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Impact of Intensive Social Interaction on Post-Stroke Depression in Individuals With Aphasia: A Proof-of-Concept Trial

2020-03-27 03:25:32 | BioPortfolio

Summary

The present controlled, parallel-group, single-center, blinded-assessment, phase-IIA trial seeks to explore the feasibility of a study protocol on intensive communicative-pragmatic social interaction as a means to promote recovery from post stroke depression in the late subacute or consolidation phase of aphasia. 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. Likewise, secondary hypotheses predict that intensive communicative-pragmatic social interaction leads to significantly improved performance on measures evaluating self-efficacy and quality of life.

Description

Background. Individuals with post-stroke aphasia frequently experience a profound loss of abilities to engage in social interaction, one major reason for the increased risk of depression after a cerebrovascular accident. Impaired communication skills in aphasia often prevent classical forms of psychotherapy in post-stroke depression, thus emphasizing the need for new rehabilitation strategies alongside antidepressant medication.

Aims. The present controlled, parallel-group, single-center, blinded-assessment, phase-IIA trial seeks to explore the feasibility of a study protocol on intensive communicative-pragmatic social interaction as a potential treatment of post-stroke depression in the late subacute or consolidation phase of aphasia (1-12 months after a cerebrovascular accident). In this period of time, prevalence of post-stroke depression was found to be particularly high.

Methods. Treatment is based on an established protocol that encourages persons 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 aphasia will be allocated 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. Primary endpoints will be changes on self-report and clinician-rated measures of depression severity (simplified version of Beck's Depression Inventory, BDI-V; 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 (Self-Efficacy Questionnaire; EuroQol Five-Dimensional Descriptive System, EQ-5D; and Aachen Aphasia Test, AAT).

Hypotheses. The primary hypothesis predicts significant between-group differences on BDI-V and HAM-D scores, indicating greater reduction in depression severity with intensive communicative-pragmatic social interaction over and above standard care alone. Secondary hypotheses predict significant between-group differences on Self-Efficacy Questionnaire and EQ-5D scores. Further exploratory analyses will consider progress in language performance from onset to end of treatment on the AAT to account for the potential relationship between changes in cognitive-affective distress and verbal expression skills.

Clinical Relevance. The current proof-of-concept trial will investigate the feasibility of a study protocol on intensive communicative-pragmatic social interaction as a possible means to promote recovery from post-stroke depression in individuals with aphasia. The results obtained will determine the design of a subsequent phase-IIB randomized controlled trial.

Study Design

Conditions

Post-stroke Depression

Intervention

Intensive communicative-pragmatic social interaction., Standard care.

Location

MEDIAN-Klinik Berlin-Kladow
Berlin
Germany
14089

Status

Recruiting

Source

University Medicine Greifswald

Results (where available)

View Results

Links

Published on BioPortfolio: 2020-03-27T03:25:32-0400

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Relevant Topics

Stroke - Cerebrovascular Disease (CVA)
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