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The Effect of Instant Message Intervention for Psychological Well-being Among Stroke Survivors

Primary Purpose

Stroke, Depressive Symptoms, Mobile Phone Use

Status
Completed
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

Eligibility Criteria

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

Inclusion Criteria:

  • Diagnosis of stroke (ICD-10 codes: I60-I69)
  • Aged ≥18
  • Able to read and communicate in Chinese (Cantonese or Putonghua)
  • Able to use text messaging function on mobile phones
  • MoCA 5-minute Protocol (cognitive screen) ≥14 (Equivalence to MMSE ≥ 21)
  • Discharged home from hospital within preceding 6 months
  • PHQ-9 (depressive symptom) score range from 5 to 19 (cf. mild: 5-9, moderate: 10-14, moderately severe: 15-19 and severe: 20-27)

Exclusion Criteria:

  • Currently receiving active stroke care in acute or post-acute inpatient settings
  • Has diagnosis of psychiatric disease or is currently taking psychotropic drug
  • PHQ-9 ≥ 20 (i.e., severe depressive symptom)
  • Currently participating in any type of psychological intervention (e.g., CBT)

Sites / Locations

  • Hong Kong PHAB Association
  • Hong Kong Stroke Association
  • NT West Community Rehabilitation Day Centre
  • Queen Mary Hospital
  • The Hong Kong Society for Rehabilitation
  • Tung Wah 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
Spiritual well-being (Sub-scale of Spirituality Scale for Chinese Elders [SSCE])
An 8-item scale with score ranging from 0 to 32, higher scores indicate better spiritual well-being
Loneliness (UCLA Loneliness Scale [ULS-8])
An 8-item scale with score ranging from 8 to 32, higher scores indicate higher level of loneliness

Full Information

First Posted
August 3, 2022
Last Updated
April 27, 2023
Sponsor
The University of Hong Kong
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1. Study Identification

Unique Protocol Identification Number
NCT05490069
Brief Title
The Effect of Instant Message Intervention for Psychological Well-being Among Stroke Survivors
Official Title
The Effect of Instant Message Intervention for Psychological Well-being Among Stroke Survivors
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
October 4, 2021 (Actual)
Primary Completion Date
December 23, 2022 (Actual)
Study Completion Date
December 23, 2022 (Actual)

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
No

5. Study Description

Brief Summary
The proposed pilot trial aims to evaluate the feasibility of iCBT based EMI, which is a real-time, real-world, personalised and cost-effective approach, for stroke survivors' psychological well-being.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Depressive Symptoms, Mobile Phone Use

7. Study Design

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

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
Other
Intervention Name(s)
iCBT-based EMI
Intervention Description
Consists of brief iCBT for psychological support (mandatory), stroke care education (optional), and 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
Spiritual well-being (Sub-scale of Spirituality Scale for Chinese Elders [SSCE])
Description
An 8-item scale with score ranging from 0 to 32, higher scores indicate better spiritual well-being
Time Frame
24-week
Title
Loneliness (UCLA Loneliness Scale [ULS-8])
Description
An 8-item scale with score ranging from 8 to 32, higher scores indicate higher level of loneliness
Time Frame
24-week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosis of stroke (ICD-10 codes: I60-I69) Aged ≥18 Able to read and communicate in Chinese (Cantonese or Putonghua) Able to use text messaging function on mobile phones MoCA 5-minute Protocol (cognitive screen) ≥14 (Equivalence to MMSE ≥ 21) Discharged home from hospital within preceding 6 months PHQ-9 (depressive symptom) score range from 5 to 19 (cf. mild: 5-9, moderate: 10-14, moderately severe: 15-19 and severe: 20-27) Exclusion Criteria: Currently receiving active stroke care in acute or post-acute inpatient settings Has diagnosis of psychiatric disease or is currently taking psychotropic drug PHQ-9 ≥ 20 (i.e., severe depressive symptom) Currently participating in any type of psychological intervention (e.g., CBT)
Facility Information:
Facility Name
Hong Kong PHAB Association
City
Hong Kong
Country
Hong Kong
Facility Name
Hong Kong Stroke Association
City
Hong Kong
Country
Hong Kong
Facility Name
NT West Community Rehabilitation Day Centre
City
Hong Kong
Country
Hong Kong
Facility Name
Queen Mary Hospital
City
Hong Kong
Country
Hong Kong
Facility Name
The Hong Kong Society for Rehabilitation
City
Hong Kong
Country
Hong Kong
Facility Name
Tung Wah Hospital
City
Hong Kong
Country
Hong Kong
Facility Name
United Christian Hospital
City
Hong Kong
Country
Hong Kong

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

The Effect of Instant Message Intervention for Psychological Well-being Among Stroke Survivors

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