NCT05682183

Multi-domain Psychoeducation Self-management Program for Adults With MDD in Singapore

A Community-based Multi-domain Psychoeducation Self-management Programme (MPSP) for Adults With Major Depressive Disorder in Singapore : A Pilot Randomized Controlled Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: National University of Singapore · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

This is a single-centre, two-arm, unblinded pilot randomised controlled trial study on 60 participants (30 in each arm) from the community mental health service (CMHS) centre within a social service agency in Singapore based on inclusion criteria. The study will examine the effects of a 5-sessions of Multi-domain Psychoeducation Self-management Programme and treatment-as-usual) over 5 weeks or control (treatment-as-usual) group.

Detailed description

This is a single-centre, two-arm, unblinded pilot randomised controlled trial study. A total of 60 participants (30 in each arm) will be conveniently recruited from the community mental health service (CMHS) centre within a social service agency in Singapore based on inclusion criteria. Block randomisation with a block size of two will be used to randomise participants into the intervention (5-sessions of Multi-domain Psychoeducation Self-management Programme and treatment-as-usual) over 5 weeks or control (treatment-as-usual) group. Primary outcomes measures which include self-management competence, self-efficacy to manage emotions, mental health quality of life and depressive symptoms severity, will be collected at three timepoints: (T1) baseline, (T2) immediately post-intervention and (T3) three months post-intervention. Quantitative data will be analysed using the Statistical Package for Social Sciences (SPSS) software using non-parametric tests. Secondary outcomes include the feasibility and acceptability of the MPSP. Feasibility of the intervention will be evaluated using pre-defined recruitment, attendance and follow-up rates. Acceptability of the intervention will be evaluated using a semi-structured interview guide based on the Theoretical Framework of Acceptability, immediately post-intervention (T2) or not more than a week from the last session. Data for acceptability will be transcribed verbatim and thematically analysed based on Braun and Clarke's thematic analysis guideline.

Conditions

• Major Depressive Disorder

Interventions

Type	Name	Description
BEHAVIORAL	Multi-domain Psychoeducation Self-management Programme	The MPSP is a 5-weeks psychoeducation programme aimed at improving the biopsychosocial health of people with MDD (PMDD). It will be conducted on every Saturday in the morning, afternoon and evening. Specific time of each session will be further discussed with the centre. Each session will last for approximately 45 minutes to 60 minutes and will be capped at 10 participants. The mode of session will be face-to-face (F2F) session conducted at MindCare.
OTHER	Treatment as usual	Care management from assigned care manager

Timeline

• Start date: 2023-01-03
• Primary completion: 2024-01-31
• Completion: 2024-12-31
• First posted: 2023-01-12
• Last updated: 2023-03-23

Locations

1 site across 1 country: Singapore