Treating Comorbid Insomnia in Patients Receiving Transdiagnostic Internet-Delivered Cognitive Behaviour Therapy for Anxiety and Depression: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 217
- 试验地点
- 2
- 主要终点
- Patient Health Questionnaire 9-item (PHQ-9)
研究概览
简要总结
Transdiagnostic Internet-delivered Cognitive Behaviour Therapy (ICBT) is an efficacious treatment option for anxiety and depression; however, not all patients benefit equally and some leave treatment before program completion. Comorbid symptoms of insomnia are extremely common among individuals seeking ICBT, yet sleep problems are rarely a primary focus of treatment in transdiagnostic ICBT despite insomnia being a known risk factor for anxiety and depression. This trial is designed to test whether an ICBT program for anxiety and depression can be improved by providing therapy for insomnia alongside the standard transdiagnostic program. For this randomized controlled trial, patients will be randomly assigned to receive either the standard ICBT program for anxiety and depression, which includes only brief supplementary information about sleep (n = 68), or a modified version that includes a lesson specifically on sleep (n = 132). The sleep lesson will introduce patients to two key behavioural strategies: sleep restriction and stimulus control, which previous research has demonstrated are effective at reducing insomnia. Patients will monitor their sleep throughout treatment and will complete measures of insomnia, anxiety and depression before treatment, at the end of the 8-week program, and 3 months after program conclusion to allow for a comparison of patient outcomes and completion rates between conditions. The acceptability of the new intervention will also be assessed by asking participants to provide feedback on the new materials and to complete measures of treatment satisfaction and working alliance.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants must reside in Saskatchewan
- •Participants must have access to a computer and feel comfortable using the internet
- •Participants must be willing to provide a medical contact (e.g., family doctor) in case of medical emergency
- •Participants must endorse some symptoms of anxiety or depression
- •Participants must also endorse significant symptoms of insomnia (Insomnia Severity Index score of 10 or above)
排除标准
- •High risk of suicide
- •Unmanaged severe psychiatric illness (e.g., psychosis, mania)
- •Severe alcohol or addictions problems that require referral
- •High probability that another sleep disorder for which sleep restriction may be contraindicated is present (e.g., restless leg syndrome, sleep apnea, or sleep problems that are exclusively related to shift work)
结局指标
主要结局
Patient Health Questionnaire 9-item (PHQ-9)
时间窗: Week 1 (pre-treatment), Week 8 (post-treatment), Week 20 (follow-up)
Change in depression symptoms from pre-treatment (Week 1) to post-treatment (8 weeks) and from pre-treatment to follow-up (20 weeks). The PHQ-9 is a 9-item self-report measure of symptoms of depression that produces a total depression severity score ranging from 0-27.
Generalized Anxiety Disorder (GAD-7)
时间窗: Week 1 (pre-treatment), Week 8 (post-treatment), Week 20 (follow-up)
Change in anxiety symptom from pre-treatment (Week 1) to post-treatment (8 weeks) and from pre-treatment to follow-up (20 weeks). The GAD-7 is a 7-item self-report measure of symptoms of anxiety that produces a total anxiety severity score ranging from 0-21.
Insomnia Severity Index (ISI)
时间窗: Week 1 (pre-treatment), Week 8 (post-treatment), Week 20 (follow-up)
Change in insomnia symptoms from pre-treatment (Week 1) to post-treatment (8 weeks) and from pre-treatment to follow-up (20 weeks). The ISI is a brief measure of insomnia comprised of 7 questions that ask about difficulties falling asleep, staying asleep, and waking too early, which respondents answer on a scale from 0 (None) to 4 (Very Severe), producing a score between 0 and 28.
次要结局
- Treatment Satisfaction(Week 8 (post-treatment))
- Panic Disorder Severity Scale (PDSS)(Week 1 (pre-treatment), Week 8 (post-treatment), Week 20 (follow-up))
- Lesson Completion(Ongoing throughout treatment (Weeks 1-8))
- Social Interaction Anxiety Scale and Social Phobia Scale - Short Form (SIAS-6/SPS-6)(Week 1 (pre-treatment), Week 8 (post-treatment), Week 20 (follow-up))