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

NCT ID: NCT05892965

Last Updated: 2024-07-11

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 160 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-01
• Study Completion Date: 2025-06-30

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.

Conditions

Stroke; Depressive Symptoms; Mobile Phone Use

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

Intervention group

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

Group Type: EXPERIMENTAL

iCBT-based EMI

Intervention Type: OTHER

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.

Control group

Receive general mental health information through instant message.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The University of Hong Kong

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hong Kong PHAB Association

Hong Kong, , Hong Kong

Site Status: RECRUITING

Hong Kong Stroke Association

Hong Kong, , Hong Kong

Site Status: RECRUITING

NT West Community Rehabilitation Day Centre

Hong Kong, , Hong Kong

Site Status: NOT_YET_RECRUITING

Queen Mary Hospital

Hong Kong, , Hong Kong

Site Status: RECRUITING

The Hong Kong Society for Rehabilitation

Hong Kong, , Hong Kong

Site Status: RECRUITING

Tung Wah Hospital

Hong Kong, , Hong Kong

Site Status: RECRUITING

United Christian Hospital

Hong Kong, , Hong Kong

Site Status: RECRUITING

Countries

Hong Kong

Central Contacts

Jung Jae LEE

Role: CONTACT

leejay@hku.hk

+85239176971

Facility Contacts

Henry Chan

Role: primary

henrychan@hkphab.org.hk

37055328

Wendy

Role: primary

hk_stroke_a@yahoo.com

23078257

So

Role: primary

ncrc.sw@naac.org.hk

24569577

Gary Lau

Role: primary

gkklau@hku.hk

22554249

Mike Cheung

Role: primary

mike.cheung@rehabsociety.org.hk

25343349

Tsz Kin Kwok

Role: primary

kwoktk@ha.org.hk

28597500

Mick Yu

Role: primary

yuct1@ha.org.hk

52156783

Other Identifiers

27615721

Identifier Type: -

Identifier Source: org_study_id