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

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05892965
• Other study ID #: 27615721
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2023
• Est. completion date: June 2025

Study information

• Verified date: July 2022
• Source: The University of Hong Kong
• Contact: Jung Jae LEE
• Phone: +85239176971
• Email: leejay[@]hku.hk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. completion date: June 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Symptoms
• Mobile Phone Use
• Stroke

Intervention

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.

Locations

Country	Name	City	State
Hong Kong	Hong Kong PHAB Association	Hong Kong
Hong Kong	Hong Kong Stroke Association	Hong Kong
Hong Kong	NT West Community Rehabilitation Day Centre	Hong Kong
Hong Kong	Queen Mary Hospital	Hong Kong
Hong Kong	The Hong Kong Society for Rehabilitation	Hong Kong
Hong Kong	Tung Wah Hospital	Hong Kong
Hong Kong	United Christian Hospital	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
The University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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