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临床试验/NCT04139785
NCT04139785Unknown不适用

Moodbuster, a Guided Self-help Intervention for Prevention of Depression in Primary Care

Mental Health Foundation, London2 个研究点 分布在 1 个国家目标入组 290 人开始时间: 2019年10月23日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
290
试验地点
2
主要终点
Depression Symptoms (Patient Health Questionnaire, 9-item)

研究概览

简要总结

Depression is a common condition and is the leading cause of disability worldwide. Preventing or delaying the onset of depression is an important way to reduce the burden of depression. Some research suggests online methods may be effective in preventing depression, but to date, few studies have looked at the application of these methods in the UK.

This study aims to assess the effects of an online self-help intervention (Moodbuster) on preventing depression in a primary care population, who are experiencing mild-moderate symptoms of depression, but do not meet the threshold for diagnosis.

A randomised control design with a six-month and nine-month follow up will be used to compare Moodbuster to a wait-listed control group. Then, a qualitative process evaluation will be used to understand the barriers and facilitators of implementing the intervention.

Eligible participants in Greater Manchester (individuals with mild to moderate symptoms of depression, who do not have a diagnosis of major depressive disorder and have access to the internet) will take part in a 6-week online self-help programme, accompanied by three telephone calls with a trained researcher to support them in their use of the programme. Researchers will follow-up with participants six and nine months after starting the programme to measure depression, anxiety, quality of life, and use of services. The process evaluation will involve qualitative interviews with participants and focus groups with practitioners who referred individuals to the study.

This study will assess the effects of Moodbuster on preventing depression and barriers and facilitators of implementing such an intervention in a UK primary care population. It is hypothesised that the intervention group will display reduced depression symptoms and incidence, reduced service use, and improved quality of life, and the intervention will be acceptable to a UK primary care population.

详细描述

Depression is a common, often recurring, condition and the leading cause of disability worldwide. In the UK, the one-week prevalence of depression is estimated at 3.3%, and by 2026, the cost of depression to the UK economy is estimated to reach £12.15 billion in lost earnings and service use costs. There are two main strategies to reduce the burden of depression, treatment and prevention. Treatment for depression is, even with full coverage of services to all those who need it, not enough.to avert the total burden of disease. Indeed, whist treatment is crucial, even if all people with depression received evidence-based treatment, it is likely that only 35% of the burden (years lived with disabilities) would be averted. Prevention strategies are an integral part of reducing the burden of depression through fully preventing, or otherwise delaying, its onset. One way to improve the reach of prevention interventions and to deliver such approaches at scale is to offer interventions via digital technologies such as websites, computer programmes, or apps. This allows for a larger reach and it may help reach communities which are currently under-served by traditional mental health services. Whilst digital tools have been shown to be effective and acceptable in primary care for the treatment of depression, less research has been conducted on its effectiveness or barriers and facilitators to implementation for prevention. A 2017 meta-analysis identified ten trials on the effectiveness of digital interventions for the prevention of anxiety and depression. The review found promising evidence for the use of digital interventions for prevention, finding a small but positive effect on depression symptoms in the short-term (0.25, [0.09-0.41], p = 0.003). However, the majority of these studies were conducted outside of the UK, in Germany, Australia, USA, Japan, Norway, and the Netherlands. The trials also represented a mix of universal interventions, and indicated/selective efforts targeted to university students, older adults, and young adults. Of the two studies identified that were conducted in the UK, both had a short-term follow up, one of 6 weeks, and the other 12 weeks and did not include diagnostic outcome assessments. This suggests there is still more to learn about the application of digital technologies in the UK for the prevention of depression, and the medium to longer term effects of such interventions.

Research questions:

  1. Can an online self-help tool reduce depression symptoms and help support the prevention of depression?
  2. What are the effects of Moodbuster on the development of depression, anxiety symptoms, quality of life, and service use, and are there any negative unintended effects?
  3. What are the barriers and facilitators to implementing an online tool for prevention in primary care and community settings?

Research hypothesis:

It is hypothesised that the intervention group will display reduced depression symptoms and incidence, reduced service use, and improved quality of life, and the intervention will be acceptable to a UK primary care population.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
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

  • Aged 18 or above
  • Willing and able to give informed consent for participation
  • Have sub-threshold mild to moderate symptoms of depression (PHQ-9 scores of 5-9)
  • Access to the internet
  • In possession of a mobile smartphone (Android) and computer
  • In possession of an e-mail address

排除标准

  • Currently, or has ever, met DSM-IV criteria for major depression, bipolar disorder, substance dependence, or a psychotic disorder
  • Has had a major depressive episode (meeting DSM-IV criteria) as measured by the BDI-II
  • Is currently receiving psychotherapy, on a waiting list for psychotherapy, or received psychotherapy in the last six months for any mental health problem
  • Is unable to speak, read, or write in English
  • Has started a course of antidepressants within the last six weeks
  • Endorsement of PHQ item 9 "thoughts you would be better off dead, or of hurting yourself in some way"

结局指标

主要结局

Depression Symptoms (Patient Health Questionnaire, 9-item)

时间窗: 9 months

Difference in self-reported depression symptoms between intervention and control groups. The PHQ-9 is formed of nine items, each item is scored from 0-3 (0 = not at all; 3 = nearly every day) yielding a total score between 0 and 27. Higher scores are associated with decreased functional status and increased symptom-related difficulties.

次要结局

  • Depression Onset (Beck Depression Inventory-II)(9 months)
  • Anxiety Symptoms (Generalised Anxiety Disorder Assessment, 7-item)(9 months)
  • Barriers and Facilitators to Intervention Use (Qualitative)(Post-Intervention (10 weeks from date of randomization))
  • Quality of Life (EQ-5D-5L)(9 months)
  • Negative Effects of Intervention (Inventory for Negative Effects of Psychotherapy)(Post-Intervention (6 weeks from date of randomization))
  • Changes in mood, rumination, sleep, and esteem (Ecological Momentary Assessments)(Once per day for duration of intervention (period of 6 weeks from date of randomization))
  • Intervention Acceptability (Client Satisfaction Questionnaire, 8-item)(Post-Intervention (6 weeks from date of randomization))

研究者

发起方
Mental Health Foundation, London
申办方类型
Other
责任方
Sponsor

研究点 (2)

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