跳至主要内容
临床试验/NCT04985422
NCT04985422招募中不适用

Ecological Momentary Intervention for Depressive Symptoms in a Community Sample in Hong Kong: a Randomised Controlled Trial

The University of Hong Kong1 个研究点 分布在 1 个国家目标入组 262 人开始时间: 2021年7月26日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
262
试验地点
1
主要终点
Change in depressive symptoms, as assessed using the Depression subscale of the Depression, Anxiety and Stress Scales (DASS-D)

研究概览

简要总结

The key aim of the study is to test the efficacy of a 4-week ecological momentary intervention (EMI), as compared with the regular weekly-based intervention (control group), in reducing (1) symptoms of depression and (2) rumination in community-dwelling individuals. The efficacy of the EMI in reducing distress and improving functioning is also examined.

For both EMI and control groups, the intervention will be delivered through SMS text messages, with a link to a user-friendly and locally-adapted intervention platform designed using Qualtrics (online survey programme).

It is hypothesised that (1) those in the EMI group, as compared to the control group, will show greater reductions in (1) depressive symptoms, (2) rumination level, (3) distress, and in (4) improving functioning. These effects are hypothesised to be observed in individuals with varying levels of symptom severity.

详细描述

Despite the growth of online-based interventions, there remains a lack of highly adaptive and personalised smartphone-based interventions that can be implemented in the course of everyday life.

The current study examines the effectiveness of a newly-developed smartphone-based ecological momentary intervention (EMI) in reducing symptoms of depression as well as rumination and distress.

Rumination is a common experience in individuals with major depressive disorder (MDD). These psychopathological symptoms occur in a population on a continuous spectrum, which may be especially pronounced after the community has experienced a series of highly stressful and traumatic events. On the high end of the spectrum, manifestations of symptoms may be considered to be clinical disorders, and professional intervention may be indicated. Rumination may affect prognosis and there are suggestions that interventions to reduce and modify rumination can improve outcomes. At the less severe end of the spectrum (i.e., not yet reached the threshold for disorders), rumination may be a risk factor that compromises outcomes and adjustment, one that can cause significant distress and functional impairment. Targeting rumination in both below- and above- threshold populations therefore has important research and clinical implications.

Mental Health Needs in Hong Kong The Hong Kong population has undergone a series of highly stressful events traceable since June 2019, from large-scale social unrest, to the outbreak of Coronavirus disease 2019 (COVID-19) first in January 2020 and a second wave of COVID-19 cases in March 2020. Each of these population-level events is accompanied by other related social, economic, and political consequences, all of which can result in significant psychological distress and mental health burdens especially when added up to individual-level stressors. Local studies have reported heightened depressive symptoms in relation to such population-level events in addition to personal stressful events. The rates observed are considerably higher than the average global prevalence, which marks it as particularly concerning when help-seeking is severely minimal in the general local population. It is anticipated that these rates will continue rising and would manifest with symptoms of other conditions (such as anxiety, as is already seen in China during COVID-19). Unsurprisingly, the widespread pandemic has already led researchers in many other countries to call for enhanced and novel psychological interventions.

A local online self-help initiative has recently been launched by the Department of Psychiatry of the University of Hong Kong, offered to individuals via different channels (including various social media platforms, non-governmental organisations, social and personal connections) in the form of an anonymous mental health recognition and support tool. The key aims of the tool are to provide users with a space to reflect on the ongoing events in their lives and their feelings, provide them with an individualised understanding of their current mental health conditions (MDD symptoms) and the potential contributing factors, as well as offer individualised suggestions for self-help and professional help when necessary. A high level of MDD as well as significant levels of rumination in response to the community stressors have been reported, particularly in young people. Of importance, rumination about such large-scale external events ("event-based rumination") was seen to be highly associated with MDD symptoms.

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
None

入排标准

年龄范围
15 Years 至 64 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Symptoms of depression indicated by DASS-D score of 10 or above
  • Aged 15 to 64 years (parental or guardian consent is required for those below 18 years)
  • Possess a smartphone with access to the Internet

排除标准

  • Significant developmental disorder, psychotic disorder, substance abuse or organic brain disorder
  • Active suicidal risk
  • Receiving active structured intervention or anticipating to receive such treatment (e.g., biweekly psychotherapy sessions, receiving pharmacotherapy)

结局指标

主要结局

Change in depressive symptoms, as assessed using the Depression subscale of the Depression, Anxiety and Stress Scales (DASS-D)

时间窗: Immediately after intervention (post 4-week intervention) and up to 3 months

The DASS-D is a 7-item measure rated on a 4-point Likert scale. Scores range from 0 to 42, where a higher score represents a higher level of depressive symptoms. The DASS-D has been validated in Hong Kong (epidemiological and clinical samples) as well as in both young people and adults.

次要结局

  • Change in psychological distress, as assessed using the Kessler Psychological Distress Scale (K6)(Immediately after intervention (post 4-week intervention) and up to 3 months)
  • Change in level of functioning, as reflected by presenteeism and absenteeism due to distress(Immediately after intervention (post 4-week intervention) and up to 3 months)
  • Change in rumination level, as assessed using the 10-item ruminative response scale (RRS-10)(Immediately after intervention (post 4-week intervention) and up to 3 months)

研究者

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

Professor Eric Y.H. Chen

Chi-Li Pao Foundation Professor in Psychiatry, Chair Professor

The University of Hong Kong

研究点 (1)

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