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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05682183
Other study ID # MPSP_2022
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date January 3, 2023
Est. completion date December 31, 2024

Study information

Verified date March 2023
Source National University of Singapore
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 60
Est. completion date December 31, 2024
Est. primary completion date January 31, 2024
Accepts healthy volunteers No
Gender All
Age group 21 Years and older
Eligibility 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


Intervention

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.
Other:
Treatment as usual
Care management from assigned care manager

Locations

Country Name City State
Singapore Alice Lee Centre for Nursing Studies Singapore

Sponsors (1)

Lead Sponsor Collaborator
National University of Singapore

Country where clinical trial is conducted

Singapore, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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)
Primary 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)
Primary 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.
Primary 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)
Primary 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)
Primary 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.
Primary 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)
Primary 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)
Primary 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.
Primary 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)
Primary 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)
Primary 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.
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