Actively Recruiting
Nurse-supported Mobile App for Self-help CBT-I in Informal Cancer Caregivers
Led by The University of Hong Kong · Updated on 2026-02-18
208
Participants Needed
1
Research Sites
50 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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\> 1. 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\> 2. 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.\*
CONDITIONS
Official Title
Nurse-supported Mobile App for Self-help CBT-I in Informal Cancer Caregivers
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 69;18 years
- Informal caregiver (family member or friend) who lives with a cancer survivor of any site or stage and provides at least 4 hours of unpaid daily care
- If multiple caregivers are available for one cancer survivor, the caregiver providing most daily care is included
- Able to understand the study and communicate in Chinese
- Able to use WeChat app
- Insomnia severity index score greater than 7
You will not qualify if you...
- Having another untreated sleep disorder besides insomnia (e.g., obstructive sleep apnea, restless leg syndrome, REM behavior disorder)
- Having psychotic disorders like bipolar disorder or schizophrenia
- Suicidal thoughts with intent or plan, or attempted suicide within past 2 months
- Currently taking psychotropic medications such as antidepressants, anxiolytics, or sleep drugs
- Having unstable or acute medical conditions or planned surgery within 6 months
- Being pregnant or having epilepsy
- Participating in another interventional program
- Previous experience with cognitive behavioral therapy for insomnia (CBT-I)
- Working night, evening, early morning, or rotating shifts
- Caring for a cancer patient in hospice care
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Shanghai University Shanghai Cancer Centre
Shanghai, China
Actively Recruiting
Research Team
Y
Yangxi Huang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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