NCT05490069CompletedNot Applicable
The Effect of Instant Message Intervention for Psychological Well-being Among Stroke Survivors
The University of Hong Kong7 sites in 1 country40 target enrollmentStarted: October 4, 2021Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- The University of Hong Kong
- Enrollment
- 40
- Locations
- 7
- Primary Endpoint
- Depressive symptoms (Patient Health Questionnaire-9 [PHQ-9])
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Diagnosis of stroke (ICD-10 codes: I60-I69)
- •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)
Arms & Interventions
Intervention group
Experimental
Receive iCBT based EMI with message content, delivery frequency and timing personalised to participants' preferences.
Intervention: iCBT-based EMI (Other)
Control group
No Intervention
Receive general mental health information through instant message.
Outcomes
Primary Outcomes
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 Outcomes
- Anxiety symptoms (Generalized Anxiety Disorder-7 [GAD-7])(24-week)
- Stress level (Perceived Stress Scale [PSS-4])(24-week)
- Spiritual well-being (Sub-scale of Spirituality Scale for Chinese Elders [SSCE])(24-week)
- Loneliness (UCLA Loneliness Scale [ULS-8])(24-week)
Investigators
Study Sites (7)
Loading locations...
Similar Trials
Completed
Not Applicable
A Patient-centered Intervention Using Technology to Reduce Colorectal Cancer Disparities in Primary CareColo-rectal CancerNCT03407417University of Florida960
Completed
Not Applicable
Coping and Adjusting to Living With Multiple SclerosisMultiple SclerosisNCT04300816University of Washington242
Completed
Not Applicable
A pilot trial of the iCanADAPT Advanced Program, an internet Cognitive Behaviour Therapy (iCBT) program for the treatment of depression and anxiety in ambulatory advanced-stage cancer patients.Mental Health - DepressionMental Health - AnxietyDepressionCancer - Any cancerCancerAnxietyACTRN12616001645448St. Vincent's Hospital, Sydney31
Completed
Not Applicable
Chat-based Support for Preventing Smoking RelapseSmoking CessationNCT04409496The University of Hong Kong108
Unknown
Not Applicable
Internet-based Cognitive Behavioral Intervention for Adolescents With Anxiety DisordersAnxiety DisordersNCT06368557Region of Southern Denmark168