Testing the Feasibility and Acceptability of a Blended Mindfulness-Based Intervention for Persistent Depression
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Reductions in depression symptomatology as assessed using the Patient Health Questionnaire-9 (PHQ-9), change measured within 1 week of starting and finishing the course and in week 5 and 9.
研究概览
简要总结
We plan to share all IPD but not any personal information.
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A current diagnosis of Major Depression as assessed by Structured Clinical Interview for DSM IV (First, Spitzer, Gibbon, & Williams, 2002).
- •A chronic or recurrent lifetime history of depression, with either chronic persistence of symptoms or a history of at least three previous episodes of depression, two of which needed to have occurred during the last two years.
- •Self-reported severity of current symptoms on a clinical level as indicated by a PHQ-9 score of 10 or more.
- •Age 18 to 65 thus excluding cases of late life depression given that such cases might differ in aetiology.
- •Fluency in spoken and written English.
- •Have individual access to a computer or mobile device with internet connection and video link.
排除标准
- •History of schizophrenia, schizoaffective disorder, bipolar disorder, current abuse of alcohol or other substances, organic mental disorder, pervasive developmental delay, primary diagnosis of obsessive-compulsive disorder or eating disorder, or regular nonsuicidal self-injury.
- •Current treatment with CBT more than once a month.
- •Regular meditation practice (meditating more than once per week).
- •Inability to complete research assessments through difficulty with English, visual impairment, or cognitive difficulties.
- •We will allow patients who are currently taking antidepressants into the study provided that the medication has not been changed during the last four weeks before entry into the study.
研究组 & 干预措施
bMBI standard practice
This is a 12-week online mindfulness-based course blended with therapist support via video link using standard practices for Mindfulness-Based Cognitive Therapy (30-minutes/day).
干预措施: bMBI standard practice (Behavioral)
bMBI shorter more frequent practice
This is a 12-week online mindfulness-based course blended with therapist support via video link using shorter, more frequent practice than standard Mindfulness-Based Cognitive Therapy (2x15-minutes/day).
干预措施: bMBI shorter more frequent practice (Behavioral)
结局指标
主要结局
Reductions in depression symptomatology as assessed using the Patient Health Questionnaire-9 (PHQ-9), change measured within 1 week of starting and finishing the course and in week 5 and 9.
时间窗: Weeks 0, 5, 9,13.
The PHQ-9 has 9 questions to assess the presence and severity of depression according to DSM-IV criteria and takes less than 3 minutes to complete. The PHQ-9 asks about patients' experiences in the last 2 weeks in relation to depression. Responses range from "0" (not at all) to "3" (nearly every day). Presence and severity of depression is scored as follows: 0-4 = minimal, 5-9 = mild, 10-14 = moderate, 15-19 moderately severe, 20-27 = severe. The PHQ-9 has been found to have a high level of validity and reliability (Kroenke, Spitzer, \& Williams, 2001).
次要结局
- Levels of mindfulness in daily life as assessed using the Five-Facet Mindfulness Questionnaire (FFMQ-15), change measured within 1 week of starting and finishing the course and in week 5 and 9.(Weeks 0, 5, 9,13.)
- Symptoms of anxiety as assessed using the Generalised Anxiety Disorder Assessment (GAD-7), change measured within 1 week of starting and finishing the course and in week 5 and 9.(Weeks 0, 5, 9,13.)
- Ability to decenter as assessed by self-report on the Experiences Questionnaire (EQ), change measured within 1 week of starting and finishing the course and in week 5 and 9.(Weeks 0, 5, 9,13.)
- Mind wandering and spontaneous thoughts as assessed by the Amsterdam Resting-State Questionnaire 2.0 (ARSQ 2.0), change measured within 1 week of starting and finishing the course and in week 5 and 9.(Weeks 0, 5, 9,13.)
- Subjective levels of stress as assessed using the Perceived Stress Scale (PSS), change measured within 1 week of starting and finishing the course and in week 5 and 9.(Weeks 0, 5, 9,13.)
- Mental wellbeing as assessed using the Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS), change measured within 1 week of starting and finishing the course and in week 5 and 9.(Weeks 0, 5, 9,13.)