Trial Description. DRKS-ID: DRKS Date of Registration in DRKS: 2014/10/31 Date of Registration in Partner Registry: [---]* Title

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1 Trial Description Title SCHILD - protective intervention for longtime course in depression Trial Acronym SCHILD URL of the trial [---]* Brief Summary in Lay Language Even if depression is treated appropriate by antidepressant and psycho-therapeutic maintenance therapy, after discharge from inpatient depression treatment, relapse and rehospitalization represent central problems. Therefore supplementary interventions to further reduce relapses are urgently needed. Such a method is the insufficiently investigated - implementation of psychoeducational group interventions for relatives. The present project investigates the effect of a psychoeducational group intervention for relatives on the course of disease of the associated patients with depression within a two-armed parallel-group multicenter randomized controlled trial at seven study centers. The psychoeducational group intervention is conducted after discharge from inpatient treatment of the associated patient, encompasses four group-sessions, each of 90 to 120 minutes duration. The group intervention is carried out within a two-week rhythm and contains three to five relatives per group. The first part of every group-session is been used to convey illness- and treatment-specific aspects of depression. The residual time is used for a problem-solving-training for difficult patient-relative-interactions. A total of 180 patient-relativetandems (90 intervention-, 90 control-group) will be included in the study. Data will be collected at five time points within one year after patients discharge from inpatient depression treatment. The effect of the intervention on the course of disease of the patients will be measured by the estimated number of depression-free days within this period. In addition the effects of the intervention on the level of burden in relatives and analysis in health economics are being carried out. Brief Summary in Scientific Language Inpatient depression treatment is a central component of depression management in, however the high risk of relapse and rehospitalization after discharge from inpatient depression treatment are health care problems. Every additional relapse increases the risk of further relapses. Thus, relapse prevention is a central aim of depression management. Although antidepressant and/or psychotherapeutic maintenance therapy can reduce the risk of relapse, interventions possessing an incremental effect to further reduce relapses are urgently needed. The German guidelines for unipolar depressive disorders recommend psychoeducation for families and relatives as a sensible addition to treatment. However, the grade of recommendation is only B, meaning that qualitative high grade studies investigating the impact of psychoeducational treatment of families and relatives on the course of disease in patients are so far Page 1 of 8

2 lacking. The project investigates the effect of a psychoeducational group intervention for relatives of patients with a depression on the course of disease of the associated patients within a twoarmed parallel-group multicenter randomized controlled trial at seven study centers (N = 180 patient-relative tandems; 90 intervention-, 90 control-group) within one year after discharge from inpatient depression treatment. The analyzed psychoeducational group intervention contains of four sessions, which take about 90 to 120 minutes and will be conducted on a fortnightly basis. The sessions are divided into two parts; the first part of the intervention provides information about illness- and treatment-specific aspects of depression; the second part deals with a problemsolving-training that aims to improve the problem solving skills of the participating relatives. The primary outcome of the study is the course of disease, measured by the estimated number of depression-free-days within one year after discharge of inpatient treatment. Main secondary outcomes are rehospitalization and the time till rehospitalization, the effects on the level of disease-related burden in relatives and the incremental cost-effectiveness-ratio in health economics. Hence the intervention effects are extensively evaluated and will contribute to close an important evidence gap. Organizational Data DRKS-ID: DRKS Date of Registration in Partner Registry or other Primary Registry: [---]* Investigator Sponsored/Initiated Trial (IST/IIT): yes Ethics Approval/Approval of the Ethics Committee: Approved (leading) Ethics Committee Nr.: 381/13, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg Secondary IDs Universal Trial Number (UTN): U Health condition or Problem studied ICD10: F32 - Depressive episode ICD10: F33 - Recurrent depressive disorder Interventions/Observational Groups Arm 1: The intervention consists of four sessions, which will be conducted on a fortnightly basis, beginning after discharge from inpatient treatment. The psychoeducational part includes information on symptoms and diagnosis, self-care, cause and development as well as treatment. The group-sessions take 90 to 120 minutes and consist of two parts. In the first part of each group-session information about illness- and treatment-specific aspects of depression will be provided. In the second part of each group-session a Page 2 of 8

3 problem-solving-training that aims to improve the problem solving skill of the relatives will be carried out. According to this technique it is possible to develop problem solving strategies for high expressed emotion situations. Patients will not take part in the intervention. To fit routine care conditions neither the inpatient depression treatment before discharge nor the patient treatment after discharge will be modified or restricted in any way. The treatment will be captured to review possible effects related to the treatment results. Arm 2: To evaluate the incremental effect of the group-intervention for relatives of depressive patients the effectiveness of the intervention will be compared to treatment-as-usual (TAU). In this study, there will be no systematic information offered to relatives in addition to that routine. The inpatient depression will not be modified or restricted in any way. However, data on the treatment received in inpatient treatment and after discharge will be gathered as they may modify the effects compared to the intervention group. Characteristics Study Type: Interventional Study Type Non-Interventional: [---]* Allocation: Randomized controlled trial Blinding: [---]* Who is blinded: data analyst Control: Control group receives no treatment Purpose: Prevention Assignment: Parallel Phase: N/A Off-label use (Zulassungsüberschreitende Anwendung eines Arzneimittels): N/A Primary Outcome Estimated number of depression free days (DFD) within one year after discharge from inpatient depression treatment measured with the Patient Health Questionnaire (PHQ-9) at five time points (T0 = at discharge from inpatient treatment, T1 = 3, T2 = 6, T3 = 9 and T4 =12 months after discharge from inpatient treatment). Secondary Outcome Patient-related: level of expressed emotion (German questionnaire on family atmosphere, FEF) T0, T2 & T4; perceived criticism of relative (Hooley & Teasdale, 1989)T0, T2 & T4; health care utilization (selfconstruction in accordance with the German Health Interview and Examination Survey for Adults (DEGS), a german questionnaire on resource utilization (Fragebogen zur Inanspruchnahme medizinischer und nicht-medizinischer Versorgungsleistungen im Alter, FIMA) and the Client Sociodemographic and Service Receipt Inventory (CSSRI-D)) T1 - T4; state of employment (DEGS, CSSRI-D) T1 - T4; days of inability to work (DEGS, CSSRI-D) T1 Page 3 of 8

4 - T4; impairment of functional capability, activity and participation (WHO Disability Assessment Schedule, WHODAS 2.0) T0 - T4; adverse events (self-construction) T2 & T4. Relative-realated : problem solving competency (Social Problem-Solving Inventory-Revised, SPSI-R) T0, T2 & T4; level of expressed emotion (Family Questionnaire, FQ) T0, T2 & T4; psychological stress (Symptomcheckliste, SCL-K-9) T0 - T4; level of disease-related burden (Involvement Evaluation Questionnaire, IEQ-EU) T0 - T4; depression literacy (Depression Literacy Test, D-Lit and selfconstruction) T0 & T2; control attributions (Illness Perception Questionnaire for Schizophrenia, IPQS-R) T0, T2 & T4; adverse events (self-construction) T2 & T4; acceptance (self-construction) T2; subjective benefit (self-construction) T2; appliance of problemsolving (self-construction) T2. Incremental cost-effective-ratio: Cost-effectiveness investigation analyses of the intervention through cost-effectiveness analysis (CEA) based on the perspective of the health insurance funds and the society. Sources of these analyses are (1.) depression-free-days, (2.) prevented days of inability to work and (3.) prevented rehospitalisation. Mediator- and moderator-analysis: Analysis in what way the EE-level both on relative-level and on patient-level, the disease-related and psychosocial burden of relatives, the problem solving competency, comorbidities, previous phase response, chronicity, relationship to the relative and sociodemographic respectively socioeconomic variables constitute mediators respectively moderators for the intervention-effects. Adherence (interventions will be tape-recorded): For research and quality assurance of the study, the group-sessions will be audiotaped and rated by trained raters using a self-constructed tool. The tape recordings enable to review if the intervention has been carried out in accordance to the requirements of the manual (treatment adherence). Countries of recruitment DE Locations of Recruitment University Medical Center Universitätsklinikum Freiburg, Klinik für Psychiatrie und Psychotherapie, Hauptstraße 5, 79104, Freiburg im Breisgau University Medical Center Universitätsklinikum Tübingen, Klinik für Psychiatrie und Psychotherapie mit Poliklinik, Abteilung Psychiatrie und Psychotherapie mit Poliklinik. Calwerstraße 14, 72076, Tübingen Medical Center Städtisches Klinikum Karlsruhe ggmbh, Klinik für Psychiatrie und Psychotherapeutische Medizin, Kaiserallee 10, 76133, Karlsruhe Page 4 of 8

5 University Medical Center Klinikum rechts der Isar, Ismaninger Straße 22, München, München Medical Center Vivantes Netzwerk für Gesundheit GmbH, Aroser Allee Berlin Medical Center Zentrum für Psychiatrie Emmendingen, Klinik für Psychiatrie und Psychotherapie, Neubronnstraße 25, 79312, Emmendingen University Medical Center Klinik für allgemeine Psychiatrie, Voßstraße 4, Heidelberg, Heidelberg Medical Center Klinik Vitos Hadamar ggmbh, Klinik für Psychiatrie und Psychotherapie, Mönchberg 8, Hadamar, Hadamar Medical Center Klinikum am Weissenhof, Zentrum für Psychiatrie Weinsberg, Weinsberg, Weinsberg Recruitment Planned/Actual: Actual (Anticipated or Actual) Date of First Enrollment: 2015/03/12 Target Sample Size: 180 Monocenter/Multicenter trial: Multicenter trial National/International: National Inclusion Criteria Gender: Both, male and female Minimum Age: 18 Years Maximum Age: no maximum age Additional Inclusion Criteria Patients: Primary treatment indication: Diagnosis of an acute depressive episode according to ICD-10 F32.xx or F33.xx; at least 18 years or older; a relative named by the patient is willing to participate in the study. Relatives: Nomination by the index-patient, who meets the inclusion criteria described above; at least 18 years or older; sufficient knowledge of the German language, to ensure that data can be gathered by questionnaire and that the contents of the psychoeducational group intervention can be understood; permanent habitation in the proximity of the particular study center (participating at the Intervention has to be feasible). Exclusion criteria Patients with the following comorbidities: dementia (F00.xx, F01.xx, F02.xx, F03.xx); borderline personality disorder (F60.31); schizoaffective disorder (F25.xx); schizophrenia (F20.xx); bipolar disorder (F31.xx); substance disorder (F10.2, F11.2, F12.2, F13.2, F14.2, F15.2, F16.2, F17. Page 5 of 8

6 2, F18.2, F19.2). Addresses Primary Sponsor Universitätsklinikum Freiburg Klinik für Psychiatrie und Psychotherapie AG Psychotherapie und Versorgungsforschung Mr. Dr. Lars P. Hölzel Hauptstraße Freiburg Telephone: 0761/ Fax: 0761/ lars.hoelzel at uniklinik-freiburg.de URL: Contact for Scientific Queries Universitätsklinikum Freiburg Klinik für Psychiatrie und Psychotherapie AG Psychotherapie und Versorgungsforschung Mr. Dr. Lars P. Hölzel Hauptstraße Freiburg Telephone: 0761/ Fax: 0761/ lars.hoelzel at uniklinik-freiburg.de URL: Contact for Public Queries Universitätsklinikum Freiburg Klinik für Psychiatrie und Psychotherapie AG Psychotherapieund Versorgungsforschung Mr. Fabian Frank Hauptstaße Freiburg Telephone: 0761/ Fax: 0761/ fabian.frank at uniklinik-freiburg.de URL: Page 6 of 8

7 Collaborator, Other Address Pädagogische Hochschule Freiburg; Public Health & Health Education Ms. Prof. Dr. med. habil. Eva Bitzer Kunzenweg Freiburg Telephone: 0761/ Fax: 0761/ evamaria.bitzer at ph-freiburg.de URL: [---]* Collaborator, Other Address Universitätsklinikum Hamburg-Eppendorf, Institut und Poliklinik für Medizinische Psychologie, AG Forschungsmethodik und Statistische Datenanalyse Mr. Dr. Levente Kriston Martinistraße 52 (Haus W26) Hamburg Telephone: Fax: l.kriston at uke.de URL: [---]* Sources of Monetary or Material Support Private sponsorship (foundations, study societies, etc.) Else Kröner-Fresenius-Stiftung Am Pilgerrain Bad Homburg v.d.h. Telephone: Fax: kontakt at ekfs.de URL: Status Recruitment Status: Recruiting ongoing Study Closing (LPLV): [---]* Page 7 of 8

8 Trial Publications, Results and other documents * This entry means the parameter is not applicable or has not been set. Page 8 of 8