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

NCT ID: NCT05682183

Last Updated: 2023-03-23

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-03
• Study Completion Date: 2024-12-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Multi-domain Psychoeducation Self-management Programme

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.

Group Type: ACTIVE_COMPARATOR

Multi-domain Psychoeducation Self-management Programme

Intervention Type: BEHAVIORAL

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.

Treatment as Usual

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.

Group Type: ACTIVE_COMPARATOR

Treatment as usual

Intervention Type: OTHER

Care management from assigned care manager

Interventions

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.

Intervention Type: BEHAVIORAL

Treatment as usual

Care management from assigned care manager

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National University of Singapore

OTHER

Sponsor Role: lead

Responsible Party

Goh Yong-Shian

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Alice Lee Centre for Nursing Studies

Singapore, , Singapore

Site Status: RECRUITING

Countries

Singapore

Facility Contacts

Yong Shian Goh, PhD

Role: primary

nurgys@nus.edu.sg

+6566011279

Other Identifiers

MPSP_2022

Identifier Type: -

Identifier Source: org_study_id