Menu
Recruiting NCT07118072

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

No phase Interventional Subthreshold Depression

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Internet-Delivered Skills Training in Affective and Interpersonal Regulation, Online general psychoeducation.
Who it may be relevant to
Registry conditions: Subthreshold Depression. Basic parameters: 21 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Singapore
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

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.

Interventions

  • Behavioral 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.
  • 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.

Primary outcome measures

  • The Patient Health Questionnaire 9 [Time frame: From enrollment to the end of follow-up at 20 weeks.]
  • Difficulties with Emotion Regulation Scale Short [Time frame: From enrollment to the end of follow-up at 20 weeks.]
  • Ruminative Response Scale short-form [Time frame: From baseline to end of follow-up at 20 weeks.]
  • Multidimensional Scale of Perceived Social Support [Time frame: From baseline to end of follow-up at 20 weeks.]
  • Positive Mental Health Instrument [Time frame: From baseline to end of follow-up at 20 weeks.]
Secondary outcome measures (3)
  • PTSD Checklist for DSM-5 [Time frame: From baseline to end of follow-up at 20 weeks.]
  • Work Productivity and Activity Impairment Questionnaire Specific Health Problem V2.0 [Time frame: At baseline and post-intervention at 8 weeks only.]
  • Session Rating Scale [Time frame: At mid-intervention at 4 weeks and at post-intervention at 8 weeks only.]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Prevention

Study locations

Singapore · 1 center
  • Institute of Mental Health — Singapore

Publications

  • 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

Identifiers

NCT: NCT07118072 · 2024-3342

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗