Adapted STAIR-NT for Post-Traumatic Stress Disorder

Overseen By Tanya Renn, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Florida State University

Disqualifiers: Not a first responder, others

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

Compensation: Varies

Number of Visits: 3

Duration: 4-6 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

The trial aims to test a specialized therapy called Adapted STAIR-NT, designed to help people manage emotions and relationships, specifically for first responders dealing with PTSD (post-traumatic stress disorder) and a history of TBI (traumatic brain injury). Participants will either receive the adapted therapy or continue with their usual treatment. The study seeks first responders in Minnesota who have experienced a TBI and currently struggle with PTSD. The goal is to determine if this new approach can provide better support and healing for those facing these challenges. As an unphased trial, the study offers a unique opportunity for participants to explore innovative therapy options that could enhance their emotional and relational well-being.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that the Adapted STAIR-NT is safe for first responders with TBI and PTSD?

Studies have shown that STAIR-NT, a therapy designed to help people manage emotions and relationships, is generally safe. Research involving women with complex PTSD (post-traumatic stress disorder) from childhood abuse tested the therapy for safety, and no major safety concerns emerged.

A review of several studies on STAIR therapy found it significantly reduced PTSD symptoms. The therapy teaches skills to better handle emotions and improve interactions with others. Although these studies do not specifically focus on the version adapted for first responders, the original STAIR-NT has been well-tolerated in different settings. This suggests it might be safe for first responders, too. However, discussing any concerns with the trial team remains important. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Adapted STAIR-NT because it offers a fresh approach to treating PTSD, focusing on emotional regulation and interpersonal skills. Unlike traditional therapies that might rely heavily on exposure or medication, this method integrates narrative therapy, helping individuals process their trauma stories in a structured way. This innovative blend of skills training and narrative therapy has the potential to empower patients with practical tools for managing their emotions and relationships, contributing to more comprehensive healing.

What evidence suggests that Adapted STAIR-NT might be an effective treatment for PTSD?

Research has shown that Skills Training in Affective and Interpersonal Regulation-Narrative Therapy (STAIR-NT) effectively reduces symptoms of complex PTSD (post-traumatic stress disorder). A review of seven studies found that STAIR therapy significantly lessened symptoms, indicating strong improvement. STAIR-NT teaches social and emotional skills, helping people with PTSD manage their symptoms better. The therapy is safe and practical in clinical settings and helps patients develop useful coping strategies. In this trial, participants in one arm will receive the Adapted STAIR-NT intervention, which could be a promising treatment for PTSD, especially for individuals like first responders who often encounter traumatic situations. ^{1 3 6 7 8}

Who Is on the Research Team?

Joseph Schwartz, PhD

Principal Investigator

Florida State University

Are You a Good Fit for This Trial?

This trial is for first responders in Minnesota, aged 18 or older, who have experienced a traumatic brain injury (TBI) and are showing signs of Post-Traumatic Stress Disorder (PTSD). Participants must screen positive for PTSD to be eligible.

Inclusion Criteria

Screen for PTSD

Be a first responder within the state of Minnesota

Have a history of a TBI

Exclusion Criteria

Does not meet inclusion criteria.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the adapted STAIR-NT intervention or treatment as usual

4-6 weeks

Weekly sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Assessments at 3 and 6 months

What Are the Treatments Tested in This Trial?

Interventions

• Adapted STAIR-NT

Trial Overview The study tests an adapted therapy called STAIR-NT, which focuses on emotional and interpersonal skills. It's designed specifically for those with TBI and PTSD. The effectiveness will be compared randomly among participants.

How Is the Trial Designed?

Group I: Adapted STAIR-NT Intervention Experimental Treatment 1 Intervention

Participants in this arm will receive the adapted version of Skills Training in Affective and Interpersonal Regulation-Narrative Therapy (STAIR-NT).

Group II: Treatment as usual (TAU) Active Control 1 Intervention

Participants in this arm will receive treatment as usual.

Who Is Running the Clinical Trial?

Florida State University

Lead Sponsor

Trials

234

Recruited

41,100+

Invisible Wounds Project

Collaborator

United States Department of Defense

Collaborator

Trials

940

Recruited

339,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9186357/

Skills Training in Affective and Interpersonal Regulation ... This pilot study examined the feasibility, safety, and outcomes of SNT for CPTSD among women with a history of childhood abuse in a Japanese clinical setting.

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2468749924001169

Skills training in affective and interpersonal regulation ... In a review of seven studies, STAIR therapy for CPTSD showed significant symptom reduction, with effect sizes ranging from d = 1.34 to 2.29 in clinician ...

3. istss.org istss.org/clinicians-corner-skills-training-in-affective-and-interpersonal-regulation-stair-marylene-cloitre-phd/

Clinician's Corner Skills Training in Affective and ... STAIR is an evidence-based skills-focused treatment that was initially developed to provide basic social and emotion management skills for individuals with ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/35695843/

Skills Training in Affective and Interpersonal Regulation ... This pilot study examined the feasibility, safety, and outcomes of SNT for CPTSD among women with a history of childhood abuse in a Japanese clinical setting.

5. researchgate.net researchgate.net/publication/339096098_Skills_Training_in_Affective_and_Interpersonal_Regulation_STAIR_Narrative_Therapy_Making_meaning_while_learning_skills

Skills Training in Affective and Interpersonal Regulation ... It is critical that veterans can access VHA mental healthcare for MST-related PTSD, such as Skills Training in Affective and Interpersonal ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT07212140

Adaptation of the STAIR-NT for First Responders This study is a randomized controlled pilot examining the implementation of an adapted intervention, Skills Training in Affective and ...

7. ptsd.va.gov ptsd.va.gov/professional/articles/article-pdf/id1633817.pdf

Enhanced Skills Training in Affective and Interpersonal ... The primary treatment outcome was CPTSD severity as assessed by its two components, post-traumatic stress dis- order (PTSD) and disturbances in ...

8. researchgate.net researchgate.net/publication/281059380_STAIR_Narrative_Therapy_A_Skills_Focused_Approach_to_Trauma-Related_Distress

A Skills Focused Approach to Trauma-Related Distress STAIR Narrative Therapy is a skills-focused approach designed to foster the development and strengthening of emotion regulation and interpersonal skills and ...