Back to resultsSTAIR for Trauma and Emotion Dysregulation
Primary Purpose
Posttraumatic Stress Disorder, Borderline Personality Disorder, Emotion Regulation
Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
STAIR
Sponsored by
About this trial
This is an interventional treatment trial for Posttraumatic Stress Disorder
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
Sites / Locations
- Stanford University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
STAIR
Waitlist control
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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
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.
Frequency of participant attendance
Calculate the number of patients who attended each week of the STAIR treatment.
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.
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.
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).
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.
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05397613
Brief Title
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
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Enrolling by invitation
Study Start Date
June 15, 2022 (Anticipated)
Primary Completion Date
June 15, 2025 (Anticipated)
Study Completion Date
June 15, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Posttraumatic Stress Disorder, Borderline Personality Disorder, Emotion Regulation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Model Description
Patients will receive 12 weeks of STAIR immediately or after a delay of 12 weeks for the waitlist control.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
STAIR
Arm Type
Experimental
Arm Description
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.
Arm Title
Waitlist control
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
STAIR
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of participants who complete the STAIR intervention
Description
This number will include those who attend the 12 weeks of STAIR with no more than three missed sessions
Time Frame
Week 12
Title
Total score of patient treatment satisfaction ratings
Description
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.
Time Frame
Week 12
Title
Frequency of participant attendance
Description
Calculate the number of patients who attended each week of the STAIR treatment.
Time Frame
Week 1 through Week 12
Title
Change in emotion regulation total score from baseline to Week 12
Description
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.
Time Frame
Baseline to Week 12
Title
Change in the severity of posttraumatic stress disorder symptom total score from baseline to Week 12
Description
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.
Time Frame
Baseline to Week 12
Title
Change in Borderline symptom severity total score from baseline to Week 12
Description
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).
Time Frame
Baseline and Week 12
Title
Change in Borderline Symptom List-23 total score from baseline to Week 12
Description
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.
Time Frame
Baseline and Week 12
Title
Change in current symptoms of psychopathology and psychological distress total score from baseline to Week 12
Description
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.
Time Frame
Baseline and Week 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sanno Zack, PhD
Organizational Affiliation
Stanford Universtiy
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Emily Livermore, PsyD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
12362957
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.
Results Reference
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STAIR for Trauma and Emotion Dysregulation
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