Caregiver BurdenNCT06221189
ACT-CSP for Family Caregivers of Palliative Care Patients
A study testing ACT-CSP in people with Caregiver Burden, run by The Hong Kong Polytechnic University.
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Caregiver Burden
- What is being tested?
- ACT-CSP
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Mar 2024to Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Mentally incompetent (Mini-Mental State Examination (MMSE) < 23),
- Participating in regular psychosocial interventions.
About this study
Official title: 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.
Read the 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
- Being tested
- ACT-CSP
- Keywords
- Palliative Care, Caregiving, Acceptance and Commitment Therapy
- Medical subject headings
- Caregiver Burden
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACT-CSPBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| ACT-CSP | Experimental | Three sessions of acceptance and commitment therapy. Receives: Behavioral: ACT-CSP |
| Usual Care | No intervention | Usual treatment provided at the participating site. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline, Week 6 and Week 8
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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
Measured: 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
Measured: Baseline, Week 6 and Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2024
- Study startMar 2024 (estimated)
- Primary completionSep 2024 (estimated)
- Study completionDec 2024 (estimated)
Why it stopped: The end of the funding to the project on 30 April 2024.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Caregiver BurdenStudies of the same condition, open and under way.
- More trials run by The Hong Kong Polytechnic UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Collaborators
- Shatin Hospital
- Responsible party
- Sponsor
- Investigators
- Doris YP Leung, Principal investigator, The Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06221189
- Sponsor's protocol ID
- ACT PC Caregivers
- Status last verified
- Nov 2023
- First submitted
- 29 Nov 2023
- Last updated
- 20 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Acceptance and Commitment Therapy - Caregiver Support Program (ACT-CSP) for Family Caregivers of Patients Receiving Palliative Care: A Feasibility Study
- ClinicalTrials.gov ID
- NCT06221189
- Acronym / sponsor ID
- ACT PC Caregivers
- Conditions
- Caregiver Burden
- Keywords
- Palliative Care, Caregiving, Acceptance and Commitment Therapy
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The end of the funding to the project on 30 April 2024.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Collaborators
- Shatin Hospital
- Study start
- Mar 2024 (estimated)
- Primary completion
- Sep 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 24 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ACT-CSP | Experimental | Behavioral: ACT-CSPThree sessions of acceptance and commitment therapy. |
| Usual Care | No intervention | –Usual treatment provided at the participating site. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (2 listed)
- Mentally incompetent (Mini-Mental State Examination (MMSE) < 23),
- Participating in regular psychosocial interventions.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ACT-CSPThe 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. | Behavioural | ACT-CSP |
Primary outcome
The Chinese version of the 13-item Caregiver Strain Index
Time frame: Baseline, Week 6 and Week 8
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
4 secondary outcomes
The Patient Health Questionnaire-4 (PHQ-4)
Time frame: Baseline, Week 6 and Week 8
The Chinese version of the 18-item modified Caregiver Inventory
Time frame: Baseline, Week 6 and Week 8
The 10-item Chinese version of the Connor-Davidson Resilience Scale
Time frame: Baseline, Week 6 and Week 8
The 10-item version of the Singapore caregiver quality of life
Time frame: Baseline, Week 6 and Week 8
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2024.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Doris YP Leung principal investigator
The Hong Kong Polytechnic University
Questions about this trial
What is this clinical trial studying?
A study testing ACT-CSP in people with Caregiver Burden, run by The Hong Kong Polytechnic University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 20 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Chinese version of the 13-item Caregiver Strain Index (time frame: Baseline, Week 6 and Week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jun 2024.