Identifying Biomarkers of Response to Digital Interventions for Mood Disorders
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Quick Inventory of Depressive Symptomatology (QIDS-SR)
研究概览
简要总结
The proposed study will be a single-arm pragmatic clinical trial examining the feasibility of online CBT within the CAN-BIND sites and the biomarkers of treatment response to online CBT for mood disorders.
详细描述
A total of 200 participants from the Canadian Biomarker Integration Network in Depression (CAN-BIND) network research sites will receive access to the Wellbeing Course for 8 Weeks with a 6-month follow-up period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Must be deemed to have capacity to provide informed consent;
- •Must sign and date the informed consent form;
- •Stated willingness to comply with all study procedures;
- •16 years of age or older;
- •Fluency in English;
- •Meet lifetime criteria for a bipolar or depressive disorder as defined by the DSM-5 and assessed in a previous CAN-BIND study;
- •Consent to the linkage of data to the previous CAN-BIND study
排除标准
- •1. Exclusion criteria for the current study include not meeting inclusion criteria only
结局指标
主要结局
Quick Inventory of Depressive Symptomatology (QIDS-SR)
时间窗: Baseline, Week 8, Week 16, Week 24, Week 32
A widely used and well-validated, 16-item measure of depression symptoms. Minimum score is 0 and Maximum score is 27, with higher scores indicating severe depression.
Quick Inventory of Depressive Symptomatology - Self Report (QIDS-SR)
时间窗: Baseline, Week 8, Week 16, Week 24, Week 32
A widely used and well-validated, 16-item measure of depression symptoms. Minimum score is 0 and Maximum score is 27, with higher scores indicating severe depression.
次要结局
- Patient Health Questionnaire (PHQ-9)(Baseline, Week 8, Week 16, Week 24, Week 32)
- Generalized Anxiety Disorder Scale (GAD-7)(Baseline, Week 8, Week 16, Week 24, Week 32)
- Snaith-Hamilton Pleasure Scale (SHAPS)(Baseline, Week 8, Week 16, Week 24, Week 32)
- Work and Social Adjustment Scale (WSAS)(Baseline, Week 8, Week 16, Week 24, Week 32)
- World Health Organization Quality of Life Assessment(Baseline, Week 8, Week 16, Week 24, Week 32)
- Perseverative Thinking Questionnaire (PTQ)(Baseline, Week 8, Week 16, Week 24, Week 32)
- Ruminative Response Scale (RRS) - Brooding Subscale(Baseline, Week 8, Week 16, Week 24, Week 32)
- Childhood Experience of Care and Abuse Questionnaire - Brief Form (CECA-Q-Brief)(Baseline)
- Patient Health Questionnaire - 9 (PHQ-9)(Baseline, Week 8, Week 16, Week 24, Week 32)
- Generalized Anxiety Disorder - 7 (GAD-7)(Baseline, Week 8, Week 16, Week 24, Week 32)
- The World Health Organization-Five Well-Being Index (WHO-5)(Baseline, Week 8, Week 16, Week 24, Week 32)
- Childhood Experience of Care and Abuse Questionnaire (CECA.Q)(Baseline)
研究者
Lena Quilty
Associate Professor
Centre for Addiction and Mental Health