ACT-CSP for Family Caregivers of Palliative Care Patients

NCT ID: NCT06221189

Last Updated: 2024-06-20

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-31
• Study Completion Date: 2024-12-31

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.

Conditions

Caregiver Burden

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

ACT-CSP

Three sessions of acceptance and commitment therapy.

Group Type: EXPERIMENTAL

ACT-CSP

Intervention Type: BEHAVIORAL

The ACT treatment will consist of three 45 to 60-min weekly sessions to be delivered to the caregiver in an individual format via online videoconferencing application e.g. ZOOM or WhatsApp within 3 weeks. The ACT-CSP can be delivered via face-to-face on request. Each session has a specific content with pre-planned materials and mindfulness exercises and metaphors. Psychological-based homework will be assigned at the end of each session. The components of ACT 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.

Usual Care

Usual treatment provided at the participating site.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

ACT-CSP

The ACT treatment will consist of three 45 to 60-min weekly sessions to be delivered to the caregiver in an individual format via online videoconferencing application e.g. ZOOM or WhatsApp within 3 weeks. The ACT-CSP can be delivered via face-to-face on request. Each session has a specific content with pre-planned materials and mindfulness exercises and metaphors. Psychological-based homework will be assigned at the end of each session. The components of ACT 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.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Shatin Hospital

OTHER

Sponsor Role: collaborator

The Hong Kong Polytechnic University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Doris YP Leung

Role: PRINCIPAL_INVESTIGATOR

The Hong Kong Polytechnic University

Other Identifiers

ACT PC Caregivers

Identifier Type: -

Identifier Source: org_study_id