Clinical trial NCT05682183: Multi-domain Psychoeducation Self-management Program for Adults With MDD in Singapore
Official title: A Community-based Multi-domain Psychoeducation Self-management Programme (MPSP) for Adults With Major Depressive Disorder in Singapore : A Pilot Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Major Depressive Disorder
Keywords: Major depressive disorder
Community dwelling adults
Lead sponsor: National University of Singapore
Sponsor class: OTHER
First posted: 2023-01-12
Enrollment: 60
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Primary outcomes:
measure: Self-Management Self-Test (T1)
timeFrame: (T1) baseline (before the start of intervention)
measure: Self-Management Self-Test (T2)
timeFrame: (T2) directly post-intervention (on the day of the final session)
measure: Self-Management Self-Test (T3)
timeFrame: (T3) three months post-intervention.
measure: Patient Reported Outcomes Measurement Information System (PROMIS) Self-efficacy for Managing Chronic Conditions- Managing Emotions (T1)
timeFrame: (T1) baseline (before the start of intervention)
measure: Patient Reported Outcomes Measurement Information System (PROMIS) Self-efficacy for Managing Chronic Conditions- Managing Emotions (T2)
timeFrame: (T2) directly post-intervention (on the day of the final session)
measure: Patient Reported Outcomes Measurement Information System (PROMIS) Self-efficacy for Managing Chronic Conditions- Managing Emotions (T3)
timeFrame: (T3) three months post-intervention.
measure: Mental Health Quality of Life Questionnaire (T1)
timeFrame: (T1) baseline (before the start of intervention)
measure: Mental Health Quality of Life Questionnaire (T2)
timeFrame: (T2) directly post-intervention (on the day of the final session)
measure: Mental Health Quality of Life Questionnaire (T3)
timeFrame: (T3) three months post-intervention.
measure: Patient Health Questionnaire (PHQ-9) (T1)
timeFrame: (T1) baseline (before the start of intervention)
measure: Patient Health Questionnaire (PHQ-9) (T2)
timeFrame: (T2) directly post-intervention (on the day of the final session)
measure: Patient Health Questionnaire (PHQ-9) (T3)
timeFrame: (T3) three months post-intervention.
Secondary outcomes:
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Alice Lee Centre for Nursing Studies
Study officials:
References: