Nurse-supported WeChat app to reduce insomnia in cancer caregivers
Effect of Nurse-supported Mobile App for Self-help Cognitive Behavioral Therapy for Insomnia in Informal Cancer Caregivers: a Randomized Controlled Trial
This trial will test whether a nurse-supported WeChat app delivering self-help CBT-I can help reduce insomnia in informal cancer caregivers compared with sleep hygiene education.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 208 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | The University of Hong Kong Academic / other |
| Locations | 1 site (Shanghai) |
| Trial ID | NCT07089797 on ClinicalTrials.gov |
What this trial studies
This mixed-methods randomized controlled trial will enroll 208 informal caregivers of cancer patients and randomly assign them to either a 6-week self-help CBT-I program delivered via a WeChat mini program with weekly nurse support sessions (up to 20 minutes) or to sleep hygiene education. Participants complete assessments at baseline, immediately post-intervention, and at 3-month follow-up, with the primary outcome being change in insomnia severity. The intervention pairs digital CBT-I content with brief nurse coaching to support adherence and address practical barriers. Qualitative components will explore user experience and acceptability among Chinese-speaking caregivers.
Who should consider this trial
Good fit: Adults (≥18) who live with and provide at least 4 hours of unpaid daily care to a cancer patient, have an Insomnia Severity Index score >7, can read and speak Chinese, and can use WeChat are ideal candidates.
Not a fit: People with other untreated sleep disorders, serious psychiatric illness (for example psychosis or recent suicidal behavior), current use of psychotropic medications, pregnancy, or those unable to use WeChat or attend the Shanghai site are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, caregivers could experience meaningful reductions in insomnia and improved daytime functioning through a scalable, nurse-supported mobile intervention.
How similar studies have performed: Digital CBT-I has demonstrated efficacy for improving insomnia in multiple populations, though nurse-supported WeChat-based delivery specifically for informal cancer caregivers is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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
Where this trial is running
Shanghai
- Shanghai University Shanghai Cancer Centre — Shanghai, China (Recruiting)
Study contacts
- Study coordinator: Yangxi Huang
- Email: hyangxi@connect.hku.hk
- Phone: +85263581459
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.