Clinical trial NCT06221189: ACT-CSP for Family Caregivers of Palliative Care Patients
Official title: An Acceptance and Commitment Therapy - Caregiver Support Program (ACT-CSP) for Family Caregivers of Patients Receiving Palliative Care: A Feasibility Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Caregiver Burden
Keywords: Palliative Care
Caregiving
Acceptance and Commitment Therapy
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
Collaborators: name: Shatin Hospital
First posted: 2024-01-24
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The goal of the study is to test the feasibility, acceptability and preliminary efficacy of an acceptance and commitment therapy for supporting caregiver programme (ACT-CSP) on reduction of caregiver burden, anxiety and depressive symptoms and enhancement of caregiving self-efficacy, resilience and quality of life by ACT when compared to usual care, for caregivers of palliative care patients.

Detailed description: This study will employ a pilot randomized controlled trial recruiting caregivers of palliative care patients to receive either a 3-week acceptance and commitment therapy for supporting caregiver programme (ACT-CSP) plus usual care (n = 15) or usual care only (n = 15). The components of acceptance and commitment therapy process will be emphasized in the intervention programme, which include perspective taking, self-as-context and defusion (i.e. recognizing worry thoughts as thoughts only), identifying values and acceptance of present-moment experience with respect to the values, and committed action. The ACT-CSP will be delivered by a trained ACT facilitator. Participants will be followed up at Week 6 and Week 8 after recruitment to collect data for assessing the study objectives.

Eligibility criteria: Inclusion Criteria:

* Aged ≥ 18;
* Self- or patient-identified as a family caregiver of an adult patient receiving palliative care at the study site
* Have been taking care of the patient in the past 3 months;
* Able to communicate in Cantonese at the time of recruitment;
* Have access to internet and videoconferencing device such as mobile phone;
* Have caregiver burden as measured by Caregiver Strain Index (CSI) ≥ 7.

Exclusion Criteria:

* Mentally incompetent (Mini-Mental State Examination (MMSE) \< 23),
* Participating in regular psychosocial interventions.

Primary outcomes:
measure: The Chinese version of the 13-item Caregiver Strain Index
timeFrame: Baseline, Week 6 and Week 8
Secondary outcomes:
measure: The Patient Health Questionnaire-4 (PHQ-4)
timeFrame: Baseline, Week 6 and Week 8
measure: The Chinese version of the 18-item modified Caregiver Inventory
timeFrame: Baseline, Week 6 and Week 8
measure: The 10-item Chinese version of the Connor-Davidson Resilience Scale
timeFrame: Baseline, Week 6 and Week 8
measure: The 10-item version of the Singapore caregiver quality of life
timeFrame: Baseline, Week 6 and Week 8
Other outcomes:
measure: The 15-item Brief Experiential Avoidance Questionnaire
timeFrame: Baseline, Week and Week 8
measure: Satisfaction to the treatment received
timeFrame: Week 6
Locations:
Study officials:
affiliation: The Hong Kong Polytechnic University
name: Doris YP Leung
role: PRINCIPAL_INVESTIGATOR
References: