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

30 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial will test if STAIR therapy can help people with PTSD, emotional issues, and borderline personality disorder by teaching them to manage their emotions and improve their relationships. STAIR therapy, which stands for Skills Training in Affective and Interpersonal Regulation, has been used in various contexts to help individuals with PTSD and other emotional issues by teaching emotion management and interpersonal skills.

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 data supports the effectiveness of the STAIR treatment for PTSD and emotion regulation?

Research shows that physical activity, which is often a component of therapies like STAIR, can reduce PTSD symptoms and improve related conditions like anxiety and depression. This suggests that incorporating physical activity into PTSD treatments may enhance their effectiveness. ^{1 2 3 4 5}

How does the STAIR treatment for PTSD differ from other treatments?

STAIR treatment is unique because it focuses on teaching skills for managing emotions and improving relationships before addressing trauma memories, which is different from other PTSD treatments that often start with trauma exploration. This approach helps patients build a foundation of emotional and interpersonal skills, making it easier to handle the trauma-focused part of therapy. ^{1 6 7 8 9}

Research Team

Sanno Zack, PhD

Principal Investigator

Stanford Universtiy

Emily Livermore, PsyD

Principal Investigator

Stanford University

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Pilot randomized controlled trial of exercise training for older veterans with PTSD. [2021]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Adding physical activity to intensive trauma-focused treatment for post-traumatic stress disorder: results of a randomized controlled trial. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Defining post-traumatic stress disorder recovery in veterans: Benchmarking symptom change against functioning indicators. [2021]

4. Hungary pubmed.ncbi.nlm.nih.gov

[Posttraumatic stress disorder (PTSD)]. [2022]

5. England pubmed.ncbi.nlm.nih.gov

The Effect of Physical Activity on PTSD. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Treatment for PTSD related to childhood abuse: a randomized controlled trial. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

A Randomized Controlled Trial of Brief Skills Training in Affective and Interpersonal Regulation (STAIR) for Veterans in Primary Care. [2021]

8. England 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. [2020]

9. United States pubmed.ncbi.nlm.nih.gov

Examining the effectiveness of an intensive, 2-week treatment program for military personnel and veterans with PTSD: Results of a pilot, open-label, prospective cohort trial. [2019]