Improving Access to Treatment for Anxiety and Depression Among French Canadians Using an Internet-Delivered Cognitive Behavior Therapy: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 2
- 主要终点
- Changes in depression as assessed by the Patient Health Questionnaire-9 (PHQ-9)
研究概览
简要总结
This study represents Phase II of a research program involving an international collaboration with Macquarie University (Sydney, Australia) to implement an Internet-based cognitive behavior therapy for the treatment of anxiety and depression in French-speaking Canadians from the Atlantic Provinces.
The primary objective is to establish the clinical efficacy of a French-Canadian self-guided format version of the Wellbeing Course by conducting a randomized-control trial where an experimental group will be compared to a waitlist control group. A secondary objective is to demonstrate the course's acceptability through participants' satisfaction with the course.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Residing in New-Brunswick, Nova-Scotia, Prince Edward Island, or Newfound land & Labrador
- •Having identified French as the first official language spoken and having good reading comprehension in French.
- •Reliable Internet access
- •Clinically significant levels of depression or anxiety reflected by significant scores on the following measures: PHQ-9 > 9, GAD-7 >7, Penn Stage Worry Questionnaire ≥ 45, Social Phobia Inventory ≥ 19, Panic and Agoraphobia Scale ≥ 19, or by answering yes to the question "Is anxiety or low mood a problem for you"
- •Not currently participating in cognitive-behavioral therapy
- •No changes in medication for 4 weeks prior to the study, nor any changes in medication for the next 2 months
- •Willing to disclose personal information
排除标准
- •Presence of psychotic symptoms
- •Presence of severe depression as indicated by scores ≥ 23 on the PHQ-9, or a score > 2 on item 9 of the PHQ-9
研究组 & 干预措施
Wellbeing Course
Will receive the French-Canadian version of the Wellbeing Course consisting of five lessons based on cognitive behavior therapy delivered through the Internet over eight weeks.
干预措施: The Wellbeing Course (Behavioral)
Waitlist-control
The Waitlist Control Group will receive the French-Canadian version of the Wellbeing Course once the treatment group will have completed treatment.
结局指标
主要结局
Changes in depression as assessed by the Patient Health Questionnaire-9 (PHQ-9)
时间窗: Pretest, posttest (week 8), 3-month follow-up
Symptoms of depression
Changes in anxiety as assessed by the Generalized Anxiety Disorder-7 (GAD-7)
时间窗: Pretest, posttest (week 8), 3-month follow-up
Symptoms of anxiety
次要结局
- Changes in life satisfaction as assessed by the Satisfaction with Life Scale (SWLS)(Pretest, posttest (week 8), 3-month follow-up)
- Changes in health as assessed by the Short-Form Health Survey(Pretest (week 1), posttest (week 8), 3-month follow-up)
- Changes in personality as assessed by the Self-administered Standardised Assessment of Personality - Abbreviated Scale(Pretest (week 1), posttest (week 8), 3-month follow-up)
- Changes in anxiety as assessed by the Penn State Worry Questionnaire (PSWQ)(Pretest (week 1), posttest (week 8), 3-month follow-up)
- Changes in social anxiety as assessed by the Social Phobia Inventory (SPIN)(Pretest (week 1), posttest (week 8), 3-month follow-up)
- Changes in panic and agoraphobia as assessed by the Panic and Agoraphobia Scale (PAS)(Pretest (week 1), posttest (week 8), 3-month follow-up)
研究者
France Talbot
Associate Professor
Universite de Moncton