An interventional study of Nurse-Supported Mobile App for Self-Help CBT-I and Sleep hygiene education in Insomnia Chronic and Cancer Caregivers, sponsored by The University of Hong Kong. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-18.
Sponsored by The University of Hong Kong · Not applicable, Interventional, and Treatment
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>
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.*
1,856 studies on the registry are indexed under Sleep Initiation and Maintenance Disorders; 594 are open to participants now.
This study's planned enrollment of 208 is above the median of 73 across 1,631 interventional studies indexed under Sleep Initiation and Maintenance Disorders.
Browse Sleep Initiation and Maintenance Disorders studies →The University of Hong Kong is the lead sponsor of 1,262 studies on the registry; 340 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
Behavioral: Nurse-Supported Mobile App for Self-Help CBT-I
Behavioral: Sleep hygiene education
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.
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.
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.
Time frame: Baseline to 18 week
Sleep patterns
Sleep patterns (i.e., total sleep time \[TST\], time in bed \[TIB\], sleep efficiency \[SE\], wake after sleep onset \[WASO\], and sleep onset latency \[SOL\]) will be assessed using the Consensus Sleep Diary (CSD). The CSD is widely used to assess subjective sleep parameters.
Time frame: Baseline to 18 week
Sleep quality
Sleep quality will be assessed using the Pittsburgh Sleep Quality Index (PSQI). The PSQI is a widely used, 19-item questionnaire designed to measure various aspects of sleep quality over the past month. Scores range from 0 to 21, with higher scores indicating poorer sleep quality.
Time frame: Baseline to 18 week
Caregiver burden
The caregiver burden will be evaluated by Zarit Burden Interview-12 (ZBI-12). The ZBI-12 is a widely used, 12-item shortened version of the original ZBI, designed to assess the subjective burden experienced by informal caregivers. Total scores range from 0 to 48, with higher scores indicating a greater level of caregiver burden.
Time frame: Baseline to 18 week
Depressive symptoms
Depressive symptoms will be assessed using the Patient Health Questionnaire-9 (PHQ-9). The PHQ-9 is a widely used, 9-item questionnaire designed to screen for, diagnose, monitor, and measure the severity of depression. Each item evaluates the frequency of depressive symptoms experienced over the past two weeks. Total scores range from 0 to 27, with higher scores indicating more severe depressive symptoms.
Time frame: Baseline to 18 week
Anxiety symptoms
Anxiety symptoms will be assessed using the Generalized Anxiety Disorder-7 (GAD-7). This self-administered, 7-item questionnaire was designed as a screening tool and a severity measure for GAD. Each item asks about the frequency of anxiety symptoms over the past two weeks. Scores range from 0 to 21, with higher scores indicating more severe anxiety symptoms.
Time frame: Baseline to 18 week
Fatigue
Fatigue will be assessed using the Multi-Dimensional Fatigue Inventory (MFI). The MFI is a 20-item self-report questionnaire designed to measure five dimensions of fatigue (i.e., general fatigue, mental fatigue, physical fatigue, reduced activity, and reduced motivation). Total scores range from 20 to 100, with higher scores indicating greater levels of fatigue.
Time frame: Baseline to 18 week
Health-related quality of life
Health-related quality of life will be assessed using the five-dimension five-level European Quality of Life scale (EQ-5D-5L). The EQ-5D-5L is a standardized questionnaire designed to evaluate five dimensions of health: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The EQ-5D-5L score ranges from -0.39 to 1, with higher scores indicating better quality of life. Additionally, the EQ-5D-5L includes a Visual Analog Scale (VAS) for overall self-rated health status, with scores ranging from 0 to 100, where higher scores represent better health-related quality of life.
Time frame: Baseline to 18 week
Participants' acceptability and satisfaction
The participants' perspectives of acceptability and satisfaction will be evaluated using eight adapted items from the Acceptability E-scale. Each item is rated on a 5-point Likert scale, with scores ranging from 1 to 5. The total score ranges from 8 to 40, with higher scores indicating greater acceptability and satisfaction with the intervention.
Time frame: Week 6 to week 18
Adverse events
All adverse events reported by the participants will be documented.
Time frame: Baseline to 18 week
Intervention delivery
The delivery of the intervention will be assessed via semi-structured qualitative interviews conducted with trial participants after the intervention. Intervention adherence will also be assessed by the number of sessions completed on the WeChat mini program and the number of weekly nurse support sessions attended by participants.
Time frame: Six weeks post-randomization
Intervention acceptability
The Intervention acceptability will be assessed via semi-structured qualitative interviews conducted with trial participants after the intervention.
Time frame: 6 weeks post-randomization
Intervention fidelity
Throughout the study, all nurse support sessions will be recorded. A random sample of 20% of the sessions will be evaluated by a psychologist for treatment fidelity using a modified version of the Yale Adherence and Competence Scale.
Time frame: 6 weeks post-intervention
Plan to share: Undecided
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