A Pilot Study to Examine the Efficacy of Internet-Delivered Skills Training in Affective and Interpersonal Regulation (i-STAIR) for Individuals With Adverse Childhood Experiences and Subsyndromal Depression

Официальное название

Internet-Delivered Skills Training in Affective and Interpersonal Regulation (i-STAIR) for Individuals With Adverse Childhood Experiences and Subsyndromal Depression: A Pilot Study

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое Internet-Delivered Skills Training in Affective and Interpersonal Regulation
  Internet-Delivered Skills Training in Affective and Interpersonal Regulation (i-STAIR) is a psychological intervention that is focused on applying skills to improve emotion regulation difficulties and reduce interpersonal problems over two months (eight sessions; one session per week). i-STAIR also significantly reduces PTSD symptoms without direct discussion of the trauma and may be used alone or adjunctively to boost the effects of trauma-focused therapies.
• Поведенческое Online general psychoeducation
  Online general psychoeducation will focus on the teaching the link between adverse childhood experiences and depression, as well as teaching healthy lifestyle changes involving diet, exercise, and sleep. The online general psychoeducation will involve engaging presentations, active discussions, and self-directed homework activities.

Первичные конечные точки

• The Patient Health Questionnaire 9 [Срок оценки: From enrollment to the end of follow-up at 20 weeks.]
• Difficulties with Emotion Regulation Scale Short [Срок оценки: From enrollment to the end of follow-up at 20 weeks.]
• Ruminative Response Scale short-form [Срок оценки: From baseline to end of follow-up at 20 weeks.]
• Multidimensional Scale of Perceived Social Support [Срок оценки: From baseline to end of follow-up at 20 weeks.]
• Positive Mental Health Instrument [Срок оценки: From baseline to end of follow-up at 20 weeks.]

Вторичные конечные точки (3)

• PTSD Checklist for DSM-5 [Срок оценки: From baseline to end of follow-up at 20 weeks.]
• Work Productivity and Activity Impairment Questionnaire Specific Health Problem V2.0 [Срок оценки: At baseline and post-intervention at 8 weeks only.]
• Session Rating Scale [Срок оценки: At mid-intervention at 4 weeks and at post-intervention at 8 weeks only.]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Профилактика

Центры проведения

Сингапур · 1 центр

• Institute of Mental Health — Singapore

Публикации

• Miu AC, Szentagotai-Tatar A, Balazsi R, Nechita D, Bunea I, Pollak SD. Emotion regulation as mediator between childhood adversity and psychopathology: A meta-analysis. Clin Psychol Rev. 2022 Apr;93:102141. doi: 10.1016/j.cpr.2022.102141. Epub 2022 Feb 21. PMID 35219929
• Subramaniam M, Abdin E, Seow E, Vaingankar JA, Shafie S, Shahwan S, Lim M, Fung D, James L, Verma S, Chong SA. Prevalence, socio-demographic correlates and associations of adverse childhood experiences with mental illnesses: Results from the Singapore Mental Health Study. Child Abuse Negl. 2020 May;103:104447. doi: 10.1016/j.chiabu.2020.104447. Epub 2020 Mar 12. PMID 32171798
• Hassija, C.M., and Cloitre, M. (2015). STAIR narrative therapy: a skills focused approach to trauma-related distress. Current Psychiatry Reviews, 11, 172-179.
• Karsten J, Penninx BW, Verboom CE, Nolen WA, Hartman CA. Course and risk factors of functional impairment in subthreshold depression and anxiety. Depress Anxiety. 2013 Apr;30(4):386-94. doi: 10.1002/da.22021. Epub 2012 Nov 16. PMID 23165799
• Kirlic N, Cohen ZP, Singh MK. Is There an Ace Up Our Sleeve? A Review of Interventions and Strategies for Addressing Behavioral and Neurobiological Effects of Adverse Childhood Experiences in Youth. Advers Resil Sci. 2020 Mar;1(1):5-28. doi: 10.1007/s42844-020-00001-x. Epub 2020 Mar 13. PMID 34278327
• Korotana LM, Dobson KS, Pusch D, Josephson T. A review of primary care interventions to improve health outcomes in adult survivors of adverse childhood experiences. Clin Psychol Rev. 2016 Jun;46:59-90. doi: 10.1016/j.cpr.2016.04.007. Epub 2016 Apr 21. PMID 27179348
• Liu J, Tan BCW, Abdin E, Padmini YS, Oh JY, Chong SA, Subramaniam M. Health care utilization, productivity losses, and burden of adverse childhood experiences in Singapore: Findings from a national survey. Psychol Trauma. 2025 Jan;17(1):1-9. doi: 10.1037/tra0001691. Epub 2024 Jun 20. PMID 38900512
• Lorenc T, Lester S, Sutcliffe K, Stansfield C, Thomas J. Interventions to support people exposed to adverse childhood experiences: systematic review of systematic reviews. BMC Public Health. 2020 May 12;20(1):657. doi: 10.1186/s12889-020-08789-0. PMID 32397975

Идентификаторы

NCT: NCT07118072 · 2024-3342

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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