Instant Message-delivered Cognitive Behavioural Therapy for Insomnia (CBT-I)Stroke Caregivers
Primary Purpose
Stroke, Insomnia, Depressive Symptoms
Status
Not yet recruiting
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
iCBTI-based EMI
Sponsored by
About this trial
This is an interventional other trial for Stroke
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 ≤ 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
Sites / Locations
- Hong Kong PHAB Association
- Hong Kong Stroke Association
- NT West Community Centre
- Queen Mary Hospital
- The Hong Kong Society for Rehabilitation
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention Group
Control Group
Arm Description
Receiving CBT-I based EMI messages.
Receiving stroke education messages.
Outcomes
Primary Outcome Measures
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.
Insomnia Severity Index (ISI)
A 7-item scale with scoring ranging from 0-28, a higher score indicate more severe insomnia symptoms
Secondary Outcome Measures
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
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
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
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
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.
Full Information
NCT ID
NCT05952245
First Posted
July 11, 2023
Last Updated
July 11, 2023
Sponsor
The University of Hong Kong
1. Study Identification
Unique Protocol Identification Number
NCT05952245
Brief Title
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
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
August 1, 2023 (Anticipated)
Primary Completion Date
July 15, 2024 (Anticipated)
Study Completion Date
October 15, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The University of Hong Kong
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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( 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Insomnia, Depressive Symptoms, Caregiver Burnout, Psychological Distress, Mobile Phone Use
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
138 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention Group
Arm Type
Experimental
Arm Description
Receiving CBT-I based EMI messages.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Receiving stroke education messages.
Intervention Type
Behavioral
Intervention Name(s)
iCBTI-based EMI
Intervention Description
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).
Primary Outcome Measure Information:
Title
Sleep Condition Indicator (SCI)
Description
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.
Time Frame
24 weeks
Title
Insomnia Severity Index (ISI)
Description
A 7-item scale with scoring ranging from 0-28, a higher score indicate more severe insomnia symptoms
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
Sleep quality (Pittsburgh Sleep Quality Index [PSQI])
Description
A 19-item scale ranging from 0 to 21 with the higher total score (referred to as global score) indicating worse sleep quality
Time Frame
24 weeks
Title
Depressive symptoms (Patient Health Questionnaire-9 [PHQ-9]):
Description
A 9-item scale with score ranging from 0 to 27, higher scores indicate higher severity of depressive symptom
Time Frame
24 weeks
Title
Anxiety symptoms (Generalized Anxiety Disorder-7 [GAD-7])
Description
A 7-item scale with score ranging from 0 to 21, higher scores indicate higher severity of anxiety symptom
Time Frame
24 weeks
Title
Caregiver's burden (Zarit Burden Interview [ZBI-4])
Description
A 4-item scale with score ranging from 0 to 16, higher scores indicate higher severity of caregiving burden
Time Frame
24 weeks
Title
Quality of life (EuroQol 5-dimension 5-level questionnaire [EQ-5D-5L])
Description
A generic tool for Patient-Reported Outcomes measurement that can assess patients' quality of life, irrespective of the disease.
Time Frame
24 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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 ≤ 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jung Jae LEE
Phone
+852 3917 6971
Email
leejay@hku.hk
Facility Information:
Facility Name
Hong Kong PHAB Association
City
Hong Kong
Country
Hong Kong
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gary Lau
Phone
24268338
Email
garypau@hkphab.org.hk
Facility Name
Hong Kong Stroke Association
City
Hong Kong
Country
Hong Kong
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ming Chui
Phone
23078257
Email
hk_stroke_a@yahoo.com
Facility Name
NT West Community Centre
City
Hong Kong
Country
Hong Kong
Facility Contact:
First Name & Middle Initial & Last Name & Degree
So
Phone
24569577
Email
ncrc.sw@naac.org.hk
Facility Name
Queen Mary Hospital
City
Hong Kong
Country
Hong Kong
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gary Lau
Phone
22554249
Email
gkklau@hku.hk
Facility Name
The Hong Kong Society for Rehabilitation
City
Hong Kong
Country
Hong Kong
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mike Cheung
Phone
22056336
Email
mike.cheung@rehabsociety.org.hk
12. IPD Sharing Statement
Learn more about this trial
Instant Message-delivered Cognitive Behavioural Therapy for Insomnia (CBT-I)Stroke Caregivers
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