Status:
COMPLETED
Impact of Intensive Social Interaction on Post-Stroke Depression in Individuals With Aphasia
Lead Sponsor:
University Medicine Greifswald
Conditions:
Post-stroke Depression
Post-stroke Aphasia
Eligibility:
All Genders
Phase:
NA
Brief 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-...
Detailed Description
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 cerebrovascula...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 15 2022
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04318951
Start Date
March 1 2020
End Date
January 15 2022
Last Update
July 5 2024
Active Locations (1)
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1
MEDIAN-Klinik Berlin-Kladow
Berlin, Germany, 14089