Nurse-supported Mobile App for Self-help CBT-I in Informal Cancer Caregivers

StatusCompleted
PhaseNot applicable
Started

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Record History

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  1. Trial completed Show 5 more changesShow less
    • Primary completion date changed from estimate of Jun 1, 2026 to Aug 10, 2026
    • Study completion date changed from estimate of Aug 1, 2026 to Aug 20, 2026
    • Eligibility criteria expanded, about 13 words
    • Secondary endpoints: details revised at 10 of 12 entries
    • Site details revised
  2. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Primary completion date: Apr 1, 2026 to Jun 1, 2026
    • Start date changed from estimate of Aug 1, 2025 to Aug 11, 2025
    v3
  3. Re-verified, no change to tracked fieldsv2
  4. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.\*
Trial Details
NCT Number NCT07089797
Lead Sponsor The University of Hong Kong
Conditions
(from sponsor)		 Insomnia Chronic, Cancer Caregivers
Related terms Sleep Initiation and Maintenance Disorders
Enrollment 208 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov