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

Not Applicable

Completed

• Conditions: Stroke; Mobile Phone Use; Depressive Symptoms
• Interventions: Other: iCBT-based EMI

• Registration Number: NCT05490069
• Lead Sponsor: The University of Hong Kong

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-10-04
• Study First Submitted: 2022-08-03
• Study First Submitted QC: 2022-08-03
• Study First Posted: 2022-08-05
• Primary Completion: 2022-12-23
• Study Completion: 2022-12-23
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-27
• Last Update Posted: 2023-05-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention group	iCBT-based EMI	Receive iCBT based EMI with message content, delivery frequency and timing personalised to participants' preferences.

Primary Outcome Measures

Name	Time	Method
Depressive symptoms (Patient Health Questionnaire-9 [PHQ-9])	24-week	A 9-item scale with score ranging from 0 to 27, higher scores indicate higher severity of depressive symptom

Secondary Outcome Measures

Name	Time	Method
Anxiety symptoms (Generalized Anxiety Disorder-7 [GAD-7])	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])	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])	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])	24-week	An 8-item scale with score ranging from 8 to 32, higher scores indicate higher level of loneliness

Trial Locations

Locations (7)

Queen Mary Hospital; 🇭🇰 Hong Kong, Hong Kong

United Christian Hospital; 🇭🇰 Hong Kong, Hong Kong

Hong Kong Stroke Association; 🇭🇰 Hong Kong, Hong Kong

The Hong Kong Society for Rehabilitation; 🇭🇰 Hong Kong, Hong Kong

NT West Community Rehabilitation Day Centre; 🇭🇰 Hong Kong, Hong Kong

Hong Kong PHAB Association; 🇭🇰 Hong Kong, Hong Kong

Tung Wah Hospital; 🇭🇰 Hong Kong, Hong Kong