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

NCT04318951 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2024-07-05

Study results available
· View outcomes & findings →

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.

Conditions

  • Post-stroke Depression
  • Post-stroke Aphasia

Interventions

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.

Sponsors & Collaborators

  • University Medicine Greifswald

    lead OTHER

Principal Investigators

  • Benjamin Stahl, PhD · University Medicine of Greifswald & Medical School Berlin

  • Agnes Flöel, MD · University Medicine of Greifswald

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-03-01
Primary Completion
2022-01-15
Completion
2022-01-15

Countries

  • Germany

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04318951 on ClinicalTrials.gov