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

Instant Message-delivered Brief Internet-based Cognitive Behavioural Therapy (iCBT) for Post-stroke Depression: a Mixed Method Study

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.

Study Overview

• Status: Recruiting
• Conditions: Stroke; Depressive Symptoms; Mobile Phone Use
• Intervention / Treatment: Other: iCBT-based EMI

• Study Type: Interventional
• Enrollment (Estimated): 160
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jung Jae LEE; Phone Number: +85239176971; Email: leejay@hku.hk

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong
    • Recruiting
    • Queen Mary Hospital
    • Contact: Gary Lau; Phone Number: 22554249; Email: gkklau@hku.hk
  • Hong Kong, Hong Kong
    • Recruiting
    • Hong Kong PHAB Association
    • Contact: Henry Chan; Phone Number: 37055328; Email: henrychan@hkphab.org.hk
  • Hong Kong, Hong Kong
    • Recruiting
    • Hong Kong Stroke Association
    • Contact: Wendy; Phone Number: 23078257; Email: hk_stroke_a@yahoo.com
  • Hong Kong, Hong Kong
    • Recruiting
    • Tung Wah Hospital
    • Contact: Tsz Kin Kwok; Phone Number: 28597500; Email: kwoktk@ha.org.hk
  • Hong Kong, Hong Kong
    • Recruiting
    • United Christian Hospital
    • Contact: Mick Yu; Phone Number: 52156783; Email: yuct1@ha.org.hk
  • Hong Kong, Hong Kong
    • Recruiting
    • The Hong Kong Society for Rehabilitation
    • Contact: Mike Cheung; Phone Number: 25343349; Email: mike.cheung@rehabsociety.org.hk
  • Hong Kong, Hong Kong
    • Not yet recruiting
    • NT West Community Rehabilitation Day Centre
    • Contact: So; Phone Number: 24569577; Email: ncrc.sw@naac.org.hk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group; Receive iCBT based EMI with message content, delivery frequency and timing personalised to participants' preferences.	Other: iCBT-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.
No Intervention: Control group; Receive general mental health information through instant message.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	24-week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	24-week
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	24-week
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	24-week
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	24-week

Collaborators and Investigators

• Sponsor: The University of Hong Kong

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2023
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): June 1, 2025

Study Registration Dates

• First Submitted: May 28, 2023
• First Submitted That Met QC Criteria: May 28, 2023
• First Posted (Actual): June 7, 2023

Study Record Updates

• Last Update Posted (Actual): July 11, 2024
• Last Update Submitted That Met QC Criteria: July 10, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke; Depression
• Other Study ID Numbers: 27615721

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No