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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21-65
SponsorInstitute of Mental Health, Singapore

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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 design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

150 Participants
are divided into 2 treatment groups
Group A: Internet-Delivered Skills Training in Affective and Interpersonal RegulationExperimental treatment 1 intervention
Group B: Online general psychoeducationActive comparator 1 intervention

Trial outcomes

Primary outcomes

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.

Time frame
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.

Time frame
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.

Time frame
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).

Time frame
From baseline to end of follow-up at 20 weeks.

Secondary outcomes

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).

Time frame
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.

Time frame
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.

Time frame
At mid-intervention at 4 weeks and at post-intervention at 8 weeks only.

Other outcomes

Sponsors and contacts

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Institute of Mental Health, Singapore

Lead sponsor

National Medical Research Council (NMRC), Singapore

Collaborator