Relationship between Post-Stroke Psychopathology, Laterality of Lesion Site and Psychological Flexibility: The PSYFLEX Trial

• Conditions: F06.3; F06.4; Organic mood [affective] disorders; Organic anxiety disorder

• Registration Number: DRKS00031204
• Lead Sponsor: Medical School Berlin

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-02-21
• Study Completion: 2023-04-28
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 39

Inclusion Criteria

(1) first-time cerebrovascular accident; (2) lesion either in the right or in the left hemisphere; (3) stage between two weeks and six months post-stroke at the time of testing.

Exclusion Criteria

(1) lesion extending to both hemispheres, brainstem or cerebellum; (2) severe deficits in speech comprehension, as determined by less than 10 correct reactions on the subscale Request for eye movement and head movement” from the Aachener Aphasie-Bedside Test (Biniek et al., 1992); (3) serious non-verbal cognitive deficits, as determined by performance on the Corsi-Block-Tapping Task more than two standard deviations below the average total score (Kessels et al., 2000); (4) premorbid diagnosis of recurrent affective disorder; (5) severe comorbid and chronic somatic disease, such as Morbus Crohn or Colitis ulcerosa.

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Here, we aimed to explore two potential sources of post-stroke psychopathology: left- or right-hemispheric localization of the acquired brain damage, and psychological flexibility as an increasingly recognized factor in mental health research.<br><br>-Depressive symptomatology: Simplified Beck Depression Inventory; Hospital Anxiety and Depression Scale, 7-Item Hamilton Depression Rating Scale, ICD-10 Symptom-Rating<br>-Anxiety symptomatology: Hospital Anxiety and Depression Scale<br>-Symptoms of obsessive-compulsive disorder, somatoform disorder, eating disorder, general<br>mental distress: ICD-10 Symptom-Rating<br>-Laterality of lesion site obtained from medical records

Secondary Outcome Measures

Name	Time	Method
Descriptive variables: (1) age, (2) sex, (3) years of education, (4) Number of secondary diagnoses (5) diagnosis of mild aphasia (6) current psychopharmacotherapy, (7) functional independence and mobility (Barthel index; Mahoney & Barthel, 1965).