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

NCT05892965 | Recruiting

• 1 other identifier: 27615721
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 7

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Anxiety symptoms (Generalized Anxiety Disorder-7 [GAD-7])

  24-week

• Stress level (Perceived Stress Scale [PSS-4])

  24-week

• Quality of life (EuroQol 5-dimension 5-level questionnaire [EQ-5D-5L])

  24-week

• Loneliness level (UCLA Loneliness Scale [ULS-8])

  24-week

Study Arms (2)

Intervention group

EXPERIMENTAL

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

Other: iCBT-based EMI

Control group

NO INTERVENTION

Receive general mental health information through instant message.

Interventions

iCBT-based EMI 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.

Intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (7)

Hong Kong PHAB Association

Hong Kong, Hong Kong

RECRUITING

Hong Kong Stroke Association

Hong Kong, Hong Kong

RECRUITING

NT West Community Rehabilitation Day Centre

Hong Kong, Hong Kong

NOT YET RECRUITING

Queen Mary Hospital

Hong Kong, Hong Kong

RECRUITING

The Hong Kong Society for Rehabilitation

Hong Kong, Hong Kong

RECRUITING

Tung Wah Hospital

Hong Kong, Hong Kong

RECRUITING

United Christian Hospital

Hong Kong, Hong Kong

RECRUITING

MeSH Terms

Conditions

Stroke; Depression; Cell Phone Use

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Behavioral Symptoms; Behavior; Communication; Social Behavior

Central Study Contacts

Jung Jae LEE

CONTACT

+85239176971; leejay@hku.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 28, 2023
• First Posted: June 7, 2023
• Study Start: May 1, 2023
• Primary Completion: December 1, 2024
• Study Completion: June 1, 2025
• Last Updated: July 11, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

HK (7)