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

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05490069
• Other study ID #: 20-526
• Status: Completed
• Phase: N/A
• Start date: October 4, 2021
• Est. completion date: December 23, 2022

Study information

• Verified date: April 2023
• Source: The University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 23, 2022
• Est. primary completion date: December 23, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Depression
• Depressive Symptoms
• Mobile Phone Use
• Stroke

Intervention

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.

Locations

Country	Name	City	State
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	Queen Mary Hospital	Hong Kong
Hong Kong	The Hong Kong Society for Rehabilitation	Hong Kong
Hong Kong	Tung Wah Hospital	Hong Kong
Hong Kong	United Christian Hospital	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
The University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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