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Instant Message-delivered Brief Internet-based Cognitive Behavioural Therapy (iCBT) for Post-stroke Depression

Primary Purpose

Stroke, Depressive Symptoms, Mobile Phone Use

Status
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

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 the text or voice messaging function on smartphone; MoCA 5-minute Protocol (cognitive screen) ≥14; Community-dwelling Less than 1 year after stroke event; 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: Diagnosis of psychiatric disease before stroke event or currently taking psychotropic drug including antidepressants PHQ-9 ≥ 20 (i.e., severe depressive symptom) Currently participating in any type of psychological intervention

Sites / Locations

  • Hong Kong PHAB AssociationRecruiting
  • Hong Kong Stroke AssociationRecruiting
  • NT West Community Rehabilitation Day Centre
  • Queen Mary HospitalRecruiting
  • The Hong Kong Society for RehabilitationRecruiting
  • Tung Wah HospitalRecruiting
  • United Christian HospitalRecruiting

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
Quality of life (EuroQol 5-dimension 5-level questionnaire [EQ-5D-5L])
A 5-item scale with predicted values ranging from -.864 to 1, higher values indicate higher health-related quality of life
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

Full Information

First Posted
May 28, 2023
Last Updated
June 7, 2023
Sponsor
The University of Hong Kong
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1. Study Identification

Unique Protocol Identification Number
NCT05892965
Brief Title
Instant Message-delivered Brief Internet-based Cognitive Behavioural Therapy (iCBT) for Post-stroke Depression
Official Title
Instant Message-delivered Brief Internet-based Cognitive Behavioural Therapy (iCBT) for Post-stroke Depression: a Mixed Method Study
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 1, 2023 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
June 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
No

5. Study Description

Brief Summary
Around one third of stroke survivors develop depression at any point of time following the stroke event. Post-stroke depression (PSD) is associated with negative care outcomes including poorer function, longer hospital stays, increased outpatient and inpatient clinic use, and higher mortality rate. In Hong Kong (HK), the prevalence of PSD within the hospital setting was 36%, and up to 68% in the community setting. However, PSD is seldom addressed in either settings in HK and elsewhere. Meta-analyses reported the effectiveness of Internet-based cognitive behavioural therapy (iCBT), particularly when guided by therapists (d = 0.63). Personalised and synchronous instant message-based intervention guided by therapists is an emerging form of psychological intervention. While such intervention showed medium to large effect (Hedges' g = 0.73) on negative psychological distress episodes including depression, no study has investigated its effect on PSD. The proposed study aims to 1) investigate the effect of therapist-guided brief iCBT delivery through instant messaging applications (e.g. WhatsApp and WeChat) to provide personalised and synchronous PSD support and 2) understand the experience of and compliance with the intervention. 160 community-dwelling stroke survivors with Patient Health Questionnaire-9 (PHQ-9) scores ranging from 5 to 19 indicating mild to moderate depressive symptoms will be recruited and then individually randomised into the Intervention group (n=80) or Control group (n=80). Intervention group will receive 1) instant message-delivered brief iCBT for 3 months at participants' chosen times and frequencies, and 2) therapist-led text or voice message-based PSD support to enhance the effects of iCBT through real-time counselling and practical advice. Control group will only receive messages on general mental health information and reminders to participate in follow-up surveys. The primary outcome is PHQ-9 score at 6 months. Secondary outcomes will include anxiety (GAD-7), perceived stress (PSS-4), loneliness (ULS-8), and quality of life (EQ-5D-5L) at 6 months. The study will strictly follow the CONSORT-EHEALTH checklist. Post-trial qualitative study will be conducted to understand the participants' experience of and compliance with the intervention (n≈20) respectively. This study will provide the first and practical evidence on the effectiveness of instant message-delivered brief iCBT intervention in addressing PSD in HK and beyond.

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
160 (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
Other
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
Quality of life (EuroQol 5-dimension 5-level questionnaire [EQ-5D-5L])
Description
A 5-item scale with predicted values ranging from -.864 to 1, higher values indicate higher health-related quality of life
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

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 the text or voice messaging function on smartphone; MoCA 5-minute Protocol (cognitive screen) ≥14; Community-dwelling Less than 1 year after stroke event; 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: Diagnosis of psychiatric disease before stroke event or currently taking psychotropic drug including antidepressants PHQ-9 ≥ 20 (i.e., severe depressive symptom) 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
+85239176971
Email
leejay@hku.hk
Facility Information:
Facility Name
Hong Kong PHAB Association
City
Hong Kong
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Henry Chan
Phone
37055328
Email
henrychan@hkphab.org.hk
Facility Name
Hong Kong Stroke Association
City
Hong Kong
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wendy
Phone
23078257
Email
hk_stroke_a@yahoo.com
Facility Name
NT West Community Rehabilitation Day Centre
City
Hong Kong
Country
Hong Kong
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
So
Phone
24569577
Email
ncrc.sw@naac.org.hk
Facility Name
Queen Mary Hospital
City
Hong Kong
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gary Lau
Phone
22554249
Email
gkklau@hku.hk
Facility Name
The Hong Kong Society for Rehabilitation
City
Hong Kong
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mike Cheung
Phone
25343349
Email
mike.cheung@rehabsociety.org.hk
Facility Name
Tung Wah Hospital
City
Hong Kong
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tsz Kin Kwok
Phone
28597500
Email
kwoktk@ha.org.hk
Facility Name
United Christian Hospital
City
Hong Kong
Country
Hong Kong
Individual Site Status
Recruiting
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 Brief Internet-based Cognitive Behavioural Therapy (iCBT) for Post-stroke Depression

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