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

NCT05682183 | Unknown

• 1 other identifier: MPSP_2022
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Major Depressive Disorder

Keywords

Major depressive disorder; Community dwelling adults

Outcome Measures

Primary Outcomes (12)

• 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.

• 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.

Study Arms (2)

Multi-domain Psychoeducation Self-management Programme

ACTIVE COMPARATOR

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

Treatment as Usual

ACTIVE COMPARATOR

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

Interventions

Multi-domain Psychoeducation Self-management Programme 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.

Multi-domain Psychoeducation Self-management Programme

Treatment as usual OTHER

Care management from assigned care manager

Treatment as Usual

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• National University of Singapore: lead

Study Sites (1)

Alice Lee Centre for Nursing Studies

Singapore, Singapore

RECRUITING

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: December 15, 2022
• First Posted: January 12, 2023
• Study Start: January 3, 2023
• Primary Completion: January 31, 2024
• Study Completion: December 31, 2024
• Last Updated: March 23, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)