Developing a self-help Intervention: Recognise, self-help and help-seeking (ReSHaPe) for depressive and anxiety symptoms to improve well-being among low-socioeconomic households in Malaysia
| ISRCTN | ISRCTN25880061 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN25880061 |
| Secondary identifying numbers | UM.TNC2/UMREC - 811 |
- Submission date
- 14/02/2021
- Registration date
- 23/02/2021
- Last edited
- 18/08/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
Depression and anxiety are common mental disorders in the general population. The National Health and Morbidity Survey has shown there is a high level of mental health issues among the low-income population as compared to the high-income group in Malaysia and intervention is important to overcome this issues and ensure better wellbeing. This research is necessary because good mental health improve self-care thus better wellbeing. As the percentage of physical illness like hypertension and diabetes are high in the low-income group and its close relationship with the development of mental illness, good self-care confers a better control of the disease. To date, the research in Malaysia pertaining to mental health is still very limited.
Who can participate?
Individuals who are part of the low-income population that staying in the Petaling District, Malaysia
What does the study involve?
Participants are required to follow through with an online psychoeducation material (ReSHaPe) with a duration of 15 to 20 minutes on alternate weeks according to their own pace. At the end of each session, they are required to answer a quiz and to complete a simple assignment. The material takes 12 weeks to complete.
What are the possible benefits and risks of participating?
Benefits: Health Promotion will be given to the participants. Referral for counselling and treatment
Risks: You may experience some emotional discomfort when answering certain questions in the mental health assessment questionnaires. You can choose to stop answering the questions and contact the researchers as stated at the end of this information sheet.
Where is the study run from?
University Malaya (Malaysia)
When is the study starting and how long is it expected to run for?
August 2019 to February 2022
Who is funding the study?
Malaysia Research University Network (MRUN)
Who is the main contact?
Wong Min Fui, wongminfui78@gmail.com
Prof. Mas Ayu Binti Said, mas@ummc.edu.my
Prof. Hazreen Bin Abdul Majid, hazreen@ummc.edu.my
Prof. Rozmi Ismail, rozmi@ukm.edu.my
Siti Shazwani Ahmad Suhaimi, shazwani.suhaimi87@gmail.com
Contact information
Scientific
No 78, Jalan Krian
Taman Rainbow
Batu 4 1/2
Jln ipoh
Kuala Lumpur
51100
Malaysia
 ORCID ID |
0000-0003-1955-521X |
|---|---|
| Phone | +60 168214959 |
| mwa190009@siswa.um.edu.my |
Scientific
University Malaya Medical Centre
Kuala Lumpur
59100
Malaysia
| ORCID ID |
0000-0002-2718-8424 |
|---|---|
| Phone | +60 (0)173887079 |
| hazreen@ummc.edu.my |
Scientific
Department of Social and Preventive Medicine
Faculty of Medicine
University of Malaya
Kuala Lumpur
50603
Malaysia
| ORCID ID |
0000-0002-1341-4582 |
|---|---|
| Phone | +60 (0)192140616 |
| mas@ummc.edu.my |
Scientific
Centre for Research in Psychology & Human Well-being
5th Floor, Blok D
Faculty of Social Sciences And Humanities
Universiti Kebangsaan Malaysia
Bangi
43600
Malaysia
| ORCID ID |
0000-0002-6473-6717 |
|---|---|
| Phone | +60 (0)193552449 |
| rozmi@ukm.edu.my |
Public
Department of Social and Development Sciences
Faculty of Human Ecology
Universiti Putra Malaysia
Serdang
43400
Malaysia
| Phone | +60 (0)17-8770551 |
|---|---|
| shazwani.suhaimi87@gmail.com |
Study information
| Study design | Interventional non-randomized study with quantitative and qualitative follow up |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Community |
| Study type | Prevention |
| Participant information sheet | https://drive.google.com/drive/folders/1VDo_BtxojFwvnXS7gjVITzh5_GF-b8AL?usp=sharing |
| Scientific title | Developing a psychosocial intervention: Recognise, Self-help and HelP-seeking (ReSHaPe) for depressive and anxiety symptoms to improve the well-being among the low-socioeconomic households at low-cost flats in Malaysia |
| Study acronym | ReSHaPe |
| Study objectives | 1. There is significant difference between the mean scores of depression, anxiety, resilience , quality of life, weight and BMI status among B40 residents at the community housing project in the intervention in comparison to the control. 2. There is significant difference between the mean different of the depression, anxiety , quality of life status, resilience , weight and BMI among B40 residents at the community housing project within the intervention arm upon repeated measure at T1 (Pre-test), T2 (Post-Test) and T3(Follow-up). |
| Ethics approval(s) | Approved 03/03/2020 Universiti Malaya Research Ethics Committee (Non-Medical) (Research Service Centre, Level 2, Research Complex, Education and Innovation, University of Malaya 50603 Kuala Lumpur, Malaysia; +60 (0)3-79676289; umrec@um.edu.my), ref: UM.TNC2/UMREC – 811 |
| Health condition(s) or problem(s) studied | Common mental disorders (depression and anxiety) at the community level among the low socioeconomic population |
| Intervention | Study Design: An internet-based controlled quasi-experimental study will be conducted with a post-intervention qualitative study to evaluate the effectiveness of the psychosocial intervention following a logic model approach. Two main evaluation processes will be conducted during the quasi-experimental study, namely, process evaluation and outcome evaluation. Data collection will be conducted at three-time points; baseline (pre-test T1), endline (post-test T2 at 3 months) and follow-up (T3 at 6 months). After the intervention period, a post-test analysis will be conducted on both groups. Settings: Eligible participants from the low socioeconomic households are recruited from the 3 sub-division of Petaling Districts namely Sungai Buloh, Petaling Jaya and Damansara through social media campaign (video of recruitment and electronic poster have been emailed to all the head of the community) Preliminary Recruitment Baseline assessment form link was sent to the community leaders at the 3 subdivision areas and filled by the low socioeconomic households. Two medical officers trained in mental healthcare were on standby and screened through the baseline assessment using PHQ-9 and GAD-7 and history of current mental illness. Eligible and consented participants will be recruited and baseline data will be filled. Participants from the area of Sungai Buloh, the Damansara and Petaling Jaya will be recruited either in the intervention arm or in the control arm according to the residential area. Intervention Arm: - ReSHape: Recognise, self-help and Help-seeking: a module developed based on the quantitative data and the qualitative data. - All the Baseline, Endline and follow-up questionnaires, healthy mind modules, ReSHaPe Modules will be delivered to the participants through RedCap database platform. - ReSHepS: 3 main modules which split into 6 submodules. - The 6 modules will be sent to the participants in video forms will be alternate with reinforcement online training: to update their record of their weekly activities for 12 weeks. - An honorarium will be given to the participants upon completing their assignment. Control Arm: - Participants who fulfilled the inclusion and exclusion criteria will be included in the control arm and will be given a healthy mind module under the ministry of health. They will be given the intervention arm module or material at the end of the study. |
| Intervention type | Behavioural |
| Primary outcome measure | Measured at baseline (pre-test T1), endline (post-test T2 at 3 months) and follow-up (T3 at 6 months): 1. Quality of Life (EQ-5D-5L) 2. Depression (PHQ 9) 3. Anxiety (GAD-7) |
| Secondary outcome measures | Measured at baseline (pre-test T1), endline (post-test T2 at 3 months) and follow-up (T3 at 6 months): 1. Resiliency (Resilience Scale 14 items) 2. Health literacy measured using the Short-Form Health Literacy Questionnaire (HLS-SF12) 3. Weight (kg), height (cm), BMI (kg/m²) 4. Help-seeking behaviour measured using the Mental Help Seeking Attitudes Scale (MHSAS) and The Self-Stigma Of Seeking Psychology Help (SSOSH) 5. Poverty Attribution measured using PA 21 |
| Overall study start date | 01/08/2019 |
| Completion date | 01/02/2022 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 100 participants : 50 for intervention arm and 50 for control arm |
| Total final enrolment | 112 |
| Key inclusion criteria | 1. Adult >18 years old from the community 2. Can communicate with English or BM language 20 Mild to moderate score on and PHQ-9 (<=10) or GAD-7 (<=8) |
| Key exclusion criteria | 1. Residents who has difficulty in speaking, hearing or any means of communication 2. Residents who have self-reported unstable severe psychotic mental illness such as schizophrenia, bipolar disorder and any form psychotic illness 3. Any PHQ-9 score ≥10 or GAD-7 score ≥ 8 will be referred for clinical diagnosis and will be excluded from the study (this is based on clinical assessment by a trained medical officer in mental health) 4. Refuse to give consent |
| Date of first enrolment | 06/02/2021 |
| Date of final enrolment | 14/02/2021 |
Locations
Countries of recruitment
- Malaysia
Study participating centre
Department of Social and Preventive Medicine
Level 5, Block I
Kuala Lumpur
50603
Malaysia
Sponsor information
University/education
CENTRE OF RESEARCH GRANT MANAGEMENT (PPGP)
Level 4, Research Management & Innovation Complex (RMIC)
University of Malaya
Kuala Lumpur
50603
Malaysia
| Phone | +603-7967 4522 |
|---|---|
| ppgp@um.edu.my |
Funders
Funder type
Research organisation
No information available
Results and Publications
| Intention to publish date | 30/06/2022 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer-review journal: Journal of Medical Internet Research. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from Universiti Malaya Research Ethics Committee (UMREC Non-Medical) (umrec@um.edu.my) and the research team Principal Investigator Prof. Mas Ayu Said (mas@ummc.edu.my). |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Basic results | 21/02/2022 | 22/02/2022 | No | No | |
| Protocol file | version 2.0 | 18/08/2022 | No | No |
Additional files
Editorial Notes
18/08/2022: Uploaded protocol (not peer-reviewed) as an additional file.
22/02/2022: The following changes were made to the trial record:
1. The basic results of this trial have been uploaded as an additional file.
2. The intention to publish date was changed from 30/12/2021 to 30/06/2022.
3. Total final enrolment and IPD sharing statement.
19/02/2021: Trial’s existence confirmed by Universiti Malaya
