Effect of Nurse-supported Mobile App for Self-help Cognitive Behavioral Therapy for Insomnia in Informal Cancer Caregivers: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 208
- 试验地点
- 1
- 主要终点
- Insomnia severity
研究概览
简要总结
This mixed-methods randomized controlled trial investigates whether a nurse-supported mobile app for self-help cognitive behavioral therapy for insomnia (CBT-I) effectively reduces insomnia severity among informal cancer caregivers, compared to sleep hygiene education.<br><br>
The primary research question is:<br> Does nurse-supported mobile app for self-help CBT-I lower insomnia severity among cancer caregivers compared to sleep hygiene education at post-intervention and 3-month follow-up?<br><br>
A total of 208 participants will:<br>
- Be randomly assigned to one of two groups:<br> (i) the nurse-supported mobile app-based self-help CBT-I group, which involves a 6-week CBT-I program delivered via a WeChat mini program along with weekly nurse support sessions (up to 20 minutes each); or<br> (ii) the sleep hygiene education group.<br>
- Complete assessments at baseline, post-intervention, and 3-month follow-up to measure changes in insomnia severity (primary outcome). Secondary outcomes include subjective sleep outcomes, psychological well-being, caregiver burden, fatigue, health-related quality of life, and participants' acceptability and satisfaction.<br><br>
As recommended for trials of complex interventions, investigators will conduct a process evaluation in alignment with the Medical Research Council (MRC) guidance. The key functions of the process evaluation include: *(1) implementation, (2) mechanisms of impact, and (3) context.*
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
- 否
入选标准
- •Age ≥18 years
- •Informal caregiver (e.g., family member or a friend) who co-resides with a cancer survivor of any site or stage and provides at least 4 hours of unpaid daily care. If two or more caregivers are available for a cancer survivor, the one providing most of the daily care will be included.
- •Able to understand the research procedures, and read and communicate in Chinese
- •Able to use WeChat
- •Insomnia severity index scores > 7
排除标准
- •Another sleep disorder (e.g., obstructive sleep apnea, restless leg syndrome, rapid eye movement behavior disorder), besides insomnia, that is not adequately treated
- •Psychotic disorders (e.g., bipolar disorder, schizophrenia); Suicidal ideation with intent and plan OR attempted suicide within the past 2 months
- •Currently taking any psychotropic drugs (e.g., antidepressants, anxiolytics, sleep medications)
- •Unstable or acute medical condition or condition requiring surgery in the next 6 months; Pregnancy; or Epilepsy
- •Currently participating in any other interventional program
- •Prior experience with CBT-I
- •Night, evening, early morning or rotating shift work
- •Currently caring for a cancer patient receiving hospice care
研究组 & 干预措施
Nurse-Supported Mobile App for Self-Help CBT-I in Cancer Caregivers
干预措施: Nurse-Supported Mobile App for Self-Help CBT-I (Behavioral)
Sleep hygiene education
干预措施: Sleep hygiene education (Behavioral)
结局指标
主要结局
Insomnia severity
时间窗: Baseline to 18 week
Insomnia severity will be assessed by Insomnia Severity Index (ISI). The ISI is a well-validated, 7-item scale designed to assess the severity of insomnia retrospectively over the past 2 weeks. Total scores range from 0 to 28, with higher scores indicating more severe insomnia symptoms.
次要结局
- Sleep patterns(Baseline to 18 week)
- Sleep quality(Baseline to 18 week)
- Caregiver burden(Baseline to 18 week)
- Depressive symptoms(Baseline to 18 week)
- Anxiety symptoms(Baseline to 18 week)
- Fatigue(Baseline to 18 week)
- Health-related quality of life(Baseline to 18 week)
- Participants' acceptability and satisfaction(Week 6 to week 18)
- Adverse events(Baseline to 18 week)
- Intervention delivery(Six weeks post-randomization)
- Intervention acceptability(6 weeks post-randomization)
- Intervention fidelity(6 weeks post-intervention)
研究者
Yangxi Huang
Principal Investigator
The University of Hong Kong