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

Not Applicable

Recruiting

• Conditions: Major Depressive Disorder

• Registration Number: NCT05682183
• Lead Sponsor: National University of Singapore

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.

Study Timeline

• Study First Submitted: 2022-12-15
• Study Start: 2023-01-03
• Study First Submitted QC: 2023-01-03
• Study First Posted: 2023-01-12
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-21
• Last Update Posted: 2023-03-23
• Primary Completion: 2024-01-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Primary Outcome Measures

Name	Time	Method
Self-Management Self-Test (T1)	(T1) baseline (before the start of intervention)	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.
Self-Management Self-Test (T2)	(T2) directly post-intervention (on the day of the final session)	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.
Self-Management Self-Test (T3)	(T3) three months post-intervention.	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.
Patient Reported Outcomes Measurement Information System (PROMIS) Self-efficacy for Managing Chronic Conditions- Managing Emotions (T1)	(T1) baseline (before the start of intervention)	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.
Patient Reported Outcomes Measurement Information System (PROMIS) Self-efficacy for Managing Chronic Conditions- Managing Emotions (T2)	(T2) directly post-intervention (on the day of the final session)	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.
Patient Reported Outcomes Measurement Information System (PROMIS) Self-efficacy for Managing Chronic Conditions- Managing Emotions (T3)	(T3) three months post-intervention.	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.
Mental Health Quality of Life Questionnaire (T1)	(T1) baseline (before the start of intervention)	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.
Mental Health Quality of Life Questionnaire (T2)	(T2) directly post-intervention (on the day of the final session)	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.
Mental Health Quality of Life Questionnaire (T3)	(T3) three months post-intervention.	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.
Patient Health Questionnaire (PHQ-9) (T1)	(T1) baseline (before the start of intervention)	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).
Patient Health Questionnaire (PHQ-9) (T2)	(T2) directly post-intervention (on the day of the final session)	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).
Patient Health Questionnaire (PHQ-9) (T3)	(T3) three months post-intervention.	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).

Trial Locations

Locations (1)

Alice Lee Centre for Nursing Studies; 🇸🇬 Singapore, Singapore