The classic website will no longer be available as of June 25, 2024. Please use the modernized ClinicalTrials.gov.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Stroke Insomnia Depressive Symptoms Caregiver Burnout Psychological Distress Mobile Phone Use Behavioral: iCBTI-based EMI Not Applicable

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 Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 138 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Other
Official Title: The Effect of Instant Message-delivered Brief Cognitive Behavioural Therapy for Insomnia (CBT-I) in Stroke Family Caregivers: a Mixed Method Study
Estimated Study Start Date : August 1, 2023
Estimated Primary Completion Date : July 15, 2024
Estimated Study Completion Date : October 15, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Caregivers

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Intervention Group
Receiving CBT-I based EMI messages.
 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).
No Intervention: Control Group
Receiving stroke education messages.


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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.

  2. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05952245


Contacts
Layout table for location contacts
Contact: Jung Jae LEE +852 3917 6971 leejay@hku.hk

Locations
Layout table for location information
Hong Kong
Hong Kong PHAB Association
Hong Kong, Hong Kong
Contact: Gary Lau    24268338    garypau@hkphab.org.hk   
Hong Kong Stroke Association
Hong Kong, Hong Kong
Contact: Ming Chui    23078257    hk_stroke_a@yahoo.com   
NT West Community Centre
Hong Kong, Hong Kong
Contact: So    24569577    ncrc.sw@naac.org.hk   
Queen Mary Hospital
Hong Kong, Hong Kong
Contact: Gary Lau    22554249    gkklau@hku.hk   
The Hong Kong Society for Rehabilitation
Hong Kong, Hong Kong
Contact: Mike Cheung    22056336    mike.cheung@rehabsociety.org.hk   
Sponsors and Collaborators
The University of Hong Kong
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: The University of Hong Kong
ClinicalTrials.gov Identifier: NCT05952245    
Other Study ID Numbers: CBTI2023
First Posted: July 19, 2023    Key Record Dates
Last Update Posted: July 19, 2023
Last Verified: June 2023

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Stroke
Sleep Initiation and Maintenance Disorders
Depression
Caregiver Burden
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Vascular Diseases
Cardiovascular Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Mental Disorders
Behavioral Symptoms
Stress, Psychological