Subthreshold Depression
Conditions
Keywords
skills training in affective and interpersonal regulation, emotion regulation, subthreshold depression, prevention intervention, digital intervention, transdiagnostic intervention, Singapore
Brief 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. 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
BEHAVIORALInternet-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.
BEHAVIORALOnline 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.
Sponsors
Institute of Mental Health, Singapore
National Medical Research Council (NMRC), Singapore
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)
Intervention 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).
Eligibility
Sex/Gender
ALL
Age
21 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Patient Health Questionnaire 9 | 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. |
| Difficulties with Emotion Regulation Scale Short | 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. |
| Ruminative Response Scale short-form | 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. |
| Multidimensional Scale of Perceived Social Support | 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). |
| Positive Mental Health Instrument | 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
| Measure | Time frame | Description |
|---|---|---|
| PTSD Checklist for DSM-5 | 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). |
| Work Productivity and Activity Impairment Questionnaire Specific Health Problem V2.0 | 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. |
| Session Rating Scale | 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. |
Countries
Singapore
Contacts
CONTACTSiow Ann Chong, MD
STUDY_DIRECTORMythily Subramaniam, MBBS, Ph.D.
Institute of Mental Health, Singapore
PRINCIPAL_INVESTIGATORSiow Ann Chong, MD
Institute of Mental Health, Singapore
Outcome results
None listed