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

NCT ID: NCT07118072

Last Updated: 2025-09-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-30

Study Completion Date

2028-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Subthreshold Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Eligible participants will be randomized into two groups: Active intervention (i-STAIR; n = 75) or control (online general psychoeducation; n =75) groups. The active intervention group will receive a free 8-week (i.e., eight online sessions; 1 session per week) i-STAIR intervention and the control group will receive online psychoeducation intervention (i.e., 5 online sessions and three self-guided activities over 8 weeks). All interventions will be delivered online over Zoom or Microsoft Teams. All participants will complete the assessment measures (i.e., emotion dysregulation, interpersonal skills, perceptions of social support, depressive symptoms, and PTSD symptoms) at baseline, mid-intervention (i.e., four weeks), post-intervention (i.e., eight weeks).
Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Caregivers Investigators Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Internet-Delivered Skills Training in Affective and Interpersonal Regulation

Intervention Type BEHAVIORAL

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.

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.

Group Type ACTIVE_COMPARATOR

Online general psychoeducation

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type BEHAVIORAL

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Medical Research Council (NMRC), Singapore

OTHER_GOV

Sponsor Role collaborator

Institute of Mental Health, Singapore

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mythily Subramaniam, MBBS, Ph.D.

Role: STUDY_DIRECTOR

Institute of Mental Health, Singapore

Siow Ann Chong, MD

Role: PRINCIPAL_INVESTIGATOR

Institute of Mental Health, Singapore

Locations

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Institute of Mental Health

Singapore, , Singapore

Site Status

Countries

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Singapore

Central Contacts

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Siow Ann Chong, MD

Role: CONTACT

+65 63892000

Facility Contacts

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Siow Ann Chong, MD

Role: primary

+65 63892000

References

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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.

Reference Type BACKGROUND
PMID: 35219929 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32171798 (View on PubMed)

Hassija, C.M., and Cloitre, M. (2015). STAIR narrative therapy: a skills focused approach to trauma-related distress. Current Psychiatry Reviews, 11, 172-179.

Reference Type BACKGROUND

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.

Reference Type BACKGROUND
PMID: 23165799 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34278327 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27179348 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 38900512 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32397975 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33596437 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12362957 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29038682 (View on PubMed)

Related Links

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Other Identifiers

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2024-3342

Identifier Type: -

Identifier Source: org_study_id

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