Clinical trial NCT05634317 - References

Dementia — Supporting Caregivers of PWD and Identifying an Effective Intervention to Reduce Their Depressive Symptoms

Citation(s)

•   Afram B, Stephan A, Verbeek H, Bleijlevens MH, Suhonen R, Sutcliffe C, Raamat K, Cabrera E, Soto ME, Hallberg IR, Meyer G, Hamers JP; RightTimePlaceCare Consortium
  Reasons for institutionalization of people with dementia: informal caregiver reports from 8 European countries. J Am Med Dir Assoc. 2014 Feb;15(2):108-16. doi: 10.1016/j.jamda.2013.09.012. Epub 2013 Nov 12.
•   Almirall D, Compton SN, Gunlicks-Stoessel M, Duan N, Murphy SA
  Designing a pilot sequential multiple assignment randomized trial for developing an adaptive treatment strategy. Stat Med. 2012 Jul 30;31(17):1887-902. doi: 10.1002/sim.4512. Epub 2012 Mar 22.
•   Anand KS, Dhikav V, Sachdeva A, Mishra P
  Perceived caregiver stress in Alzheimer's disease and mild cognitive impairment: A case control study. Ann Indian Acad Neurol. 2016 Jan-Mar;19(1):58-62. doi: 10.4103/0972-2327.167695.
•   Au A, Gallagher-Thompson D, Wong MK, Leung J, Chan WC, Chan CC, Lu HJ, Lai MK, Chan K
  Behavioral activation for dementia caregivers: scheduling pleasant events and enhancing communications. Clin Interv Aging. 2015 Mar 26;10:611-9. doi: 10.2147/CIA.S72348. eCollection 2015.
•   Au A, Yip HM, Lai S, Ngai S, Cheng ST, Losada A, Thompson L, Gallagher-Thompson D
  Telephone-based behavioral activation intervention for dementia family caregivers: Outcomes and mediation effect of a randomized controlled trial. Patient Educ Couns. 2019 Nov;102(11):2049-2059. doi: 10.1016/j.pec.2019.06.009. Epub 2019 Jun 26.
•   Bellg AJ, Borrelli B, Resnick B, Hecht J, Minicucci DS, Ory M, Ogedegbe G, Orwig D, Ernst D, Czajkowski S; Treatment Fidelity Workgroup of the NIH Behavior Change Consortium
  Enhancing treatment fidelity in health behavior change studies: best practices and recommendations from the NIH Behavior Change Consortium. Health Psychol. 2004 Sep;23(5):443-51. doi: 10.1037/0278-6133.23.5.443.
•   Brown EL, Ruggiano N, Li J, Clarke PJ, Kay ES, Hristidis V
  Smartphone-Based Health Technologies for Dementia Care: Opportunities, Challenges, and Current Practices. J Appl Gerontol. 2019 Jan;38(1):73-91. doi: 10.1177/0733464817723088. Epub 2017 Aug 4.
•   Cheng ST, Li KK, Losada A, Zhang F, Au A, Thompson LW, Gallagher-Thompson D
  The effectiveness of nonpharmacological interventions for informal dementia caregivers: An updated systematic review and meta-analysis. Psychol Aging. 2020 Feb;35(1):55-77. doi: 10.1037/pag0000401.
•   Cheung DSK, Kor PPK, Jones C, Davies N, Moyle W, Chien WT, Yip ALK, Chambers S, Yu CTK, Lai CKY
  The Use of Modified Mindfulness-Based Stress Reduction and Mindfulness-Based Cognitive Therapy Program for Family Caregivers of People Living with Dementia: A Feasibility Study. Asian Nurs Res (Korean Soc Nurs Sci). 2020 Oct;14(4):221-230. doi: 10.1016/j.anr.2020.08.009. Epub 2020 Sep 12.
•   Choi NG, Caamano J, Vences K, Marti CN, Kunik ME
  Acceptability and effects of tele-delivered behavioral activation for depression in low-income homebound older adults: in their own words. Aging Ment Health. 2021 Oct;25(10):1803-1810. doi: 10.1080/13607863.2020.1783516. Epub 2020 Jul 22.
•   Chong AML, Cheung C-k
  Factor structure of a Cantonese-version Pittsburgh Sleep Quality Index. Sleep and Biological Rhythms. 2012;10(2):118-25.
•   Elderly Health Service DoHHK
  Dementia. In: Health Do, editor. Hong Kong2016.
•   Glick HA, Doshi JA, Sonnad SS, Polsky D
  Economic evaluation in clinical trials: OUP Oxford; 2014.
•   Greenglass ER, Fiksenbaum L
  Proactive coping, positive affect, and well-being: Testing for mediation using path analysis. European psychologist. 2009;14(1):29-39.
•   Hou J, Wong SY, Lo HH, Mak WW, Ma HS
  Validation of a Chinese version of the Five Facet Mindfulness Questionnaire in Hong Kong and development of a short form. Assessment. 2014 Jun;21(3):363-71. doi: 10.1177/1073191113485121. Epub 2013 Apr 16.
•   Jiang D, Warner LM, Chong AM, Li T, Wolff JK, Chou KL
  Promoting Volunteering Among Older Adults in Hong Kong: A Randomized Controlled Trial. Gerontologist. 2020 Jul 15;60(5):968-977. doi: 10.1093/geront/gnz076.
•   Kor PPK, Chien WT, Liu JYW, Lai CKY
  Mindfulness-Based Intervention for Stress Reduction of Family Caregivers of People with Dementia: A Systematic Review and Meta-Analysis. Mindfulness. 2018;9(1):7-22.
•   Kor PPK, Liu JYW, Chien WT
  Effects of a modified mindfulness-based cognitive therapy for family caregivers of people with dementia: A pilot randomized controlled trial. Int J Nurs Stud. 2019 Oct;98:107-117. doi: 10.1016/j.ijnurstu.2019.02.020. Epub 2019 Mar 8.
•   Kor PPK, Liu JYW, Chien WT
  Effects of a Modified Mindfulness-Based Cognitive Therapy for Family Caregivers of People With Dementia: A Randomized Clinical Trial. Gerontologist. 2021 Aug 13;61(6):977-990. doi: 10.1093/geront/gnaa125.
•   Leung DY, Lam TH, Chan SS
  Three versions of Perceived Stress Scale: validation in a sample of Chinese cardiac patients who smoke. BMC Public Health. 2010 Aug 25;10:513. doi: 10.1186/1471-2458-10-513.
•   Liu Y, Kim K, Zarit SH
  Health trajectories of family caregivers: associations with care transitions and adult day service use. J Aging Health. 2015 Jun;27(4):686-710. doi: 10.1177/0898264314555319. Epub 2014 Oct 27.
•   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.
•   Mak WW, Tong AC, Yip SY, Lui WW, Chio FH, Chan AT, Wong CC
  Efficacy and Moderation of Mobile App-Based Programs for Mindfulness-Based Training, Self-Compassion Training, and Cognitive Behavioral Psychoeducation on Mental Health: Randomized Controlled Noninferiority Trial. JMIR Ment Health. 2018 Oct 11;5(4):e60. doi: 10.2196/mental.8597.
•   Nahum-Shani I, Qian M, Almirall D, Pelham WE, Gnagy B, Fabiano GA, Waxmonsky JG, Yu J, Murphy SA
  Experimental design and primary data analysis methods for comparing adaptive interventions. Psychol Methods. 2012 Dec;17(4):457-477. doi: 10.1037/a0029372. Epub 2012 Oct 1.
•   O'Dwyer ST, Moyle W, Zimmer-Gembeck M, De Leo D
  Suicidal ideation in family carers of people with dementia. Aging Ment Health. 2016;20(2):222-30. doi: 10.1080/13607863.2015.1063109. Epub 2015 Jul 10.
•   Oetting A, Levy J, Weiss R, Murphy S
  Causality and psychopathology: Finding the determinants of disorders and their cures. Shrout, P. 2007.
•   Organization WH
  Dementia: key facts. Retrieved March. 2019;31:2020.
•   Richards DA, Ekers D, McMillan D, Taylor RS, Byford S, Warren FC, Barrett B, Farrand PA, Gilbody S, Kuyken W, O'Mahen H, Watkins ER, Wright KA, Hollon SD, Reed N, Rhodes S, Fletcher E, Finning K
  Cost and Outcome of Behavioural Activation versus Cognitive Behavioural Therapy for Depression (COBRA): a randomised, controlled, non-inferiority trial. Lancet. 2016 Aug 27;388(10047):871-80. doi: 10.1016/S0140-6736(16)31140-0. Epub 2016 Jul 23.
•   Romero-Moreno R, Losada A, Marquez-Gonzalez M, Mausbach BT
  Stressors and anxiety in dementia caregiving: multiple mediation analysis of rumination, experiential avoidance, and leisure. Int Psychogeriatr. 2016 Nov;28(11):1835-1844. doi: 10.1017/S1041610216001009. Epub 2016 Jul 26.
•   Segal ZV, Williams JMG, Teasdale JD
  Mindfulness-based cognitive therapy for depression : a new approach to preventing relapse. New York: New York : Guilford Press; 2002.
•   Verbeke G
  Linear mixed models for longitudinal data. Linear mixed models in practice: Springer; 1997. p. 63-153.
•   Walter E, Pinquart M
  How Effective Are Dementia Caregiver Interventions? An Updated Comprehensive Meta-Analysis. Gerontologist. 2020 Nov 23;60(8):609-619. doi: 10.1093/geront/gnz118.
•   Wong ELY, Ramos-Goñi JM, Cheung AWL, Wong AYK, Rivero-Arias O
  Assessing the Use of a Feedback Module to Model EQ-5D-5L Health States Values in Hong Kong. Patient. 2018 Apr;11(2):235-247. doi: 10.1007/s40271-017-0278-0.
•   Xu XY, Kwan RYC, Leung AYM
  Behavioural activation for family dementia caregivers: A systematic review and meta-analysis. Geriatr Nurs. 2020 Sep - Oct;41(5):544-552. doi: 10.1016/j.gerinurse.2020.02.003. Epub 2020 Mar 3.
•   Yu X, Tam WW, Wong PT, Lam TH, Stewart SM
  The Patient Health Questionnaire-9 for measuring depressive symptoms among the general population in Hong Kong. Compr Psychiatry. 2012 Jan;53(1):95-102. doi: 10.1016/j.comppsych.2010.11.002. Epub 2010 Dec 28.
•   Zabihi S, Lemmel FK, Orgeta V
  Behavioural Activation for Depression in Informal Caregivers: A Systematic Review and Meta-Analysis of Randomised Controlled Clinical Trials. J Affect Disord. 2020 Sep 1;274:1173-1183. doi: 10.1016/j.jad.2020.03.124. Epub 2020 Apr 29.
•   Zeng Q-Z, He Y-L, Liu H, Miao J-M, Chen J-X, Xu H-N, et al
  Reliability and validity of Chinese version of the Generalized Anxiety Disorder 7-item (GAD-7) scale in screening anxiety disorders in outpatients from traditional Chinese internal department. [Reliability and validity of Chinese version of the Generalized Anxiety Disorder 7-item (GAD-7) scale in screening anxiety disorders in outpatients from traditional Chinese internal department.]. Chinese Mental Health Journal. 2013;27(3):163-8.
•   Zhu CW, Scarmeas N, Ornstein K, Albert M, Brandt J, Blacker D, Sano M, Stern Y
  Health-care use and cost in dementia caregivers: Longitudinal results from the Predictors Caregiver Study. Alzheimers Dement. 2015 Apr;11(4):444-54. doi: 10.1016/j.jalz.2013.12.018. Epub 2014 Mar 15.

Supporting Family Caregivers of People With Dementia and Identifying an Effective Adaptive Intervention to Reduce Their Depressive Symptoms: a Sequential Multiple Assignment Randomized Trial

Details for clinical trial NCT05634317