The Effect of Instant Message Intervention for Psychological Well-being Among Stroke Survivors

Overview

The proposed pilot trial aims to evaluate the feasibility of iCBT based EMI, which is a real-time, real-world, personalised and cost-effective approach, for stroke survivors' psychological well-being.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Other
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: December 2022

Interventions

  • Other: iCBT-based EMI
    • Consists of brief iCBT for psychological support (mandatory), stroke care education (optional), and real-time chat-based support messages, delivered according to participants’ preferences.

Arms, Groups and Cohorts

  • Experimental: Intervention group
    • Receive iCBT based EMI with message content, delivery frequency and timing personalised to participants’ preferences.
  • No Intervention: Control group
    • Receive general mental health information through instant message.

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • 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
  • 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
  • Spiritual well-being (Sub-scale of Spirituality Scale for Chinese Elders [SSCE])
    • Time Frame: 24-week
    • An 8-item scale with score ranging from 0 to 32, higher scores indicate better spiritual well-being
  • Loneliness (UCLA Loneliness Scale [ULS-8])
    • Time Frame: 24-week
    • An 8-item scale with score ranging from 8 to 32, higher scores indicate higher level of loneliness

Participating in This Clinical Trial

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 text messaging function on mobile phones – MoCA 5-minute Protocol (cognitive screen) ≥14 (Equivalence to MMSE ≥ 21) – Discharged home from hospital within preceding 6 months – PHQ-9 (depressive symptom) score range from 5 to 19 (cf. mild: 5-9, moderate: 10-14, moderately severe: 15-19 and severe: 20-27) Exclusion Criteria:

  • Currently receiving active stroke care in acute or post-acute inpatient settings – Has diagnosis of psychiatric disease or is currently taking psychotropic drug – PHQ-9 ≥ 20 (i.e., severe depressive symptom) – Currently participating in any type of psychological intervention (e.g., CBT)

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • The University of Hong Kong
  • Provider of Information About this Clinical Study
    • Sponsor

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