N/A
Completed N=60
Impact of Intensive Social Interaction on Post-Stroke Depression in Individuals With Aphasia
Source: ClinicalTrials.gov NCT04318951 ↗Enrolled (actual)
60
Serious AEs
0.0%
Results posted
Jul 2024
Primary outcomePrimary: Change in Beck's Depression Inventory, BDI. — -12.6; -5.8 score on a scale
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Beck's Depression Inventory, BDI. |
-12.6; -5.8 | — |
| PRIMARY Change in Hamilton Rating Scale for Depression, HAM-D. Higher Values Represent Higher Degree of Depression. |
-5.0; -3.3 | — |
| SECONDARY Self-Efficacy Questionnaire. |
20.1; 18.3 | — |
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.
Data sourced from ClinicalTrials.gov (NCT04318951). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.