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临床试验/NCT03304392
NCT03304392已完成不适用

Advancing Mental Health Care by Improving the Delivery of Therapist-guided, Internet-delivered Cognitive Behavioural Therapy in Clinical Practice

University of Regina2 个研究点 分布在 1 个国家目标入组 449 人开始时间: 2017年10月11日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
449
试验地点
2
主要终点
Change in depression

研究概览

简要总结

Depression and anxiety are prevalent and disabling conditions that often go untreated. Internet-delivered Cognitive Behaviour Therapy (ICBT) is a relatively new approach to treatment that is a convenient way for patients to access care. ICBT is typically highly standardized and involves patients reviewing weekly lessons over the Internet. Patients also receive brief weekly support from a therapist via secure emails or phone calls. Past research shows that ~75% of patients complete ICBT and report large symptom improvements. Although these results are very promising, research also suggests that ICBT could potentially be improved by being more personalized in terms of amount of therapist contact, especially for clients with more severe symptoms. The current trial will involve therapists who work in a clinic that specializes in ICBT. Over one year, 440 patients with depression and/or anxiety will be randomized to either receive standardized (5 lessons completed in 8 weeks; once week therapist contact) or personalized ICBT (5 lessons completed in 8 weeks; personalized therapist contact depending on needs of patient). Psychosocial outcomes of patients in the two treatment arms will be compared post-treatment and at 3-month, 6-month, and 1-year follow-up from enrollment. Data on intervention usage, satisfaction measures, and costs will also be assessed.

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

入选标准

  • 18 years of age or older
  • residing in Saskatchewan, Canada
  • endorsing symptoms of anxiety or depression
  • able to access a computer and internet service
  • willing to provide a physician as emergency contact

排除标准

  • high suicide risk
  • suicide attempt or hospitalization in the last year
  • primary problems with psychosis, alcohol or drug problems, mania
  • currently receiving active psychological treatment for anxiety or depression
  • not present in province during treatment; concerns about online therapy

结局指标

主要结局

Change in depression

时间窗: baseline, start of each Lesson 2-5, 8 weeks, 3 months, 6 months, and 1 year follow up

Measured by Patient Health Questionnaire - 9 Item (PHQ-9)

Change in anxiety

时间窗: baseline, start of each Lesson 2-5, 8 weeks, 3 months, 6 months, and 1 year follow up

Measured by Generalize Anxiety Disorder - 7 Item (GAD7)

次要结局

  • Treatment satisfaction(8 weeks)
  • Change in psychological distress(baseline, 8 weeks, 3 months, 6 months, and 1 year follow up)
  • Change in post-traumatic symptoms(Administered to only those participants meeting criteria for post-traumatic stress based on the modified brief Life Events Checklist for DSM 5 (LEC-5) at each time point: baseline, 3 months, 6 months, and 1 year follow up)
  • Change in quality of life symptoms(baseline, 8 weeks, 3 months, 6 months, and 1 year follow up)
  • Change in social phobia symptoms(baseline, 8 weeks, 3 months, 6 months, and 1 year follow up)
  • Change in treatment costs(Part 1 and 2: baseline, 3 months, 6 months, and 1 year follow up; Part 3: baseline and 1 year follow up)
  • Therapeutic alliance(8 weeks)
  • Treatment credibility(baseline and 8 weeks)
  • Change in panic symptoms(baseline, 8 weeks, 3 months, 6 months, and 1 year follow up)
  • Change in social anxiety symptoms(baseline, 8 weeks, 3 months, 6 months, and 1 year follow up)
  • Engagement(8 weeks)
  • Change in disability(baseline, 8 weeks, 3 months, 6 months, and 1 year follow up)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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