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NCT Number: 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

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.

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Key information

Age range

21 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Internet-Delivered Skills Training in Affective and Interpersonal Regulation

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

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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).

  5. 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.

Secondary outcomes

  1. 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).

  2. 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.

  3. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Siow Ann Chong, MD

CONTACT

[email protected]

+65 63892000

Sponsors and collaborators

Lead sponsor

Institute of Mental Health, Singapore

Other

Collaborators

  • National Medical Research Council (NMRC), Singapore

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Aug 12, 2025
Registry last updated
Feb 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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