Effects of a Virtual Mindfulness-based Intervention for Depression and Anxiety in a Community Psychiatric Sample
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 43
- 试验地点
- 2
- 主要终点
- Generalized Anxiety Disorder - 7 (GAD-7)
研究概览
简要总结
Mindfulness-based interventions (MBIs) have emerged as clinically effective interventions for anxiety, depression, and general distress. However, there are significant barriers to accessing MBIs in the general population including length of treatment and cost. Furthermore, in the present COVID-19 pandemic, there is a demand to conduct virtual clinical services. However, to date, not much is known regarding the effectiveness of mindfulness groups that are conducted virtually. The aim of the present study is to examine the effectiveness of a five-week abbreviated MBCT intervention delivered virtually for a physician-referred, treatment-seeking, community sample. The virtual mindfulness group will be compared to a five-week wait-list control group. All wait-listed study participants will be given the opportunity to participate in the intervention after study completion. At present, clinical wait times for services far exceed five weeks, thus participants that are wait-listed will not experience delay in their treatment.
详细描述
Symptoms of depression and anxiety are extremely prevalent in the population. Unfortunately, patients often face barriers to accessing mental health care, particularly psychotherapeutic interventions, including long wait-times and demanding therapeutic protocols. For instance, standardized MBIs such as mindfulness-based cognitive therapy (MBCT) and mindfulness-based stress reduction (MBSR) are typically eight weeks in length. MBSR and MBCT, traditional MBTs, can demand over 30 hours of clinical time, and 50-60 hours of homework, all of which can be barriers to care. Furthermore, many clients are unable to access in-person interventions. At present the Sunnybrook Mindfulness Clinic is not conducting any virtual services due to the unknown benefit of virtual mindfulness interventions, creating significant barriers to clinical care for patients. The goal of this project is to compare the effectiveness of virtually delivered, abbreviated MBI (<10 hours of clinical time and <10 hours of homework) to a wait-list control condition in terms of reducing symptoms of depression/anxiety/stress and improving wellbeing. If effective, this abbreviated MBI conducted virtually could enable clients to pursue virtual services during the current COVID-19 pandemic.
MBTs use a non-stigmatizing approach, combining secularized eastern meditative practices with western psychological advances to improve stress-management and self-care. Participants learn to generate less distress, engage more positively and fully in their lives and experiences, and respond more adaptively to challenges instead of reacting in automatic and unhelpful ways. Participants in MBI often describe the intervention as transformative. The abbreviated MBI protocol has been piloted in an uncontrolled study and indicated significant benefit for patients in terms of symptom improvement. However, this will be the first time that the investigators pilot a virtual adaptation to the mindfulness group.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •≥18 years of age
- •are referred to the mindfulness group by a physician
排除标准
- •have previously completed a full (≥8-week) MBI in the past 3 years
- •meet criteria for substance abuse, psychosis, and/or mania
- •express active suicidality.
结局指标
主要结局
Generalized Anxiety Disorder - 7 (GAD-7)
时间窗: At Baseline (week 0), Mid-treatment (week 3) and post-treatment (week 5) over five week intervention period.
The GAD-7 is a 7-item self-report measure that assesses the presence of generalized anxiety symptoms within previous two weeks. Measure will be used to assess change in presence of generalized anxiety symptoms at baseline, mid-treatment, and post-treatment. Response options for the 7-item scale range from 0 (Not at All) to 3 (Nearly every day), and scale scores range can from 0 to 21.
Depression, Anxiety, Stress Scale-21 (DASS-21)
时间窗: At Baseline (week 0), Mid-treatment (week 3) and post-treatment (week 5) over five week intervention period.
The DASS-21 is a 21-item measure used to assess depression, anxiety, and stress symptoms. Measure will be used to assess change in presence of depression, stress, and anxiety symptoms at baseline, mid-treatment, and post-treatment. The DASS-21 is a shortened version of the original DASS, which was 42 items in length.
Patient Health Questionnaire - 9 (PHQ-9)
时间窗: At Baseline (week 0), Mid-treatment (week 3) and post-treatment (week 5) over five week intervention period.
The PHQ-9 is a 9-item measure for assessing depression severity. Measure will be used to assess change in depressive severity at baseline, mid-treatment, and post treatment. PHQ-9 scores can range from 0 to 27, as each of the 9 items can be scored from 0 (not at all) to 3 (nearly every day)
次要结局
- Self-Compassion Scale(At three time points (weeks 0,3, and 5) over 5 week intervention period.)
- Five Facet Mindfulness Questionnaire (FFMQ)(At three time points (weeks 0,3, and 5) over 5 week intervention period.)
- Maslach Burnout Inventory (MBI)(At three time points (weeks 0,3, and 5) over 5 week intervention period.)
- Perceived Stress Scale (PSS)(At three time points (weeks 0,3, and 5) over 5 week intervention period.)
- Warwick Edinburgh Mental Well- Being Scale (WEMWBS)(At three time points (weeks 0,3, and 5) over 5 week intervention period.)
研究者
Dr. Neil Rector
Senior Scientist
Sunnybrook Health Sciences Centre