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

February 25, 2026 updated by: Institute of Mental Health, Singapore

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Singapore
      • Singapore, Singapore
        • Recruiting
        • Institute of Mental Health
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
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.
Active Comparator: 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Patient Health Questionnaire 9
Time Frame: 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.
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.
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.
Ruminative Response Scale short-form
Time Frame: 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.
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.
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.
Positive Mental Health Instrument
Time Frame: 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.
From baseline to end of follow-up at 20 weeks.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PTSD Checklist for DSM-5
Time Frame: From baseline to end of follow-up at 20 weeks.
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.
Work Productivity and Activity Impairment Questionnaire Specific Health Problem V2.0
Time Frame: At baseline and post-intervention at 8 weeks only.
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.
Session Rating Scale
Time Frame: At mid-intervention at 4 weeks and at post-intervention at 8 weeks only.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institute of Mental Health, Singapore

Collaborators

National Medical Research Council (NMRC), Singapore

Investigators

  • Study Director: Mythily Subramaniam, MBBS, Ph.D., Institute of Mental Health, Singapore
  • Principal Investigator: Siow Ann Chong, MD, Institute of Mental Health, Singapore

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 31, 2025

Primary Completion (Estimated)

December 1, 2028

Study Completion (Estimated)

December 1, 2028

Study Registration Dates

First Submitted

August 5, 2025

First Submitted That Met QC Criteria

August 5, 2025

First Posted (Actual)

August 12, 2025

Study Record Updates

Last Update Posted (Actual)

February 27, 2026

Last Update Submitted That Met QC Criteria

February 25, 2026

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024-3342

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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