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Instant Message-delivered Early Psychological Intervention in Stroke Family Caregivers (EPI)

Primary Purpose

Stroke, Caregiver Burden, Mobile Phone Use

Status
Not yet recruiting
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
iCBT-based EMI
Sponsored by
The University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Stroke focused on measuring Cognitive-behavioural therapy, ecological momentary intervention, early psychological intervention

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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: 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.

Sites / Locations

  • Kwong Wah Hospital
  • Princess Margaret Hospital
  • Queen Elizabeth Hospital
  • Queen Mary Hospital
  • United Christian Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention Group

Control Group

Arm Description

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

Receive general mental health information through instant message.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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
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
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

Full Information

First Posted
June 7, 2023
Last Updated
July 11, 2023
Sponsor
The University of Hong Kong
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1. Study Identification

Unique Protocol Identification Number
NCT05907005
Brief Title
Instant Message-delivered Early Psychological Intervention in Stroke Family Caregivers
Acronym
EPI
Official Title
Instant Message-delivered Early Psychological Intervention in Stroke Family Caregivers: a Mixed-method Study
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
July 24, 2023 (Anticipated)
Primary Completion Date
July 24, 2025 (Anticipated)
Study Completion Date
July 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The University of Hong Kong

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Caregiver Burden, Mobile Phone Use
Keywords
Cognitive-behavioural therapy, ecological momentary intervention, early psychological intervention

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
152 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention Group
Arm Type
Experimental
Arm Description
Receive iCBT-based EMI with message content, delivery frequency and timing personalised to participants' preferences.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Receive general mental health information through instant message.
Intervention Type
Behavioral
Intervention Name(s)
iCBT-based EMI
Intervention Description
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.
Primary Outcome Measure Information:
Title
Depressive symptoms (Patient Health Questionnaire-9 [PHQ-9])
Description
A 9-item scale with score ranging from 0 to 27, higher scores indicate higher severity of depressive symptom
Time Frame
24-week
Secondary Outcome Measure Information:
Title
Anxiety symptoms (Generalized Anxiety Disorder-7 [GAD-7])
Description
A 7-item scale with score ranging from 0 to 21, higher scores indicate higher severity of anxiety symptoms
Time Frame
24-week
Title
Stress level (Perceived Stress Scale [PSS-4])
Description
A 4-item scale with score ranging from 0 to 16, higher scores indicate higher severity of stress
Time Frame
24-week
Title
Loneliness level (UCLA Loneliness Scale [ULS-8])
Description
The total score (8 items) ranges from 8 to 32 points, with higher scores suggesting a higher degree of loneliness
Time Frame
24-week
Title
Acceptance and Action Questionnaire-II (AAQ-II)
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jung Jae LEE
Phone
+852 3917 6971
Email
leejay@hku.hk
Facility Information:
Facility Name
Kwong Wah Hospital
City
Hong Kong
Country
Hong Kong
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Peter Woo
Email
wym307@ha.org.hk
Facility Name
Princess Margaret Hospital
City
Hong Kong
Country
Hong Kong
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ryan Chu
Phone
29903205
Email
cmk019@ha.org.hk
Facility Name
Queen Elizabeth Hospital
City
Hong Kong
Country
Hong Kong
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vivian Kwok
Phone
35064579
Email
bkwyv02@ha.org.hk
Facility Name
Queen Mary Hospital
City
Hong Kong
Country
Hong Kong
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gary Lau
Phone
22554249
Email
gkklau@hku.hk
Facility Name
United Christian Hospital
City
Hong Kong
Country
Hong Kong
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mick Yu
Phone
52156783
Email
yuct1@ha.org.hk

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Instant Message-delivered Early Psychological Intervention in Stroke Family Caregivers

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