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

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ClinicalTrials.gov Identifier: NCT04318951
Recruitment Status : Recruiting
First Posted : March 24, 2020
Last Update Posted : March 24, 2020
Sponsor:
Information provided by (Responsible Party):
University Medicine Greifswald

Brief 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.

Condition or disease Intervention/treatment Phase
Post-stroke Depression Post-stroke Aphasia Behavioral: Intensive communicative-pragmatic social interaction. Behavioral: Standard care. Not Applicable

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Impact of Intensive Social Interaction on Post-Stroke Depression in Individuals With Aphasia: A Proof-of-Concept Trial
Actual Study Start Date : March 1, 2020
Estimated Primary Completion Date : December 1, 2020
Estimated Study Completion Date : March 1, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intensive communicative-pragmatic social interaction
Intensive Language-Action Therapy (ILAT).
Behavioral: Intensive communicative-pragmatic social interaction.
ILAT requires individuals with aphasia to engage in social interaction. Groups of three patients and a therapist are seated around a table and provided with picture cards showing different objects (e.g., bottle). Each card has a duplicate that is owned by one of the other players. The goal is to obtain this duplicate from a fellow player by requesting the depicted object (e.g., "Give me the […]"). If the duplicate is available, the addressee hands over the corresponding card to the person who initiated the request sequence. If the duplicate is not available, the addressee rejects the request. In the event of misunderstandings, the players ask clarifying questions. Throughout the training, participants use formulaic expressions to indicate whether a request is accepted ("Here you are," "Thank you," "You're welcome"), rejected ("I'm sorry," "No problem," "Too bad") or unclear ("Pardon me?"). Treatment duration will be four weeks.

Behavioral: Standard care.
Depending on the participants' diagnoses and needs, standard care will include: occupational therapy (2-3 hours of weekly practice), physiotherapy (3 hours of weekly practice), and speech-language therapy (2-3 hours of weekly practice with non-communicative, impairment-specific exercises). Standard care will be delivered in accordance with state-of-the-art procedures in rehabilitation centers certified in Germany. Treatment duration will be four weeks.

Standard care
All participants will receive standard care.
Behavioral: Standard care.
Depending on the participants' diagnoses and needs, standard care will include: occupational therapy (2-3 hours of weekly practice), physiotherapy (3 hours of weekly practice), and speech-language therapy (2-3 hours of weekly practice with non-communicative, impairment-specific exercises). Standard care will be delivered in accordance with state-of-the-art procedures in rehabilitation centers certified in Germany. Treatment duration will be four weeks.




Primary Outcome Measures :
  1. Change in a simplified version of Beck's Depression Inventory, BDI-V. [ Time Frame: 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.

  2. Change in Hamilton Rating Scale for Depression, HAM-D. [ Time Frame: 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.


Secondary Outcome Measures :
  1. Change in Self-Efficacy Questionnaire. [ Time Frame: Change from 1 day before start of treatment until immediately after 4 weeks of treatment. ]
    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). Reduced self-efficacy is discussed as one risk factor for depression.

  2. Change in EuroQol Five-Dimensional Descriptive System, EQ-5D. [ Time Frame: Change from 1 day before start of treatment until immediately after 4 weeks of treatment. ]
    This self-report questionnaire is used to express perceived health on Likert scales ranging from 0 (very bad) to 4 (best possible health condition), and on a visual analogue scale ranging from 0% (very bad) to 100% (best possible health condition).


Other Outcome Measures:
  1. Change in Aachen Aphasia Test, AAT. [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 the AAT, with less than the maximum score of 10 error points on the first part of the subscale Token Test to ensure basic comprehension of spoken instructions (Huber et al., 1984); and
  • Late subacute or consolidation phase (1-12 months after the onset of disease) where risk of post-stroke depression is particularly high (Shi et al., 2014).

Exclusion Criteria:

  • More than one clinically apparent stroke;
  • Pre-morbid history of depression;
  • Other psychopathological or neurological conditions;
  • Severely impaired vision 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;
  • Changes in antidepressant medication within six weeks prior to study enrolment to rule out pharmacologically induced reduction of cognitive-affective distress during the treatment period; and
  • No informed consent.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04318951


Contacts
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Contact: Benjamin Stahl, PhD +49 30 450 ext 539 709 b.stahl@uni-greifswald.de
Contact: Benjamin Stahl, PhD +49 30 450 ext 539 709 benjamin.stahl@charite.de

Locations
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Germany
MEDIAN-Klinik Berlin-Kladow Recruiting
Berlin, Germany, 14089
Contact: Benjamin Stahl, PhD    +49 30 450 ext 539 709    b.stahl@uni-greifswald.de   
Contact: Benjamin, PhD    +49 30 450 ext 539 709    benjamin.stahl@charite.de   
Sponsors and Collaborators
University Medicine Greifswald
Investigators
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Principal Investigator: Benjamin Stahl, PhD University Medicine of Greifswald
Principal Investigator: Agnes Flöel, MD University Medicine of Greifswald
Additional Information:
Publications:

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Responsible Party: University Medicine Greifswald
ClinicalTrials.gov Identifier: NCT04318951    
Other Study ID Numbers: BB 033/17
First Posted: March 24, 2020    Key Record Dates
Last Update Posted: March 24, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Stroke
Aphasia
Depression
Depressive Disorder
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Behavioral Symptoms
Mood Disorders
Mental Disorders
Speech Disorders
Language Disorders
Communication Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Signs and Symptoms