STAIR for Trauma and Emotion Dysregulation

May 25, 2022 updated by: Sanno Zack, Stanford University

Examining the Effectiveness of STAIR as an Alternative to DBT for Patients With Emotion Dysregulation and PTSD

This study will examine the impact of Skills Training in Affective and Interpersonal Regulation (STAIR) group, using self-report measures, on Posttraumatic Stress Disorder (PTSD), emotional dysregulation, borderline personality disorder symptoms, global psychopathology, and access to quality mental health care. Aims include assessing the feasibility of STAIR, reducing patients' trauma and emotion dysregulation symptoms, examining whether STAIR may be used as an alternative to DBT for patients on the DBT, and improving patient satisfaction and clinic efficiency

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Enrolling by invitation

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Stanford, California, United States, 94305
        • Stanford University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Be 18 years or older.
  • Have a DSM-5 diagnosis and/or symptoms for which DBT is an indicated treatment
  • Meet DSM-5 criteria for a diagnosis of posttraumatic stress disorder (PTSD)
  • Meet criteria at a subclinical level for BPD (a minimum of three symptoms)
  • Must be able to make group commitments for attendance, safety, and sobriety during group

Exclusion Criteria:

  • If currently receiving individual therapy that follows the DBT protocol or is an evidence-based trauma-focused therapy
  • If the STAIR therapy group is determined to be clinically contraindicated

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: STAIR
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.
Behavioral: STAIR
Clinician led session that hones in on a particular deficit within these skills, including identifying and labeling emotions, managing emotions, tolerating distress, accepting feelings and increasing positive emotions, identifying trauma-based interpersonal schemas, identifying conflict between trauma-related feelings and goals, role plays surrounding issues of power and control, and role-plays related to developing flexibility in interpersonal situations involving power differentials. STAIR is a cognitive-behavioral treatment that addresses emotion regulation and interpersonal difficulties and their impact on daily living.
Experimental: Waitlist control
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.
Behavioral: STAIR
Clinician led session that hones in on a particular deficit within these skills, including identifying and labeling emotions, managing emotions, tolerating distress, accepting feelings and increasing positive emotions, identifying trauma-based interpersonal schemas, identifying conflict between trauma-related feelings and goals, role plays surrounding issues of power and control, and role-plays related to developing flexibility in interpersonal situations involving power differentials. STAIR is a cognitive-behavioral treatment that addresses emotion regulation and interpersonal difficulties and their impact on daily living.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of participants who complete the STAIR intervention
Time Frame: Week 12
This number will include those who attend the 12 weeks of STAIR with no more than three missed sessions
Week 12
Total score of patient treatment satisfaction ratings
Time Frame: Week 12
Calculate the total score for each participant on the Client Satisfaction Questionnaire-8, and find the average of those scores. Scores are summed across items. Items 2, 4, 5, and 8 are reverse scored. Total scores range from 8 to 32, with the higher number indicating greater satisfaction.
Week 12
Frequency of participant attendance
Time Frame: Week 1 through Week 12
Calculate the number of patients who attended each week of the STAIR treatment.
Week 1 through Week 12
Change in emotion regulation total score from baseline to Week 12
Time Frame: Baseline to Week 12
Problems with emotion regulation will be assessed using the Difficulty in Emotion Regulation Scale. Total score ranges from 36 to 180. Higher scores indicate greater problems with emotion regulation.
Baseline to Week 12
Change in the severity of posttraumatic stress disorder symptom total score from baseline to Week 12
Time Frame: Baseline to Week 12
The severity of posttraumatic stress disorder symptoms is measured using the PCL-5. Items are rated using a 5-point likert scale ranging from 0 "not at all" to 4 "extremely." All 20 items are summed to obtain a total score (0 to 80), higher scores indicate higher severity of PTSD symptoms.
Baseline to Week 12
Change in Borderline symptom severity total score from baseline to Week 12
Time Frame: Baseline and Week 12
Using the Borderline Evaluation of Severity Scale comprising of 15 items using a likert scale rated from 5 "Almost Always" to 1 "Almost Never." There are three subscales that comprise this measure: (1) Thoughts and Emotions (2) Behaviors-Negative and (3) Behaviors-Positive. The total for each subscale is determined to score the BEST. The scores of subscales A and B are then added together and the total from subscale C is subtracted. A correction factor of 15 is added to yield the final score which can range from 12 (best) to 72 (worst).
Baseline and Week 12
Change in Borderline Symptom List-23 total score from baseline to Week 12
Time Frame: Baseline and Week 12
This measure assesses feelings and experiences commonly endorsed by patients with BPD. The 23-item scale utilizes a 5-point Likert scale ranging from 0 = "not at all" to 4 = "very strong." The BSL-23 is scored by summing up the scores for all of the items. Total score ranges from 0 to 92, with higher scores reflecting more severe borderline personality symptoms.
Baseline and Week 12
Change in current symptoms of psychopathology and psychological distress total score from baseline to Week 12
Time Frame: Baseline and Week 12
The Symptom Checklist-90-Revised is a 90-item multidimensional self-report symptom measure that assesses current symptoms of psychopathology and psychological distress. The items were scored on a 5-point Likert scale ranging from 0 (not at all) to 4 (extremely). It assesses nine symptom dimensions (somatization, obsessive compulsive, interpersonal sensitivity, depression, anxiety, hostility, phobic anxiety, paranoid ideation, psychoticism). Global measures are provided to summarize overall distress, and these include the Global Severity Index, Positive Symptom Distress Index, and Positive Symptom Total. Raw scores are calculated by dividing the sum of scores for a specific dimension by the number of items in the dimension. Global severity index is calculated by summing the scores of the nine dimensions and additional items, then dividing by the total number of responses. Total score ranges from 0 to 360. Higher scores indicate worsening of disease.
Baseline and Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Stanford University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Sanno Zack, PhD, Stanford Universtiy
  • Principal Investigator: Emily Livermore, PsyD, Stanford University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 15, 2022

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 15, 2025

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 15, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 24, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 25, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 31, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 31, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 25, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 64219

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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