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

June 22, 2022 updated by: University Medicine Greifswald
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany, 14089
        • MEDIAN-Klinik Berlin-Kladow

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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.
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Beck's Depression Inventory, BDI.
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.
Change from 1 day before start of treatment until immediately after 4 weeks of treatment.
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.
Change from 1 day before start of treatment until immediately after 4 weeks of treatment.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Self-Efficacy Questionnaire.
Time Frame: Immediately after 4 weeks of treatment (used 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). Reduced self-efficacy is discussed as one risk factor for depression.
Immediately after 4 weeks of treatment (used as an external criterion to explore the psychometric adequacy of the self-report co-primary outcome, the BDI)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Change from 1 day before start of treatment until immediately after 4 weeks of treatment.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Medicine Greifswald

Investigators

  • Principal Investigator: Benjamin Stahl, PhD, University Medicine of Greifswald
  • Principal Investigator: Agnes Flöel, MD, University Medicine of Greifswald

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2020

Primary Completion (Actual)

January 15, 2022

Study Completion (Actual)

January 15, 2022

Study Registration Dates

First Submitted

March 17, 2020

First Submitted That Met QC Criteria

March 20, 2020

First Posted (Actual)

March 24, 2020

Study Record Updates

Last Update Posted (Actual)

June 29, 2022

Last Update Submitted That Met QC Criteria

June 22, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BB 033/17

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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