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

Institute of Mental Health, Singapore

Status: Not yet enrolling

Conditions: Subthreshold Depression

Treatments: Behavioral: Internet-Delivered Skills Training in Affective and Interpersonal Regulation; Behavioral: Online general psychoeducation

Study type: Interventional

Funder types: Other

Identifiers

NCT07118072

2024-3342

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 estimated patients

Sex: All

Ages: 21 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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150 participants in 2 patient groups

Internet-Delivered Skills Training in Affective and Interpersonal Regulation

Experimental group

Description:

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.

Treatment:

Behavioral: Internet-Delivered Skills Training in Affective and Interpersonal Regulation

Online general psychoeducation

Active Comparator group

Description:

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.

Treatment:

Behavioral: Online general psychoeducation