impact of intensive social interaction on post-stroke depression in individuals with aphasia

Conditions: Post-stroke Depression; Post-stroke Aphasia

Summary: the present parallel-group, single-center, blinded-assessment controlled trial seeks to explore the feasibility - in terms of high completion rates - and potential efficacy of intensive communicative-pragmatic social interaction for treatment of post stroke depression in subacute aphasia. apart from evidence of treatment feasibility, the primary hypothesis predicts significantly greater progress on self-report and clinician-rated measures of depression severity after (i) intensive communicative-pragmatic social interaction combined with standard care, compared to (ii) standard care alone.

background. individuals with post-stroke aphasia often experience a profound loss of abilities to engage in social interaction, one major reason for increased risk of depression after a cerebrovascular accident. impaired communication skills in aphasia can prevent classical forms of psychotherapy, thus emphasizing the need for new rehabilitation strategies alongside antidepressant medication. aims. the present parallel-group, single-center, blinded-assessment controlled trial seeks to explore the feasibility - in terms of high completion rates (primary outcome) - and potential efficacy (co-primary and secondary outcomes, as defined below) of intensive communicative-pragmatic social interaction for treatment of post-stroke depression in subacute aphasia. in this early time window after a cerebrovascular accident, prevalence of post-stroke depression is generally high. methods. treatment is based on a linguistically validated protocol that encourages individuals with aphasia to use neural resources of verbal communication embedded in intensive social interaction. in a routine-healthcare outpatient setting, 60 individuals with post-stroke depression and subacute aphasia will be assigned to one of two groups in a pseudorandomized fashion: (i) intensive communicative-pragmatic social interaction combined with standard care, or (ii) standard care alone. endpoints and outcomes. apart from evidence of treatment feasibility, endpoint will be change on self-report and clinician-rated measures of depression severity (co-primary outcomes: beck's depression inventory, bdi; and hamilton rating scale for depression, ham-d) after a 1-month treatment period (5 hours of weekly training). secondary outcomes include measures evaluating self-efficacy, quality of life, and language performance (secondary outcomes: self-efficacy questionnaire; and aachen aphasia test, aat). hypotheses. aside from evidence of treatment feasibility, the primary hypothesis predicts significant between-group differences on bdi and ham-d scores, indicating greater reduction in depression severity with intensive communicative-pragmatic social interaction over and above standard care alone. secondary analyses will focus on the self-efficacy questionnaire as an external criterion to explore the psychometric adequacy of the self-report co-primary outcome, the bdi, and consider progress in language performance from onset to end of treatment on the aat to account for the potential relationship between change in cognitive-affective distress and verbal expression skills. clinical relevance. the current proof-of-concept trial will investigate the feasibility and potential efficacy of intensive communicative-pragmatic social interaction as a means to promote recovery from post-stroke depression in subacute aphasia. the results obtained will determine the design of a subsequent phase-iii randomized controlled trial.

Eligibility criteria:
inclusion criteria: * left-hemisphere cortical or subcortical stroke; * native speaker of german; * right-handedness according to the edinburgh handedness inventory (oldfield, 1971); * diagnosis of post-stroke depression, as defined in the international statistical classification of diseases and related health problems (icd-11); * diagnosis of aphasia, as confirmed by standardized tests (e.g., huber et al., 1984); and * late subacute or consolidation phase (i.e., 0.5-6 months following stroke) where risk of post-stroke depression is particularly high (shi et al., 2014). exclusion criteria: * other neurological conditions; * pre-morbid history of depression; * other psychopathological conditions; * severely impaired vision or hearing that may prevent participants from engaging in intensive communicative-pragmatic social interaction during therapy or testing, thus adopting routine-healthcare standards from a large-scale phase-iii randomized controlled trial (breitenstein et al., 2017); * serious non-verbal cognitive deficits; and * no informed consent.