protocolSection identificationModule nctId: NCT06298695, orgStudyIdInfo id: 2012939, secondaryIdInfos id: 10390022210010, type: OTHER_GRANT, domain: ZonMw, briefTitle: Schema Therapy for Treatment-resistant Anxiety Disorders, acronym: PaDoLA, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-09-01, primaryCompletionDateStruct date: 2024-09-30, completionDateStruct date: 2030-12-31, studyFirstPostDateStruct date: 2024-03-07, lastUpdatePostDateStruct date: 2024-03-07, sponsorCollaboratorsModule leadSponsor name: Amsterdam UMC, location VUmc, class: OTHER, collaborators name: ZonMw: The Netherlands Organisation for Health Research and Development, collaborators name: ADF Stichting, collaborators name: University of Amsterdam, collaborators name: Maastricht University, collaborators name: GGZ inGeest, collaborators name: Pro Persona Mental Health Care Foundation, collaborators name: Mondriaan, collaborators name: GGNet, collaborators name: GGZ Delfland, descriptionModule briefSummary: The aim of this study is to assess the cost-effectiveness of schema therapy compared to treatment as usual (TAU) in patients with treatment-resistant anxiety disorders. In a multicenter randomized controlled trial, patients will be assigned to receive individual schema therapy (maximum of 40 sessions) or treatment as usual (control group) within one year. The primary outcome is the difference between ST and TAU conditions in anxiety symptoms as measured with the Beck Anxiety Inventroy (BAI) at post treatment. Secondary outcomes include quality of life, societal costs, general mental health, remission from the anxiety disorders and/or comorbid affective disorders, positive and negative effects of psychotherapy, schemas and schema modes, and satisfaction. Measurements take place at baseline and after 1, 3, 6, 12, 24 and 36 months (follow-up of two years)., conditionsModule conditions: Anxiety Disorders, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: A multicenter parallel group randomized controlled clinical intervention trial, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 172, type: ESTIMATED, armsInterventionsModule interventions name: Individual Schema Therapy, interventions name: TAU, outcomesModule primaryOutcomes measure: Changes in the severity of anxiety symptoms, primaryOutcomes measure: Health-related quality of life, primaryOutcomes measure: Mental health quality of life, primaryOutcomes measure: Health care utilization and productivity losses, secondaryOutcomes measure: Remission from the primary anxiety disorder and from comorbid disorders, secondaryOutcomes measure: Screening for DSM-5 personality disorders, secondaryOutcomes measure: Assessment of DSM-5 personality disorders, secondaryOutcomes measure: Demographics, secondaryOutcomes measure: (Strength of) treatment preference, secondaryOutcomes measure: Assessment of childhood trauma, secondaryOutcomes measure: Assessment of autistic traits, secondaryOutcomes measure: Assessment of general mental health, secondaryOutcomes measure: Functioning and recovery in psychiatric patients, secondaryOutcomes measure: Early Maladaptive Schemas, secondaryOutcomes measure: Schema Modes, secondaryOutcomes measure: Positive and negative effects of psychotherapy, secondaryOutcomes measure: The level of satisfaction with the psychological treatment, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False