Nurse-supported Mobile App for Self-help CBT-I in Informal Cancer Caregivers
Recruiting now · Not applicable
Conditions studied: Insomnia Chronic, Cancer Caregivers
In brief
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.\*
Key facts
- Study ID
- NCT07089797
- Run by
- The University of Hong Kong
- People needed
- 208
- Starts
- 2025-08-11
- Expected to finish
- 2026-08-01
- Last updated by the study team
- 2026-02-18
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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 it is running
- Shanghai University Shanghai Cancer Centre — Shanghai, China (enrolling)
Full record on ClinicalTrials.gov
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