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The dual-modal (face-to-face and online approaches), client-customized Caregivers Of dementia Processing Emotions (COPE) programme aims to
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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Center of Epidemiological Studies of Depression Revised - Chinese Version | Assess caregivers' depression | From enrollment to the end of intervention at 7 weeks and end of study at 20 weeks. |
| Dyadic Relationship Scale - Chinese Version |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| YU Sau Fung, RN, PhD, FHKAN, FAAN, FGSA | Contact | 852 + 39176319 | dyu1@hku.hk |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Hong Kong | Recruiting | Hong Kong | Hong Kong |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29409164 | Background | 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. | |
| 9153155 | 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. |
Not provided
Not provided
Not provided
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Evaluate caregivers' perspective of dyadic and family relationships in their daily caregiving activities
| 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. | 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. | From enrollment to the end of intervention at 7 weeks and end of study at 20 weeks. |
| 24915293 | 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. |
| 27333896 | 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. |
| 18192628 | 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. |
| 26281832 | 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. |
| 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. |
| 22169081 | 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. |
| 24337642 | 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. |
| 17201189 | 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. |
| 9211580 | 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. |
| 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] |
| 26077904 | 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. |
| 23916631 | 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. |
| 31651321 | 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. |
| 33526012 | 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. |
| 25978672 | 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. |
| 15960057 | 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. |
| 12003455 | 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. |
| 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. |
| 2024141 | 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. |
| 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. |
| 35158171 | 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. |
| 26742605 | 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. |
| 23826863 | 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. |
| 26569025 | 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. |
| 24811189 | 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. |
| 33585929 | 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. |
| 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. |
| 25731881 | 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. |
| 32823921 | 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. |
| 31884487 | 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. |
| Background | Alzheimer's Association. 2022 Alzheimer's Disease Facts and Figures. More Than Normal Aging: Understanding Mild Cognitive Impairment. Published online 2022. |
| ID | Term |
|---|---|
| D001519 | Behavior |
| D003863 | Depression |
| D000084802 | Caregiver Burden |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D013315 | Stress, Psychological |
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| ID | Term |
|---|---|
| D064866 | Mindfulness |
| D015928 | Cognitive Behavioral Therapy |
| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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