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NCT07089797
Nurse-supported Mobile App for Self-help CBT-I in Informal Cancer Caregivers
NA trial testing Nurse-Supported Mobile App for Self-Help CBT-I in Insomnia Chronic in 208 participants. Currently enrolling.
1 June 2026
Quick facts
| Lead sponsor | The University of Hong Kong |
|---|---|
| Phase | NA |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 208 |
| Start date | 11 August 2025 |
| Primary completion | 1 June 2026 |
| Estimated completion | 1 August 2026 |
| Sites | 1 location across China |
Drugs / interventions tested
- Nurse-Supported Mobile App for Self-Help CBT-I
- Sleep hygiene education
Conditions studied
- Insomnia Chronic — all drugs for Insomnia Chronic →
- Cancer Caregivers — all drugs for Cancer Caregivers →
Sponsor
The University of Hong Kong
Who can join
18 and older, any sex, with Insomnia Chronic or Cancer Caregivers. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.\*
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT07089797
- Europe PMC full search
- ASCO Meeting Library
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Related trials
Other trials of Nurse-Supported Mobile App for Self-Help CBT-I
Trials testing the same drug.
- NCT06889571 — Feasibility of a Nurse-Supported Mobile App for Self-Help CBT-I in Cancer Caregivers · NA · completed
Other recruiting trials for Insomnia Chronic
Currently open trials in the same condition.
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- NCT06736548 — Sleep Treatment Education Program for Cancer Survivors: STEP-Together · NA · recruiting
- NCT06926348 — Assessment of Usability and Preliminary Effectiveness of a Digital Sleep Aid in an Italian Sample · NA · recruiting
- NCT06767137 — Comparative Efficacy of BRT and CBT-I for Insomnia · NA · recruiting
- NCT06827626 — Tailored Treatment of Insomnia in Social and Health Care Sector Shift Workers in Occupational Health Care · NA · active not recruiting
Other The University of Hong Kong trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07089797 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by The University of Hong Kong
- Last refreshed: 18 February 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07089797.
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