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

National University of Singapore

Status: Enrolling

Conditions: Major Depressive Disorder

Treatments: Behavioral: Multi-domain Psychoeducation Self-management Programme; Other: Treatment as usual

Study type: Interventional

Funder types: Other

Identifiers

NCT05682183

MPSP_2022

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Clinically diagnosed with Major Depressive Disorder
• Community-dwelling adults aged 21 to 80 years old
• Singaporean or permanent residents
• Literate in the English language
• Willing to be video or audio-recorded during the qualitative interview sessions for acceptability of intervention

Exclusion criteria

• Clinically diagnosed with maternal depression
• Clinically diagnosed with cognitive impairment/ intellectual disability
• Pregnant women
• Currently institutionalised in a long-term care facility
• Currently attending other psychoeducation self-management programmes
• Those who do not agree to the audio or video recording.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Multi-domain Psychoeducation Self-management Programme

Active Comparator group

Description:

Participants will be registered at the care centre and will receive usual care from their care manager who is assigned to them when they register with the centre. Those who are randomised into the intervention arm will undergo 5-sessions of Multi-domain Psychoeducation Self-management Programme over 5 weeks.

Treatment:

Behavioral: Multi-domain Psychoeducation Self-management Programme

Treatment as Usual

Active Comparator group

Description:

Participants will be registered at the care centre and will receive usual care from their care manager who is assigned to them when they register with the centre.

Treatment:

Other: Treatment as usual