Nurse-supported Mobile App for Self-help CBT-I in Informal Cancer Caregivers
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Nurse-Supported Mobile App for Self-Help CBT-I, Sleep hygiene education.
- Who it may be relevant to
- Registry conditions: Insomnia Chronic, Cancer Caregivers. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Effect of Nurse-supported Mobile App for Self-help Cognitive Behavioral Therapy for Insomnia in Informal Cancer Caregivers: a Randomized Controlled Trial
Overview
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.\*
Interventions
- Behavioral 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. - Behavioral 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.
Primary outcome measures
- Insomnia severity [Time frame: Baseline to 18 week]
Secondary outcome measures (12)
- Sleep patterns [Time frame: Baseline to 18 week]
- Sleep quality [Time frame: Baseline to 18 week]
- Caregiver burden [Time frame: Baseline to 18 week]
- Depressive symptoms [Time frame: Baseline to 18 week]
- Anxiety symptoms [Time frame: Baseline to 18 week]
- Fatigue [Time frame: Baseline to 18 week]
- Health-related quality of life [Time frame: Baseline to 18 week]
- Participants' acceptability and satisfaction [Time frame: Week 6 to week 18]
- Adverse events [Time frame: Baseline to 18 week]
- Intervention delivery [Time frame: Six weeks post-randomization]
- Intervention acceptability [Time frame: 6 weeks post-randomization]
- Intervention fidelity [Time frame: 6 weeks post-intervention]
Eligibility criteria
Inclusion criteria
- 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
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Shanghai University Shanghai Cancer Centre — Shanghai
Identifiers
NCT: NCT07089797 · Nurse-supported CBT-I (FULL)