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| A multicenter, randomized clinical trial to assess the efficacy of a therapeutic intervention program for caregivers of people with dementia |
| Yoo R, Yeom J, Kim GH, Park HK, Kang Y, Hwang J, Choi SH, Na HR, Cho S-J, Yu K-H, Kim DH, Lee J-H, Jeong JH |
| Journal of Clinical Neurology 2019 Apr;15(2):235-242 |
| clinical trial |
| 5/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: No; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: Yes; Adequate follow-up: No; Intention-to-treat analysis: No; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed* |
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BACKGROUND AND PURPOSE: Caregivers experience tremendous social, financial, physical, and psychological burdens in caring for people with dementia. This study aimed to determine the efficacy of a multicomponent therapeutic intervention program for the caregivers of people with dementia (CGPWD) through a multicenter clinical trial: the intervention program-caregivers of people with dementia study. METHODS: The 38 caregivers of dementia patients at 8 sites were randomized into 2 groups: treatment (n = 19) and control (n = 19). The treatment group received the intervention program for 8 to 10 weeks, including one group session for dementia education and three individual sessions (on cognitive behavioral therapy, coping with stress, and stress management) and single targeted training for daily activities. The Korean version of the Zarit Burden Interview (ZBI-K) and the Geriatric Depression Scale (GDS) were evaluated at pre- and postintervention as primary efficacy measures. RESULTS: The treatment group displayed significant improvements in scores on the ZBI-K and GDS. The ZBI-K score at postintervention was significantly reduced in the treatment group compared to that in the control group (6.2-point decrease versus 3.7-point increase, t[37] = -2.9, p < 0.01). There was a significant difference in the GDS score between the treatment and control groups (2.2-point decrease versus 1.3-point increase, t[18] = 2.5, p < 0.05). CONCLUSIONS: The findings of this study imply that a multicomponent therapeutic intervention program is effective in reducing the burden experienced by and depression among CGPWD. Further research is warranted to investigate the long-term effects of the intervention program for CGPWD.
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