Impact of Intensive Social Interaction on Post-Stroke Depression in Individuals With Aphasia

Not Applicable

Completed

Conditions: Post-stroke Aphasia
Post-stroke Depression

Interventions: Behavioral: Intensive communicative-pragmatic social interaction.
Behavioral: Standard care.

Registration Number: NCT04318951

Lead Sponsor: University Medicine Greifswald

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-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.

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 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 60

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intensive communicative-pragmatic social interaction.	Intensive communicative-pragmatic social interaction.	Intensive Language-Action Therapy (ILAT).
Intensive communicative-pragmatic social interaction.	Standard care.	Intensive Language-Action Therapy (ILAT).
Standard care.	Standard care.	All participants will receive standard care.

Primary Outcome Measures

Name	Time	Method
Change in Beck's Depression Inventory, BDI.	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.
Change in Hamilton Rating Scale for Depression, HAM-D. Higher Values Represent Higher Degree of Depression.	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.

Secondary Outcome Measures

Name	Time	Method
Self-Efficacy Questionnaire.	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 adequacy of the self-report co-primary outcome, the BDI.