Clinical trial NCT05397613: STAIR for Trauma and Emotion Dysregulation
Official title: Examining the Effectiveness of STAIR as an Alternative to DBT for Patients With Emotion Dysregulation and PTSD
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Posttraumatic Stress Disorder
Borderline Personality Disorder
Emotion Regulation
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2022-05-31
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Patients will receive 12 weeks of STAIR immediately or after a delay of 12 weeks for the waitlist control.
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: Number of participants who complete the STAIR intervention
timeFrame: Week 12
measure: Total score of patient treatment satisfaction ratings
timeFrame: Week 12
measure: Frequency of participant attendance
timeFrame: Week 1 through Week 12
measure: Change in emotion regulation total score from baseline to Week 12
timeFrame: Baseline to Week 12
measure: Change in the severity of posttraumatic stress disorder symptom total score from baseline to Week 12
timeFrame: Baseline to Week 12
measure: Change in Borderline symptom severity total score from baseline to Week 12
timeFrame: Baseline and Week 12
measure: Change in Borderline Symptom List-23 total score from baseline to Week 12
timeFrame: Baseline and Week 12
measure: Change in current symptoms of psychopathology and psychological distress total score from baseline to Week 12
timeFrame: Baseline and Week 12
Secondary outcomes:
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University
state: California
Study officials:
affiliation: Stanford Universtiy
name: Sanno Zack, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Stanford University
name: Emily Livermore, PsyD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. doi: 10.1037//0022-006x.70.5.1067.