STAIR Therapy for Post-Traumatic Stress Disorder and Emotion Regulation

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Stanford University

Disqualifiers: DBT therapy, Trauma-focused therapy, others

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

Compensation: Varies

Number of Visits: 12

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new therapy called STAIR (Skills Training in Affective and Interpersonal Regulation) to help people with PTSD manage emotions and relationships more effectively. Participants are divided into two groups: one receives STAIR therapy immediately, while the other begins after a 12-week wait. The trial aims to determine if STAIR can reduce trauma symptoms and perform as well as or better than other therapies like DBT. This trial suits adults with PTSD and some symptoms of borderline personality disorder who can attend weekly group sessions. As an unphased trial, participants contribute to important research that may enhance PTSD treatments.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. It mainly focuses on therapy participation and does not mention medication changes.

What prior data suggests that STAIR is safe for treating PTSD and emotion regulation?

Research has shown that Skills Training in Affective and Interpersonal Regulation (STAIR) is generally well-received by participants. STAIR helps individuals develop emotional and social skills, aiding in managing feelings and improving relationships. Reports of negative effects from these sessions are rare. As a form of therapy rather than medication, STAIR does not have the side effects associated with drugs. Participants typically join group sessions, which are considered safe and supportive. Overall, STAIR is regarded as a safe option for managing PTSD symptoms and enhancing emotional control. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about STAIR, a treatment for Post-Traumatic Stress Disorder (PTSD), because it focuses on enhancing emotion regulation and interpersonal skills, which are often areas of struggle for people with PTSD. Unlike standard treatments like Cognitive Behavioral Therapy (CBT) or medication, STAIR is a structured group therapy that emphasizes skill-building in a supportive community setting. This approach not only aims to reduce PTSD symptoms but also improves overall emotional well-being and relationship dynamics, offering a holistic treatment option that addresses multiple facets of a person’s life.

What evidence suggests that STAIR is effective for PTSD?

Research has shown that Skills Training in Affective and Interpersonal Regulation (STAIR) therapy effectively reduces trauma symptoms and improves quality of life. A review of seven studies found that this therapy significantly reduced symptoms. One study reported that 17 patients experienced significant improvements in their trauma symptoms and quality of life. In this trial, participants will receive STAIR therapy either immediately or after a waitlist period. STAIR may also serve as a good alternative to other trauma-focused therapies. This therapy helps individuals manage emotions and improve relationships, which can be very beneficial for those with conditions like PTSD. ^{2 6 7 8 9}

Who Is on the Research Team?

Sanno Zack, PhD

Principal Investigator

Stanford Universtiy

Emily Livermore, PsyD

Principal Investigator

Stanford University

Are You a Good Fit for This Trial?

This trial is for adults with PTSD or Borderline Personality Disorder symptoms, who can commit to group therapy rules. It's not suitable for those already in DBT or trauma-focused therapy.

Inclusion Criteria

I have a mental health condition that can be treated with DBT.

Meet DSM-5 criteria for a diagnosis of posttraumatic stress disorder (PTSD)

Must be able to make group commitments for attendance, safety, and sobriety during group

Exclusion Criteria

I am currently undergoing a specific therapy for trauma.

My doctor advised against STAIR therapy for me.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Waitlist Control

Participants remain on the DBT waitlist for 12 weeks receiving no active intervention and complete pre and post-measures

12 weeks

Pre and post-measures

STAIR Treatment

Participants complete 1.5 hr group sessions once per week for 12 weeks of Skills Training in Affective and Interpersonal Regulation (STAIR)

12 weeks

12 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• STAIR

Trial Overview The study tests the STAIR group therapy's effectiveness on PTSD and emotional dysregulation compared to standard treatments like DBT, aiming to improve mental health care quality.

How Is the Trial Designed?

Group I: Waitlist control Experimental Treatment 1 Intervention

First, participants will remain on the DBT waitlist for 12 weeks receiving no active intervention and will complete pre and post-measures. Then participants will complete 1.5 hr group sessions once per week for 12 weeks of Skills Training in Affective and Interpersonal Regulation (STAIR). Participants will complete self-report measures pre, post, and at one month intervals.

Group II: STAIR Experimental Treatment 1 Intervention

Participants will complete 1.5 hr group sessions once per week for 12 weeks of Skills Training in Affective and Interpersonal Regulation (STAIR). Participants will complete self-report measures pre, post, and at one month intervals.

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+

Published Research Related to This Trial

A pilot trial involving 54 veterans aged 60 and older with PTSD showed that supervised exercise training is safe and well-accepted, with high adherence rates of 82% and minimal attrition of 14%.

Participants experienced clinically significant improvements in PTSD symptoms and related conditions after 12 weeks of exercise, suggesting that exercise could be an effective intervention for older adults with PTSD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pilot randomized controlled trial of exercise training for older veterans with PTSD. Hall, KS., Morey, MC., Bosworth, HB., et al.[2021]

Posttraumatic stress disorder (PTSD) affects 1-9% of the general population, but its prevalence can rise to 19-70% among those who have experienced traumatic events, indicating a significant impact on affected individuals.

Selective serotonin reuptake inhibitors (SSRIs) have been shown to be effective in treating PTSD, with studies demonstrating significant improvements in both civilian and veteran populations, and no gender-related differences in clinical response.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Posttraumatic stress disorder (PTSD)]. Martényi, F.[2022]

In a study of 104 women with PTSD related to childhood abuse, a treatment combining skills training in affect regulation followed by exposure therapy (STAIR/Exposure) led to a higher rate of sustained PTSD remission (27%) compared to supportive counseling followed by exposure (13%) and skills training followed by supportive counseling (0%).

The STAIR/Exposure group also showed greater improvements in emotion regulation and interpersonal problems, had a lower dropout rate, and experienced fewer worsening PTSD symptoms during treatment compared to the other two conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment for PTSD related to childhood abuse: a randomized controlled trial. Cloitre, M., Stovall-McClough, KC., Nooner, K., et al.[2022]

In a study involving 164 participants with acute and chronic PTSD, cognitive and affective computerized training showed significant improvement in identifying fearful faces and a trend towards reducing PTSD symptoms, particularly in re-experiencing symptoms.

The training was more effective for individuals with better cognitive performance at baseline, suggesting that cognitive capacity may influence the effectiveness of such interventions in treating PTSD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Internet-delivered computerized cognitive & affective remediation training for the treatment of acute and chronic posttraumatic stress disorder: Two randomized clinical trials. Fonzo, GA., Fine, NB., Wright, RN., et al.[2020]

Physical activity (PA) is an effective adjunct therapy for reducing PTSD symptoms, particularly in individuals with subsyndromal symptoms or those resistant to standard treatments, as highlighted by the review of existing literature.

There is a need for further research to determine the most effective types, doses, and durations of exercise for PTSD treatment, as findings from observational and controlled studies have been inconsistent.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effect of Physical Activity on PTSD. Oppizzi, LM., Umberger, R.[2019]

Citations

1. 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 ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11738333/

Evaluating the Effectiveness of Skills Training in Affective ... 17 patients completed STAIR delivered by CPTs. There was statistically significant mean improvement in Quality of Life (p = 0.001), trauma symptoms (p = 0.009) ...

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 ... Data thus far are encouraging, suggesting that STAIR may be a powerful alternative to trauma-focused work (Cloitre et al, 2010). Clinical trials on group STAIR ...

4. tandfonline.com tandfonline.com/doi/full/10.1080/20008198.2022.2080933

Full article: Skills Training in Affective and Interpersonal ... 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. cebc4cw.org cebc4cw.org/program/skills-training-in-affective-and-interpersonal-regulation-plus-modified-prolonged-exposure/detailed

Skills Training In Affective And Interpersonal Regulation ... Results indicate that compared with those in the minimal attention wait-list control, participants in STAIR/MPE showed significant improvement in affect ...

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

Skills Training in Affective and Interpersonal Regulation ... The first module (STAIR) includes skill training to develop emotional and interpersonal resources that have been compromised by long-term ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT06431022

Web-administered STAIR for Patients on Behavioral Health ... The aim of this randomized study is to implement webSTAIR at BMC in the Recovery from Stress and Trauma through Outpatient Care, Research, and Education ( ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11152001/

Enhanced Skills Training in Affective and Interpersonal ... ESTAIR involves 25 sessions; a formulation session plus four modules of 6 sessions on average, each addressing the different symptom clusters of ...

9. mydoctor.kaiserpermanente.org mydoctor.kaiserpermanente.org/ncal/Images/webex-STAIR-Virtual-Whole-Curriculum_tcm75-2407863.pdf

Welcome to STAIR for Trauma Web Group Week 1 What is STAIR? o Skills Training in Affect and Interpersonal Regulation o Program focus is learning skills to manage emotions and improve relationships. Goals ...