Day-Clinic and Inpatient Psychotherapy for Depression (DIP-D): A Randomized Controlled Pilot Study in Routine Clinical Care

by randomization with the RANDI-2 software [8] . Afterwards, patients were admitted to either the day-clinic or inpatient setting and treated for 8 weeks with multimodal psychotherapy. Four weeks after discharge, patients received a follow-up assessment, which served as primary outcome assessment point. All patients gave written informed consent, the study protocol was approved by the local ethics committee and the study was registered at the German Clinical Trials Register (DRKS00000550). The therapy unit combines inpatient and day-clinic treatment, therapeutic staff is the same for both treatment arms. Both groups received equal amounts of psychotherapeutic interventions. These included psychodynamic individual psychotherapy, psychodynamic-interactional group psychotherapy, non-verbal therapies, and social competence trainings. Psychopharmacological antidepressant treatment followed the German national treatment guidelines for depression [9] . In order to be representative for routine clinical practice, no further specifications with regard to psychopharmacological medications were made for the study. Inpatients were free to leave the unit outside of night hours and therapy sessions and spent 6 weekends at home. Day-clinic patients attended therapy on 5 weekdays from 8 a.m. to 4 p.m. There were no group differences for socio-demographic variables, antidepressant medication, DSM-IV diagnoses, or depression severity. Two patients dropped out before admission to dayclinic. During therapy, 3 patients terminated prematurely (2 inpatient, 1 day-clinic), 1 patient was discharged due to illegal drug consumption during day-clinic therapy, and another patient (dayclinic) was excluded due to a first manic episode. Two inpatients dropped out of the study in order to continue treatment in the day-clinic setting. In total, 9 patients dropped out following randomization, leaving 35 completers (18 inpatient, 17 day-clinic). Dropouts were invited to the follow-up assessment, only 3 refused further assessments (2 inpatient, 1 day-clinic). There were no significant differences for socio-demographic variables or diagnoses between completers and dropouts, but depression severity showed a non-significant trend towards lower initial severity for dropouts (HDRS completers, mean 19.5 (SD 5.42); HDRS dropouts, mean 15.8 (SD 6.06); t (42) = –1.78, p = 0.08). At admission, 22 patients (50%) were taking antidepressant medication. Within the completer sample, 11 patients (31.4%) had a change in antidepressant medication during treatment. Antidepressants were reduced or terminated for 6 patients (17.2%) and increased or started for 4 patients (11.4%). One patient had a change of drug class. At termination, 51.4% of completer patients were taking antidepressant medication. There were no differences between groups for change during therapy or medication at termination. Change of medication was not related to initial depression severity and beginning or increasing medication was not significantly related to symptom reduction. Change of symptoms was examined with multilevel models for completers as well as the intent-to-treat sample ( table 1 ). DepresDepending on the severity of depression, patients may be treated at different levels of care with psychotherapy and/or antidepressant medication [1] . Randomized controlled studies comparing different levels of care for severely impaired patients are still lacking. This is of special relevance with regard to a growing interest in multimodal psychotherapeutic day-clinic settings which have been increasing since the 1960s [2] due to the high costs of inpatient care [3] and specific advantages of the setting. Compared to inpatient therapy, the daily transition between therapy and the home environment can be more demanding [4] , but the greater proximity to daily stressors may facilitate a successful transfer of therapeutic gains to everyday life. Both treatments are intensive forms of time-limited multimodal psychotherapy. The psychotherapeutic hospital setting in Germany is indicated for patients with a history of treatment failures in outpatient therapy. Typically, patients are admitted in the context of an exacerbation that poses a threat to their long-term social and economic functioning. While several previous studies compared the efficacy of different levels of care for psychotherapy of personality disorders [5] , sufficient data is lacking for the comparison of day-clinic and inpatient psychotherapy for depression. The current pilot study evaluates the feasibility of randomization in a routine hospital setting and compares preliminary efficacy for day-clinic and inpatient psychotherapy for depression. A total of 1,412 new incoming patients were screened at the hospital outpatient center. A total of 144 patients met inclusion criteria. Of these, 65 agreed to a detailed patient briefing, after which 44 patients agreed to participate. Of these, 97.7% had a major depressive episode, 1 patient was primarily diagnosed with dysthymia. Comorbid diagnoses included anxiety (45.5%), somatoform (13.6%), obsessive-compulsive (6.8%), and personality disorder (33.3%). Participants had a mean age of 35.1 years (range 18–55), 50% were female. Patients received structured diagnostic interviews (SCID) [6] , depressive symptoms were measured by two independent observers with the Hamilton Depression Rating Scale (HDRS) [7] . Their interrater reliability was r = 0.96. Initial assessment was followed Received: September 6, 2013 Accepted after revision: November 18, 2013 Published online: April 17, 2014