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

Sponsor
The University of Hong Kong (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05907005
Collaborator
(none)
152
5
2
24.6
30.4
1.2

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: iCBT-based EMI
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
152 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Other
Official Title:
Instant Message-delivered Early Psychological Intervention in Stroke Family Caregivers: a Mixed-method Study
Anticipated Study Start Date :
Jun 12, 2023
Anticipated Primary Completion Date :
Dec 31, 2024
Anticipated Study Completion Date :
Jun 30, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: Intervention Group

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

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

No Intervention: Control Group

Receive general mental health information through instant message.

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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

  2. 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

  3. Loneliness level (UCLA Loneliness Scale [ULS-8]) [24-week]

    The total score (8 items) ranges from 8 to 32 points, with higher scores suggesting a higher degree of loneliness

  4. Acceptance and Action Questionnaire-II (AAQ-II) [24-week]

    The total score (7 items) ranges from 7 to 49 points, with higher scores suggesting a higher degree of psychological inflexibility and experiential avoidance

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Kwong Wah Hospital Hong Kong Hong Kong
2 Princess Margaret Hospital Hong Kong Hong Kong
3 Queen Elizabeth Hospital Hong Kong Hong Kong
4 Queen Mary Hospital Hong Kong Hong Kong
5 United Christian Hospital Hong Kong Hong Kong

Sponsors and Collaborators

  • The University of Hong Kong

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
The University of Hong Kong
ClinicalTrials.gov Identifier:
NCT05907005
Other Study ID Numbers:
  • EPI2023
First Posted:
Jun 18, 2023
Last Update Posted:
Jun 18, 2023
Last Verified:
Jun 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by The University of Hong Kong
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 18, 2023