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临床试验/NCT05395312
NCT05395312已完成不适用

Evaluation of Blended Stepped-care Mental Well-being Intervention for Adults: A Randomized Controlled Trial

Chinese University of Hong Kong2 个研究点 分布在 1 个国家目标入组 360 人开始时间: 2022年7月30日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
360
试验地点
2
主要终点
Depressive symptoms - Patient Health Questionnaire (PHQ-9)

研究概览

简要总结

This study aims to evaluate the effectiveness and cost-effectiveness of the online stepped-care mental well-being system together with offline programs in comparison to care as usual. This study will provide important findings for future health economic analyses of blended stepped-care mental well-being interventions which may increase public's access to mental well-being services and ease the long waiting time under the current public healthcare system. It is hypothesized that participants in the intervention group show (H1) greater reduction in depressive and anxiety symptoms, (H2) better improvement of well-being, (H3) better improvement of quality of life, and (H4) lower incremental cost-effectiveness ratio (ICER), compared to care as usual.

详细描述

In Hong Kong, mental disorders such as anxiety and depression are common. With the 13.3% of respondents reported to have symptoms of anxiety, depression, or comorbid anxiety and depression, only 26% of them sought for mental health services within the past year. The same morbidity survey also revealed as much as 11.25% of working adults were affected by symptoms of common mood disorders. The COVID-19 pandemic and social movement further increase stress and feelings of uncertainties on the general population. Two telephone surveys of over 1000 working adults each conducted in Dec 2017 and Feb 2020 suggested that 24.3% and 26.3% of working adults experienced anxiety and depressive symptoms in the past two weeks (the Jockey Club TourHeart Project, JCTH). Yet, 46% and 28% of respondents indicated they would not seek help for their psychological distress.

The services provided by the current public health system and private sector in Hong Kong are insufficient, mainly due to a shortage of professionals such as clinical psychologists and psychiatrists. There are also relatively less resources from the government and non-governmental organizations to the working adults comparing with the more 'vulnerable' populations, such as children, adolescents, and older people. A survey conducted in 2019 found more than 90% of the interviewees expressed that their companies did not offer sufficient support on employees' mental well-being. The same study suggested that 55% of the interviewees reported feeling ashamed about their own mental health issues or knowing someone with mental health issues, with these being named barriers to service. The needs of the working adults are unlikely to be fulfilled by companies or employers because of tightened budget, lack of awareness and knowledge, and stigma on mental illness. There exists a significant gap between the tremendous need for taking care of mental well-being and the mental well-being support services among the working adults in Hong Kong.

Online Stepped-Care Mental Well-being Interventions

The mental well-being services provided by the current public healthcare system in Hong Kong mainly rely on the traditional face-to-face and one-to-one therapy sessions. Due to the shortage of professionals, the waiting time for new service users is unbearably long while the follow-ups for returning users is infrequent. Also, priority is usually given to people with more severe mental well-being issues which causes the waiting time for people with mild to moderate mental well-being needs even longer.

The stepped-care model takes the approach of using the least restrictive method to commensurate with mental well-being needs and profiles of the service users with self-correcting process. Based on timely assessment of mental well-being status of the service users, corresponding treatments with matched levels of intensity could be utilized. According to treatment progress of the service users, stepped-care model enables mechanism to step up or down by adjusting the levels of intensity of the interventions. The National Institute of Health and Care Excellence (NICE) has issued evidence-based guidance detailing the stepped-care model for treatment of depression and anxiety in order to enhance treatment of these common mental disorders. A systematic review and meta-analysis suggested that the stepped-care approach was significantly better than care-as-usual in the treatment of anxiety although it could not significantly prevent or reduce future incidence of depression and anxiety. The stepped-care approach is proposed to reduce time, cost, and associated treatment burden on the clinicians and the service users.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Investigator)

盲法说明

Researchers do not know the group allocation until the end of study. An individual party is responsible to randomly allocate participants into blended stepped-care group and waitlist control group.

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

  • Working adults aged 18 years old or above
  • Able to read and understand Chinese, spoken Cantonese
  • Have access to the Internet

排除标准

  • High suicidal risk
  • Who are unwilling to receive the intervention by random assignment
  • Existing users of the JCTH project platform
  • Non-working adults

研究组 & 干预措施

Waitlist control group

No Intervention

Participants in the waitlist control group will receive their usual treatment and follow their usual practice if any. They will be offered the opportunity to receive the services in the blended stepped-care group after the study has ended.

Blended stepped-care group

Experimental

Participants in the blended stepped-care group can access the online materials at levels based on their psychological distress through login to the platform of the JCTH+ project. They can choose their preferred online courses by using online course taster. Also, they can join offline programs corresponding to their levels of psychological distress.

干预措施: Online blended stepped-care mental well-being platform (Other)

结局指标

主要结局

Depressive symptoms - Patient Health Questionnaire (PHQ-9)

时间窗: 6th month

It includes 9 items to assess the extent of which respondents are bothered by depression related symptoms using a 4-point Likert scale from 0 (not at all) to 3 (nearly every day). PHQ-9 has been validated and used widely in the general population for screening and measuring depression severity. Total scores range from 0 to 27. Scores of 5, 10, 15, and 20 denote mild, moderate, moderately severe, and severe level of depression respectively.

Anxiety symptoms - Generalized Anxiety Disorder Assessment (GAD-7)

时间窗: 6th month

It is a 7-item scale to assess the extent of which respondents are bothered by anxiety related symptoms using a 4-point Likert scale from 0 (not at all) to 3 (nearly every day). GAD-7 is a well-established scale with good reliability and procedural validity. Total scores range from 0 to 21. Scores of 5, 10, and 15 denote mild, moderate, and severe level of anxiety respectively.

次要结局

  • Workplace well-being(at baseline, 3rd, and 6th month)
  • Treatment acceptability(at baseline, 3rd, and 6th month)
  • Quality of life - Short-Form Six Dimensions Health Survey (SF-6D)(at baseline, 3rd, and 6th month)
  • Productivity - The Institute for Medical Technology Assessment (iMTA) Productivity Costs Questionnaire (iPCQ)(at baseline, 3rd, and 6th month)
  • Medical consumption - Utilization of Health Services(at baseline, 3rd, and 6th month)
  • Resilience - Connor-Davidson Resilience Scale (CD-RISC-2)(at baseline, 3rd, and 6th month)
  • Emotion Regulation - Emotion Regulation Questionnaire (ERQ)(at baseline, 3rd, and 6th month)
  • Self-Efficacy - General Self-Efficacy Scale (GSE-6)(at baseline, 3rd, and 6th month)
  • Self-Stigma - The Self-Stigma of Seeking Psychological Help (SSOSH)(at baseline, 3rd, and 6th month)
  • Coping strategy - The Proactive Coping Inventory (PCI)(at baseline, 3rd, and 6th month)
  • Tolerance for Ambiguity - Tolerance for Ambiguity Scale (TAS)(at baseline, 3rd, and 6th month)
  • Well-being - PERMA-Profiler (PERMA)(at baseline, 3rd, and 6th month)
  • Implicit Theories of Intelligence (Self-Theory Scale)(at baseline, 3rd, and 6th month)
  • Daily Hassles - LIVES-Daily Hassles Scale (LIVES-DHS)(at baseline, 3rd, and 6th month)
  • Nonattachment - Nonattachment Scale-Short Form (NAS-SF)(at baseline, 3rd, and 6th month)
  • Work and Social Adjustment - Work and Social Adjustment (WSAS)(at baseline, 3rd, and 6th month)
  • Subjective Norm - E-therapy Attitude and Process Questionnaire (eTAP)(at baseline, 3rd, and 6th month)
  • Attitude towards Psychological Online Intervention (APOI)(at baseline, 3rd, and 6th month)
  • Behavioural Intention - E-therapy Attitude and Process Questionnaire (eTAP)(at baseline, 3rd, and 6th month)
  • System Usability - System Usability Scale(at baseline, 3rd, and 6th month)
  • Mental Health Experiences - The Mental Health Experiences Questionnaire(at baseline, 3rd, and 6th month)
  • Work Engagement - Utrecht Work Engagement Scale (UWES-3)(at baseline, 3rd, and 6th month)

研究者

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

Winnie W.S. MAK

Professor

Chinese University of Hong Kong

研究点 (2)

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