Integrative Therapeutic Programme to Regulate Expressed Emotions Among Informal Caregivers of People With Dementia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Caregivers Of dementia Processing Emotions (COPE).
- Who it may be relevant to
- Registry conditions: BPSD (Behavioral and Psycological Symptoms of Dementia), Expressed Emotion, Depressive Symptom, Caregiving Stress. Basic parameters: 18 years — 100 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Hong Kong
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Integrative Therapeutic Programme to Regulate Expressed Emotions Among Informal Caregivers of People With Dementia: a Pilot Randomized Controlled Trial
Overview
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
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.
Interventions
- Behavioral Caregivers 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 t
Primary outcome measures
- Family Attitude Scale- Chinese Version [Time frame: From enrollment to the end of intervention at 7 weeks and end of study at 20 weeks.]
Secondary outcome measures (4)
- 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.]
Eligibility criteria
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
- (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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Hong Kong · 1 center
- University of Hong Kong — Hong Kong
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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 22169081
Identifiers
NCT: NCT07305415 · COPE