Effects of Schema Therapy vs. Cognitive Behavioral Therapy vs. Individual Supportive Therapy

The OPTIMA-Study: Optimized Treatment Identification at the Max Planck Institute of Psychiatry: An outline Depressive disorders represent one of the most frequent diseases worldwide. Schema therapy, which was originally developed for patients with personality disorders and focuses on emotion activating techniques, became popular in the field of psychotherapy in the recent years and was also applied on axis-I-disorders such as depression. The current study aims to close the gap of increasing popularity of ST and missing empirical evidence of its effectiveness. This aim breaks down into three main research questions dealing with (1) general effectiveness of ST measured by multiple operationalizations (i.e. depressive symptoms, biological markers, relapse prevention, or need for medication), (2) specific effectiveness of ST (i.e. interpersonal problems and emotion regulation), and (3) the identification of parameters in the sense of an individualized psychotherapy approach in order to fit patient needs with certain psychotherapy offers. After participants have given informed consent, they undergo a comprehensive baseline measurement which covers psychometric measures (such as questionnaires and clinical ratings), biological parameters (blood samples, endocrine activity), neuropsychological testing (such as word fluency), and actimetry measures (circadian rhythms). After finishing the diagnostic procedure, participants will be randomized to three different experimental conditions: (1) a schema therapy condition, (2) a cognitive behavioral therapy condition, and (3) an individualized supportive therapy condition. After undergoing a comprehensive baseline measurement process in study week one, patients participate in an intensive seven-week-treatment-program, in addition to the regular pharmacological treatment, which is not object of the study. The measures are repeated during the fourth and seventh week of psychotherapeutical treatment and on the occasion of a follow-up visit six months after discharge from the clinic. Additionally, the investigators test among sub-samples the effects of psychotherapeutical interventions on psychophysiological outcomes, sleep-patterns, and neuronal substrates in the context of emotional regulation and social interaction. Thus, the study will give valuables insights in the effectiveness of an innovative psychotherapy approach and breaks new ground in the field of individualized psychotherapy and its biological implications.

major depressive disorder, cognitive behavioral therapy, supportive therapy, schema therapy, biomarkers, neuropsychology, circadian rhythm

Incoming patients from the clinic of Max Planck Institute of Psychiatry are continuously screened for study eligibility and - after they have given informed consent - are block wise randomly assigned to one of 3 study arms (schema therapy, cognitive behavioral therapy, individual supportive therapy)

The intervention consists of a seven-week program of schema therapy, which is a further development of cognitive behavioral therapy, designed in a three-phase combined group and single session concept

The intervention consists of a seven-week program of cognitive behavioral therapy, which is the current gold standard of treatment

The intervention consists of a seven-week program of individualized supportive therapy, including different therapeutic offers from the clinic and a high frequency of physician contacts.

Decrease in depression symptoms, measured by "benefit" changes in scores of BDI-II (Beck-Depression-Inventory-II) questionnaire (self rating) from baseline over the course of seven weeks of treatment up to six months after discharge from the clinic

Assessed as baseline measure after informed consent was given, and on a weekly base over the course of seven weeks of treatment. Additionally in a follow-up assessment six months after discharge from the clinic.

Decrease in depression symptoms, "benefit" changes from baseline to week 4 and 7 of treatment up to six months after discharge from the clinic, clinical rating

Assessed as baseline measure after informed consent was given, in week 4 and 7 of the treatment.Additionally in a follow-up assessment six months after discharge from the clinic.

Decrease in symptoms or recovery from DSM-5 diagnosis of depression, "benefit" changes from baseline to week 7 of treatment and up to six months after discharge from the clinic

Assessed as baseline measure after informed consent was given, in week 7 of the treatment. Additionally in a follow-up assessment six months after discharge from the clinic.

Decrease in general psychopathology, "benefit" changes from baseline over the course of seven weeks of treatment up to six months after discharge from the clinic

Assessed as baseline measure after informed consent was given, and on a weekly base over the course of seven weeks of treatment. Additionally in a follow-up assessment six months after discharge from the clinic.

Increase in quality of life, "benefit" changes from baseline to week 4 and 7 of treatment and up to six months after discharge from the clinic

Assessed as baseline measure after informed consent was given, in week 4 and 7 of the treatment. Additionally in a follow-up assessment six months after discharge from the clinic.

Neuropsychological testing (including sections on episodic memory, working memory, inhibition, cognitive flexibility, word fluency, sensitivity to interference, and attention)

Increase of cognitive functioning, "benefit" changes from baseline to week 4 and 7 of treatment and up to six months after discharge from the clinic

Assessed as baseline measure after informed consent was given, in week 4 and 7 of the treatment. Additionally in a follow-up assessment six months after discharge from the clinic.

Comparison between baseline measurement before treatment start and end of therapy treatment of seven weeks

Assessed after all participants were recruited, enrolled, treated and finished their final measurements (approx. after eight years)

Decrease in symptoms or recovery from DSM-5 diagnosis of depression, "benefit" changes from baseline to week 7 of treatment and up to six months after discharge from the clinic

Assessed as baseline measure after informed consent was given, in week 7 of the treatment. Additionally in a follow-up assessment six months after discharge from the clinic.

Assessed as baseline measure after informed consent was given and in week 7 after finishing the treatment. Additionally in a follow-up assessment six months after discharge from the clinic.

Assessed as baseline measure after informed consent was given and in week 7 after finishing the treatment.. Additionally in a follow-up assessment six months after discharge from the clinic.

Assessed as baseline measure after informed consent was given and in week 7 after finishing the treatment. Additionally in a follow-up assessment six months after discharge from the clinic.

Assessed as baseline measure after informed consent was given and in week 7 after finishing the treatment. Additionally in a follow-up assessment six months after discharge from the clinic.

Assessed as baseline measure after informed consent was given and in week 7 after finishing the treatment. Additionally in a follow-up assessment six months after discharge from the clinic.

Assessed as baseline measure after informed consent was given and in week 7 after finishing the treatment. Additionally in a follow-up assessment six months after discharge from the clinic.

Assessed as baseline measure after informed consent was given and in week 7 after finishing the treatment. Additionally in a follow-up assessment six months after discharge from the clinic.

Assessed as baseline measure after informed consent was given and in week 7 after finishing the treatment. Additionally in a follow-up assessment six months after discharge from the clinic.

Assessed as baseline measure after informed consent was given, in week 4 and 7 of the treatment.Additionally in a follow-up assessment six months after discharge from the clinic.

Inclusion Criteria: Main diagnosis of major depressive disorder, single episode or recurrent, moderate or severe without psychotic symptoms according to DSM-5 criteria (F32.1, F32.2, F33.1, F33.2 according to ICD-10) age between 18 and 75 years informed consent to the study procedures and assessments (in written form) Exclusion Criteria: Major depressive disorder, single episode or recurrent, severe with psychotic symptoms (F32.3, F33.3 according to ICD-10) Severe mutism or stupor lifetime history of any psychotic or bipolar disorder severe neurological or internal concomitant diseases IQ < 80; severe learning disability, brain damage or pervasive developmental disorder current alcohol or any illicit drug withdrawal syndrome according to DSM-5 mental disorders secondary to a medical conditions or substance use disorders acute suicidality pregnancy and lactation period Missing eligibility for psychotherapy because of missing language skills Electroconvulsive therapy (ECT) in preparation Participation in further scientific studies

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Ferrari AJ, Charlson FJ, Norman RE, Patten SB, Freedman G, Murray CJ, Vos T, Whiteford HA. Burden of depressive disorders by country, sex, age, and year: findings from the global burden of disease study 2010. PLoS Med. 2013 Nov;10(11):e1001547. doi: 10.1371/journal.pmed.1001547. Epub 2013 Nov 5.

Kopf-Beck J, Zimmermann P, Egli S, Rein M, Kappelmann N, Fietz J, Tamm J, Rek K, Lucae S, Brem AK, Samann P, Schilbach L, Keck ME. Schema therapy versus cognitive behavioral therapy versus individual supportive therapy for depression in an inpatient and day clinic setting: study protocol of the OPTIMA-RCT. BMC Psychiatry. 2020 Oct 14;20(1):506. doi: 10.1186/s12888-020-02880-x.