NCT05952245

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
138

participants targeted

Target at P75+ for not_applicable stroke

Timeline
Completed

Started Dec 2023

Geographic Reach
1 country

5 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 11, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 19, 2023

Completed
5 months until next milestone

Study Start

First participant enrolled

December 1, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2025

Completed
Last Updated

May 30, 2024

Status Verified

June 1, 2023

Enrollment Period

1 year

First QC Date

July 11, 2023

Last Update Submit

May 28, 2024

Conditions

StrokeInsomniaDepressive SymptomsCaregiver BurnoutPsychological DistressMobile Phone Use

Outcome Measures

Primary Outcomes (2)

  • 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.

    24 weeks

  • Insomnia Severity Index (ISI)

    A 7-item scale with scoring ranging from 0-28, a higher score indicate more severe insomnia symptoms

    24 weeks

Secondary Outcomes (15)

  • Sleep quality (Pittsburgh Sleep Quality Index [PSQI])

    24 weeks

  • Depressive symptoms (Patient Health Questionnaire-9 [PHQ-9]):

    24 weeks

  • Anxiety symptoms (Generalized Anxiety Disorder-7 [GAD-7])

    24 weeks

  • Caregiver's burden (Zarit Burden Interview [ZBI-4])

    24 weeks

  • Quality of life (EuroQol 5-dimension 5-level questionnaire [EQ-5D-5L])

    24 weeks

  • +10 more secondary outcomes

Study Arms (2)

Intervention Group

EXPERIMENTAL

Receiving CBT-I based EMI messages.

Behavioral: iCBTI-based EMI

Control Group

ACTIVE COMPARATOR

Receiving education-based EMI messages.

Behavioral: Education-based EMI

Interventions

iCBTI-based EMIBEHAVIORAL

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).

Intervention Group
Education-based EMIBEHAVIORAL

Stroke and brief sleep hygiene education with chat-based support on the topics.

Control Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Hong Kong PHAB Association

Hong Kong, Hong Kong

RECRUITING

Hong Kong Stroke Association

Hong Kong, Hong Kong

RECRUITING

NT West Community Centre

Hong Kong, Hong Kong

RECRUITING

Queen Mary Hospital

Hong Kong, Hong Kong

RECRUITING

The Hong Kong Society for Rehabilitation

Hong Kong, Hong Kong

RECRUITING

MeSH Terms

Conditions

StrokeSleep Initiation and Maintenance DisordersDepressionCaregiver BurdenCell Phone Use

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersMental DisordersBehavioral SymptomsBehaviorStress, PsychologicalCommunicationSocial Behavior

Central Study Contacts

Jung Jae LEE

CONTACT

+852 3917 6971leejay@hku.hk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 11, 2023

First Posted

July 19, 2023

Study Start

December 1, 2023

Primary Completion

December 1, 2024

Study Completion

March 1, 2025

Last Updated

May 30, 2024

Record last verified: 2023-06

Locations

HK(5)