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NCT Number: NCT05892965

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hong Kong PHAB Association, Hong Kong

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Depressive symptoms (Patient Health Questionnaire-9 [PHQ-9])

    Time frame: 24-week

    A 9-item scale with score ranging from 0 to 27, higher scores indicate higher severity of depressive symptom

Secondary outcomes

  1. Anxiety symptoms (Generalized Anxiety Disorder-7 [GAD-7])

    Time frame: 24-week

    A 7-item scale with score ranging from 0 to 21, higher scores indicate higher severity of anxiety symptoms

  2. Stress level (Perceived Stress Scale [PSS-4])

    Time frame: 24-week

    A 4-item scale with score ranging from 0 to 16, higher scores indicate higher severity of stress

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

    Time frame: 24-week

    A 5-item scale with predicted values ranging from -.864 to 1, higher values indicate higher health-related quality of life

  4. Loneliness level (UCLA Loneliness Scale [ULS-8])

    Time frame: 24-week

    The total score (8 items) ranges from 8 to 32 points, with higher scores suggesting a higher degree of loneliness

Study contacts

Contact information is provided by the study sponsor or research team.

Jung Jae LEE

CONTACT

[email protected]

+85239176971

Sponsors and collaborators

Lead sponsor

The University of Hong Kong

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Jun 7, 2023
Registry last updated
Jul 11, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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