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

NCT07305415 | Recruiting DMC

• 1 other identifier: COPE
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

The dual-modal (face-to-face and online approaches), client-customized Caregivers Of dementia Processing Emotions (COPE) programme aims to

1. 1.reduce caregivers' Expressed Emotion (EE),
2. 2.reduce caregivers' depressive symptoms,
3. 3.reduce the behaviourally interactive social dynamic of maladaptation (i.e., dysfunctional dyadic relationship and quality of care), and
4. 4.improve caregivers' perceived stress from PwD's Behavioral and Psychological Symptoms of Dementia (BPSD).

Conditions

Expressed Emotion; BPSD (Behavioral and Psycological Symptoms of Dementia); 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

Outcome Measures

Primary Outcomes (1)

• Family Attitude Scale- Chinese Version

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

  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

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

• Dyadic Relationship Scale - Chinese Version

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

• Interaction Quality Scale - Chinese Version

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

• Neuropsychiatric Inventory - Chinese Version

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

Study Arms (2)

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, with the focus to ameliorate negative causal attrition of BPSD, increase emotional regulation and enhance social interaction skills with PwD. The group size of 4 is used to optimize the social interactions between the peer caregivers. The first session will adopt a face-to-face mode to better develop their rapport with each other, 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)

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. These sessions will be administered by a research assistant (RA2) following a standardized PowerPoint presentation developed in accordance with established clinical practice guidelines. The implementation of an active control condition, rather than a passive or waitlist control, provides more robust evidence regarding the specific efficacy of the experimental intervention. Furthermore, this approach enhances both participant recruitment and retention rates by ensuring that all participants receive a credible and potentially beneficial intervention.

Behavioral: Caregivers Of dementia Processing Emotions (COPE)

Interventions

Caregivers Of dementia Processing Emotions (COPE) BEHAVIORAL

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

COPE Intervention Group; Control group

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (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

You may not qualify if:

• (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.

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

University of Hong Kong

Hong Kong, Hong Kong

RECRUITING

Related Publications (36)

• 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.

  PMID: 29409164 BACKGROUND

• 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.

  PMID: 9153155 BACKGROUND

• 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.

  PMID: 24915293 BACKGROUND

• 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.

  PMID: 27333896 BACKGROUND

• 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.

  PMID: 18192628 BACKGROUND

• 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.

  PMID: 26281832 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 22169081 BACKGROUND

• 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.

  PMID: 24337642 BACKGROUND

• 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.

  PMID: 17201189 BACKGROUND

• 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.

  PMID: 9211580 BACKGROUND

• Rothbaum BO, Meadows EA, Resick P, Foy DW. Cognitive-behavioral therapy. Published online 2000.

  BACKGROUND

• Bejan A, Merkx GW. Constructal Theory of Social Dynamics. Springer London NetLibrary, Inc. [distributor]

  BACKGROUND

• 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.

  PMID: 26077904 BACKGROUND

• 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.

  PMID: 23916631 BACKGROUND

• 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.

  PMID: 31651321 BACKGROUND

• 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.

  PMID: 33526012 BACKGROUND

• 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.

  PMID: 25978672 BACKGROUND

• 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.

  PMID: 15960057 BACKGROUND

• 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.

  PMID: 12003455 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 2024141 BACKGROUND

• Weiner B. An Attributional Theory of Motivation and Emotion. Springer Science & Business Media; 2012.

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 35158171 BACKGROUND

• 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.

  PMID: 26742605 BACKGROUND

• 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.

  PMID: 23826863 BACKGROUND

• 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.

  PMID: 26569025 BACKGROUND

• 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.

  PMID: 24811189 BACKGROUND

• 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.

  PMID: 33585929 BACKGROUND

• 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

  BACKGROUND

• Alzheimer's Association. 2018 Alzheimer's disease facts and figures. Alzheimer's & Dementia. 2018;14(3):367-429.

  BACKGROUND

• 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.

  PMID: 25731881 BACKGROUND

• 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.

  PMID: 32823921 BACKGROUND

• 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.

  PMID: 31884487 BACKGROUND

• Alzheimer's Association. 2022 Alzheimer's Disease Facts and Figures. More Than Normal Aging: Understanding Mild Cognitive Impairment. Published online 2022.

  BACKGROUND

MeSH Terms

Conditions

Behavior; Depression; Caregiver Burden

Interventions

Mindfulness; Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Stress, Psychological

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Central Study Contacts

YU Sau Fung, RN, PhD, FHKAN, FAAN, FGSA

CONTACT

852 + 39176319; dyu1@hku.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Proferssor

Study Record Dates

• First Submitted: December 12, 2025
• First Posted: December 26, 2025
• Study Start: December 20, 2025
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): March 30, 2027
• Last Updated: March 31, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)