InsomniaNCT06889571
Feasibility of a Nurse-Supported Mobile App for Self-Help CBT-I in Cancer Caregivers
A study testing Nurse-Supported Mobile App for Self-Help CBT-I in people with Insomnia and Cancer Caregivers, run by The University of Hong Kong at 1 site in China.
Trial summary
Study Goal The goal of this clinical trial is to evaluate whether a nurse-supported mobile app for self-help cognitive behavioral therapy for insomnia (CBT-I) is feasible for cancer caregivers and whether it can improve their sleep-related outcomes and overall well-being. Main Questions 1. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Insomnia, Cancer Caregivers
- What is being tested?
- Nurse-Supported Mobile App for Self-Help CBT-I
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteChina
- Study dates
- 12 May 2025to 23 Jul 2025
- 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 members, friends, or neighbors) who co-resides with and provides unpaid care for cancer survivors of any site or stage, with daily contact of at least 4 hours. 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: A Single-arm Feasibility Study of Nurse-supported Mobile App for Self-help CBT-I in Cancer Caregivers
Study Goal The goal of this clinical trial is to evaluate whether a nurse-supported mobile app for self-help cognitive behavioral therapy for insomnia (CBT-I) is feasible for cancer caregivers and whether it can improve their sleep-related outcomes and overall well-being.
Main Questions
Read more
- Feasibility: Can the intervention be successfully implemented in terms of recruitment, retention, adherence to the intervention protocol, safety, and participant satisfaction?
- Preliminary Effects:
Does the intervention improve subjective sleep outcomes (e.g., insomnia severity, sleep quality, total sleep time, time in bed, sleep efficiency, wake after sleep onset, and sleep onset latency) as well as depressive symptoms, anxiety symptoms, fatigue, caregiver burden, and health-related quality of life?
What Participants Will Do i) Use a 6-week self-help CBT-I program delivered via a WeChat mini program. ii) Receive weekly nurse support sessions (up to 20 minutes each) for six weeks.
- These sessions may be conducted via phone calls or instant messaging, based on participant preference.
- Each session includes reviewing weekly progress, addressing any barriers to adherence, and planning next steps.
- Conditions
- Insomnia, Cancer Caregivers
- Being tested
- Nurse-Supported Mobile App for Self-Help CBT-I
- 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 delivered 6-week self-help CBT-I program; and 2) Weekly nurse support session.
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment rate
The recruitment rate will be evaluated by the percentage of the target number of participants successfully recruited per month.
Measured: Every month, up to 1 year
Retention rate
The retention rate will be assessed by the percentage of recruited participants providing outcome data at post-intervention time point.
Measured: Post-intervention (i.e., at the end of the 6-week intervention period)
Adherence rate
The adherence rate will be measured by the percentage of recruited participants who adhere to the proposed intervention, including reviewing sessions on the WeChat mini program and engaging in weekly nurse support sessions.
Measured: Post-intervention (i.e., at the end of the 6-week intervention period)
Participants' perspectives of 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: Post-intervention (i.e., at the end of the 6-week intervention period)
Adverse events
All adverse events reported by the participants will be documented.
Measured: Throughout the study period (from baseline to post-intervention [i.e., at the end of the 6-week intervention period])
Participants' perceived experiences of the proposed intervention
Participants' perceived experiences of the proposed intervention (e.g., intervention delivery, adherence, safety, and satisfaction) will be assessed through post-intervention qualitative interviews to provide a further understanding of the intervention's feasibility.
Measured: Post-intervention (i.e., at the end of the 6-week intervention period)
Secondary outcomes (8)
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: T0 (Baseline): prior to the start of the intervention, T1 (6 weeks): Post-intervention (i.e., at the end of the 6-week intervention period）
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 and help capture more subtle variations in sleep.
Measured: T0 (Baseline): prior to the start of the intervention, T1 (6 weeks): Post-intervention (i.e., at the end of the 6-week intervention period)
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: T0 (Baseline): prior to the start of the intervention, T1 (6 weeks): Post-intervention (i.e., at the end of the 6-week intervention period)
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: T0 (Baseline): prior to the start of the intervention, T1 (6 weeks): Post-intervention (i.e., at the end of the 6-week intervention period)
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: T0 (Baseline): prior to the start of the intervention, T1 (6 weeks): Post-intervention (i.e., at the end of the 6-week intervention period)
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: T0 (Baseline): prior to the start of the intervention, T1 (6 weeks): Post-intervention (i.e., at the end of the 6-week intervention period)
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: T0 (Baseline): prior to the start of the intervention, T1 (6 weeks): Post-intervention (i.e., at the end of the 6-week intervention period)
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: T0 (Baseline): prior to the start of the intervention, T1 (6 weeks): Post-intervention (i.e., at the end of the 6-week intervention period)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2025
- Study start12 May 2025
- Primary completion20 Jul 2025
- Study completion23 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InsomniaStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 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
- NCT06889571
- Sponsor's protocol ID
- Nurse-supported CBT-I 2025
- Status last verified
- Jul 2025
- First submitted
- 11 Mar 2025
- Last updated
- 3 Aug 2025
- Results posted
- No
- Data monitoring committee
- 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 3 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-arm Feasibility Study of Nurse-supported Mobile App for Self-help CBT-I in Cancer Caregivers
- ClinicalTrials.gov ID
- NCT06889571
- Acronym / sponsor ID
- Nurse-supported CBT-I 2025
- Conditions
- Insomnia, Cancer Caregivers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 12 May 2025 (actual)
- Primary completion
- 20 Jul 2025 (actual)
- Study completion
- 23 Jul 2025 (actual)
- First posted
- 21 Mar 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.
Study Goal The goal of this clinical trial is to evaluate whether a nurse-supported mobile app for self-help cognitive behavioral therapy for insomnia (CBT-I) is feasible for cancer caregivers and whether it can improve their sleep-related outcomes and overall well-being.
Main Questions
- Feasibility: Can the intervention be successfully implemented in terms of recruitment, retention, adherence to the intervention protocol, safety, and participant satisfaction?
- Preliminary Effects:
Does the intervention improve subjective sleep outcomes (e.g., insomnia severity, sleep quality, total sleep time, time in bed, sleep efficiency, wake after sleep onset, and sleep onset latency) as well as depressive symptoms, anxiety symptoms, fatigue, caregiver burden, and health-related quality of life?
What Participants Will Do i) Use a 6-week self-help CBT-I program delivered via a WeChat mini program. ii) Receive weekly nurse support sessions (up to 20 minutes each) for six weeks.
- These sessions may be conducted via phone calls or instant messaging, based on participant preference.
- Each session includes reviewing weekly progress, addressing any barriers to adherence, and planning next steps.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| 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 |
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 members, friends, or neighbors) who co-resides with and provides unpaid care for cancer survivors of any site or stage, with daily contact of at least 4 hours. 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 delivered 6-week self-help CBT-I program; and 2) Weekly nurse support session. | Behavioural | Nurse-Supported Mobile App for Self-Help CBT-I in Cancer Caregivers |
Primary outcome
Recruitment rate
Time frame: Every month, up to 1 year
The recruitment rate will be evaluated by the percentage of the target number of participants successfully recruited per month.
Retention rate
Time frame: Post-intervention (i.e., at the end of the 6-week intervention period)
The retention rate will be assessed by the percentage of recruited participants providing outcome data at post-intervention time point.
Adherence rate
Time frame: Post-intervention (i.e., at the end of the 6-week intervention period)
The adherence rate will be measured by the percentage of recruited participants who adhere to the proposed intervention, including reviewing sessions on the WeChat mini program and engaging in weekly nurse support sessions.
Participants' perspectives of acceptability and satisfaction
Time frame: Post-intervention (i.e., at the end of the 6-week intervention period)
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.
Adverse events
Time frame: Throughout the study period (from baseline to post-intervention [i.e., at the end of the 6-week intervention period])
All adverse events reported by the participants will be documented.
Participants' perceived experiences of the proposed intervention
Time frame: Post-intervention (i.e., at the end of the 6-week intervention period)
Participants' perceived experiences of the proposed intervention (e.g., intervention delivery, adherence, safety, and satisfaction) will be assessed through post-intervention qualitative interviews to provide a further understanding of the intervention's feasibility.
8 secondary outcomes
Insomnia severity
Time frame: T0 (Baseline): prior to the start of the intervention, T1 (6 weeks): Post-intervention (i.e., at the end of the 6-week intervention period）
Sleep patterns
Time frame: T0 (Baseline): prior to the start of the intervention, T1 (6 weeks): Post-intervention (i.e., at the end of the 6-week intervention period)
Sleep quality
Time frame: T0 (Baseline): prior to the start of the intervention, T1 (6 weeks): Post-intervention (i.e., at the end of the 6-week intervention period)
Caregiver burden
Time frame: T0 (Baseline): prior to the start of the intervention, T1 (6 weeks): Post-intervention (i.e., at the end of the 6-week intervention period)
Depressive symptoms
Time frame: T0 (Baseline): prior to the start of the intervention, T1 (6 weeks): Post-intervention (i.e., at the end of the 6-week intervention period)
Anxiety symptoms
Time frame: T0 (Baseline): prior to the start of the intervention, T1 (6 weeks): Post-intervention (i.e., at the end of the 6-week intervention period)
Fatigue
Time frame: T0 (Baseline): prior to the start of the intervention, T1 (6 weeks): Post-intervention (i.e., at the end of the 6-week intervention period)
Health-related quality of life
Time frame: T0 (Baseline): prior to the start of the intervention, T1 (6 weeks): Post-intervention (i.e., at the end of the 6-week intervention period)
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 3 Aug 2025.
- 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 in people with Insomnia 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 3 Aug 2025. 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?
Recruitment rate (time frame: Every month, up to 1 year). The study lists 6 primary outcomes in all. 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 3 Aug 2025.