Nurse-supported Mobile App for Self-help CBT-I in Informal Cancer Caregivers
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorThe University of Hong Kong
About this 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\>
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.\*
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Nurse-Supported Mobile App for Self-Help CBT-I
BehavioralThe 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
BehavioralThe 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.
Treatment groups
208 Participants
are divided into 2 treatment groupsGroup A: Nurse-Supported Mobile App for Self-Help CBT-I in Cancer CaregiversExperimental treatment 1 intervention
Group B: Sleep hygiene educationActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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 weekSecondary outcomes
1
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 week2
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 week3
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 week4
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 weekSponsors and contacts
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Source ClinicalTrials.gov