ClinicalTrials.gg
Status unknownNCT05907005EPIUpdated Jul 11, 2024

Instant Message-delivered Early Psychological Intervention in Stroke Family Caregivers

An interventional study of iCBT-based EMI in Stroke, Caregiver Burden and Mobile Phone Use, sponsored by The University of Hong Kong. Status unknown at 5 sites in Hong Kong. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-07-11.

Sponsored by The University of Hong Kong · Not applicable, Interventional, and Other

The sponsor has not verified this record recently (last verified Jul 2024), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
152
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

Psychological distress including depression and anxiety is a major component of caregiver stress, and its negative impact on caregivers' health and well-being has been established in the literature. A recent meta-analysis reported the prevalence of depression and anxiety in stroke caregivers as 40.2% and 21.4% respectively.

An evidence profile report by the World Health Organization(WHO) has emphasised that psychological support is crucial in helping caregivers in the community to continue caring for individuals with long-term disabilities, such as stroke patients. Therefore, early psychological intervention (EPI) is crucial to improve the management and prognosis of an individual who are facing stressful events like caregiving.

The main aim of this study is to prevent or alleviate the significant psychological consequences in carers resulting from stroke events in family members. Internet-delivered cognitive-behavioural therapy (iCBT) is delivered as an ecological momentary intervention (EMI) to support the clients to engage in cognitive reframing and empower them with proper knowledge, skills and attitudes to make behavioural changes.

02

Conditions studied

  • Stroke
  • Caregiver Burden
  • Mobile Phone Use

Keywords

  • Cognitive-behavioural therapy
  • ecological momentary intervention
  • early psychological intervention
03

In context

Stroke

7,443 studies on the registry are indexed under Stroke; 2,012 are open to participants now.

This study's planned enrollment of 152 is above the median of 50 across 5,482 interventional studies indexed under Stroke.

Browse Stroke studies →

Lead sponsor

The University of Hong Kong is the lead sponsor of 1,286 studies on the registry; 343 are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Primary family caregiver of first-ever stroke patient who has \<15 modified Barthel Index(mBI) scores (moderate disability);
  • Caregiver of a stroke patient who has a hospital inpatient stay of ≥6 days and ≤21days;
  • Aged ≥18;
  • Able to read and communicate in Chinese (Cantonese or Putonghua);
  • Able to use mobile phone instant messaging function; and
  • PHQ-9 (depressive symptom) score ranging from 5 to 19 (note. mild: 5-9, moderate: 10-14, moderately severe: 15-19 and severe: 20-27)

Exclusion criteria

Exclusion Criteria:

  • Caregiver of stroke patient who is admitted to intensive care unit;
  • Professional medical personnel and/or professional carer;
  • Diagnosis of psychiatric disease before stroke event or currently taking psychotropic drug including antidepressants;
  • PHQ-9≥20 (we shall provide information on mental health services; if needed, we shall make the appropriate referrals); and
  • Currently participating in any type of psychological intervention.
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
152 participants (estimated)

Study arms

  • Experimental
    Intervention Group

    Receive iCBT-based EMI with message content, delivery frequency and timing personalised to participants' preferences.

    Behavioral: iCBT-based EMI

  • No intervention
    Control Group

    Receive general mental health information through instant message.

Interventions

  • BehavioraliCBT-based EMI

    Consists of brief iCBT for psychological support (mandatory), stroke care education (optional), and nurse-led real-time chat-based support messages, delivered according to participants' preferences.

06

What researchers measure

Primary outcomes

  1. Depressive symptoms (Patient Health Questionnaire-9 [PHQ-9])

    A 9-item scale with score ranging from 0 to 27, higher scores indicate higher severity of depressive symptom

    Time frame: 24-week

Secondary outcomes

  1. Anxiety symptoms (Generalized Anxiety Disorder-7 [GAD-7])

    A 7-item scale with score ranging from 0 to 21, higher scores indicate higher severity of anxiety symptoms

    Time frame: 24-week

  2. Stress level (Perceived Stress Scale [PSS-4])

    A 4-item scale with score ranging from 0 to 16, higher scores indicate higher severity of stress

    Time frame: 24-week

  3. Loneliness level (UCLA Loneliness Scale [ULS-8])

    The total score (8 items) ranges from 8 to 32 points, with higher scores suggesting a higher degree of loneliness

    Time frame: 24-week

  4. Acceptance and Action Questionnaire-II (AAQ-II)

    The total score (7 items) ranges from 7 to 49 points, with higher scores suggesting a higher degree of psychological inflexibility and experiential avoidance

    Time frame: 24-week

07

Study locations

4 of 5 sites recruiting
  • Kwong Wah Hospital
    Hong Kong, Hong Kong
    Not yet recruiting
  • Princess Margaret Hospital
    Hong Kong, Hong Kong
    Recruiting
  • Queen Elizabeth Hospital
    Hong Kong, Hong Kong
    Recruiting
  • Queen Mary Hospital
    Hong Kong, Hong Kong
    Recruiting
  • United Christian Hospital
    Hong Kong, Hong Kong
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jul 2023 (actual). Primary completion is estimated for Jul 2025, 24 months after the start.

Of 2,859 non-industry interventional studies with no phase under Stroke, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 45. This study's planned 24 months is close to that.

Counting every sponsor, half of 2,988 studies reached it within 23 months; a quarter within 10 and three quarters within 45.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 7, 2023
First posted
Jun 18, 2023
StartActual
Jul 24, 2023
Primary completionEst.
Jul 24, 2025
CompletionEst.
Jul 31, 2025
Last update
Jul 11, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 11, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05907005
Responsible party
Sponsor
First posted
Jun 18, 2023
Start date
Jul 24, 2023
Primary completion
Jul 24, 2025 (estimated)
Completion
Jul 31, 2025 (estimated)
Last update
Jul 11, 2024

Study contacts

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

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.

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