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Subthreshold DepressionNCT07118072

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

A study testing Internet-Delivered Skills Training in Affective and Interpersonal Regulation and Online general psychoeducation in people with Subthreshold Depression, run by Institute of Mental Health, Singapore at 1 site in Singapore.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 21 to 65 years
Conditions the study is for
Subthreshold Depression
What is being tested?
Internet-Delivered Skills Training in Affective and Interpersonal Regulation and Online general psychoeducation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
150 participants
Where
1 siteSingapore
Study dates
31 Oct 2025to Dec 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Siow Ann Chong, MD contact

+65 63892000

imhresearch@imh.com.sg

Singapore1 site, 1 recruiting
  • Institute of Mental Health

    Singapore

    Siow Ann Chong, MD, +65 63892000, imhresearch@imh.com.sg

    Recruiting

Other trials in Singapore

About this study

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

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.

Read the 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.

Being tested
Internet-Delivered Skills Training in Affective and Interpersonal Regulation, Online general psychoeducation
Keywords
skills training in affective and interpersonal regulation, emotion regulation, subthreshold depression, prevention intervention, digital intervention, transdiagnostic intervention, Singapore
Medical subject headings
Emotional Regulation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Internet-Delivered Skills Training in Affective and Interpersonal RegulationBehavioural

    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 psychoeducationBehavioural

    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.

Study groups in NCT07118072
Study groupRoleWhat they receive
Internet-Delivered Skills Training in Affective and Interpersonal RegulationExperimentali-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.
Receives: Behavioral: Internet-Delivered Skills Training in Affective and Interpersonal Regulation
Online general psychoeducationActive comparatorOnline 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.
Receives: Behavioral: Online general psychoeducation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The Patient Health Questionnaire 9

    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.

    Measured: From enrollment to the end of follow-up at 20 weeks.

  2. Difficulties with Emotion Regulation Scale Short

    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.

    Measured: From enrollment to the end of follow-up at 20 weeks.

  3. Ruminative Response Scale short-form

    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.

    Measured: From baseline to end of follow-up at 20 weeks.

  4. Multidimensional Scale of Perceived Social Support

    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).

    Measured: From baseline to end of follow-up at 20 weeks.

  5. Positive Mental Health Instrument

    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.

    Measured: From baseline to end of follow-up at 20 weeks.

Secondary outcomes (3)
  1. PTSD Checklist for DSM-5

    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).

    Measured: From baseline to end of follow-up at 20 weeks.

  2. Work Productivity and Activity Impairment Questionnaire Specific Health Problem V2.0

    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.

    Measured: At baseline and post-intervention at 8 weeks only.

  3. Session Rating Scale

    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.

    Measured: At mid-intervention at 4 weeks and at post-intervention at 8 weeks only.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Aug 2025
  2. Study start31 Oct 2025
  3. Primary completionDec 2028 (estimated)
  4. Study completionDec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
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).
Masking
Triple blind
Who is masked
Care provider, Investigator, Outcomes assessor
Enrolment
150 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07118072
Sponsor's protocol ID
2024-3342
Status last verified
Nov 2026
First submitted
5 Aug 2025
Last updated
4 Nov 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: 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.

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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 32397975
  • 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.

    PubMed 33596437
  • 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.

    PubMed 12362957
  • 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.

    PubMed 29038682

Questions about this trial

What is this clinical trial studying?

A study testing Internet-Delivered Skills Training in Affective and Interpersonal Regulation and Online general psychoeducation in people with Subthreshold Depression, run by Institute of Mental Health, Singapore at 1 site in Singapore.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Siow Ann Chong, MD (+65 63892000, imhresearch@imh.com.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The Patient Health Questionnaire 9 (time frame: From enrollment to the end of follow-up at 20 weeks.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07118072, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2026.

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