跳至主要内容
临床试验/NCT05397613
NCT05397613Enrolling By Invitation不适用

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

Stanford University2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2022年6月15日最近更新:
适应症

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
30
试验地点
2
主要终点
Total score of patient treatment satisfaction ratings

研究概览

简要总结

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

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Sequential
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

Total score of patient treatment satisfaction ratings

时间窗: 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.

Number of participants who complete the STAIR intervention

时间窗: Week 12

This number will include those who attend the 12 weeks of STAIR with no more than three missed sessions

Change in emotion regulation total score from baseline to Week 12

时间窗: 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 Borderline Symptom List-23 total score from baseline to Week 12

时间窗: 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.

Frequency of participant attendance

时间窗: Week 1 through Week 12

Calculate the number of patients who attended each week of the STAIR treatment.

Change in current symptoms of psychopathology and psychological distress total score from baseline to Week 12

时间窗: 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.

Change in the severity of posttraumatic stress disorder symptom total score from baseline to Week 12

时间窗: 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

时间窗: 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).

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sanno Zack

Clinical Professor

Stanford University

研究点 (2)

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