Insomnia ChronicNCT07089797
Nurse-supported Mobile App for Self-help CBT-I in Informal Cancer Caregivers
A study testing Nurse-Supported Mobile App for Self-Help CBT-I and Sleep hygiene education in people with Insomnia Chronic and Cancer Caregivers, run by The University of Hong Kong at 1 site in China.
Trial 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>… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Insomnia Chronic, Cancer Caregivers
- What is being tested?
- Nurse-Supported Mobile App for Self-Help CBT-I and Sleep hygiene education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 208 participants
- Where
- 1 siteChina
- Study dates
- 11 Aug 2025to 20 Aug 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Nurse-supported Mobile App for Self-help Cognitive Behavioral Therapy for Insomnia in Informal Cancer Caregivers: a Randomized Controlled Trial
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>
Read more
A total of 208 participants will:<br>
- 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>
- 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.*
- Conditions
- Insomnia Chronic, Cancer Caregivers
- Being tested
- Nurse-Supported Mobile App for Self-Help CBT-I, Sleep hygiene education
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nurse-Supported Mobile App for Self-Help CBT-IBehavioural
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 educationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Nurse-Supported Mobile App for Self-Help CBT-I in Cancer Caregivers | Experimental | Not described Receives: Behavioral: Nurse-Supported Mobile App for Self-Help CBT-I |
| Sleep hygiene education | Active comparator | Not described Receives: Behavioral: Sleep hygiene education |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to 18 week
Secondary outcomes (12)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Week 6 to week 18
Adverse events
All adverse events reported by the participants will be documented.
Measured: 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.
Measured: Six weeks post-randomization
Intervention acceptability
The Intervention acceptability will be assessed via semi-structured qualitative interviews conducted with trial participants after the intervention.
Measured: 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.
Measured: 6 weeks post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2025
- Study start11 Aug 2025
- Primary completion10 Aug 2026
- Study completion20 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Insomnia ChronicStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 208 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yangxi Huang, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07089797
- Sponsor's protocol ID
- Nurse-supported CBT-I (FULL)
- Status last verified
- Oct 2026
- First submitted
- 25 Jul 2025
- Last updated
- 19 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Nurse-supported Mobile App for Self-help Cognitive Behavioral Therapy for Insomnia in Informal Cancer Caregivers: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07089797
- Acronym / sponsor ID
- Nurse-supported CBT-I (FULL)
- Conditions
- Insomnia Chronic, Cancer Caregivers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 208 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 11 Aug 2025 (actual)
- Primary completion
- 10 Aug 2026 (actual)
- Study completion
- 20 Aug 2026 (actual)
- First posted
- 28 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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>
- 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>
- 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.*
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nurse-Supported Mobile App for Self-Help CBT-IThe 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. | Behavioural | Nurse-Supported Mobile App for Self-Help CBT-I in Cancer Caregivers |
| Sleep hygiene educationThe 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. | Behavioural | Sleep hygiene education |
Primary outcome
Insomnia severity
Time frame: Baseline to 18 week
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.
12 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nurse-Supported Mobile App for Self-Help CBT-I and Sleep hygiene education in people with Insomnia Chronic and Cancer Caregivers, run by The University of Hong Kong at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Insomnia severity (time frame: Baseline to 18 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2026.