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STAIR for Trauma and Emotion Dysregulation

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05397613
Enrollment
30
Registered
2022-05-31
Start date
2022-06-15
Completion date
2025-06-15
Last updated
2022-05-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Borderline Personality Disorder, Emotion Regulation, Posttraumatic Stress Disorder

Brief summary

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

Interventions

BEHAVIORALSTAIR

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.

Sponsors

Stanford University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

Patients will receive 12 weeks of STAIR immediately or after a delay of 12 weeks for the waitlist control.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Number of participants who complete the STAIR interventionWeek 12This number will include those who attend the 12 weeks of STAIR with no more than three missed sessions
Total score of patient treatment satisfaction ratingsWeek 12Calculate 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.
Frequency of participant attendanceWeek 1 through Week 12Calculate the number of patients who attended each week of the STAIR treatment.
Change in emotion regulation total score from baseline to Week 12Baseline to Week 12Problems 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.
Change in the severity of posttraumatic stress disorder symptom total score from baseline to Week 12Baseline to Week 12The 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.
Change in Borderline symptom severity total score from baseline to Week 12Baseline and Week 12Using 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).
Change in Borderline Symptom List-23 total score from baseline to Week 12Baseline and Week 12This 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.
Change in current symptoms of psychopathology and psychological distress total score from baseline to Week 12Baseline and Week 12The 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026