Instant Message-delivered Early Psychological Intervention in Stroke Family Caregivers
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorThe University of Hong Kong
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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);
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
iCBT-based EMI
BehavioralConsists 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.
Treatment groups
152 Participants
are divided into 2 treatment groupsGroup A: Intervention GroupExperimental treatment 1 intervention
Group B: Control GroupNo intervention 0 interventions
Trial outcomes
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
Time frame
24-weekSecondary outcomes
1
Anxiety symptoms (Generalized Anxiety Disorder-7 [GAD-7])
A 7-item scale with score ranging from 0 to 21, higher scores indicate higher severity of anxiety symptoms
Time frame
24-week2
Stress level (Perceived Stress Scale [PSS-4])
A 4-item scale with score ranging from 0 to 16, higher scores indicate higher severity of stress
Time frame
24-week3
Loneliness level (UCLA Loneliness Scale [ULS-8])
The total score (8 items) ranges from 8 to 32 points, with higher scores suggesting a higher degree of loneliness
Time frame
24-week4
Acceptance and Action Questionnaire-II (AAQ-II)
The total score (7 items) ranges from 7 to 49 points, with higher scores suggesting a higher degree of psychological inflexibility and experiential avoidance
Time frame
24-weekSponsors and contacts
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Source ClinicalTrials.gov