Discipline of Clinical Psychology, University of Technology Sydney, Ultimo, NSW, Australia.
Centre of Research Excellence in Aphasia Rehabilitation Recovery, La Trobe University, Bundoora, Victoria, Australia.
Int J Stroke. 2023 Oct;18(8):996-1004. doi: 10.1177/17474930231176718. Epub 2023 Jun 5.
Stroke patients with aphasia and their caregivers have higher incidence of depression than those without aphasia.
The objective of the study is to determine whether a tailored intervention program (Action Success Knowledge; ASK) led to better mood and quality of life (QoL) outcomes than an attention control with a 12-month end point at cluster and individual participant level.
A multi-site, pragmatic, two-level single-blind cluster randomized controlled trial compared ASK to an attention control (secondary stroke prevention program). Ten metropolitan and 10 non-metropolitan health regions were randomized. People with aphasia and their family members were recruited within 6 months post-stroke who scored ⩽12 on the Stroke Aphasic Depression Questionnaire Hospital Version-10 at screening. Each arm received manualized intervention over 6-8 weeks followed by monthly telephone calls. Blinded assessments of QoL and depression were taken at 12 months post-onset.
Twenty clusters (health regions) were randomized. Trained speech pathologists screened 1744 people with aphasia and 373 participants consented to intervention (n = 231 people with aphasia and 142 family members). The attrition rate after consent was 26% with 86 and 85 participants with aphasia in the ASK arm and attention control arm, respectively, receiving intervention. Of those 171 who did receive treatment, only 41 met the prescribed minimum dose. Multilevel mixed effects modeling under the intention-to-treat protocol showed a significant difference on the Stroke and Aphasia Depression Questionnaire-21 (SADQ-21, N = 122, 17 clusters) in favor of the attention control (β = -2.74, 95% confidence interval (CI) = -4.76 to -0.73, p = 0.008). Individual data analysis using a minimal detectable change score for the SADQ-21 showed the difference was not meaningful.
ASK showed no benefit over attention control in improving mood and preventing depression in people with aphasia or their family members.
伴有失语症的脑卒中患者及其照料者比无失语症的脑卒中患者更容易发生抑郁。
本研究旨在确定量身定制的干预方案（行动成功知识；ASK）是否比注意力对照组（二级卒中预防计划）在 12 个月的时间点在集群和个体参与者水平上具有更好的情绪和生活质量（QoL）结果。
一项多地点、实用、两级单盲集群随机对照试验比较了 ASK 与注意力对照组（二级卒中预防计划）。10 个大都市和 10 个非大都市卫生区被随机分配。在卒中后 6 个月内，通过脑卒中失语抑郁问卷医院版 10 项评分筛选出评分 ⩽12 的失语症患者及其家属参与本研究。每组均接受 6-8 周的规范化干预，随后每月进行电话随访。在发病后 12 个月进行 QoL 和抑郁的盲法评估。
20 个集群（卫生区）被随机分配。经过培训的言语病理学家对 1744 名伴有失语症的患者进行了筛查，有 373 名患者同意参与干预（n=231 名伴有失语症的患者和 142 名家属）。同意后，有 26%的患者失访，ASK 组和注意力对照组分别有 86 名和 85 名伴有失语症的患者接受了干预。在接受治疗的 171 名患者中，只有 41 名达到了规定的最低剂量。根据意向治疗方案进行的多层次混合效应模型显示，在脑卒中与失语症抑郁问卷-21（SADQ-21，N=122，17 个集群）上，注意力对照组有显著差异（β=-2.74，95%置信区间（CI）=-4.76 至-0.73，p=0.008）。使用 SADQ-21 的最小可检测变化评分进行个体数据分析表明，差异无统计学意义。
ASK 在改善伴有失语症的脑卒中患者及其家属的情绪和预防抑郁方面，并未显示优于注意力对照组。
