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临床试验/NCT03500237
NCT03500237已完成不适用

Effectiveness of Internet-delivered Cognitive Behaviour Therapy for Chronic Conditions: Comparing Low Intensity Delivery Models

University of Regina2 个研究点 分布在 1 个国家目标入组 188 人开始时间: 2018年4月16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
188
试验地点
2
主要终点
Change in anxiety

研究概览

简要总结

Chronic health conditions (e.g., heart disease, cancer, diabetes) represent any physical condition that persist for 3 months or more that requires ongoing management. Chronic health conditions are very common, and increase in prevalence with age. Internet-delivered Cognitive Behaviour Therapy (ICBT) is a promising approach for overcoming these barriers, and improving access to mental health care. In ICBT, clients receive content from traditional face-to-face CBT over the Internet, while receiving support and assistance from a guide through secure e-mail. The Chronic Conditions Course is an 8-week, 5 lesson ICBT program that consists of education and relapse prevention as well as cognitive, behavioural, and physical strategies for managing chronic conditions. This intervention has traditionally been delivered either with no support or with weekly brief (15 minute) individual therapist guidance via email and phone. However, in order to provide a faster response to clients using an on the demand (responding as quickly as possible and for sure within one business day team based approach (e.g., first available therapist responds) may be beneficial.

The proposed trial will examine the Chronic Conditions Course delivered by a team at the Online Therapy Unit based at the University of Regina versus a self-directed program. In the team based approach, participants will be able to contact the Online Therapy Unit if they have any questions regarding the content of the Chronic Conditions Course during the 8 week program. Participants in this group will receive a response from one of the members of the team within one business day. In the self-directed group, clients will receive automatic messages from the Online Therapy Unit that encourage participation during the 8 week program but otherwise will work on the course on their own. All participants will complete questionnaires prior to the start of the program, before each lesson of the program, once they have completed the program, and 3 months after completing the program. The primary outcome measures include anxiety and depression. Secondary outcomes include fatigue, pain, self-efficacy, disability, overall quality of life, and life satisfaction.

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 Canada
  • endorsing symptoms of anxiety or depression
  • diagnosed with a chronic medical health condition
  • chronic condition does not impact ability to complete treatment (ex. cognitive impairment)
  • 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 country during treatment
  • concerns about online therapy

结局指标

主要结局

Change in anxiety

时间窗: baseline, 8 weeks, 3 months

Measured by Generalize Anxiety Disorder - 7 Item (GAD7)

Change in depression

时间窗: baseline, 8 weeks, 3 months

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

次要结局

  • Treatment credibility(baseline)
  • Change in life satisfaction(baseline, 8 weeks, 3 months)
  • Change in self-efficacy(baseline, 8 weeks, 3 months)
  • Change in psychological distress(baseline, 8 weeks, 3 months)
  • Change in treatment costs(baseline, 3 months)
  • Treatment satisfaction(8 weeks)
  • Change in pain(baseline, 8 weeks, 3 months)
  • Change in disability(baseline, 8 weeks, 3 months)
  • Change in quality of life symptoms(baseline, 8 weeks, 3 months)
  • Change in fatigue(baseline, 8 weeks, 3 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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