Effectiveness of a brief psychoeducational group intervention for relatives on the course of disease in patients after inpatient depression treatment compared with treatment as usual--study protocol of a multisite randomised controlled trial.
BACKGROUND
Relapses and rehospitalisations are common after acute inpatient treatment in depressive disorders. Interventions for stabilising treatment outcomes are urgently needed. Psychoeducational group interventions for relatives were shown to be suitable for improving the course of disease in schizophrenia and bipolar disorders. A small Japanese monocentre randomised controlled trial also showed promising results for depressive disorders. However, the evidence regarding psychoeducation for relatives of patients with depressive disorders is unclear.


METHODS
The study is conducted as a two-arm multisite randomised controlled trial to evaluate the incremental effect of a brief psychoeducational group intervention for relatives as a maintenance treatment on the course of disease compared to treatment as usual. Primary outcome is the estimated number of depression-free-days in patients within one year after discharge from inpatient treatment. 180 patients diagnosed with unipolar depressive disorders as well as one key relative per patient will be included during inpatient treatment and randomly allocated to the conditions at discharge. In the intervention group, relatives will participate in a brief psychoeducational group intervention following the patient's discharge. The intervention consists of four group sessions lasting 90 to 120 min each. Every group session contains informational parts as well as structured training in problem-solving. In both study conditions, patients will receive treatment as usual. Patients as well as relatives will be surveyed by means of questionnaires at discharge and three, six, nine and twelve months after discharge. In addition to the primary outcome, several patient-related and relative-related secondary outcomes will be considered and health economics will be investigated.


CONCLUSIONS
Our study will provide evidence on the incremental effect of a brief psychoeducational intervention for relatives as a maintenance treatment after inpatient depression treatment. Positive results may have a major impact on health care for depression.


BACKGROUND
German Clinical Trials Register (DRKS): DRKS00006819; Trial registration date: 2014 Oktober 31; Universal Trial Number (UTN): U1111-1163-5391.
Department of Psychiatry and Psychotherapy, Research Group Psychotherapy and Health Services Research, Medical Center - University of Freiburg, Hauptstraße 5, D-79104, Freiburg, Germany. fabian.frank@uniklinik-freiburg.de.|Department of Public Health and Health Education, University of Education Freiburg, Kunzenweg 21, D-79117, Freiburg, Germany. fabian.frank@uniklinik-freiburg.de.
Fabian
F
Frank
Department of Psychiatry and Psychotherapy, Research Group Psychotherapy and Health Services Research, Medical Center - University of Freiburg, Hauptstraße 5, D-79104, Freiburg, Germany. juliette.wilk@uniklinik-freiburg.de.
Juliette
J
Wilk
Department of Medical Psychology, University Medical Center Hamburg-Eppendorf, Martinistraße 52, D-20246, Hamburg, Germany. l.kriston@uke.de.
Levente
L
Kriston
Department of Medical Psychology, University Medical Center Hamburg-Eppendorf, Martinistraße 52, D-20246, Hamburg, Germany. r.meister@uke.de.
Ramona
R
Meister
Department of Neuropsychiatry, Kochi Medical School, Kohasu, Okoh-cho, Nankokushi, Kochi, 783-8505, Japan. shimodes@kochi-u.ac.jp.
Shinji
S
Shimodera
Department of Psychiatry and Psychotherapy, University Medical Center Tübingen, Calwerstraße 14, D-72072, Tübingen, Germany. klaus.hesse@med.uni-tuebingen.de.
Klaus
K
Hesse
Department of Public Health and Health Education, University of Education Freiburg, Kunzenweg 21, D-79117, Freiburg, Germany. evamaria.bitzer@ph-freiburg.de.
Eva-Maria
EM
Bitzer
Department of Psychiatry and Psychotherapy, Research Group Psychotherapy and Health Services Research, Medical Center - University of Freiburg, Hauptstraße 5, D-79104, Freiburg, Germany. mathias.berger@uniklinik-freiburg.de.
Mathias
M
Berger
Department of Psychiatry and Psychotherapy, Research Group Psychotherapy and Health Services Research, Medical Center - University of Freiburg, Hauptstraße 5, D-79104, Freiburg, Germany. lars.hoelzel@uniklinik-freiburg.de.
Lars P
LP
Hölzel
D000328:Adult; D000368:Aged; D000704:Analysis of Variance; D001714:Bipolar Disorder / Q000628:therapy; D017028:Caregivers / Q000193:education; D003866:Depressive Disorder / Q000628:therapy*; D005190:Family; D005260:Female; D006760:Hospitalization; D006801:Humans; D008297:Male; D008875:Middle Aged; D010353:Patient Education as Topic / Q000379:methods*; D011340:Problem Solving; D011615:Psychotherapy, Group / Q000379:methods*; D012559:Schizophrenia / Q000628:therapy; D011795:Surveys and Questionnaires; D016896:Treatment Outcome