NCT06889571

Feasibility of a Nurse-Supported Mobile App for Self-Help CBT-I in Cancer Caregivers

A Single-arm Feasibility Study of Nurse-supported Mobile App for Self-help CBT-I in Cancer Caregivers

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: The University of Hong Kong · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Study Goal The goal of this clinical trial is to evaluate whether a nurse-supported mobile app for self-help cognitive behavioral therapy for insomnia (CBT-I) is feasible for cancer caregivers and whether it can improve their sleep-related outcomes and overall well-being. Main Questions 1. Feasibility: Can the intervention be successfully implemented in terms of recruitment, retention, adherence to the intervention protocol, safety, and participant satisfaction? 2. Preliminary Effects: Does the intervention improve subjective sleep outcomes (e.g., insomnia severity, sleep quality, total sleep time, time in bed, sleep efficiency, wake after sleep onset, and sleep onset latency) as well as depressive symptoms, anxiety symptoms, fatigue, caregiver burden, and health-related quality of life? What Participants Will Do i) Use a 6-week self-help CBT-I program delivered via a WeChat mini program. ii) Receive weekly nurse support sessions (up to 20 minutes each) for six weeks. * These sessions may be conducted via phone calls or instant messaging, based on participant preference. * Each session includes reviewing weekly progress, addressing any barriers to adherence, and planning next steps.

Conditions

• Insomnia
• Cancer Caregivers

Interventions

Type	Name	Description
BEHAVIORAL	Nurse-Supported Mobile App for Self-Help CBT-I	The intervention consists of two components: 1) a mobile app delivered 6-week self-help CBT-I program; and 2) Weekly nurse support session.

Timeline

• Start date: 2025-05-12
• Primary completion: 2025-07-20
• Completion: 2025-07-23
• First posted: 2025-03-21
• Last updated: 2025-08-03

Locations

1 site across 1 country: China