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

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.

Study Overview

• Status: Recruiting
• Conditions: Major Depressive Disorder
• Intervention / Treatment: Behavioral: Multi-domain Psychoeducation Self-management Programme; Other: Treatment as usual

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.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Singapore
  • Singapore, Singapore
    • Recruiting
    • Alice Lee Centre for Nursing Studies
    • Contact: Yong Shian Goh, PhD; Phone Number: +6566011279; Email: nurgys@nus.edu.sg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	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.
Active Comparator: 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.	Other: Treatment as usual; Care management from assigned care manager

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Health Questionnaire (PHQ-9) (T1)	The self-reported 9-item scale is a dual-purpose scale that measures the severity of depressive symptoms. All items have a 4-point Likert scale, with '0' indicating 'not at all' and '3' indicating 'nearly every day'; higher scores represent greater severity of depression. The summation of scores can be categorised to represent depression severity: 0-4 indicates none to minimal severity; 5-9 indicates mild severity; 10-14 indicates moderate severity; 15-19 indicates moderately severe and; 20-27 indicates severe depression (PHQ Screeners, 2002).	(T1) baseline (before the start of intervention)
Patient Health Questionnaire (PHQ-9) (T2)	The self-reported 9-item scale is a dual-purpose scale that measures the severity of depressive symptoms. All items have a 4-point Likert scale, with '0' indicating 'not at all' and '3' indicating 'nearly every day'; higher scores represent greater severity of depression. The summation of scores can be categorised to represent depression severity: 0-4 indicates none to minimal severity; 5-9 indicates mild severity; 10-14 indicates moderate severity; 15-19 indicates moderately severe and; 20-27 indicates severe depression (PHQ Screeners, 2002).	(T2) directly post-intervention (on the day of the final session)
Patient Health Questionnaire (PHQ-9) (T3)	The self-reported 9-item scale is a dual-purpose scale that measures the severity of depressive symptoms. All items have a 4-point Likert scale, with '0' indicating 'not at all' and '3' indicating 'nearly every day'; higher scores represent greater severity of depression. The summation of scores can be categorised to represent depression severity: 0-4 indicates none to minimal severity; 5-9 indicates mild severity; 10-14 indicates moderate severity; 15-19 indicates moderately severe and; 20-27 indicates severe depression (PHQ Screeners, 2002).	(T3) three months post-intervention.
Self-Management Self-Test (T1)	The self-reported 5-item scale measures the degree of perceived competence of self-management among individuals with or without psychiatric disorders. Each item consists of a 5-point Likert scale, with a score of '0' indicating poor self-management and '4' excellent self-management; hence, higher score represents better perceived self-management practice. The lowest possible score for this scale is 0 and the highest possible score for the scale is 25.	(T1) baseline (before the start of intervention)
Self-Management Self-Test (T2)	The self-reported 5-item scale measures the degree of perceived competence of self-management among individuals with or without psychiatric disorders. Each item consists of a 5-point Likert scale, with a score of '0' indicating poor self-management and '4' excellent self-management; hence, higher score represents better perceived self-management practice. The lowest possible score for this scale is 0 and the highest possible score for the scale is 25.	(T2) directly post-intervention (on the day of the final session)
Self-Management Self-Test (T3)	The self-reported 5-item scale measures the degree of perceived competence of self-management among individuals with or without psychiatric disorders. Each item consists of a 5-point Likert scale, with a score of '0' indicating poor self-management and '4' excellent self-management; hence, higher score represents better perceived self-management practice. The lowest possible score for this scale is 0 and the highest possible score for the scale is 25.	(T3) three months post-intervention.
Patient Reported Outcomes Measurement Information System (PROMIS) Self-efficacy for Managing Chronic Conditions- Managing Emotions (T1)	The self-reported 8-item scale specifically evaluates an individual's confidence to manage or control symptoms of anxiety, depression, helplessness and discouragements, amongst others. Each item consists of a 5-point Likert scale, with a score of' 1' indicating the least confidence and '5' indicating the utmost confidence; hence, a higher score represents greater self-efficacy. The lowest possible score for this scale is 8 and the highest possible score for the scale is 40.	(T1) baseline (before the start of intervention)
Patient Reported Outcomes Measurement Information System (PROMIS) Self-efficacy for Managing Chronic Conditions- Managing Emotions (T2)	The self-reported 8-item scale specifically evaluates an individual's confidence to manage or control symptoms of anxiety, depression, helplessness and discouragements, amongst others. Each item consists of a 5-point Likert scale, with a score of' 1' indicating the least confidence and '5' indicating the utmost confidence; hence, a higher score represents greater self-efficacy. The lowest possible score for this scale is 8 and the highest possible score for the scale is 40.	(T2) directly post-intervention (on the day of the final session)
Patient Reported Outcomes Measurement Information System (PROMIS) Self-efficacy for Managing Chronic Conditions- Managing Emotions (T3)	The self-reported 8-item scale specifically evaluates an individual's confidence to manage or control symptoms of anxiety, depression, helplessness and discouragements, amongst others. Each item consists of a 5-point Likert scale, with a score of' 1' indicating the least confidence and '5' indicating the utmost confidence; hence, a higher score represents greater self-efficacy. The lowest possible score for this scale is 8 and the highest possible score for the scale is 40.	(T3) three months post-intervention.
Mental Health Quality of Life Questionnaire (T1)	The self-administered 7-item scale measures the quality of life of an individual based on the context of mental health. It was developed based on seven quality of life dimensions: self-image; independence; mood; relationships; daily activities; physical health and; future. Each item has a 4-point response level. An overall index score will be calculated based on the summation of each item's score; higher scores indicate better quality of life. The lowest possible score for this scale is 7 and the highest possible score for the scale is 28.	(T1) baseline (before the start of intervention)
Mental Health Quality of Life Questionnaire (T2)	The self-administered 7-item scale measures the quality of life of an individual based on the context of mental health. It was developed based on seven quality of life dimensions: self-image; independence; mood; relationships; daily activities; physical health and; future. Each item has a 4-point response level. An overall index score will be calculated based on the summation of each item's score; higher scores indicate better quality of life. The lowest possible score for this scale is 7 and the highest possible score for the scale is 28.	(T2) directly post-intervention (on the day of the final session)
Mental Health Quality of Life Questionnaire (T3)	The self-administered 7-item scale measures the quality of life of an individual based on the context of mental health. It was developed based on seven quality of life dimensions: self-image; independence; mood; relationships; daily activities; physical health and; future. Each item has a 4-point response level. An overall index score will be calculated based on the summation of each item's score; higher scores indicate better quality of life. The lowest possible score for this scale is 7 and the highest possible score for the scale is 28.	(T3) three months post-intervention.

Collaborators and Investigators

• Sponsor: National University of Singapore

Study record dates

Study Major Dates

• Study Start (Actual): January 3, 2023
• Primary Completion (Anticipated): January 31, 2024
• Study Completion (Anticipated): December 31, 2024

Study Registration Dates

• First Submitted: December 15, 2022
• First Submitted That Met QC Criteria: January 3, 2023
• First Posted (Actual): January 12, 2023

Study Record Updates

• Last Update Posted (Actual): March 23, 2023
• Last Update Submitted That Met QC Criteria: March 21, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Major depressive disorder; Community dwelling adults
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder; Depressive Disorder, Major
• Other Study ID Numbers: MPSP_2022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No