Clinical trial NCT05892965: 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
Overall status: RECRUITING
Phase: NA
Conditions: Stroke
Depressive Symptoms
Mobile Phone Use
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2023-06-07
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


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

Primary outcomes:
measure: Depressive symptoms (Patient Health Questionnaire-9 [PHQ-9])
timeFrame: 24-week
Secondary outcomes:
measure: Anxiety symptoms (Generalized Anxiety Disorder-7 [GAD-7])
timeFrame: 24-week
measure: Stress level (Perceived Stress Scale [PSS-4])
timeFrame: 24-week
measure: Quality of life (EuroQol 5-dimension 5-level questionnaire [EQ-5D-5L])
timeFrame: 24-week
measure: Loneliness level (UCLA Loneliness Scale [ULS-8])
timeFrame: 24-week
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Hong Kong PHAB Association
city: Hong Kong
country: Hong Kong
facility: Hong Kong Stroke Association
city: Hong Kong
country: Hong Kong
facility: NT West Community Rehabilitation Day Centre
city: Hong Kong
country: Hong Kong
facility: Queen Mary Hospital
city: Hong Kong
country: Hong Kong
facility: The Hong Kong Society for Rehabilitation
city: Hong Kong
country: Hong Kong
facility: Tung Wah Hospital
city: Hong Kong
country: Hong Kong
facility: United Christian Hospital
Study officials:
References: