protocolSection identificationModule nctId: NCT06282029, orgStudyIdInfo id: I-2720-0018-0003, briefTitle: ACT-group for Stroke Survivors (Pilot Study), statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-01, primaryCompletionDateStruct date: 2024-05, completionDateStruct date: 2024-05, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Bielefeld University, class: OTHER, collaborators name: Bielefeld Young Researchers' Fund, descriptionModule briefSummary: The goal of this clinical pilot trial is to test the feasibility, acceptance and preliminary efficacy of an adapted group psychotherapy manual in stroke survivors with psychological stress. The main questions it aims to answer are:* Is the group therapy feasible?* Is the group therapy accepted by stroke survivors and therapists?* Are there first indications on the efficacy of the group therapy to improve mental health?Participants will take part in 8 weekly group therapy sessions of 90 minutes each., conditionsModule conditions: Stroke, conditions: Intracerebral Hemorrhage, conditions: Depressive Symptoms, conditions: Anxiety, conditions: Stress, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: This pilot study includes a pre-/post test of a small intervention sample without control group., primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 12, type: ESTIMATED, armsInterventionsModule interventions name: Group Therapy, outcomesModule primaryOutcomes measure: Drop-out rate, primaryOutcomes measure: Session adherence, primaryOutcomes measure: Homework completion, primaryOutcomes measure: Completion of outcome measures, primaryOutcomes measure: Treatment fidelity, primaryOutcomes measure: Group therapy session questionnaire - patients (Zoubek, 2013; Plain German), primaryOutcomes measure: Group therapy session questionnaire - therapists (Zoubek, 2013; Plain German), primaryOutcomes measure: Acceptance and Action Questionnaire-Acquired Brain Injury (Sylvester, 2011; Plain German), primaryOutcomes measure: Depression and Anxiety Stress Scales-21 (Lovibond, 1995; Plain German), secondaryOutcomes measure: Valuing Questionnaire (Smout, 2014; Plain German), secondaryOutcomes measure: Self-as-context scale (Zettle, 2018; Plain German), secondaryOutcomes measure: Patient Health Questionnaire-9 (Kroenke, 2001; Plain German), secondaryOutcomes measure: Generalized Anxiety Disorder-7 (Spitzer, 2006; Plain German), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University Neuropsychological Outpatient Clinic, status: RECRUITING, city: Bielefeld, zip: 33607, country: Germany, contacts name: Simon Ladwig, PhD, role: CONTACT, phone: 017664716035, email: simon.ladwig@uni-bielefeld.de, geoPoint lat: 52.03333, lon: 8.53333, documentSection largeDocumentModule largeDocs typeAbbrev: Prot_SAP, hasProtocol: True, hasSap: True, hasIcf: False, label: Study Protocol and Statistical Analysis Plan, date: 2024-02-12, uploadDate: 2024-02-12T06:57, filename: Prot_SAP_000.pdf, size: 260777, hasResults: False