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

NCT04318951 | Completed Results DMC

• 1 other identifier: BB 033/17
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Post-stroke Depression; Post-stroke Aphasia

Outcome Measures

Primary Outcomes (2)

• Change in Beck's Depression Inventory, BDI.

  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 from 1 day before start of treatment until immediately after 4 weeks of treatment.

• Change in Hamilton Rating Scale for Depression, HAM-D. Higher Values Represent Higher Degree of Depression.

  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.

  Change from 1 day before start of treatment until immediately after 4 weeks of treatment.

Secondary Outcomes (1)

• 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)

Other Outcomes (1)

• Change in Aachen Aphasia Test, AAT.

  Change from 1 day before start of treatment until immediately after 4 weeks of treatment.

Study Arms (2)

Intensive communicative-pragmatic social interaction.

EXPERIMENTAL

Intensive Language-Action Therapy (ILAT).

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

Standard care.

OTHER

All participants will receive standard care.

Behavioral: Standard care.

Interventions

Intensive communicative-pragmatic social interaction. BEHAVIORAL

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.

Intensive communicative-pragmatic social interaction.

Standard care. BEHAVIORAL

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.

Intensive communicative-pragmatic social interaction.; Standard care.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Medicine Greifswald: lead

Study Sites (1)

MEDIAN-Klinik Berlin-Kladow

Berlin, 14089, Germany

Location

Related Publications (8)

• Stahl B, Van Lancker Sidtis D. Tapping into neural resources of communication: formulaic language in aphasia therapy. Front Psychol. 2015 Oct 20;6:1526. doi: 10.3389/fpsyg.2015.01526. eCollection 2015. No abstract available.

  PMID: 26539131 BACKGROUND

• Stahl B, Mohr B, Dreyer FR, Lucchese G, Pulvermuller F. Using language for social interaction: Communication mechanisms promote recovery from chronic non-fluent aphasia. Cortex. 2016 Dec;85:90-99. doi: 10.1016/j.cortex.2016.09.021. Epub 2016 Oct 15.

  PMID: 27842269 BACKGROUND

• Stahl B, Mohr B, Buscher V, Dreyer FR, Lucchese G, Pulvermuller F. Efficacy of intensive aphasia therapy in patients with chronic stroke: a randomised controlled trial. J Neurol Neurosurg Psychiatry. 2018 Jun;89(6):586-592. doi: 10.1136/jnnp-2017-315962. Epub 2017 Dec 22.

  PMID: 29273692 BACKGROUND

• Breitenstein C, Grewe T, Floel A, Ziegler W, Springer L, Martus P, Huber W, Willmes K, Ringelstein EB, Haeusler KG, Abel S, Glindemann R, Domahs F, Regenbrecht F, Schlenck KJ, Thomas M, Obrig H, de Langen E, Rocker R, Wigbers F, Ruhmkorf C, Hempen I, List J, Baumgaertner A; FCET2EC study group. Intensive speech and language therapy in patients with chronic aphasia after stroke: a randomised, open-label, blinded-endpoint, controlled trial in a health-care setting. Lancet. 2017 Apr 15;389(10078):1528-1538. doi: 10.1016/S0140-6736(17)30067-3. Epub 2017 Mar 1.

  PMID: 28256356 BACKGROUND

• Huber W, Poeck K, Willmes K. The Aachen Aphasia Test. Adv Neurol. 1984;42:291-303. No abstract available.

  PMID: 6209953 BACKGROUND

• Oldfield RC. The assessment and analysis of handedness: the Edinburgh inventory. Neuropsychologia. 1971 Mar;9(1):97-113. doi: 10.1016/0028-3932(71)90067-4. No abstract available.

  PMID: 5146491 BACKGROUND

• Shi YZ, Xiang YT, Wu SL, Zhang N, Zhou J, Bai Y, Wang S, Wang YL, Zhao XQ, Ungvari GS, Chiu HF, Wang YJ, Wang CX. The relationship between frontal lobe lesions, course of post-stroke depression, and 1-year prognosis in patients with first-ever ischemic stroke. PLoS One. 2014 Jul 8;9(7):e100456. doi: 10.1371/journal.pone.0100456. eCollection 2014.

  PMID: 25003990 BACKGROUND

• Stahl B, Millrose S, Denzler P, Lucchese G, Jacobi F, Floel A. Intensive Social Interaction for Treatment of Poststroke Depression in Subacute Aphasia: The CONNECT Trial. Stroke. 2022 Dec;53(12):3530-3537. doi: 10.1161/STROKEAHA.122.039995. Epub 2022 Sep 20.

  PMID: 36124755 RESULT

Related Links

• Documentary feature on the present clinical trial.

MeSH Terms

Interventions

Standard of Care

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Results Point of Contact

• Title: Prof. Dr. Benjamin Stahl
• Organization: Medical School Berlin

benjamin.stahl@medicalschool-berlin.de

+49 30 7668 375 708

Study Officials

• Benjamin Stahl, PhD

  University Medicine of Greifswald & Medical School Berlin

  PRINCIPAL INVESTIGATOR

• Agnes Flöel, MD

  University Medicine of Greifswald

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2020
• First Posted: March 24, 2020
• Study Start: March 1, 2020
• Primary Completion: January 15, 2022
• Study Completion: January 15, 2022
• Last Updated: July 5, 2024
• Results First Posted: July 5, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)