跳至主要内容
临床试验/NCT07337148
NCT07337148已完成不适用

Increasing Mental Health Literacy and Peer Support Among Caregivers: An Electronic Painting and Peer Supportive (EPPS) Platform

The Hong Kong Polytechnic University1 个研究点 分布在 1 个国家目标入组 727 人开始时间: 2023年5月1日最近更新:
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
727
试验地点
1
主要终点
Attitudes Toward Seeking Professional Psychological Help-Short Form (ATSPPH-SF)

研究概览

简要总结

This study aims to assess the efficacy of an electronic painting and peer support platform on help seeking behaviour and emotion (depression, anxiety and stress) among caregivers. This is a 2-arm randomized controlled trial with 700 caregivers being randomized to intervention group (IG) or control group (CG). Participants of the IG will use the EPPS system for 8 weeks, making electronic paintings, sharing the paintings with peers, self-assessing emotion and use the provided list to seek for help if necessary. 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 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 draw paintings 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. The findings of the study will provide evidence of technology use in supporting caregivers for help seeking and reducing depression, anxiety and stress.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Family caregivers who take care of elderly, disabled, demented, or mentally ill persons
  • Able to speak Cantonese
  • Live in Hong Kong

排除标准

  • currently suffer from severe acute illnesses

研究组 & 干预措施

Intervention Group (IG)

Experimental

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).

干预措施: Electronic Painting and Peer Supportive (Behavioral)

Control group (CG)

Active Comparator

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.

干预措施: Usual Care (Behavioral)

结局指标

主要结局

Attitudes Toward Seeking Professional Psychological Help-Short Form (ATSPPH-SF)

时间窗: 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.

次要结局

  • PHQ-2(T0 (baseline), T1 (after the intervention at Week 9), and T2 (week 12))
  • DASS-8(T0 (baseline), T1 (after the intervention at Week 9), and T2 (week 12))
  • WHO-5(T0 (baseline), T1 (after the intervention at Week 9), and T2 (week 12))
  • Chinese version of Zarit Burden Interview (CZBI-short)(T0 (baseline), T1 (after the intervention at Week 9), and T2 (week 12))
  • Modified Medical Outcome Study Social Support Survey (mMOS-SS)(T0 (baseline), T1 (after the intervention at Week 9), and T2 (week 12))
  • Multidimensional Scale of Perceived Social Support (MSPSS)(T0 (baseline), T1 (after the intervention at Week 9), and T2 (Week 12))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr Angela Leung

Professor, Associate Head (Research)

The Hong Kong Polytechnic University

研究点 (1)

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