What side effects are associated with this type of intervention?

Common treatments for emotion regulation, such as cognitive-behavioral therapy (CBT), dialectical behavior therapy (DBT), and mindfulness-based interventions, generally have minimal physical side effects. However, patients may experience emotional discomfort as they confront and process difficult emotions and memories. Some individuals might feel increased anxiety or distress during the initial stages of therapy. Additionally, there can be a temporary increase in emotional sensitivity or vulnerability as patients learn new coping strategies. Overall, these therapies are considered safe and the benefits often outweigh the potential for transient emotional discomfort.

What prior FDA approvals exist?

The FDA has approved several medications for the treatment of disorders involving emotion regulation, such as selective serotonin reuptake inhibitors (SSRIs) like fluoxetine and sertraline, which are commonly used for depression and anxiety disorders. Additionally, cognitive-behavioral therapy (CBT), which shares similarities with STAIR in its focus on improving emotional and interpersonal regulation, is a well-established, evidence-based treatment for these conditions. While specific FDA approvals for psychotherapeutic interventions like STAIR are not typically issued, these therapies are widely recognized and recommended in clinical guidelines for managing emotional dysregulation.

What other types of research exist?

Promising alternatives to STAIR for emotion regulation include Dialectical Behavior Therapy (DBT), which has shown efficacy in managing borderline personality disorder and emotional dysregulation. Additionally, Cognitive Behavioral Therapy (CBT) and Schema Therapy are also effective options. These therapies focus on modifying dysfunctional thoughts and behaviors, improving emotional regulation, and enhancing interpersonal skills.

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STAIR Therapy for Post-Traumatic Stress Disorder and Emotion Regulation

N/A

Waitlist Available

Led By Sanno Zack, PhD

Research Sponsored by Stanford University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Have a DSM-5 diagnosis and/or symptoms for which DBT is an indicated treatment

Be 18 years or older

Must not have

STAIR therapy group is determined to be clinically contraindicated

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 1 through week 12

Awards & highlights

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

STAIR is a psychological intervention; side effects may include temporary increases in distress as difficult emotions and experiences are processed during treatment.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My doctor advised against STAIR therapy for me.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 1 through week 12

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 1 through week 12

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 1 through week 12 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Borderline Symptom List-23 total score from baseline to Week 12

Change in Borderline symptom severity total score from baseline to Week 12

Change in current symptoms of psychopathology and psychological distress total score from baseline to Week 12

+5 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: Waitlist controlExperimental Treatment1 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: STAIRExperimental Treatment1 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

STAIR

2011

N/A

~70

0 / 3Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Emotion Regulation, such as Skills Training in Affective and Interpersonal Regulation (STAIR), utilize cognitive-behavioral techniques, mindfulness, and skills training to enhance emotional awareness, regulation, and interpersonal effectiveness. These therapies help patients identify and modify maladaptive emotional responses and behaviors, providing them with practical tools to manage stress and maintain healthy relationships. This is crucial for Emotion Regulation patients as it improves their ability to handle emotional dysregulation, significantly enhancing their daily functioning and quality of life.

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Who is running the clinical trial?

Stanford UniversityLead Sponsor

2,448 Previous Clinical Trials

17,492,364 Total Patients Enrolled

4 Trials studying Emotion Regulation

527 Patients Enrolled for Emotion Regulation

Sanno Zack, PhDPrincipal InvestigatorStanford Universtiy

Emily Livermore, PsyDPrincipal InvestigatorStanford University

Media Library

STAIR Clinical Trial Eligibility Overview. Trial Name: NCT05397613 — N/A

Emotion Regulation Research Study Groups: STAIR, Waitlist control

Emotion Regulation Clinical Trial 2023: STAIR Highlights & Side Effects. Trial Name: NCT05397613 — N/A

STAIR 2023 Treatment Timeline for Medical Study. Trial Name: NCT05397613 — N/A

Emotion Regulation Patient Testimony for trial: Trial Name: NCT05397613 — N/A

~7 spots leftby Jun 2025

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