Clinical trial NCT03852121: Bibliotherapy for Improving Caregiving Appraisal Among Informal Caregivers of People With Dementia: A Pilot RCT
Official title: Bibliotherapy for Improving Caregiving Appraisal Among Informal Caregivers of People With Dementia: A Pilot Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dementia
Keywords: caregiving appraisal
bibliotherapy
psychological wellbeing
informal caregiver
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
First posted: 2019-02-25
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a 8-week pilot randomized controlled trial utilizing bibliotherapy compared with usual care to investigate the feasibility and acceptability of bibliotherapy among informal caregivers of people with dementia in China, and preliminarily examine the efficacy on improving caregiving appraisal.

Detailed description: Background: China is one of the countries with the highest number of people with dementia (PWD), while over 90% of PWD are cared by informal caregivers in the community. Informal caregivers are found to have higher level of stress, and lower level of well-being than non-caregivers. However, positive outcomes of caregiving have also been noted. Caregiving appraisal is caregivers' cognitive evaluation of potential caregiving stressors and the efficacy of their coping efforts related to caregiving experience. Based on Lawton's Caregiving Appraisal and Psychological Well-being Model, caregiving appraisal is an important factor that leads to the positive or negative well-being outcomes of caregivers. Addressing the caregiving appraisal of informal caregiver may be able to help in promoting the caregiver well-being and delay premature institutionalization. Intervention for improving dementia caregiving appraisal is still scarce, especially in China. Bibliotherapy is the process of learning from high-quality written materials for therapeutic benefits, it has been proved to be effective in improving caregiving appraisal of informal caregivers of people with psychosis and depression, its effect on dementia caregivers is unsure.

Objectives: There are two research objectives in this study: (1) To determine the feasibility and acceptability of the evidence-based bibliotherapy protocol among informal caregivers of PWD in China. (2) To preliminarily explore the efficacy of bibliotherapy on improving caregiving appraisal.

Methods:

Sixty participants will be recruited from Zhengzhou, China, and will be randomly allocated to either the intervention group or usual care group. The feasibility of the intervention will be explored in terms of the ease of participant recruitment, attendance rate and the attrition rate. The acceptability will be explored by interviews of participants in the intervention group at post-intervention. The Chinese version of Caregiving Appraisal Scale, the Chinese version of Ways of Coping Questionnaire, the Chinese version of Positive Aspects of Caregiving Scale, the Chinese version of Ryff's Psychological Well-being Scale, Alzheimer's Disease Knowledge Scale and Dementia Attitude Scale will be used to measure caregiving appraisal, coping, positive aspects of caregiving, psychological well-being, knowledge of dementia and attitude toward dementia of informal caregivers of PWD respectively. Descriptive statistics, Chi-square test, Mann Whitney U test, and independent t-test will be used to describe the participants' characteristics and compare the difference between groups at baseline. GEE will be used to examine the intervention efficacy.

Eligibility criteria: Inclusion Criteria:

* Caregiver who provides regular care to a person with early to moderate level of any type of medical diagnosis of dementia (PWD) for at least 5 hours per week for at least 6 months;
* Aged 18 or above;
* Not paid for the care provided;
* Assist with at least one of PWD's daily activities;
* Be able to read;
* Can be contacted by phone.

Exclusion Criteria:

* Caregivers with unstable physical or mental conditions;
* Those with cognitive impairment;
* Those involved in another interventional study.

Primary outcomes:
measure: Changes in caregiving appraisal
timeFrame: At baseline, immediate post intervention
Secondary outcomes:
measure: Changes in caregiver's coping
timeFrame: At baseline, immediate post intervention
measure: Changes in caregiver's psychological well-being
timeFrame: At baseline, immediate post intervention
measure: Changes in positive aspects of caregiving
timeFrame: At baseline, immediate post intervention
measure: Changes in knowledge of dementia
timeFrame: At baseline, immediate post intervention
measure: Changes in attitude toward dementia
timeFrame: At baseline, immediate post intervention
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: School of Nursing, The Hong Kong Polytechnic University
Study officials:
affiliation: School of Nursing, The Hong Kong Polytechnic University
name: Daphne Cheung, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Arain M, Campbell MJ, Cooper CL, Lancaster GA. What is a pilot or feasibility study? A review of current practice and editorial policy. BMC Med Res Methodol. 2010 Jul 16;10:67. doi: 10.1186/1471-2288-10-67.
citation: Bilich LL, Deane FP, Phipps AB, Barisic M, Gould G. Effectiveness of bibliotherapy self-help for depression with varying levels of telephone helpline support. Clin Psychol Psychother. 2008 Mar-Apr;15(2):61-74. doi: 10.1002/cpp.562.
citation: Campbell LF, Smith TP. Integrating self-help books into psychotherapy. J Clin Psychol. 2003 Feb;59(2):177-86. doi: 10.1002/jclp.10140.
citation: Folkman, S., & Lazarus, R. S. (1988). Ways of coping questionnaire: Consulting Psychologists Press.
citation: Hsiao HY, Liu Z, Xu L, Huang Y, Chi I. Knowledge, Attitudes, and Clinical Practices for Patients With Dementia Among Mental Health Providers in China: City and Town Differences. Gerontol Geriatr Educ. 2016 Oct-Dec;37(4):342-358. doi: 10.1080/02701960.2014.990152. Epub 2015 Jan 27.
citation: Lawton MP, Kleban MH, Moss M, Rovine M, Glicksman A. Measuring caregiving appraisal. J Gerontol. 1989 May;44(3):P61-71. doi: 10.1093/geronj/44.3.p61.
citation: Lawton MP, Moss M, Kleban MH, Glicksman A, Rovine M. A two-factor model of caregiving appraisal and psychological well-being. J Gerontol. 1991 Jul;46(4):P181-9. doi: 10.1093/geronj/46.4.p181.
citation: Lazarus, R. S., & Folkman, S. (1986). Stress, appraisal, and coping. New York: pringer.
citation: Li, R.-H. (2014). Reliability and validity of a shorter Chinese version for Ryff's psychological well-being scale. Health Education Journal, 73(4), 446-452.
citation: Lou VW, Lau BH, Cheung KS. Positive aspects of caregiving (PAC): scale validation among Chinese dementia caregivers (CG). Arch Gerontol Geriatr. 2015 Mar-Apr;60(2):299-306. doi: 10.1016/j.archger.2014.10.019. Epub 2014 Nov 7.
citation: Sclan SG, Reisberg B. Functional assessment staging (FAST) in Alzheimer's disease: reliability, validity, and ordinality. Int Psychogeriatr. 1992;4 Suppl 1:55-69. doi: 10.1017/s1041610292001157.
citation: Shechtman, Z. (2009). Bibliotherapy as a Method of Treatment. In Treating Child and Adolescent Aggression Through Bibliotherapy (pp. 1-17).
citation: Wang S, Cheung DSK, Leung AYM. Overview of dementia care under the three-tier long-term care system of China. Public Health Nurs. 2019 Mar;36(2):199-206. doi: 10.1111/phn.12573. Epub 2018 Dec 13.
citation: Zheng X, Chung JO, Woo BK. Exploring the Impact of a Culturally Tailored Short Film in Modifying Dementia Stigma Among Chinese Americans: A Pilot Study. Acad Psychiatry. 2016 Apr;40(2):372-4. doi: 10.1007/s40596-015-0397-7. Epub 2015 Aug 26.