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Instant Message-delivered Early Psychological Intervention in Stroke Family Caregivers (EPI)

The University of Hong Kong (HKU) logo

The University of Hong Kong (HKU)

Status

Enrolling

Conditions

Stroke
Caregiver Burden
Mobile Phone Use

Treatments

Behavioral: iCBT-based EMI

Study type

Interventional

Funder types

Other

Identifiers

NCT05907005
EPI2023

Details and patient eligibility

About

Psychological distress including depression and anxiety is a major component of caregiver stress, and its negative impact on caregivers' health and well-being has been established in the literature. A recent meta-analysis reported the prevalence of depression and anxiety in stroke caregivers as 40.2% and 21.4% respectively.

An evidence profile report by the World Health Organization(WHO) has emphasised that psychological support is crucial in helping caregivers in the community to continue caring for individuals with long-term disabilities, such as stroke patients. Therefore, early psychological intervention (EPI) is crucial to improve the management and prognosis of an individual who are facing stressful events like caregiving.

The main aim of this study is to prevent or alleviate the significant psychological consequences in carers resulting from stroke events in family members. Internet-delivered cognitive-behavioural therapy (iCBT) is delivered as an ecological momentary intervention (EMI) to support the clients to engage in cognitive reframing and empower them with proper knowledge, skills and attitudes to make behavioural changes.

Enrollment

152 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Primary family caregiver of first-ever stroke patient who has <15 modified Barthel Index(mBI) scores (moderate disability);
  • Caregiver of a stroke patient who has a hospital inpatient stay of ≥6 days and ≤21days;
  • Aged ≥18;
  • Able to read and communicate in Chinese (Cantonese or Putonghua);
  • Able to use mobile phone instant messaging function; and
  • PHQ-9 (depressive symptom) score ranging from 5 to 19 (note. mild: 5-9, moderate: 10-14, moderately severe: 15-19 and severe: 20-27)

Exclusion criteria

  • Caregiver of stroke patient who is admitted to intensive care unit;
  • Professional medical personnel and/or professional carer;
  • Diagnosis of psychiatric disease before stroke event or currently taking psychotropic drug including antidepressants;
  • PHQ-9≥20 (we shall provide information on mental health services; if needed, we shall make the appropriate referrals); and
  • Currently participating in any type of psychological intervention.

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

152 participants in 2 patient groups

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

Trial contacts and locations

5

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Central trial contact

Jung Jae LEE

Data sourced from clinicaltrials.gov

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