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

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 Overview

• Status: Completed
• Conditions: Stroke; Depressive Symptoms; Mobile Phone Use
• Intervention / Treatment: Other: iCBT-based EMI

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong
    • Queen Mary Hospital
  • Hong Kong, Hong Kong
    • Tung Wah Hospital
  • Hong Kong, Hong Kong
    • United Christian Hospital
  • Hong Kong, Hong Kong
    • Hong Kong PHAB Association
  • Hong Kong, Hong Kong
    • Hong Kong Stroke Association
  • Hong Kong, Hong Kong
    • NT West Community Rehabilitation Day Centre
  • Hong Kong, Hong Kong
    • The Hong Kong Society for Rehabilitation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group; Receive iCBT based EMI with message content, delivery frequency and timing personalised to participants' preferences.	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.
No Intervention: Control group; Receive general mental health information through instant message.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anxiety symptoms (Generalized Anxiety Disorder-7 [GAD-7])	A 7-item scale with score ranging from 0 to 21, higher scores indicate higher severity of anxiety symptoms	24-week
Stress level (Perceived Stress Scale [PSS-4])	A 4-item scale with score ranging from 0 to 16, higher scores indicate higher severity of stress	24-week
Spiritual well-being (Sub-scale of Spirituality Scale for Chinese Elders [SSCE])	An 8-item scale with score ranging from 0 to 32, higher scores indicate better spiritual well-being	24-week
Loneliness (UCLA Loneliness Scale [ULS-8])	An 8-item scale with score ranging from 8 to 32, higher scores indicate higher level of loneliness	24-week

Collaborators and Investigators

• Sponsor: The University of Hong Kong

Study record dates

Study Major Dates

• Study Start (Actual): October 4, 2021
• Primary Completion (Actual): December 23, 2022
• Study Completion (Actual): December 23, 2022

Study Registration Dates

• First Submitted: August 3, 2022
• First Submitted That Met QC Criteria: August 3, 2022
• First Posted (Actual): August 5, 2022

Study Record Updates

• Last Update Posted (Actual): May 1, 2023
• Last Update Submitted That Met QC Criteria: April 27, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke; Depression
• Other Study ID Numbers: 20-526

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No