ACT-CSP for Family Caregivers of Palliative Care Patients

Caregiver Burden Clinical Trial

Official title:

An Acceptance and Commitment Therapy - Caregiver Support Program (ACT-CSP) for Family Caregivers of Patients Receiving Palliative Care: A Feasibility Study

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT06221189
• Other study ID #: ACT PC Caregivers
• Status: Withdrawn
• Phase: N/A
• Start date: March 2024
• Est. completion date: December 2024

Study information

• Verified date: November 2023
• Source: The Hong Kong Polytechnic University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2024
• Est. primary completion date: September 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Caregiver Burden

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
The Hong Kong Polytechnic University	Shatin Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The 15-item Brief Experiential Avoidance Questionnaire	The overall scores range 15-90, with higher scores indicating lower levels of psychological flexibility	Baseline, Week and Week 8
Other	Satisfaction to the treatment received	One item on a 0-10 VAS scale, with higher scores indicating higher levels of satisfaction.	Week 6
Primary	The Chinese version of the 13-item Caregiver Strain Index	Items are rated on a yes (1) or no (0) response, with the total score ranges from 0-13 and higher scores indicating higher caregiver burden	Baseline, Week 6 and Week 8
Secondary	The Patient Health Questionnaire-4 (PHQ-4)	The scale scores range from 0 to 12, with higher scores indicating higher levels of anxiety and depression.	Baseline, Week 6 and Week 8
Secondary	The Chinese version of the 18-item modified Caregiver Inventory	The scale covers 3 dimensions: Care of the Care Recipient (7 items), Managing information and Self-care (7 items), and Managing emotional interaction with care recipient (4 items). The first two dimensions have scores ranging from 7 to 63 while the last dimension has scores ranging from 4 to 36, with higher scores indicating higher levels of self-efficacy in that dimension.	Baseline, Week 6 and Week 8
Secondary	The 10-item Chinese version of the Connor-Davidson Resilience Scale	The overall scores range 0-40, with higher scores indicating higher levels of resilience	Baseline, Week 6 and Week 8
Secondary	The 10-item version of the Singapore caregiver quality of life	The overall scores range 0-40, with higher scores indicating higher levels of quality of life	Baseline, Week 6 and Week 8