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NCT Number: NCT05907005

Instant Message-delivered Early Psychological Intervention in Stroke Family Caregivers

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.

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Key information

Conditions

Stroke Behavior Behavioral Symptoms Brain Diseases Cardiovascular Diseases Caregiver Burden Cell Phone Use Central Nervous System Diseases Cerebrovascular Disorders Communication Mobile Phone Use Nervous System Diseases Social Behavior Stress, Psychological Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kwong Wah Hospital, 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

  • 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.

Treatment and study plan

iCBT-based EMI

Behavioral

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.

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

    Time frame: 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)

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Jung Jae LEE

CONTACT

[email protected]

+852 3917 6971

Sponsors and collaborators

Lead sponsor

The University of Hong Kong

Other

Registry information

Official study title

Instant Message-delivered Early Psychological Intervention in Stroke Family Caregivers: a Mixed-method Study

Acronym: EPI

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jun 18, 2023
Registry last updated
Jul 11, 2024

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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