BPSD (Behavioral and Psycological Symptoms of Dementia)COPENCT07305415
Integrative Therapeutic Programme to Regulate Expressed Emotions Among Informal Caregivers of People With Dementia
A study testing Caregivers Of dementia Processing Emotions (COPE) in people with BPSD (Behavioral and Psycological Symptoms of Dementia) and Expressed Emotion, run by The University of Hong Kong at 1 site in Hong Kong.
Trial summary
The dual-modal (face-to-face and online approaches), client-customized Caregivers Of dementia Processing Emotions (COPE) programme aims to 1. reduce caregivers' Expressed Emotion (EE), 2. reduce caregivers' depressive symptoms, 3. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- BPSD (Behavioral and Psycological Symptoms of Dementia), Expressed Emotion, Depressive Symptom
- What is being tested?
- Caregivers Of dementia Processing Emotions (COPE)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteHong Kong
- Study dates
- 20 Dec 2025to 30 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- (1) With a high level of EE as indicated by a cut-off score of 35 or above on the Family Attitude Scale (Chinese version; FAS-C)
- (2) Provides care at least 4 hours per day
- (3) Consent to participate
- (4) No acute psychiatric illness
Who cannot join
- (1) With a score below 35 on the Family Attitude Scale (Chinese version; FAS-C)
- (2) Provides care no more than 4 hours per day
- (3) Does not consent to participate
- (4) With acute psychiatric illness.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong1 site, 1 recruiting
- Recruiting
University of Hong Kong
Hong Kong
YU Sau Fung, 852 + 39176319, dyu1@hku.hk
About this study
Official title: Integrative Therapeutic Programme to Regulate Expressed Emotions Among Informal Caregivers of People With Dementia: a Pilot Randomized Controlled Trial
The dual-modal (face-to-face and online approaches), client-customized Caregivers Of dementia Processing Emotions (COPE) programme aims to
- reduce caregivers' Expressed Emotion (EE),
- reduce caregivers' depressive symptoms,
- reduce the behaviourally interactive social dynamic of maladaptation (i.e., dysfunctional dyadic relationship and quality of care), and
- improve caregivers' perceived stress from PwD's Behavioral and Psychological Symptoms of Dementia (BPSD).
Read more
Researchers will compare COPE to a control group (standard therapy) to examine how effective the COPE programme is.
Participants will take part in:
Pretest prior to COPE implementation Post-test after COPE completion Follow up test in 3 months after COPE completion
Read the detailed description
Primary Purpose Prevention: Assessing the effectiveness of a novel intervention for preventing the development of negative outcomes in caregivers as a result of managing behavioral psychological symptoms of dementia.
Interventional Study Model:
Parallel: Participants are assigned to one of two groups in parallel for the duration of the study.
Model Description:
Participants are assigned to either COPE group or control group on a random basis. Baseline data are collected either face-to-face or online before the implementation. After six weeks of implementation, post-test data will be collected either face-to-face or online. Three months after post-test, follow-up data will be collected either face-to-face or online.
Number of Arms:
Two total arms, one for the COPE intervention group and one for the standard therapy control group.
Masking:
Participants Outcomes Assessors
Allocation:
Randomized: Participants are assigned to intervention groups by chance
Enrollment:
At least 56 subjects are needed for the two arms to allow the most accurate variance estimation for intervention of small to medium standardised effect size (0.2-0.6) at 80% power and 5% level of significance, with a 10% attrition rate. The social workers in the Psychogeriatric Day Hospital (Queen Mary Hospital) will refer the potential family caregivers of PwD to the RA for eligibility screening. Informed consent will be obtained accordingly.
- Conditions
- BPSD (Behavioral and Psycological Symptoms of Dementia), Expressed Emotion, Depressive Symptom, Caregiving Stress
- Being tested
- Caregivers Of dementia Processing Emotions (COPE)
- Keywords
- BPSD, behavioral and psychological symptoms of dementia, Expressed Emotion, Dementia caregivers, Dementia caregiving, preceived stress, caregiver depression, caregiving stress, caregiving relationship, dyadic care relationship
- Medical subject headings
- Behavior, Depression, Caregiver Burden
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Caregivers Of dementia Processing Emotions (COPE)Behavioural
Also called COPE, Mindfulness and Cognitive Behavioral Therapy
This is the first study to develop an easily accessible and feasible intervention programme, namely the Caregivers Of dementia Processing Emotions (COPE), to primarily reduce expressed emotion (EE) in family caregivers of PwD via processing one's attributional biases, dysregulated emotion, dysfunctional social dynamics using an integrative therapy. By displacing these negative thoughts and emotions, the integrative therapy has great potential to reduce the depressive symptoms in caregivers and thus mitigate their perceived stress from BPSD. In addition, the interactive social dynamics in the dementia caregiving context can be improved.
| Study group | Role | What they receive |
|---|---|---|
| COPE Intervention Group | Experimental | COPE is a 6-week group-based programme comprising one face-to-face workshop (4 caregivers per group) and five online sessions (4 caregivers per group) delivered via Zoom. The COPE programme integrates the strategies from cognitive behavioral therapy (CBT), emotional-focused mindfulness therapy and social skill training to improve the expressed emotion (EE) of the caregivers.
The group size of 4 is used to optimize the social interactions between the peer and to facilitate their self-reflection and disclosure on their social interaction with the care recipients in day-to-day caregiving. Receives: Behavioral: Caregivers Of dementia Processing Emotions (COPE) |
| Control group | Active comparator | Structured education will function as the control intervention to mitigate potential confounding effects attributable to additional attention. The control condition will comprise one initial face-to-face session followed by five consecutive weekly online educational sessions focusing on dementia caregiving. Receives: Behavioral: Caregivers Of dementia Processing Emotions (COPE) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Family Attitude Scale- Chinese Version
Measure caregivers' expressed emotions (EE) (i.e., criticism and hostility) held towards the PwD.
Measured: From enrollment to the end of intervention at 7 weeks and end of study at 20 weeks.
Secondary outcomes (4)
Center of Epidemiological Studies of Depression Revised - Chinese Version
Assess caregivers' depression
Measured: From enrollment to the end of intervention at 7 weeks and end of study at 20 weeks.
Dyadic Relationship Scale - Chinese Version
Evaluate caregivers' perspective of dyadic and family relationships in their daily caregiving activities
Measured: From enrollment to the end of intervention at 7 weeks and end of study at 20 weeks.
Interaction Quality Scale - Chinese Version
Measure the quality of care.
Measured: From enrollment to the end of intervention at 7 weeks and end of study at 20 weeks.
Neuropsychiatric Inventory - Chinese Version
Assess the severity of BPSD manifested in PwD reported by their caregivers.
Measured: From enrollment to the end of intervention at 7 weeks and end of study at 20 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2025
- Study start20 Dec 2025
- Primary completion30 Nov 2026 (estimated)
- Study completion30 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (36)Papers the sponsor has linked to this study.
- Other trials for BPSD (Behavioral and Psycological Symptoms of Dementia)Studies of the same condition, open and under way.
- More trials run by The University of Hong KongThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Yu, Doris Sau Fung, The University of Hong Kong
- Investigators
- Doris Sau Fung YU, PhD, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07305415
- Sponsor's protocol ID
- COPE
- Acronym
- COPE
- Status last verified
- Sep 2026
- First submitted
- 12 Dec 2025
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chen S, Lin K, Wang H, Yamakawa M, Makimoto K, Liao X. Reliability and structural validity of the Chinese version of the Neuropsychiatric Inventory, Nursing Home version. Psychogeriatrics. 2018 Mar;18(2):113-122. doi: 10.1111/psyg.12292. Epub 2018 Feb 6.
PubMed 29409164Cummings JL. The Neuropsychiatric Inventory: assessing psychopathology in dementia patients. Neurology. 1997 May;48(5 Suppl 6):S10-6. doi: 10.1212/wnl.48.5_suppl_6.10s.
PubMed 9153155Joseph NT, Kamarck TW, Muldoon MF, Manuck SB. Daily marital interaction quality and carotid artery intima-medial thickness in healthy middle-aged adults. Psychosom Med. 2014 Jun;76(5):347-54. doi: 10.1097/PSY.0000000000000071.
PubMed 24915293Cundiff JM, Kamarck TW, Manuck SB. Daily Interpersonal Experience Partially Explains the Association Between Social Rank and Physical Health. Ann Behav Med. 2016 Dec;50(6):854-861. doi: 10.1007/s12160-016-9811-y.
PubMed 27333896Sebern MD, Whitlatch CJ. Dyadic relationship scale: a measure of the impact of the provision and receipt of family care. Gerontologist. 2007 Dec;47(6):741-51. doi: 10.1093/geront/47.6.741.
PubMed 18192628Zhang Y, Ting RZ, Lam MH, Lam SP, Yeung RO, Nan H, Ozaki R, Luk AO, Kong AP, Wing YK, Sartorius N, Chan JC. Measuring depression with CES-D in Chinese patients with type 2 diabetes: the validity and its comparison to PHQ-9. BMC Psychiatry. 2015 Aug 18;15:198. doi: 10.1186/s12888-015-0580-0.
PubMed 26281832Radloff LS. The CES-D scale: A self-report depression scale for research in the general population. Applied psychological measurement. 1977;1(3):385-401.
Sim J, Lewis M. The size of a pilot study for a clinical trial should be calculated in relation to considerations of precision and efficiency. J Clin Epidemiol. 2012 Mar;65(3):301-8. doi: 10.1016/j.jclinepi.2011.07.011. Epub 2011 Dec 9.
PubMed 22169081Moon H, Adams KB. The effectiveness of dyadic interventions for people with dementia and their caregivers. Dementia (London). 2013 Nov;12(6):821-39. doi: 10.1177/1471301212447026. Epub 2012 May 21.
PubMed 24337642Van Humbeeck G, Van Audenhove Ch, De Hert M, Pieters G, Storms G. Expressed emotion: a review of assessment instruments. Clin Psychol Rev. 2002 Apr;22(3):323-43. doi: 10.1016/s0272-7358(01)00098-8.
PubMed 17201189Kavanagh DJ, O'Halloran P, Manicavasagar V, Clark D, Piatkowska O, Tennant C, Rosen A. The Family Attitude Scale: reliability and validity of a new scale for measuring the emotional climate of families. Psychiatry Res. 1997 May 30;70(3):185-95. doi: 10.1016/s0165-1781(97)00033-4.
PubMed 9211580Rothbaum BO, Meadows EA, Resick P, Foy DW. Cognitive-behavioral therapy. Published online 2000.
Bejan A, Merkx GW. Constructal Theory of Social Dynamics. Springer London NetLibrary, Inc. [distributor]
Steffen AM, Gant JR. A telehealth behavioral coaching intervention for neurocognitive disorder family carers. Int J Geriatr Psychiatry. 2016 Feb;31(2):195-203. doi: 10.1002/gps.4312. Epub 2015 Jun 15.
PubMed 26077904Moore RC, Chattillion EA, Ceglowski J, Ho J, von Kanel R, Mills PJ, Ziegler MG, Patterson TL, Grant I, Mausbach BT. A randomized clinical trial of Behavioral Activation (BA) therapy for improving psychological and physical health in dementia caregivers: results of the Pleasant Events Program (PEP). Behav Res Ther. 2013 Oct;51(10):623-32. doi: 10.1016/j.brat.2013.07.005. Epub 2013 Jul 19.
PubMed 23916631
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrative Therapeutic Programme to Regulate Expressed Emotions Among Informal Caregivers of People With Dementia: a Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07305415
- Acronym / sponsor ID
- COPE / COPE
- Conditions
- BPSD (Behavioral and Psycological Symptoms of Dementia), Expressed Emotion, Depressive Symptom, Caregiving Stress
- Keywords
- BPSD, behavioral and psychological symptoms of dementia, Expressed Emotion, Dementia caregivers, Dementia caregiving, preceived stress, caregiver depression, caregiving stress
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 20 Dec 2025 (actual)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 30 Mar 2027 (estimated)
- First posted
- 26 Dec 2025 (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 dual-modal (face-to-face and online approaches), client-customized Caregivers Of dementia Processing Emotions (COPE) programme aims to
- reduce caregivers' Expressed Emotion (EE),
- reduce caregivers' depressive symptoms,
- reduce the behaviourally interactive social dynamic of maladaptation (i.e., dysfunctional dyadic relationship and quality of care), and
- improve caregivers' perceived stress from PwD's Behavioral and Psychological Symptoms of Dementia (BPSD).
Researchers will compare COPE to a control group (standard therapy) to examine how effective the COPE programme is.
Participants will take part in:
Pretest prior to COPE implementation Post-test after COPE completion Follow up test in 3 months after COPE completion
Detailed description
Primary Purpose Prevention: Assessing the effectiveness of a novel intervention for preventing the development of negative outcomes in caregivers as a result of managing behavioral psychological symptoms of dementia.
Interventional Study Model:
Parallel: Participants are assigned to one of two groups in parallel for the duration of the study.
Model Description:
Participants are assigned to either COPE group or control group on a random basis. Baseline data are collected either face-to-face or online before the implementation. After six weeks of implementation, post-test data will be collected either face-to-face or online. Three months after post-test, follow-up data will be collected either face-to-face or online.
Number of Arms:
Two total arms, one for the COPE intervention group and one for the standard therapy control group.
Masking:
Participants Outcomes Assessors
Allocation:
Randomized: Participants are assigned to intervention groups by chance
Enrollment:
At least 56 subjects are needed for the two arms to allow the most accurate variance estimation for intervention of small to medium standardised effect size (0.2-0.6) at 80% power and 5% level of significance, with a 10% attrition rate. The social workers in the Psychogeriatric Day Hospital (Queen Mary Hospital) will refer the potential family caregivers of PwD to the RA for eligibility screening. Informed consent will be obtained accordingly.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| COPE Intervention Group | Experimental | Behavioral: Caregivers Of dementia Processing Emotions (COPE)COPE is a 6-week group-based programme comprising one face-to-face workshop (4 caregivers per group) and five online sessions (4 caregivers per group) delivered via Zoom. The COPE programme integrates the strategies from cognitive behavioral therapy (CBT), emotional-focused mindfulness therapy and social skill training to improve the expressed emotion (EE) of the caregivers. The group size of 4 is used to optimize the social interactions between the peer and to facilitate their self-reflection and disclosure on their social interaction with the care recipients in day-to-day caregiving. |
| Control group | Active comparator | Behavioral: Caregivers Of dementia Processing Emotions (COPE)Structured education will function as the control intervention to mitigate potential confounding effects attributable to additional attention. The control condition will comprise one initial face-to-face session followed by five consecutive weekly online educational sessions focusing on dementia caregiving. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- (1) With a high level of EE as indicated by a cut-off score of 35 or above on the Family Attitude Scale (Chinese version; FAS-C)
- (2) Provides care at least 4 hours per day
- (3) Consent to participate
- (4) No acute psychiatric illness
Key exclusion criteria (4 listed)
- (1) With a score below 35 on the Family Attitude Scale (Chinese version; FAS-C)
- (2) Provides care no more than 4 hours per day
- (3) Does not consent to participate
- (4) With acute psychiatric illness.
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 |
|---|---|---|
| Caregivers Of dementia Processing Emotions (COPE)Also: COPE, Mindfulness and Cognitive Behavioral TherapyThis is the first study to develop an easily accessible and feasible intervention programme, namely the Caregivers Of dementia Processing Emotions (COPE), to primarily reduce expressed emotion (EE) in family caregivers of PwD via processing one's attributional biases, dysregulated emotion, dysfunctional social dynamics using an integrative therapy. By displacing these negative thoughts and emotions, the integrative therapy has great potential to reduce the depressive symptoms in caregivers and thus mitigate their perceived stress from BPSD. In addition, the interactive social dynamics in the dementia caregiving context can be improved. | Behavioural | COPE Intervention Group, Control group |
Primary outcome
Family Attitude Scale- Chinese Version
Time frame: From enrollment to the end of intervention at 7 weeks and end of study at 20 weeks.
Measure caregivers' expressed emotions (EE) (i.e., criticism and hostility) held towards the PwD.
4 secondary outcomes
Center of Epidemiological Studies of Depression Revised - Chinese Version
Time frame: From enrollment to the end of intervention at 7 weeks and end of study at 20 weeks.
Dyadic Relationship Scale - Chinese Version
Time frame: From enrollment to the end of intervention at 7 weeks and end of study at 20 weeks.
Interaction Quality Scale - Chinese Version
Time frame: From enrollment to the end of intervention at 7 weeks and end of study at 20 weeks.
Neuropsychiatric Inventory - Chinese Version
Time frame: From enrollment to the end of intervention at 7 weeks and end of study at 20 weeks.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2026.
- Background: PubMed 29409164Chen S, Lin K, Wang H, Yamakawa M, Makimoto K, Liao X. Reliability and structural validity of the Chinese version of the Neuropsychiatric Inventory, Nursing Home version. Psychogeriatrics. 2018 Mar;18(2):113-122. doi: 10.1111/psyg.12292. Epub 2018 Feb 6.
- Background: PubMed 9153155Cummings JL. The Neuropsychiatric Inventory: assessing psychopathology in dementia patients. Neurology. 1997 May;48(5 Suppl 6):S10-6. doi: 10.1212/wnl.48.5_suppl_6.10s.
- Background: PubMed 24915293Joseph NT, Kamarck TW, Muldoon MF, Manuck SB. Daily marital interaction quality and carotid artery intima-medial thickness in healthy middle-aged adults. Psychosom Med. 2014 Jun;76(5):347-54. doi: 10.1097/PSY.0000000000000071.
- Background: PubMed 27333896Cundiff JM, Kamarck TW, Manuck SB. Daily Interpersonal Experience Partially Explains the Association Between Social Rank and Physical Health. Ann Behav Med. 2016 Dec;50(6):854-861. doi: 10.1007/s12160-016-9811-y.
- Background: PubMed 18192628Sebern MD, Whitlatch CJ. Dyadic relationship scale: a measure of the impact of the provision and receipt of family care. Gerontologist. 2007 Dec;47(6):741-51. doi: 10.1093/geront/47.6.741.
- Background: PubMed 26281832Zhang Y, Ting RZ, Lam MH, Lam SP, Yeung RO, Nan H, Ozaki R, Luk AO, Kong AP, Wing YK, Sartorius N, Chan JC. Measuring depression with CES-D in Chinese patients with type 2 diabetes: the validity and its comparison to PHQ-9. BMC Psychiatry. 2015 Aug 18;15:198. doi: 10.1186/s12888-015-0580-0.
- BackgroundRadloff LS. The CES-D scale: A self-report depression scale for research in the general population. Applied psychological measurement. 1977;1(3):385-401.
- Background: PubMed 22169081Sim J, Lewis M. The size of a pilot study for a clinical trial should be calculated in relation to considerations of precision and efficiency. J Clin Epidemiol. 2012 Mar;65(3):301-8. doi: 10.1016/j.jclinepi.2011.07.011. Epub 2011 Dec 9.
- Background: PubMed 24337642Moon H, Adams KB. The effectiveness of dyadic interventions for people with dementia and their caregivers. Dementia (London). 2013 Nov;12(6):821-39. doi: 10.1177/1471301212447026. Epub 2012 May 21.
- Background: PubMed 17201189Van Humbeeck G, Van Audenhove Ch, De Hert M, Pieters G, Storms G. Expressed emotion: a review of assessment instruments. Clin Psychol Rev. 2002 Apr;22(3):323-43. doi: 10.1016/s0272-7358(01)00098-8.
- Background: PubMed 9211580Kavanagh DJ, O'Halloran P, Manicavasagar V, Clark D, Piatkowska O, Tennant C, Rosen A. The Family Attitude Scale: reliability and validity of a new scale for measuring the emotional climate of families. Psychiatry Res. 1997 May 30;70(3):185-95. doi: 10.1016/s0165-1781(97)00033-4.
- BackgroundRothbaum BO, Meadows EA, Resick P, Foy DW. Cognitive-behavioral therapy. Published online 2000.
- Individual participant dataSharing planned: No
Related trials for BPSD (Behavioral and Psycological Symptoms of Dementia)
Active, not recruiting
Psychosocial Intervention for Behavioral Symptoms in Hospitalized Patients With Dementia or Delirium
BPSD (Behavioral and Psycological Symptoms of Dementia)
Not yet recruitingObservational study
Electroacupuncture Treatment of Behavioral and Psycological Symptoms in Patients With Alzheimer's Disease
BPSD (Behavioral and Psycological Symptoms of Dementia), Alzheimer's Dementia
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.
Doris Sau Fung YU, PhD principal investigator
The University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Caregivers Of dementia Processing Emotions (COPE) in people with BPSD (Behavioral and Psycological Symptoms of Dementia) and Expressed Emotion, run by The University of Hong Kong at 1 site in Hong Kong.
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 4 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Doris Sau Fung YU, PhD (+852 39176319, dyu1@hku.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Family Attitude Scale- Chinese Version (time frame: From enrollment to the end of intervention at 7 weeks and end of study at 20 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07305415, which also lists 36 linked publications.
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 2 Nov 2026.