Integrative-interpersonal dynamic therapy for poststroke depression (INID): study protocol of a randomised controlled pilot trial

Volz, Matthias; Mundiyanapurath, Sibu; Schauenburg, Henning; Meuth, Sven Guenther; Wild, Beate; Werheid, Katja; Barber, Jacques P.; Schäfer, Ralf; Beerbaum, Luisa; Dinger, Ulrike

dc.date.accessioned	2023-08-25T04:44:18Z
dc.date.available	2023-08-25T04:44:18Z
dc.date.issued	2023-08-08
dc.identifier	doi:10.17170/kobra-202308188639
dc.identifier.uri	http://hdl.handle.net/123456789/15028
dc.description.sponsorship	Gefördert durch den Publikationsfonds der Universität Kassel
dc.language.iso	eng
dc.rights	Namensnennung-Nicht-kommerziell 4.0 International	*
dc.rights.uri	http://creativecommons.org/licenses/by-nc/4.0/	*
dc.subject.ddc	150
dc.subject.ddc	610
dc.title	Integrative-interpersonal dynamic therapy for poststroke depression (INID): study protocol of a randomised controlled pilot trial	eng
dc.type	Aufsatz
dcterms.abstract	Introduction Depression is the most frequent psychiatric disorder following stroke, affecting about one-third of stroke survivors. Patients experience poorer recovery, lower quality of life and higher mortality compared with stroke survivors without depression. Despite these well-known malign consequences, poststroke depression (PSD) is regarded underdiagnosed and undertreated. Evidence of beneficial effects of psychotherapy to treat PSD remains scarce and inconclusive and is limited by heterogeneity in design, content and timing of the intervention. This pilot study aims to assess the feasibility of a newly developed integrative-interpersonal dynamic PSD intervention in an outpatient setting and provide a first estimation of the potential effect size as basis for the sample size estimation for a subsequent definite trial. Method and analysis Patients will be recruited from two German stroke units. After discharge from inpatient rehabilitation, depressed stroke survivors will be randomised to short-term psychotherapy (12 weeks, ≤16 sessions) or enhanced treatment as usual. The manualised psychotherapy integrates key features of the Unified Psychodynamic and Cognitive-Behavioural Unified Protocol for emotional disorders and was adapted for PSD. Primary endpoints are recruitment feasibility and treatment acceptability, defined as a recruitment rate of ≥20% for eligible patients consenting to randomisation and ≥70% completion-rate of patients participating in the treatment condition. A preliminary estimation of the treatment effect based on the mean difference in Patient Health Questionnaire-9 (PHQ-9) scores between intervention and control group six months poststroke is calculated. Secondary endpoints include changes in depression (PHQ-9/ Hamilton Depression Scale) and anxiety (Generalised Anxiety Disorder 7) of all participants across all follow-ups during the first year poststroke.	eng
dcterms.accessRights	open access
dcterms.creator	Volz, Matthias
dcterms.creator	Mundiyanapurath, Sibu
dcterms.creator	Schauenburg, Henning
dcterms.creator	Meuth, Sven Guenther
dcterms.creator	Wild, Beate
dcterms.creator	Werheid, Katja
dcterms.creator	Barber, Jacques P.
dcterms.creator	Schäfer, Ralf
dcterms.creator	Beerbaum, Luisa
dcterms.creator	Dinger, Ulrike
dc.relation.doi	doi:10.1136/bmjopen-2023-077656
dc.subject.swd	Medizin	ger
dc.subject.swd	Psychologie	ger
dc.subject.swd	Schlaganfall	ger
dc.subject.swd	Depression	ger
dc.subject.swd	Kontrollierte klinische Studie	ger
dc.type.version	publishedVersion
dcterms.source.identifier	eissn:2044-6055
dcterms.source.issue	Issue 8
dcterms.source.journal	BMJ Open	eng
dcterms.source.volume	Volume 13
kup.iskup	false
dcterms.source.articlenumber	077656