- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07337148
Mental Health Literacy and Peer Support Among Caregivers
Increasing Mental Health Literacy and Peer Support Among Caregivers: An Electronic Painting and Peer Supportive (EPPS) Platform
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
During the 8-week period, caregivers are encouraged to draw paintings. There is no fixed frequency for making the paintings but they are recommended to draw at least one painting per week. Caregivers could draw the electronic paintings at any time when they are free. They could share the paintings with friends or peers in the group. 10-12 caregivers will be gathered as a small group for interaction supported by a supportive team member (e-chat). During this period, the supportive team members will announce a theme for drawing each week. Caregivers can self-assess their mental health status by using the validated scale, Depression, Anxiety and Stress Scale (DASS-8) which is installed in the EPPS system at Week 0, Week 8 and Week 12. At any time, they draw the painting, caregivers can self-assess their mood by completing PHQ-2. Caregivers can look for the available mental health support services (shown in the system) and seek help, if necessary. They would also approach the facilitators if they need help. On the other hand, the supportive team members will also monitor the mental health assessment scores and make referral to the professionals if necessary.
Study design. A randomized controlled trial with focus group interviews with caregivers and members of supportive team will be used to assess the efficacy of the EPPS system. Caregivers will be randomly assigned to intervention group (IG) and control group (CG). Caregivers in the IG will use all the features in the EPPS system for 8 weeks (at the same time, they will continue to receive the usual supportive service to caregivers in the NGOs) while the caregivers in the CG will use only the e-chat function in the EPPS system and receive usual care (the usual supportive service to caregivers in the NGOs). After 8 weeks, the caregivers in the CG will be given opportunities to use all the features in the EPPS system. All caregivers are invited to complete an online survey at Week 0 (before they use the system), Week 8 (immediately after the system use) and Week 12 (4 weeks after the system use). 30 to 40 caregivers will be invited to attend focus group interviews to indicate their comments and views on the use of the EPPS system after Week 8. Such qualitative data collection will be ceased when no new comments is received (data is saturated).
Outcome measures in the evaluation: Attitudes Toward Seeking Professional Psychological Help-Short Form (ATSPPH-SF) (primary outcome). It consists of 10 items measuring the propensity for seeking help for mental disorders. A 4-point Likert scale ranging from "0=disagree" to "3=agree" is used as the response options. Total score, ranging from 0 to 30, is calculated by summing up all the items - higher scores indicate higher propensity to seek help. There are two subscales (1) openness to seeking treatment and (2) need in seeking treatment in this instrument. Other outcome measures include: DASS-8, WHO-5 [9], Chinese version of Zarit Burden Interview (CZBI-short), Modified Medical Outcome Study Social Support Survey (mMOS-SS) and PHQ-2 [12]. The DASS-8 is the shortest version of the DASS-21. It is composed of three subscales: depression (three items, e.g., felt that I had nothing to look forward), anxiety (three items, e.g., felt close to panic), and stress (two items, e.g., was using a lot of my mental energy) (36, 38). The minimum score of the DASS-8 and its subscales is 0, while the maximum scores are 24, 9, 9, and 6, respectively. Cronbach alpha = 0.933, and its correlation with DASS-21 is 0.977.
The sample size required for evaluating the efficacy of the EPPS system (using RCT) is calculated with reference to ATSPPH-SF (primary outcome). In a previous study, 65 adults changed their help seeking behaviour (total score of ATSPPH-SF) after watching a short video, and the mean ATSPPH-SF score was 18.1 (SD = 4.3) at pre-test and 19.4 (SD = 3.8) at post-test. The effect size of this e-learning was 0.46. Using a conservative approach, we assume the learning from the AIMHS system has small effect size (=0.3). Using G*Power 3.1.9.4, we assume an effect size of 0.3 with 90% power, two-tailed 5% significance, and 1:1 allocation ratio, the estimated sample size required is 382 (191 per group). Assuming 55% attrition, we intend to recruit about 700 caregivers.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Hong Kong, Hong Kong
- The Hong Kong Polytechnic University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Family caregivers who take care of elderly, disabled, demented, or mentally ill persons
- Able to speak Cantonese
- Live in Hong Kong
Exclusion Criteria:
- currently suffer from severe acute illnesses
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention Group (IG)
Caregivers in the IG will use the e-painting and e-chat features in the EPPS system for 8 weeks (at the same time, they will continue to receive the usual supportive service to caregivers in the NGOs).
|
The EPPS system consists of five features: 1) electronic painting (e-painting); 2) picture sharing; 3) e-chat; 4) mood self-assessment and 5) announcement.
The IG is given all the five features for 8 weeks.
At the same time, they will continue to receive the usual supportive service to caregivers in the NGOs.
|
|
Active Comparator: Control group (CG)
The caregivers in the CG will receive e-chat and usual care (the usual supportive service to caregivers in the NGOs).
After 8 weeks, the caregivers in the CG will be given opportunities to use the e-painting in the EPPS system.
|
The CG receives usual supportive service to caregivers in the NGOs and get access to e-chat in the EPPS system.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Attitudes Toward Seeking Professional Psychological Help-Short Form (ATSPPH-SF)
Time Frame: T0 (baseline), T1 (after the intervention at Week 9), and T2 (week 12)
|
It consists of 10 items measuring the propensity for seeking help for mental disorders.
A 4-point Likert scale ranging from "0=disagree" to "3=agree" is used as the response options.
Total score, ranging from 0 to 30, is calculated by summing up all the items - higher scores indicate higher propensity to seek help.
There are two subscales (1) openness to seeking treatment and (2) need in seeking treatment in this instrument.
|
T0 (baseline), T1 (after the intervention at Week 9), and T2 (week 12)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
DASS-8
Time Frame: T0 (baseline), T1 (after the intervention at Week 9), and T2 (week 12)
|
The DASS-8 is the shortest version of the DASS-21.
It is composed of three subscales: depression (three items, e.g., felt that I had nothing to look forward), anxiety (three items, e.g., felt close to panic), and stress (two items, e.g., was using a lot of my mental energy) (36, 38).
The minimum score of the DASS-8 and its subscales is 0, while the maximum scores are 24, 9, 9, and 6, respectively.
Cronbach alpha = 0.933, and its correlation with DASS-21 is 0.977
|
T0 (baseline), T1 (after the intervention at Week 9), and T2 (week 12)
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WHO-5
Time Frame: T0 (baseline), T1 (after the intervention at Week 9), and T2 (week 12)
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The WHO-5 is a self-report instrument measuring mental well-being.
It consists of five statements relating to the past two weeks.
Each statement is rated on a 6-point scale, with higher scores indicating better mental well-being.
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T0 (baseline), T1 (after the intervention at Week 9), and T2 (week 12)
|
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Chinese version of Zarit Burden Interview (CZBI-short)
Time Frame: T0 (baseline), T1 (after the intervention at Week 9), and T2 (week 12)
|
The Chinese version of the Zarit Burden Interview (CZBI) is a tool used to assess the burden experienced by caregivers of individuals with dementia.
It has a full 22-item version and a shorter 12-item version, known as the CZBI-Short, which is specifically validated for use with Cantonese-speaking caregivers in clinical and social care settings.
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T0 (baseline), T1 (after the intervention at Week 9), and T2 (week 12)
|
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Modified Medical Outcome Study Social Support Survey (mMOS-SS)
Time Frame: T0 (baseline), T1 (after the intervention at Week 9), and T2 (week 12)
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The Modified Medical Outcomes Study Social Support Survey (mMOS-SS) is a shortened, 8-item version of the original 19-item Medical Outcomes Study Social Support Survey (MOS-SS).
It assesses an individual's perception of social support, specifically focusing on emotional and instrumental (tangible) support.
The abbreviated version is designed to be more time-efficient while maintaining the core structure of the original survey and identifying potential deficits in social support.
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T0 (baseline), T1 (after the intervention at Week 9), and T2 (week 12)
|
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PHQ-2
Time Frame: T0 (baseline), T1 (after the intervention at Week 9), and T2 (week 12)
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Patient Health Questionnaire-2, is a brief two-question screening tool used to identify individuals who may be experiencing symptoms of depression.
It is a subset of the PHQ-9 and focuses on the frequency of depressed mood and anhedonia (loss of interest or pleasure) over the past two weeks.
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T0 (baseline), T1 (after the intervention at Week 9), and T2 (week 12)
|
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Multidimensional Scale of Perceived Social Support (MSPSS)
Time Frame: T0 (baseline), T1 (after the intervention at Week 9), and T2 (Week 12)
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The MSPSS has 12 items measuring perceived social support from 3 sources: family, friends and a significant other.
Items were rated on a 7-point Likert scale.
The MSPSS total score ranges 7 - 84 and scores of the three dimensions range 4 -24, with higher scores indicating higher levels of social support.
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T0 (baseline), T1 (after the intervention at Week 9), and T2 (Week 12)
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Collaborators and Investigators
Investigators
- Principal Investigator: Angela Leung, PhD, The Hong Kong Polytechnic University
Publications and helpful links
General Publications
- Topp CW, Ostergaard SD, Sondergaard S, Bech P. The WHO-5 Well-Being Index: a systematic review of the literature. Psychother Psychosom. 2015;84(3):167-76. doi: 10.1159/000376585. Epub 2015 Mar 28.
- Liang X, Guo Q, Luo J, Li F, Ding D, Zhao Q, Hong Z. Anxiety and depression symptoms among caregivers of care-recipients with subjective cognitive decline and cognitive impairment. BMC Neurol. 2016 Oct 3;16(1):191. doi: 10.1186/s12883-016-0712-2.
- Ma M, Dorstyn D, Ward L, Prentice S. Alzheimers' disease and caregiving: a meta-analytic review comparing the mental health of primary carers to controls. Aging Ment Health. 2018 Nov;22(11):1395-1405. doi: 10.1080/13607863.2017.1370689. Epub 2017 Sep 5.
- Xu XY, Leung D, Leung AYM, Kwan RYC, Liang TN, Chai AJ. "Am I entitled to take a break in caregiving?": Perceptions of leisure activities of family caregivers of loved ones with dementia in China. Dementia (London). 2022 Jul;21(5):1682-1698. doi: 10.1177/14713012221093879. Epub 2022 Apr 28.
- Leung AYM, Cheung T, Fong TKH, Zhao IY, Kabir ZN. The Use of an Electronic Painting Platform by Family Caregivers of Persons with Dementia: A Feasibility and Acceptability Study. Healthcare (Basel). 2022 May 9;10(5):870. doi: 10.3390/healthcare10050870.
- Confectioner K, Currie A, Gabana N, van Gerven N, Kerkhoffs GMMJ, Gouttebarge V. Help-seeking behaviours related to mental health symptoms in professional football. BMJ Open Sport Exerc Med. 2021 May 17;7(2):e001070. doi: 10.1136/bmjsem-2021-001070. eCollection 2021.
- Ali AM, Alameri RA, Hendawy AO, Al-Amer R, Shahrour G, Ali EM, Alkhamees AA, Ibrahim N, Hassan BH. Psychometric evaluation of the depression anxiety stress scale 8-items (DASS-8)/DASS-12/DASS-21 among family caregivers of patients with dementia. Front Public Health. 2022 Oct 25;10:1012311. doi: 10.3389/fpubh.2022.1012311. eCollection 2022.
- Tang JY, Ho AH, Luo H, Wong GH, Lau BH, Lum TY, Cheung KS. Validating a Cantonese short version of the Zarit Burden Interview (CZBI-Short) for dementia caregivers. Aging Ment Health. 2016 Sep;20(9):996-1001. doi: 10.1080/13607863.2015.1047323. Epub 2015 May 27.
- Moser A, Stuck AE, Silliman RA, Ganz PA, Clough-Gorr KM. The eight-item modified Medical Outcomes Study Social Support Survey: psychometric evaluation showed excellent performance. J Clin Epidemiol. 2012 Oct;65(10):1107-16. doi: 10.1016/j.jclinepi.2012.04.007. Epub 2012 Jul 20.
- Kroenke K, Spitzer RL, Williams JB. The Patient Health Questionnaire-2: validity of a two-item depression screener. Med Care. 2003 Nov;41(11):1284-92. doi: 10.1097/01.MLR.0000093487.78664.3C.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HSEARS20230421001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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