Eligibility, any sex, with Post-stroke Depression or Post-stroke Aphasia. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Change in Beck's Depression Inventory, BDI.Primary· Change from 1 day before start of treatment until immediately after 4 weeks of treatment.
This self-report measure of depression severity is derived from a standardized questionnaire known for its good psychometric properties, including construct validity and test-retest reliability, in individuals without aphasia. Scale range: 0-120. Higher values represent higher degree of depression.
Group
Value
95% CI
Intensive Communicative-pragmatic Social Interaction.
-12.6
-17.5 – -7.7
Standard Care.
-5.8
-11.7 – -2.6
Change in Hamilton Rating Scale for Depression, HAM-D. Higher Values Represent Higher Degree of Depression.Primary· Change from 1 day before start of treatment until immediately after 4 weeks of treatment.
This clinician-rated measure of depression severity is known for its good psychometric properties, including construct validity and test-retest reliability, in individuals without aphasia. Scale range: 0-35.
Group
Value
95% CI
Intensive Communicative-pragmatic Social Interaction.
-5.0
-6.4 – -3.6
Standard Care.
-3.3
-4.5 – -2.1
Self-Efficacy Questionnaire.Secondary· Immediately after 4 weeks of treatment (used only as an external criterion to explore the psychometric adequacy of the self-report co-primary outcome, the BDI)
This self-report questionnaire was conceived to quantify a person's confidence to overcome obstacles encountered when completing a difficult task. Results are expressed on a Likert scale ranging from 0 (very low self-efficacy) to 3 (very high self-efficacy). Results are expressed as sum scores ranging from 0 (very low self-efficacy) to 30 (very high self-efficacy). Reduced self-efficacy is discussed as one risk factor for depression. This instrument was used only for cross-sectional assessment, not for longitudinal assessment, to serve as an external criterion to explore the psychometric adequ
Group
Value
95% CI
Intensive Communicative-pragmatic Social Interaction.
20.1
± 7.1
Standard Care.
18.3
± 7.8
Change in Aachen Aphasia Test, AAT.Secondary· Change from 1 day before start of treatment until immediately after 4 weeks of treatment.
This standardized aphasia test battery was found to be sensitive to treatment-induced short-term progress in language performance. To address the potential relationship between changes in cognitive-affective distress and verbal expression skills, we will use the combined AAT subscales "Repetition" and "Naming" as a covariate in exploratory evaluations. The AAT subscales "Repetition" and "Naming" as well as the resulting combined average score are based on a T-score distribution (M = 50; SD = 10). Higher T-scores represent better verbal expression skills. The results below indicate change over
Group
Value
95% CI
Intensive Communicative-pragmatic Social Interaction.
3.5
2.0 – 5.0
Standard Care.
2.9
1.0 – 4.8
Sponsor's own description
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.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by University Medicine Greifswald
Last refreshed: 5 July 2024
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