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临床试验/NCT05892965
NCT05892965招募中不适用

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

The University of Hong Kong7 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2023年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
160
试验地点
7
主要终点
Depressive symptoms (Patient Health Questionnaire-9 [PHQ-9])

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Double (Participant, Investigator)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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)

排除标准

  • 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

结局指标

主要结局

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

时间窗: 24-week

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

次要结局

  • 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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (7)

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