ACT-CSP for Family Caregivers of Palliative Care Patients

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Caregiver Burden
• Intervention / Treatment: Behavioral: ACT-CSP

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.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Doris YP Leung; Phone Number: 852 2766 6423; Email: doris.yp.leung@polyu.edu.hk
• Study Contact Backup: Name: Yim Wah Mak; Email: yw.mak@polyu.edu.hk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ACT-CSP; Three sessions of acceptance and commitment therapy.	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.
No Intervention: Usual Care; Usual treatment provided at the participating site.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Satisfaction to the treatment received	One item on a 0-10 VAS scale, with higher scores indicating higher levels of satisfaction.	Week 6

Collaborators and Investigators

• Sponsor: The Hong Kong Polytechnic University
• Collaborators: Shatin Hospital
• Investigators: Principal Investigator: Doris YP Leung, The Hong Kong Polytechnic University

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2024
• Primary Completion (Estimated): September 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: November 29, 2023
• First Submitted That Met QC Criteria: January 14, 2024
• First Posted (Actual): January 24, 2024

Study Record Updates

• Last Update Posted (Actual): February 28, 2024
• Last Update Submitted That Met QC Criteria: February 27, 2024
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Acceptance and Commitment Therapy; Palliative Care; Caregiving
• Additional Relevant MeSH Terms: Behavioral Symptoms; Stress, Psychological; Caregiver Burden
• Other Study ID Numbers: ACT PC Caregivers

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data are not readily shared because permission to use the data by other researchers has to seek approval from the ethical committee. Requests to access IPD should be directed to PI for further consideration and seeking approval from ethical committee.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No