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

The University of Hong Kong (HKU)

Status: Not yet enrolling

Conditions: Cancer Caregivers; Insomnia

Treatments: Behavioral: Nurse-Supported Mobile App for Self-Help CBT-I

Study type: Interventional

Funder types: Other

Identifiers

NCT06889571

Nurse-supported CBT-I 2025

Details and patient eligibility

About

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.

Enrollment: 12 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age ≥18 years
• Informal caregiver (e.g., family members, friends, or neighbors) who co-resides with and provides unpaid care for cancer survivors of any site or stage, with daily contact of at least 4 hours. 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

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

Experimental group

Treatment:

Behavioral: Nurse-Supported Mobile App for Self-Help CBT-I