Abstract
BACKGROUND: Stroke patients with aphasia and their caregivers have higher incidence of depression than those without aphasia. AIMS: 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. METHODS: 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. RESULTS: 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. CONCLUSION: ASK showed no benefit over attention control in improving mood and preventing depression in people with aphasia or their family members.