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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 : Recruiting
First Posted : July 19, 2023
Last Update Posted : May 30, 2024
Sponsor:
Information provided by (Responsible Party):
The University of Hong Kong

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 Behavioral: Education-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 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.

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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
Actual Study Start Date : December 1, 2023
Estimated Primary Completion Date : December 2024
Estimated Study Completion Date : March 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Caregivers

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).

Active Comparator: Control Group
Receiving education-based EMI messages.
Behavioral: Education-based EMI
Stroke and brief sleep hygiene education with chat-based support on the topics.




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 ]

    The EQ-5D-5L assesses five health dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, each rated on five levels of severity, with scores ranging from -0.864 to 1, where higher scores indicate better quality of life.

    Additionally, it includes a visual analogue scale (VAS), ranging from 0 (the worst health imaginable) to 100 (the best health imaginable).


  6. Positive experiences from caregiving (Positive Aspect of Caregiving [PAC]) [ Time Frame: 24 weeks ]
    An 11-item scale with scores ranging from 0 to 44. A higher score indicates a more positive caregiving experience.

  7. Caregiving self-efficacy (Caregiving Self-Efficacy Scale [CSES-8]) [ Time Frame: 24 weeks ]
    An 8-item scale with scores ranging from 1 to 10, with higher scores indicating higher self-efficacy.

  8. Sleep parameters (Consensus Sleep Diary Core Version) [ Time Frame: 24 weeks ]
    The Consensus Sleep Diary Core Version will be used to collect sleep parameters (e.g., sleep efficiency and total sleep time).

  9. Dysfunctional Beliefs and attitudes about Sleep (Dysfunctional Beliefs and attitudes about Sleep [DBAS]) [ Time Frame: 24 weeks ]
    A 16-item scale with scores ranging from 0 to 160, with higher scores indicating greater dysfunctional beliefs about sleep.

  10. Sleep hygiene statue (Sleep Hygiene Index [SHI]) [ Time Frame: 24 weeks ]
    A 13-item scale with ratings from 0 to 52, where higher scores indicate poorer sleep hygiene status.

  11. Sleep-related behavior (Chinese short-form of the sleep-related behavior questionnaire [SRBQ-SF]) [ Time Frame: 24 weeks ]
    A 23-item scale with scores ranging from 0 to 92. A higher score indicates more sleep-related safety behaviors.

  12. State of sleep effort (Glasgow Sleep Effort Scale [GSES]) [ Time Frame: 24 weeks ]
    A 7-item scale with scores ranging from 0 to 14, where higher scores indicate greater effort to sleep over the past week.

  13. Sleep-related quality of life (Glasgow Sleep Impact Index [GSII]) [ Time Frame: 24 weeks ]

    The primary measureable outcomes for the GSII reflect VAS scores (0-100; with lower scores reflecting negative impact) for each of the three specified ranks, capturing impairment in the past two weeks.

    GSII reflect VAS scores (0-100; with lower scores reflecting negative impact) for each of the three


  14. Feedback on iCBT-I intervention [ Time Frame: 24 weeks ]
    Feedback on the sleep support programme will be collected, focusing on various aspects such as perceived usefulness and willingness to recommend the program. Each aspect will be evaluated using a 5-point Likert scale, where higher scores indicate more positive evaluations.

  15. Adverse events [ Time Frame: 24 weeks ]
    Feedback on adverse events related to the iCBT-I intervention, such as fatigue, will be collected.



Information from the National Library of Medicine

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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 ≤ 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

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
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Contact: Jung Jae LEE +852 3917 6971 leejay@hku.hk

Locations
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Hong Kong
Hong Kong PHAB Association Recruiting
Hong Kong, Hong Kong
Contact: Gary Lau    24268338    garypau@hkphab.org.hk   
Hong Kong Stroke Association Recruiting
Hong Kong, Hong Kong
Contact: Ming Chui    23078257    hk_stroke_a@yahoo.com   
NT West Community Centre Recruiting
Hong Kong, Hong Kong
Contact: So    24569577    ncrc.sw@naac.org.hk   
Queen Mary Hospital Recruiting
Hong Kong, Hong Kong
Contact: Gary Lau    22554249    gkklau@hku.hk   
The Hong Kong Society for Rehabilitation Recruiting
Hong Kong, Hong Kong
Contact: Mike Cheung    22056336    mike.cheung@rehabsociety.org.hk   
Sponsors and Collaborators
The University of Hong Kong
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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: May 30, 2024
Last Verified: June 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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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