "webSTAIR" (Web-Based Skills Training in Affective Regulation and Interpersonal Relationships Program) will be used to guide Female Veterans (FVets) through each of the 10 webSTAIR skill modules for 5-weeks followed by 5 weeks of standard, patient-centered, exposure therapy (ExpoTx) delivered by a therapist.

Group II: PsychoEd+ExpoTx Active Control 2 Interventions

5 online sessions of psycho-education followed by 5 online sessions of exposure therapy

Who Is Running the Clinical Trial?

Icahn School of Medicine at Mount Sinai

Lead Sponsor

Trials

933

Recruited

579,000+

Baylor College of Medicine

Collaborator

Trials

1,044

Recruited

6,031,000+

Citations

1. ptsd.va.gov ptsd.va.gov/professional/treat/txessentials/written_exposure_therapy.asp

Written Exposure Therapy for PTSD Patients who receive WET show significant reductions in PTSD symptoms, with large within-group effects observed in each of the studies. Moreover, many of those ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9006570/

The efficacy and acceptability of exposure therapy for ... This meta-analysis found that ET showed superiority in terms of efficacy at post-treatment/follow-up and depressive symptoms improvement in treating PTSD in ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0272735821001586

Review Exposure therapy for PTSD: A meta-analysis The results of this meta-analysis demonstrate the efficacy of exposure therapy for reducing PTSD symptoms among adults diagnosed with PTSD.

4. jamanetwork.com jamanetwork.com/journals/jamapsychiatry/fullarticle/2808302

Written Exposure Therapy vs Prolonged ... Conclusions and Relevance In this study, WET was noninferior to PE in PTSD symptom change and was associated with significantly less attrition.

5. bmcpsychiatry.biomedcentral.com bmcpsychiatry.biomedcentral.com/articles/10.1186/s12888-024-05656-9

12-month follow-up of intensive outpatient treatment for PTSD ... The treatment response rates showed that 46–60% of patients achieved recovery with respect to PTSD symptoms, and that 44–48% no longer met ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11034887/

To Expose or Not to Expose: A Comprehensive Perspective ... Keywords: exposure therapy, post-traumatic stress disorder, psychotherapy mechanisms, neurobiology of trauma. Posttraumatic stress disorder (PTSD) is a ...

7. ptsd.va.gov ptsd.va.gov/professional/articles/article-pdf/id1585394.pdf

Exposure therapy for PTSD: A meta-analysis Posttraumatic stress disorder (PTSD) is associated with high morbidity and functional impairment in the absence of effective treatment.

8. sciencedirect.com sciencedirect.com/science/article/pii/S2215036623003735/pdf

The efficacy of psychological interventions for adult post ... About 4% of individuals worldwide have post-traumatic stress disorder (PTSD), which is a condition characterised by intrusive traumatic memories, avoidance, ...

9. nature.com nature.com/articles/s41398-022-02066-x

a randomized clinical trial of virtual reality and imaginal ... We tested the efficacy of virtual reality exposure (VRE) or prolonged imaginal exposure (PE), augmented with D-cycloserine (DCS) for combat-related PTSD.

10. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6487906/

Efficacy of Integrated Exposure Therapy vs ... This randomized clinical trial of veterans compares the efficacy of integrated prolonged exposure therapy with present-centered integrated coping skills ...