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OpenTrials
Completed

NCT Number: NCT05490069

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.

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Key information

Conditions

Stroke Behavior Behavioral Symptoms Brain Diseases Cardiovascular Diseases Cell Phone Use Central Nervous System Diseases Cerebrovascular Disorders Communication Depression Depressive Symptoms Mobile Phone Use Nervous System Diseases Social Behavior Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hong Kong PHAB Association, Hong Kong

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

iCBT-based EMI

Other

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

Primary outcomes

  1. 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

  1. 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

  2. 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

  3. 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

  4. 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

Sponsors and collaborators

Lead sponsor

The University of Hong Kong

Other

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Aug 5, 2022
Registry last updated
May 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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