Instant Message-delivered Early Psychological Intervention in Stroke Family Caregivers

NCT05907005 | Recruiting DMC

• 1 other identifier: EPI2023
• Study Type: interventional
• Target: 152
• Locations: 1 country
• Sites: 5

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.

Conditions

Stroke; Caregiver Burden; Mobile Phone Use

Keywords

Cognitive-behavioural therapy; ecological momentary intervention; early psychological intervention

Outcome Measures

Primary Outcomes (1)

• Depressive symptoms (Patient Health Questionnaire-9 [PHQ-9])

  A 9-item scale with score ranging from 0 to 27, higher scores indicate higher severity of depressive symptom

  24-week

Secondary Outcomes (4)

• Anxiety symptoms (Generalized Anxiety Disorder-7 [GAD-7])

  24-week

• Stress level (Perceived Stress Scale [PSS-4])

  24-week

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

  24-week

• Acceptance and Action Questionnaire-II (AAQ-II)

  24-week

Study Arms (2)

Intervention Group

EXPERIMENTAL

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

Behavioral: iCBT-based EMI

Control Group

NO INTERVENTION

Receive general mental health information through instant message.

Interventions

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.

Intervention Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (5)

Kwong Wah Hospital

Hong Kong, Hong Kong

NOT YET RECRUITING

Princess Margaret Hospital

Hong Kong, Hong Kong

RECRUITING

Queen Elizabeth Hospital

Hong Kong, Hong Kong

RECRUITING

Queen Mary Hospital

Hong Kong, Hong Kong

RECRUITING

United Christian Hospital

Hong Kong, Hong Kong

RECRUITING

MeSH Terms

Conditions

Stroke; Caregiver Burden; Cell Phone Use

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Stress, Psychological; Behavioral Symptoms; Behavior; Communication; Social Behavior

Central Study Contacts

Jung Jae LEE

CONTACT

+852 3917 6971; leejay@hku.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 7, 2023
• First Posted: June 18, 2023
• Study Start: July 24, 2023
• Primary Completion: July 24, 2025
• Study Completion: July 31, 2025
• Last Updated: July 11, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

HK (5)