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

May 28, 2024 updated by: The University of Hong Kong

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

138

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Jung Jae Lee
  • Phone Number: +852 3917 6971
  • Email: leejay@hku.hk

Study Locations

  • Hong Kong
      • Hong Kong, Hong Kong
        • Recruiting
        • Queen Mary Hospital
        • Contact:
      • Hong Kong, Hong Kong
        • Recruiting
        • Hong Kong PHAB Association
        • Contact:
      • Hong Kong, Hong Kong
        • Recruiting
        • Hong Kong Stroke Association
        • Contact:
      • Hong Kong, Hong Kong
      • Hong Kong, Hong Kong
        • Recruiting
        • NT West Community Centre
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
24 weeks
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
24 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
24 weeks
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
24 weeks
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
24 weeks
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
24 weeks
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).
24 weeks
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.
24 weeks
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.
24 weeks
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).
24 weeks
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.
24 weeks
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.
24 weeks
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.
24 weeks
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.
24 weeks
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
24 weeks
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.
24 weeks
Adverse events
Time Frame: 24 weeks
Feedback on adverse events related to the iCBT-I intervention, such as fatigue, will be collected.
24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Hong Kong

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2023

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

March 1, 2025

Study Registration Dates

First Submitted

July 11, 2023

First Submitted That Met QC Criteria

July 11, 2023

First Posted (Actual)

July 19, 2023

Study Record Updates

Last Update Posted (Actual)

May 30, 2024

Last Update Submitted That Met QC Criteria

May 28, 2024

Last Verified

June 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CBTI2023

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Stroke

Clinical Trials on iCBTI-based EMI

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Benin

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe