Uno studio pilota per esaminare l'efficacia della formazione delle competenze consegnata a Internet in regolamentazione affettiva e interpersonale (I-Stair) per le persone con esperienze infantili avverse e depressione subsindromica
Formazione delle competenze consegnate a Internet in regolamentazione affettiva e interpersonale (I-Stair) per individui con esperienze infantili avverse e depressione subsindromica: uno studio pilota
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.
Panoramica dello studio
Stato
Stato
Condizioni
Condizioni
Intervento / Trattamento
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Tipo di studio
Iscrizione (Stimato)
Iscrizione
Fase
Fase
- Non applicabile
Contatti e Sedi
Contatto studio
Contatto studio
- Nome: Siow Ann Chong, MD
- Numero di telefono: +65 63892000
- Email: imhresearch@imh.com.sg
Luoghi di studio
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Singapore, Singapore
- Reclutamento
- Institute of Mental Health
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Contatto:
- Siow Ann Chong, MD
- Numero di telefono: +65 63892000
- Email: imhresearch@imh.com.sg
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Criteri di partecipazione
Criteri di ammissibilità
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Prevenzione
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Triplicare
Numero di armi
Armi e interventi
Gruppo di partecipanti / ArmGruppo di partecipanti / Arm |
Intervento / TrattamentoIntervento / Trattamento |
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Sperimentale: Internet-Delivered Skills Training in Affective and Interpersonal Regulation
i-STAIR specifically targets emotion dysregulation and poor interpersonal skills. i-STAIR comprises eight sessions (one hour per session, per week) and each session focuses on a particular skills deficit. In general, session-by-session topics include: (1) labelling and identifying feelings; (2) emotion management (i.e., focus on anger and anxiety); (3) distress tolerance; (4) acceptance of feelings and enhanced experiencing of positive emotions; (5) identification of trauma-based interpersonal schemas and their enactment in day-to-day life; (6) identification of conflict between trauma-generated feelings and current interpersonal goals; (7) role plays related to issues of power and control; and (8) role plays related to developing flexibility in interpersonal situations involving power differentials. |
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. |
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Comparatore attivo: Online general psychoeducation
Online general psychoeducation comprises five online sessions (one hour per session on Week 1, Week 2, Week 4, Week 6, and Week 8) where a trained research staff will provide psychoeducation to the participant for up to 1 hour, as well as three weeks of self-guided activities where the participant will work on a specific activity on their own and feedback will be provided during the online sessions. The online psychoeducation content will focus on the link between adverse childhood experiences and depression, and healthy lifestyle changes including healthy diet, exercise, and sleep. |
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. |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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The Patient Health Questionnaire 9
Lasso di tempo: From enrollment to the end of follow-up at 20 weeks.
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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. |
From enrollment to the end of follow-up at 20 weeks.
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Difficulties with Emotion Regulation Scale Short
Lasso di tempo: From enrollment to the end of follow-up at 20 weeks.
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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. |
From enrollment to the end of follow-up at 20 weeks.
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Ruminative Response Scale short-form
Lasso di tempo: From baseline to end of follow-up at 20 weeks.
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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. |
From baseline to end of follow-up at 20 weeks.
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Multidimensional Scale of Perceived Social Support
Lasso di tempo: From baseline to end of follow-up at 20 weeks.
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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). |
From baseline to end of follow-up at 20 weeks.
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Positive Mental Health Instrument
Lasso di tempo: From baseline to end of follow-up at 20 weeks.
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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. |
From baseline to end of follow-up at 20 weeks.
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Misure di risultato secondarie
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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PTSD Checklist for DSM-5
Lasso di tempo: From baseline to end of follow-up at 20 weeks.
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The PCL-5 will be used to assess for self-reported PTSD symptoms. The PCL-5 is self-rated and higher scores indicate more severe PTSD symptoms (total score range from 0 to 80). |
From baseline to end of follow-up at 20 weeks.
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Work Productivity and Activity Impairment Questionnaire Specific Health Problem V2.0
Lasso di tempo: At baseline and post-intervention at 8 weeks only.
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The WPAI will be used to assess for the impact of health problems (e.g. physical or mental) on an individual's ability to work and perform regular activities. The WPAI: SHP comprises 1 dichotomous (yes/no) item asking if the respondent is currently employed, 3 items asking about the number of hours that the respondent worked or did not work in the past week, and 2 eleven-point Likert-type scales (ranging from 0 to 10; higher scores indicate more problems) asking about how much health problems affected the respondent's work productivity and ability to do regular daily activities. |
At baseline and post-intervention at 8 weeks only.
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Session Rating Scale
Lasso di tempo: At mid-intervention at 4 weeks and at post-intervention at 8 weeks only.
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The SRS will be used to assess for therapeutic alliance between the participant and research therapist. The SRS has three scales that assess for the relational bond between participant and research therapist, goal agreement, and task agreement. An overall scale also assesses whether the participant felt that "there was something missing in the session" versus "overall the session was good for me". Overall, the SRS has a total of four scales and they are all assessed along a 100mm. Visual Analogue Scale. |
At mid-intervention at 4 weeks and at post-intervention at 8 weeks only.
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Collaboratori e investigatori
Sponsor
Sponsor
Collaboratori
Collaboratori
Investigatori
Investigatori
- Direttore dello studio: Mythily Subramaniam, MBBS, Ph.D., Institute of Mental Health, Singapore
- Investigatore principale: Siow Ann Chong, MD, Institute of Mental Health, Singapore
Pubblicazioni e link utili
Pubblicazioni generali
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Cuijpers P, Pineda BS, Ng MY, Weisz JR, Munoz RF, Gentili C, Quero S, Karyotaki E. A Meta-analytic Review: Psychological Treatment of Subthreshold Depression in Children and Adolescents. J Am Acad Child Adolesc Psychiatry. 2021 Sep;60(9):1072-1084. doi: 10.1016/j.jaac.2020.11.024. Epub 2021 Feb 14.
- Cloitre M, Garvert DW, Weiss BJ. Depression as a moderator of STAIR Narrative Therapy for women with post-traumatic stress disorder related to childhood abuse. Eur J Psychotraumatol. 2017 Oct 10;8(1):1377028. doi: 10.1080/20008198.2017.1377028. eCollection 2017.
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Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
Altri numeri di identificazione dello studio
- 2024-3342
Piano per i dati dei singoli partecipanti (IPD)
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Descrizione del piano IPD
The IPD will be subjected to review and ethical clearance by our ethics board. Hence, we may not be allowed to share IPD due to ethical requirements.
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