Internet-Delivered Skills Training in Affective and Interpersonal Regulation (i-STAIR) for Individuals With Adverse Childhood Experiences and Subsyndromal Depression: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- The Patient Health Questionnaire 9
研究概览
简要总结
The present study aims to pilot internet-delivered Skills Training in Affective and Interpersonal Regulation (i-STAIR) as a transdiagnostic emotion dysregulation intervention to prevent progression to depression in individuals with adverse childhood experiences (ACEs) and subsyndromal depression. The aims of the study are: (i) to examine the effectiveness of i-STAIR on emotion dysregulation, interpersonal skills, depressive and PTSD symptoms at post-intervention i.e. on completion of the intervention (8 weeks); (ii) to examine if gains were maintained at 3 month post- intervention follow-up.
详细描述
Internet-delivered Skills Training in Affective and Interpersonal Regulation (i-STAIR) will be an effective intervention for preventing depression among those with adverse childhood experiences and subsyndromal depression. In contrast to the control group (i.e., individuals who received online general psychoeducation), we hypothesize that participants who receive i-STAIR will experience a significant reduction of depressive/PTSD symptoms and emotion dysregulation, as well as experience significant positive increases in interpersonal skills and perceptions of social support at post-intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Exposed to mild, moderate or severe adverse childhood experiences (ACEs)
- •Screened positive for subsyndromal depression
- •Singapore citizens or permanent residents (PRs)
- •Aged 21 years to 65 years
- •Able to speak and understand English
- •Willing and able to undergo intervention and assessment online
排除标准
- •Currently diagnosed with any mental disorder diagnoses;
- •Experience cognitive impairment as determined by attending physician
- •Have received or currently receiving dialectical behavior therapy (DBT) due to similarities with i-STAIR
- •Female participants who are pregnant
结局指标
主要结局
The Patient Health Questionnaire 9
时间窗: From enrollment to the end of follow-up at 20 weeks.
The PHQ-9 will be used to assess for self-reported depressive symptoms. The PHQ-9 comprises 9 items which are rated on a 4-point Likert scale (ranging from 0=not at all to 3=nearly every day). Higher scores indicate more severe depressive symptoms. The PHQ-9 is used in the local clinical setting for routine screening of depressive symptoms.
Difficulties with Emotion Regulation Scale Short
时间窗: From enrollment to the end of follow-up at 20 weeks.
The DERS-S will be used to assess for global emotion dysregulation. Global emotion dysregulation comprises 6 dimensions: non-acceptance of emotional response, difficulties engaging in goal-directed behavior, impulse control difficulties, lack of emotional awareness, limited access to emotion regulation strategies, and lack of emotional clarity. Higher scores will indicate more severe global emotion dysregulation.
Positive Mental Health Instrument
时间窗: From baseline to end of follow-up at 20 weeks.
The PMHI will be used to measure interpersonal skills. The PMHI and its subscales have been locally validated and demonstrated good psychometric properties in previous studies.
Ruminative Response Scale short-form
时间窗: From baseline to end of follow-up at 20 weeks.
The RRS will be used to measure habitual rumination. Rumination is a prevalent maladaptive emotion regulation strategy among patients with mental disorders and exerts a moderate to strong effect on psychopathology. Higher scores on the RRS will indicate more frequent use of rumination. The RRS demonstrated good psychometric properties in the literature.
Multidimensional Scale of Perceived Social Support
时间窗: From baseline to end of follow-up at 20 weeks.
The MSPSS will be used to measure an individual's level of perceived social support from three sources: Significant Others, Family and Friends. The MSPSS comprises 12 items and each item is rated on a seven-point Likert-type scale (ranging from 1=Very Strongly Disagree to 7=Very Strongly Agree).
次要结局
- PTSD Checklist for DSM-5(From baseline to end of follow-up at 20 weeks.)
- Work Productivity and Activity Impairment Questionnaire Specific Health Problem V2.0(At baseline and post-intervention at 8 weeks only.)
- Session Rating Scale(At mid-intervention at 4 weeks and at post-intervention at 8 weeks only.)