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

NCT07089797 | Recruiting

• 1 other identifier: Nurse-supported CBT-I (FULL)
• Study Type: interventional
• Target: 208
• Locations: 1 country
• Sites: 1

Brief Summary

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. 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. 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\>

Conditions

Insomnia Chronic; Cancer Caregivers

Outcome Measures

Primary Outcomes (1)

• Insomnia severity

  Insomnia severity will be assessed by Insomnia Severity Index (ISI). The ISI is a well-validated, 7-item scale designed to assess the severity of insomnia retrospectively over the past 2 weeks. Total scores range from 0 to 28, with higher scores indicating more severe insomnia symptoms.

  Baseline to 18 week

Secondary Outcomes (12)

• Sleep patterns

  Baseline to 18 week

• Sleep quality

  Baseline to 18 week

• Caregiver burden

  Baseline to 18 week

• Depressive symptoms

  Baseline to 18 week

• Anxiety symptoms

  Baseline to 18 week

Study Arms (2)

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

EXPERIMENTAL

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

Sleep hygiene education

ACTIVE COMPARATOR

Behavioral: Sleep hygiene education

Interventions

Nurse-Supported Mobile App for Self-Help CBT-I BEHAVIORAL

The intervention consists of two components: 1) a mobile app (i.e., WeChat mini program) delivered 6-week self-help CBT-I program; and 2) Weekly nurse support session (up to 20 minutes each) across a 6 week intervention period.

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

Sleep hygiene education BEHAVIORAL

The participants in the control group will receive only sleep hygiene (one-page handout) via WeChat. Access to the CBT-I WeChat mini program will be offered to these participants after the completion of the 3-month follow-up assessment.

Sleep hygiene education

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

Shanghai University Shanghai Cancer Centre

Shanghai, China

RECRUITING

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Central Study Contacts

Yangxi Huang

CONTACT

+85263581459; hyangxi@connect.hku.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 25, 2025
• First Posted: July 28, 2025
• Study Start: August 11, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: February 18, 2026

Record last verified: 2026-02

Locations

CN (1)