STAIR for Trauma and Emotion Dysregulation

Posttraumatic Stress Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05397613
• Other study ID #: 64219
• Status: Enrolling by invitation
• Phase: N/A
• Start date: June 15, 2022
• Est. completion date: June 15, 2025

Study information

• Verified date: May 2022
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 30
• Est. completion date: June 15, 2025
• Est. primary completion date: June 15, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Borderline Personality Disorder
• Disease
• Emotion Regulation
• Personality Disorders
• Posttraumatic Stress Disorder
• Stress Disorders, Post-Traumatic

Intervention

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.

Locations

Country	Name	City	State
United States	Stanford University	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

References & Publications (1)

Cloitre M, Koenen KC, Cohen LR, Han H. Skills training in affective and interpersonal regulation followed by exposure: a phase-based treatment for PTSD related to childhood abuse. J Consult Clin Psychol. 2002 Oct;70(5):1067-74. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants who complete the STAIR intervention	This number will include those who attend the 12 weeks of STAIR with no more than three missed sessions	Week 12
Primary	Total score of patient treatment satisfaction ratings	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
Primary	Frequency of participant attendance	Calculate the number of patients who attended each week of the STAIR treatment.	Week 1 through Week 12
Primary	Change in emotion regulation total score from 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
Primary	Change in the severity of posttraumatic stress disorder symptom total score from 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
Primary	Change in Borderline symptom severity total score from baseline to 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
Primary	Change in Borderline Symptom List-23 total score from baseline to 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
Primary	Change in current symptoms of psychopathology and psychological distress total score from baseline to 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