An Innovative Smartphone-enabled Health Coaching Intervention for Youth Diagnosed With Major Depressive Disorders
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 入组人数
- 168
- 试验地点
- 1
- 主要终点
- Beck Depression Inventory II
研究概览
简要总结
Randomized controlled trial (RCT) comparing youth diagnosed with major depressive disorder treated with online mindfulness-based cognitive behavioural therapy vs. standard psychiatric care (as wait-list controls). Eligible subjects will be recruited from the wait-lists of the Centre for Addiction and Mental Health. N = 168 subjects will consist of youth from First Nations background (18-30 yrs) and youth from all other ethnic backgrounds stratified to two intervention groups and two wait-list control groups consisting of 50% First Nations youth and 50% youth of all other ethnic backgrounds.
详细描述
A high proportion (70%) of mental health problems appear before 25 yrs. and can become become long-standing, significant disorders that impair all life domains. Early signs of disorder left untreated is an acute problem for Canadian youth as 15-25 yrs is the most likely age-strata for diagnosable psychiatric disorders, substance dependencies and suicide. Progress in youth treatments that engage the tendencies of youth to respond to online internet contact are likely to be especially strategic.
In this randomized controlled trial (RCT) diagnosed depressed youth are treated with online mindfulness-based cognitive behavioural therapy (MB-CBT) and standard psychiatric care or just standard psychiatric care (as wait-list controls). Eligible subjects will be recruited from the wait-lists of the Centre for Addiction and Mental Health (CAMH), and from community-based practices and clinics proximal to CAMH. The consented 168 subjects will be from First Nations background (18-30 yrs) and from all other ethnic backgrounds, stratified into two intervention groups and two wait-list control groups.
Primary outcome is self reported depression using the Beck Depression Inventory II while secondary outcomes include self reported anxiety (Beck Anxiety Inventory), depression (Quick Inventory of Depressive Symptomatology, 24-item Hamilton Rating Scale for Depression (HRSD-24)), pain (Brief Pain Inventory) mindfulness (Five-Facet Mindfulness Questionnaire) and intervention costs.
If hypotheses are confirmed that youth can be effectively treated with online MB-CBT at reduced costs, effective treatment can be delivered to greater numbers with less geographic restriction.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Care Provider, Investigator, Outcomes Assessor)
盲法说明
Psychiatrists providing psychiatric care will be blinded to the group allocation of subjects under their treatment. One outcome assessor (who will conduct the 24-item Hamilton Rating Scale for Depression (HRSD-24) will be blinded. Investigators will be blinded.
入排标准
- 年龄范围
- 18 Years 至 30 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18-30 yrs
- •First Nations background or other ethnicity
- •BDI-II at mild-moderate levels (i.e., BDI-II score ≥ 14 and < 29 )
- •diagnosis of major depressive disorder
- •fluent in english
- •diagnosis by a CAMH physician and diagnosis confirmed by a MINI International Neuropsychiatric Interview
排除标准
- •< 18 yrs and > 30 yrs
- •BDI-II in severe range ≥ 29 or < 14
- •does not qualify for diagnosis of major depressive disorder or diagnosis not confirmed by MINI International Neuropsychiatric Interview
研究组 & 干预措施
Control
Standard psychiatric care
Smartphone-Assisted MB-CBT
Online intervention accessed through smartphone or online accessed computer comprised of Mindfulness-Based Cognitive Behaviour content
干预措施: Smartphone-Assisted MB-CBT (Behavioral)
结局指标
主要结局
Beck Depression Inventory II
时间窗: Baseline, 3 months, 6 months
Change from baseline self report of symptoms of depression
次要结局
- Quick Inventory of Depressive Symptomatology(Baseline, 3 months, 6 months)
- Hamilton Depression Rating Scale (HRDS-24)(Baseline, 3 months, 6 months)
- Brief Pain Inventory(Baseline, 3 months, 6 months)
- Beck Anxiety Scale(Baseline, 3 months, 6 months)
- Five-Facet Mindfulness Questionnaire(Baseline, 3 months, 6 months)