ClinicalTrials.gg
RecruitingNCT07305415COPEUpdated Nov 2, 2026

Integrative Therapeutic Programme to Regulate Expressed Emotions Among Informal Caregivers of People With Dementia

An interventional study of Caregivers Of dementia Processing Emotions (COPE) in BPSD (Behavioral and Psycological Symptoms of Dementia), Expressed Emotion and Depressive Symptom, sponsored by The University of Hong Kong. Recruiting at 1 site in Hong Kong. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2026-11-02.

Sponsored by The University of Hong Kong · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Dec 2025; still recruiting 10 months later.
Updated Nov 2, 2026Primary completion movedGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
56
Allocation
Randomized
Ages
18 Years to 100 Years
Sex
All
01

Study 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. reduce the behaviourally interactive social dynamic of maladaptation (i.e., dysfunctional dyadic relationship and quality of care), and
  4. 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

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.

02

Conditions studied

  • 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
  • caregiving relationship
  • dyadic care relationship
03

In context

Behavior

1,573 studies on the registry are indexed under Behavior; 313 are open to participants now.

This study's planned enrollment of 56 is below the median of 120 across 1,197 interventional studies indexed under Behavior.

Browse Behavior studies →

Lead sponsor

The University of Hong Kong is the lead sponsor of 1,292 studies on the registry; 348 are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 100 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • (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

Exclusion criteria

Exclusion Criteria:

  • (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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
56 participants (estimated)

Study arms

  • Experimental
    COPE Intervention Group

    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.

    Behavioral: Caregivers Of dementia Processing Emotions (COPE)

  • Active comparator
    Control group

    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.

    Behavioral: Caregivers Of dementia Processing Emotions (COPE)

Interventions

  • BehavioralCaregivers Of dementia Processing Emotions (COPE)

    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.

    Also known as: COPE, Mindfulness and Cognitive Behavioral Therapy

06

What researchers measure

Primary outcomes

  1. Family Attitude Scale- Chinese Version

    Measure caregivers' expressed emotions (EE) (i.e., criticism and hostility) held towards the PwD.

    Time frame: From enrollment to the end of intervention at 7 weeks and end of study at 20 weeks.

Secondary outcomes

  1. Center of Epidemiological Studies of Depression Revised - Chinese Version

    Assess caregivers' depression

    Time frame: From enrollment to the end of intervention at 7 weeks and end of study at 20 weeks.

  2. Dyadic Relationship Scale - Chinese Version

    Evaluate caregivers' perspective of dyadic and family relationships in their daily caregiving activities

    Time frame: From enrollment to the end of intervention at 7 weeks and end of study at 20 weeks.

  3. Interaction Quality Scale - Chinese Version

    Measure the quality of care.

    Time frame: From enrollment to the end of intervention at 7 weeks and end of study at 20 weeks.

  4. Neuropsychiatric Inventory - Chinese Version

    Assess the severity of BPSD manifested in PwD reported by their caregivers.

    Time frame: From enrollment to the end of intervention at 7 weeks and end of study at 20 weeks.

07

Study locations

1 of 1 sites recruiting
08

References and documents

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 29409164 ↗
  • Cummings 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 9153155 ↗
  • Joseph 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 24915293 ↗
  • Cundiff 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 27333896 ↗
  • Sebern 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 18192628 ↗
  • Zhang 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 26281832 ↗
  • Radloff 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 22169081 ↗
  • Moon 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 24337642 ↗
  • Van 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 17201189 ↗
  • Kavanagh 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 9211580 ↗
  • Rothbaum 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 26077904 ↗
  • Moore 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 ↗
  • Bjorge H, Kvaal K, Ulstein I. The effect of psychosocial support on caregivers' perceived criticism and emotional over-involvement of persons with dementia: an assessor-blinded randomized controlled trial. BMC Health Serv Res. 2019 Oct 24;19(1):744. doi: 10.1186/s12913-019-4551-x. PubMed 31651321 ↗
  • Wiegelmann H, Speller S, Verhaert LM, Schirra-Weirich L, Wolf-Ostermann K. Psychosocial interventions to support the mental health of informal caregivers of persons living with dementia - a systematic literature review. BMC Geriatr. 2021 Feb 1;21(1):94. doi: 10.1186/s12877-021-02020-4. PubMed 33526012 ↗
  • Scott JL, Dawkins S, Quinn MG, Sanderson K, Elliott KE, Stirling C, Schuz B, Robinson A. Caring for the carer: a systematic review of pure technology-based cognitive behavioral therapy (TB-CBT) interventions for dementia carers. Aging Ment Health. 2016 Aug;20(8):793-803. doi: 10.1080/13607863.2015.1040724. Epub 2015 May 15. PubMed 25978672 ↗
  • Kovach CR, Noonan PE, Schlidt AM, Wells T. A model of consequences of need-driven, dementia-compromised behavior. J Nurs Scholarsh. 2005;37(2):134-40; discussion 140. doi: 10.1111/j.1547-5069.2005.00025_1.x. PubMed 15960057 ↗
  • Tarrier N, Barrowclough C, Ward J, Donaldson C, Burns A, Gregg L. Expressed emotion and attributions in the carers of patients with Alzheimer's disease: the effect on carer burden. J Abnorm Psychol. 2002 May;111(2):340-9. doi: 10.1037//0021-843x.111.2.340. PubMed 12003455 ↗
  • Hooley JM, Richters JE. Expressed emotion: A developmental perspective. In: Emotion, Cognition, and Representation. Rochester symposium on developmental psychopathology, Vol. 6. University of Rochester Press; 1995:133-166.
  • Kelly RB, Zyzanski SJ, Alemagno SA. Prediction of motivation and behavior change following health promotion: role of health beliefs, social support, and self-efficacy. Soc Sci Med. 1991;32(3):311-20. doi: 10.1016/0277-9536(91)90109-p. PubMed 2024141 ↗
  • Weiner B. An Attributional Theory of Motivation and Emotion. Springer Science & Business Media; 2012.
  • Weiner B. A cognitive (attribution)-emotion-action model of motivated behavior: An analysis of judgments of help-giving. Journal of Personality and Social psychology. 1980;39(2):186.
  • Zhang S, Ying X, Fang S, Wang W, Zhu X, Dong Y, He M, Chang A, Sun J. The influence path of caregivers' positive aspects, expressed emotion and coping style on behavioral and psychological symptoms of dementia. Geriatr Nurs. 2022 Mar-Apr;44:143-150. doi: 10.1016/j.gerinurse.2022.01.013. Epub 2022 Feb 12. PubMed 35158171 ↗
  • Yu DS, Kwok T, Choy J, Kavanagh DJ. Measuring the expressed emotion in Chinese family caregivers of persons with dementia: Validation of a Chinese version of the Family Attitude Scale. Int J Nurs Stud. 2016 Mar;55:50-9. doi: 10.1016/j.ijnurstu.2015.11.005. Epub 2015 Dec 17. PubMed 26742605 ↗
  • Li CY, Lewis FM. Expressed emotion and depression in caregivers of older adults with dementia: results from Taiwan. Aging Ment Health. 2013;17(8):924-9. doi: 10.1080/13607863.2013.814098. Epub 2013 Jul 4. PubMed 23826863 ↗
  • Safavi R, Berry K, Wearden A. Expressed Emotion in relatives of persons with dementia: a systematic review and meta-analysis. Aging Ment Health. 2017 Feb;21(2):113-124. doi: 10.1080/13607863.2015.1111863. Epub 2015 Nov 16. PubMed 26569025 ↗
  • Li CY, Murray M. A review of conceptualisation of expressed emotion in caregivers of older adults with dementia. J Clin Nurs. 2015 Feb;24(3-4):332-43. doi: 10.1111/jocn.12619. Epub 2014 May 9. PubMed 24811189 ↗
  • Friedman EM, Kennedy DP. Typologies of Dementia Caregiver Support Networks: A Pilot Study. Gerontologist. 2021 Nov 15;61(8):1221-1230. doi: 10.1093/geront/gnab013. PubMed 33585929 ↗
  • National Alliance for Caregiving and the Alzheimer's Association. Dementia Caregiving in the U.S. National Alliance for Caregiving and the Alzheimer's Association; 2017. https://www.caregiving.org/wp-content/uploads/2020/05/Dementia-Caregiving-Report 2017_Research-Recommendations_FINAL.pdf
  • Alzheimer's Association. 2018 Alzheimer's disease facts and figures. Alzheimer's & Dementia. 2018;14(3):367-429.
  • Kales HC, Gitlin LN, Lyketsos CG. Assessment and management of behavioral and psychological symptoms of dementia. BMJ. 2015 Mar 2;350:h369. doi: 10.1136/bmj.h369. PubMed 25731881 ↗
  • Scassellati C, Ciani M, Maj C, Geroldi C, Zanetti O, Gennarelli M, Bonvicini C. Behavioral and Psychological Symptoms of Dementia (BPSD): Clinical Characterization and Genetic Correlates in an Italian Alzheimer's Disease Cohort. J Pers Med. 2020 Aug 14;10(3):90. doi: 10.3390/jpm10030090. PubMed 32823921 ↗
  • Cao Q, Tan CC, Xu W, Hu H, Cao XP, Dong Q, Tan L, Yu JT. The Prevalence of Dementia: A Systematic Review and Meta-Analysis. J Alzheimers Dis. 2020;73(3):1157-1166. doi: 10.3233/JAD-191092. PubMed 31884487 ↗
  • Alzheimer's Association. 2022 Alzheimer's Disease Facts and Figures. More Than Normal Aging: Understanding Mild Cognitive Impairment. Published online 2022.

Individual participant data

Plan to share: No

09

Updates

1 registry update since Sep 25, 2026
Primary completion
Sep 30, 2026→Nov 30, 2026
Nov 2, 2026
Show all 1 update
  1. Nov 2, 2026
    Primary completion Sep 30, 2026→Nov 30, 2026

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07305415
Responsible party
Prof. Yu, Doris Sau Fung (Proferssor, The University of Hong Kong) — Principal investigator
First posted
Dec 26, 2025
Start date
Dec 20, 2025
Primary completion
Nov 30, 2026 (estimated)
Completion
Mar 30, 2027 (estimated)
Last update
Nov 2, 2026

Study contacts

Doris Sau Fung YU, PhD
Contact
dyu1@hku.hk
+852 39176319
Doris Sau Fung YU, PhD
principal investigator · The University of Hong Kong

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion