Clinical trial NCT05952245: Instant Message-delivered Cognitive Behavioural Therapy for Insomnia (CBT-I)Stroke Caregivers
Official title: The Effect of Instant Message-delivered Brief Cognitive Behavioural Therapy for Insomnia (CBT-I) in Stroke Family Caregivers: a Mixed Method Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stroke
Insomnia
Depressive Symptoms
Caregiver Burnout
Psychological Distress
Mobile Phone Use
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2023-07-19
Enrollment: 138
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The proposed trial aims to assess the effectiveness of Cognitive-behavioural therapy for insomnia (CBT-I) based ecological momentary intervention (EMI) for reducing insomnia symptoms among stroke caregivers.

Detailed description: Existing studies reported that 40-95% of family caregivers had clinically significant insomnia symptoms including reduced total sleep duration, prolonged sleep onset latency, frequent night awakenings, and poor sleep efficiency and quality.

Cognitive-behavioural therapy for insomnia (CBT-I) has shown a large effect in reducing insomnia among adults. Innovative and interactive technologies, such as Internet-delivered CBT-I (iCBT-T), have therefore been incorporated into CBT-I, which was identified to have similar effects to that of traditional CBT-I.

In the proposed trial, screened stroke caregivers will be recruited from community centres, rehabilitation centres, and tertiary hospitals in HK. The intervention group will receive CBTI-based EMI through instant messaging applications as personalised and real-time psychological support led by nurses for 3 months. The control group will only receive stroke and brief sleep hygiene education with chat-based support on the topics.The primary outcomes are Sleep Condition Indicator (SCI) and Insomnia Severity Index (ISI) scores. Secondary outcomes will include sleep quality, depressive symptoms, anxiety symptoms, caregiver's burden, quality of life, and et al. A post-trial qualitative study will be conducted to understand the participants' experience of and compliance with the EMI.

Eligibility criteria: Inclusion Criteria:

* Primary family caregiver (Aged ≥18) of stroke survivor
* Able to read and communicate in Chinese
* Engaged caregiving roles for \> 4 hours per day;
* Able to use a smartphone messaging app (e.g., WhatsApp and WeChat)
* SCI ≤ 21 scores (i.e., clinically significant insomnia)

Exclusion Criteria:

* Has provided care for \<1 month prior to recruitment
* Has a diagnosis of psychiatric disease or is currently taking psychotropic drugs
* Currently taking medication to help with sleep
* Currently participating in any type of psychological intervention

Primary outcomes:
measure: Sleep Condition Indicator (SCI)
timeFrame: 24 weeks
measure: Insomnia Severity Index (ISI)
timeFrame: 24 weeks
Secondary outcomes:
measure: Sleep quality (Pittsburgh Sleep Quality Index [PSQI])
timeFrame: 24 weeks
measure: Depressive symptoms (Patient Health Questionnaire-9 [PHQ-9]):
timeFrame: 24 weeks
measure: Anxiety symptoms (Generalized Anxiety Disorder-7 [GAD-7])
timeFrame: 24 weeks
measure: Caregiver's burden (Zarit Burden Interview [ZBI-4])
timeFrame: 24 weeks
measure: Quality of life (EuroQol 5-dimension 5-level questionnaire [EQ-5D-5L])
timeFrame: 24 weeks
measure: Positive experiences from caregiving (Positive Aspect of Caregiving [PAC])
timeFrame: 24 weeks
measure: Caregiving self-efficacy (Caregiving Self-Efficacy Scale [CSES-8])
timeFrame: 24 weeks
measure: Sleep parameters (Consensus Sleep Diary Core Version)
timeFrame: 24 weeks
measure: Dysfunctional Beliefs and attitudes about Sleep (Dysfunctional Beliefs and attitudes about Sleep [DBAS])
timeFrame: 24 weeks
measure: Sleep hygiene statue (Sleep Hygiene Index [SHI])
timeFrame: 24 weeks
measure: Sleep-related behavior (Chinese short-form of the sleep-related behavior questionnaire [SRBQ-SF])
timeFrame: 24 weeks
measure: State of sleep effort (Glasgow Sleep Effort Scale [GSES])
timeFrame: 24 weeks
measure: Sleep-related quality of life (Glasgow Sleep Impact Index [GSII])
timeFrame: 24 weeks
measure: Feedback on iCBT-I intervention
timeFrame: 24 weeks
measure: Adverse events
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Hong Kong PHAB Association
city: Hong Kong
country: Hong Kong
facility: Hong Kong Stroke Association
city: Hong Kong
country: Hong Kong
facility: NT West Community Centre
city: Hong Kong
country: Hong Kong
facility: Queen Mary Hospital
city: Hong Kong
country: Hong Kong
facility: The Hong Kong Society for Rehabilitation
Study officials:
References: