Nurse-supported Mobile App for Self-help CBT-I in Informal Cancer Caregivers
NCT ID: NCT07089797
Last Updated: 2025-08-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
208 participants
INTERVENTIONAL
2025-08-01
2026-08-01
Brief Summary
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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.\*
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Nurse-Supported Mobile App for Self-Help CBT-I in Cancer Caregivers
Nurse-Supported Mobile App for Self-Help CBT-I
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.
Sleep hygiene education
Sleep hygiene education
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.
Interventions
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Nurse-Supported Mobile App for Self-Help CBT-I
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.
Sleep hygiene education
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.
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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The University of Hong Kong
OTHER
Responsible Party
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Yangxi Huang
Principal Investigator
Central Contacts
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Other Identifiers
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Nurse-supported CBT-I (FULL)
Identifier Type: -
Identifier Source: org_study_id
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