ACT-CSP for Family Caregivers of Palliative Care Patients

NCT06221189 | Withdrawn

• 1 other identifier: ACT PC Caregivers
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Caregiver Burden

Keywords

Palliative Care; Caregiving; Acceptance and Commitment Therapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• The Patient Health Questionnaire-4 (PHQ-4)

  Baseline, Week 6 and Week 8

• The Chinese version of the 18-item modified Caregiver Inventory

  Baseline, Week 6 and Week 8

• The 10-item Chinese version of the Connor-Davidson Resilience Scale

  Baseline, Week 6 and Week 8

• The 10-item version of the Singapore caregiver quality of life

  Baseline, Week 6 and Week 8

Other Outcomes (2)

• The 15-item Brief Experiential Avoidance Questionnaire

  Baseline, Week and Week 8

• Satisfaction to the treatment received

  Week 6

Study Arms (2)

ACT-CSP

EXPERIMENTAL

Three sessions of acceptance and commitment therapy.

Behavioral: ACT-CSP

Usual Care

NO INTERVENTION

Usual treatment provided at the participating site.

Interventions

ACT-CSP 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.

ACT-CSP

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• The Hong Kong Polytechnic University: lead
• Shatin Hospital: collaborator

MeSH Terms

Conditions

Caregiver Burden

Condition Hierarchy (Ancestors)

Stress, Psychological; Behavioral Symptoms; Behavior

Study Officials

• Doris YP Leung

  The Hong Kong Polytechnic University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 29, 2023
• First Posted: January 24, 2024
• Study Start: March 1, 2024
• Primary Completion: September 1, 2024
• Study Completion: December 1, 2024
• Last Updated: June 20, 2024

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share