Optimizing Duration of Therapist-guided Internet-delivered Cognitive Behaviour Therapy for Anxiety and Depression
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 410
- 试验地点
- 2
- 主要终点
- Patient Health Questionnaire 9-item (PHQ-9)
研究概览
简要总结
Depression and anxiety are common and prevalent conditions that are frequently under treated. In an attempt to increase timely and accessible psychological treatment, Internet-delivered Cognitive Behaviour Therapy (ICBT) has emerged. ICBT involves delivering therapeutic content to manage depression and or anxiety via structured online lessons. This is often combined with brief therapist guidance, for example once per week for 8 weeks via secure messaging or phone calls. Although outcomes of ICBT are very impressive, there is room for improvement in terms of completion rates and outcomes. Feedback from patients suggest that some patients would prefer longer term support or follow-up care.
In this two-factorial randomized controlled trial, the investigators aim to contribute to the literature by examining whether the efficacy of ICBT is improved by offering an extended period of support to clients (from 8 weeks to 12 weeks) and being offered a booster session at 16 weeks after treatment enrollment (yes vs no). Follow-up assessments will be conducted at 8, 16 and 26 weeks after treatment enrollment. Primary outcomes are reduced anxiety and depression. Secondary outcomes include reduced panic, social anxiety, trauma, quality of life, disability, work productivity, and healthcare use.
详细描述
Past research of ICBT offered in routine care has found that patients and therapists often recommend "personalizing" the delivery of ICBT, for example, by increasing the length of time therapist support is available or offering booster sessions after treatment has ended. To date, in terms of ICBT, there has been limited research on the impact of extending support after treatment materials have been delivered or offering a booster session.
In this trial, the investigators will examine if the efficacy of ICBT is improved by offering an extended period of support to clients (from 8 weeks to 12 weeks) or by being offered a booster session at 16 weeks after treatment enrollment (yes vs no). Follow-up assessments will be conducted at 8, 16 and 26 weeks after treatment enrollment. Primary outcomes are reduced anxiety and depression. Secondary outcomes include reduced panic, social anxiety, trauma, quality of life, disability, work productivity, and healthcare use. The impact of these factors on intervention usage (e.g., completion rates, log-ins, emails sent) and treatment satisfaction will also be examined.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 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
- 否
入选标准
- •18 years or older
- •Endorse symptoms of anxiety or depression
- •Resident of Saskatchewan
- •Access to a computer and the Internet
排除标准
- •Have a severe psychiatric illness (e.g. psychosis)
- •Assessed as being at high risk of suicide
- •Report severe problems with alcohol or drugs
- •Report severe cognitive impairment
结局指标
主要结局
Patient Health Questionnaire 9-item (PHQ-9)
时间窗: Baseline (Screening), weeks 1-12, 16 and 26 week from enrollment
Change in depression symptoms. 9 items are summed into a total score, with scores ranging from 0 to 27. Higher scores are associated with higher depression severity.
Generalized Anxiety Disorder 7-item (GAD-7)
时间窗: Baseline (Screening), weeks 1-12 and 16 and 26 week from enrollment
Change in anxiety symptoms. 7 items are summed into a total score ranging from 0 to 21, with higher scores indicating more severe self-reported levels of anxiety.
次要结局
- Social Interaction Anxiety Scale (6 items)(Baseline (Screening), week 8, 16 and 26 week from enrollment)
- Quality of Life (EQ-ED-5L)(Baseline (Screening), week 8, 16 and 26 week from enrollment)
- Panic Disorder Severity Scale Self-report(Baseline (Screening), week 8, 16 and 26 week from enrollment)
- Social Phobia Scale-Short form (6 items)(Baseline (Screening), week 8, 16 and 26 week from enrollment)
- Mental Health Service Use, Medication, and Employment(Baseline (Screening) and Week 26 week from enrollment)
- Treatment Satisfaction(Week 8, 16 and 26 week from enrollment)
- Sheehan Disability Scale (SDS)(Baseline (Screening), week 8, 16 and 26 week from enrollment)
- Life Events Checklist for DSM-5 (LEC-5)(Baseline (Screening))
- PTSD Checklist for DSM-5 (PCL-5)(Baseline (Screening), week 8, 16 and 26 week from enrollment)
- Insomnia Severity Index (ISI)(Baseline)