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

Официальное название

Integrative Therapeutic Programme to Regulate Expressed Emotions Among Informal Caregivers of People With Dementia: a Pilot Randomized Controlled Trial

Обзор

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

Подробное описание

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.

Вмешательства

• Поведенческое 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

Первичные конечные точки

• Family Attitude Scale- Chinese Version [Срок оценки: From enrollment to the end of intervention at 7 weeks and end of study at 20 weeks.]

Вторичные конечные точки (4)

• Center of Epidemiological Studies of Depression Revised - Chinese Version [Срок оценки: From enrollment to the end of intervention at 7 weeks and end of study at 20 weeks.]
• Dyadic Relationship Scale - Chinese Version [Срок оценки: From enrollment to the end of intervention at 7 weeks and end of study at 20 weeks.]
• Interaction Quality Scale - Chinese Version [Срок оценки: From enrollment to the end of intervention at 7 weeks and end of study at 20 weeks.]
• Neuropsychiatric Inventory - Chinese Version [Срок оценки: From enrollment to the end of intervention at 7 weeks and end of study at 20 weeks.]

Критерии участия

Критерии включения

• (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

Критерии исключения

• (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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Гонконг · 1 центр

• University of Hong Kong — Гонконг

Публикации

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• 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

Идентификаторы

NCT: NCT07305415 · COPE

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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