The Effects of the "Be Mindful" Intervention in Previously Depressed College Students Currently Experiencing Subclinical Symptoms of Depression
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 137
- 试验地点
- 2
- 主要终点
- Mean Change in Depressive Symptoms from Baseline as Measured by the Patient Health Questionnaire 9 at 3-Month Follow-Up
研究概览
简要总结
This study is designed to help individuals cope with their current depressive symptoms by providing them access to a 4-week online Mindfulness-Based Cognitive Therapy: Be Mindful. Research has shown that completion of the Be Mindful intervention can reduce depressive symptoms in a community sample, and this study aims to evaluate if it can also help reduce depressive symptoms in individuals with a confirmed history of depression. Participants will either receive the intervention at the start of the study or four months after the start of the study (i.e., at 3-month follow-up), which will allow research staff to assess if reductions in depression are due to the intervention or something else. Research staff will also evaluate if the reduction in depressive symptoms lasts over the three months following intervention, and will investigate possible reasons for the change in depression (i.e., why the intervention produces change).
详细描述
Participant outcome variables will be assessed weekly for the first month after baseline. This will include the primary dependent variable (i.e., depressive symptoms), but will also include variables that will be explored as potential mechanisms of change (i.e., mindfulness, decentering, rumination, worry, self-compassion, and dysfunctional attitudes). The final weekly assessment will represent the Post-Intervention assessment.
Brief follow-up assessments of the primary dependent variable will be given 1-month and 2-months after the final weekly questionnaire. There will be a 3-month assessment that measures potential mechanisms of change in addition to the primary dependent variable.
After the 3-month follow-up, the Waitlist Control condition will be given access to the intervention. All participants (i.e., in both conditions) will be asked to complete another month of weekly questionnaires. These questionnaires will be identical to the first set of weekly questionnaires, and will allow mechanisms of change to be evaluated in the Waitlist Control condition.
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
- •currently experiencing mild to moderate depressive symptoms (Patient Health Questionnaire 9 Current scores between 5 and 14)
- •meet Diagnostic and Statistical Manual of Mental Disorders (fifth edition; DSM-5) criteria for Past Major Depressive Disorder (determined by clinical interview)
排除标准
- •responses suggest they have never experienced a Major Depressive Episode
- •responses suggest they are not currently experiencing sub-threshold symptoms of depression
- •they state they are not open to learning mindfulness or meditation techniques
- •they indicate they are currently receiving therapeutic treatment for depression or stress management elsewhere
- •they indicate their age is not between 18 and 65
- •they state they do not currently live in New York State
结局指标
主要结局
Mean Change in Depressive Symptoms from Baseline as Measured by the Patient Health Questionnaire 9 at 3-Month Follow-Up
时间窗: at regular intervals until 3-month follow-up (approximately 4-5 months after the start of the study)
Participants are asked to rate items on a scale of 0 (Not at all) to 3 (Nearly every day).
Mean Change in Depressive Symptoms from Baseline as Measured by the Patient Health Questionnaire 9 Post-Intervention
时间窗: weekly during intervention, approximately 1-2 months
Participants are asked to rate items on a scale of 0 (Not at all) to 3 (Nearly every day).
次要结局
- Mean Change in Mindfulness from Baseline as Measured by the Five Factor Mindfulness Questionnaire Short Form(through study completion, which can take up to 6 months)
- Mean Change in Rumination from Baseline as Measured by the Ruminative Response Questionnaire(through study completion, which can take up to 6 months)
- Mean Change in Decentering from Baseline as Measured by the Toronto Mindfulness Scale(through study completion, which can take up to 6 months)
- Mean Change in Dysfunctional Attitudes from Baseline as Measured by the Dysfunctional Attitudes Scale (Short Form 1)(through study completion, which can take up to 6 months)
- Mean Change in Worry from Baseline as Measured by the Penn State Worry Questionnaire(through study completion, which can take up to 6 months)
- Mean Change in Dysfunctional Attitudes from Baseline as Measured by the Single-Item Self-Esteem Scale(through study completion, which can take up to 6 months)
- Mean Change in Self-Compassion from Baseline as Measured by the Self-Compassion Scale Short Form(through study completion, which can take up to 6 months)
- Mean Change in Dysfunctional Attitudes from Baseline as Measured by the Rosenberg Self-Esteem Scale(through study completion, which can take up to 6 months)
研究者
Meghan Bauer
Principal Investigator
State University of New York at Buffalo