Intensive Social Interaction for Treatment of Poststroke Depression in Subacute Aphasia: The CONNECT Trial.

BACKGROUND: Limiting the ability to engage in social interaction, aphasia increases the risk of poststroke depression and may prevent classical forms of psychotherapy. Our parallel-group, blinded-assessment, quasi-randomized controlled trial explores the feasibility and potential efficacy of intensive social interaction as a means to alleviate poststroke depression in subacute aphasia. METHODS: We adopted a linguistically validated treatment program based on massed practice and conversational turn-taking (Intensive Language-Action Therapy). In a routine outpatient setting, 60 individuals with poststroke depression and subacute aphasia (0.5-6 months following left-hemispheric ischemia or hemorrhage) were assigned to Intensive Language-Action Therapy combined with standard care (Group I) or standard care alone (Group II). End points included feasibility (primary outcome) alongside change on self-report and clinician-rated measures of depression severity (co-primary outcomes: Beck's Depression Inventory; Hamilton Rating Scale for Depression) after a 1-month treatment period (5 weekly 1-hour sessions), controlled for progress in language performance (secondary outcome: Aachen Aphasia Test, AAT). RESULTS: 100% treatment participation demonstrated feasibility of Intensive Language-Action Therapy in poststroke depression. Analyses (n=60) revealed significant between-group differences on the Beck's Depression Inventory (change in Group I [95% CI]: -12.6 [±4.9]; in Group II: -5.8 [±3.2]; P=0.040) and Hamilton Rating Scale for Depression (change in Group I: -5.0 [±1.4]; in Group II: -3.3 [±1.2]; P=0.002), indicating small-to-medium effect sizes in reducing depression severity with Intensive Language-Action Therapy (η2≤0.101). No significant between-group differences emerged on expressive AAT subscales. CONCLUSIONS: Our results confirm the feasibility and potential efficacy of intensive social interaction for treatment of poststroke depression in subacute aphasia. REGISTRATION: URL: www. CLINICALTRIALS: gov; Unique identifier: NCT04318951.