Instant Message-delivered Cognitive Behavioural Therapy for Insomnia (CBT-I)Stroke Caregivers

Stroke Clinical Trial

Official title:

The Effect of Instant Message-delivered Brief Cognitive Behavioural Therapy for Insomnia (CBT-I) in Stroke Family Caregivers: a Mixed Method Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05952245
• Other study ID #: CBTI2023
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 1, 2023
• Est. completion date: October 15, 2024

Study information

• Verified date: June 2023
• Source: The University of Hong Kong
• Contact: Jung Jae LEE
• Phone: +852 3917 6971
• Email: leejay[@]hku.hk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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( e.g., WhatsApp) as personalised and real-time psychological support led by nurses for 12 weeks. The control group will only receive stroke education messages and chat-based psychological support without the CBT-I content. 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, and quality of life. A post-trial qualitative study will be conducted to understand the participants' experience of and compliance with the EMI.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 138
• Est. completion date: October 15, 2024
• Est. primary completion date: July 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 = 20 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

Related Conditions & MeSH terms

• Caregiver Burden
• Caregiver Burnout
• Depression
• Depressive Symptoms
• Insomnia
• Mobile Phone Use
• Psychological Distress
• Sleep Initiation and Maintenance Disorders
• Stroke

Intervention

Behavioral:
• iCBTI-based EMI
Including brief iCBT-I for sleep support, stroke care education, and nurse-led real-time chat-based support messages, which were delivered according to participants' preferences (e.g., time and frequency).

Locations

Country	Name	City	State
Hong Kong	Hong Kong PHAB Association	Hong Kong
Hong Kong	Hong Kong Stroke Association	Hong Kong
Hong Kong	NT West Community Centre	Hong Kong
Hong Kong	Queen Mary Hospital	Hong Kong
Hong Kong	The Hong Kong Society for Rehabilitation	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
The University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sleep Condition Indicator (SCI)	An eight-item rating scale that was developed to screen for insomnia disorder based on DSM-5 criteria. Possible total score ranges from 0 to 32, with higher values indicative of better sleep.	24 weeks
Primary	Insomnia Severity Index (ISI)	A 7-item scale with scoring ranging from 0-28, a higher score indicate more severe insomnia symptoms	24 weeks
Secondary	Sleep quality (Pittsburgh Sleep Quality Index [PSQI])	A 19-item scale ranging from 0 to 21 with the higher total score (referred to as global score) indicating worse sleep quality	24 weeks
Secondary	Depressive symptoms (Patient Health Questionnaire-9 [PHQ-9]):	A 9-item scale with score ranging from 0 to 27, higher scores indicate higher severity of depressive symptom	24 weeks
Secondary	Anxiety symptoms (Generalized Anxiety Disorder-7 [GAD-7])	A 7-item scale with score ranging from 0 to 21, higher scores indicate higher severity of anxiety symptom	24 weeks
Secondary	Caregiver's burden (Zarit Burden Interview [ZBI-4])	A 4-item scale with score ranging from 0 to 16, higher scores indicate higher severity of caregiving burden	24 weeks
Secondary	Quality of life (EuroQol 5-dimension 5-level questionnaire [EQ-5D-5L])	A generic tool for Patient-Reported Outcomes measurement that can assess patients' quality of life, irrespective of the disease.	24 weeks