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

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ClinicalTrials.gov Identifier: NCT05952245
Recruitment Status : Not yet recruiting
First Posted : July 19, 2023
Last Update Posted : July 19, 2023
Sponsor:
Information provided by (Responsible Party):
The University of Hong Kong

Tracking Information
First Submitted Date  ICMJE July 11, 2023
First Posted Date  ICMJE July 19, 2023
Last Update Posted Date July 19, 2023
Estimated Study Start Date  ICMJE August 1, 2023
Estimated Primary Completion Date July 15, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 11, 2023)
  • Sleep Condition Indicator (SCI) [ Time Frame: 24 weeks ]
    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) [ Time Frame: 24 weeks ]
    A 7-item scale with scoring ranging from 0-28, a higher score indicate more severe insomnia symptoms
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: July 11, 2023)
  • Sleep quality (Pittsburgh Sleep Quality Index [PSQI]) [ Time Frame: 24 weeks ]
    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]): [ Time Frame: 24 weeks ]
    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]) [ Time Frame: 24 weeks ]
    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]) [ Time Frame: 24 weeks ]
    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]) [ Time Frame: 24 weeks ]
    A generic tool for Patient-Reported Outcomes measurement that can assess patients' quality of life, irrespective of the disease.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Instant Message-delivered Cognitive Behavioural Therapy for Insomnia (CBT-I)Stroke Caregivers
Official Title  ICMJE The Effect of Instant Message-delivered Brief Cognitive Behavioural Therapy for Insomnia (CBT-I) in Stroke Family Caregivers: a Mixed Method Study
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Other
Condition  ICMJE
  • Stroke
  • Insomnia
  • Depressive Symptoms
  • Caregiver Burnout
  • Psychological Distress
  • Mobile Phone Use
Intervention  ICMJE 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).
Study Arms  ICMJE
  • Experimental: Intervention Group
    Receiving CBT-I based EMI messages.
    Intervention: Behavioral: iCBTI-based EMI
  • No Intervention: Control Group
    Receiving stroke education messages.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: July 11, 2023)
138
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 15, 2024
Estimated Primary Completion Date July 15, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Jung Jae LEE +852 3917 6971 leejay@hku.hk
Listed Location Countries  ICMJE Hong Kong
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05952245
Other Study ID Numbers  ICMJE CBTI2023
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party The University of Hong Kong
Original Responsible Party Same as current
Current Study Sponsor  ICMJE The University of Hong Kong
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account The University of Hong Kong
Verification Date June 2023

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP