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

Study Overview
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Brief Summary
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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.

Official Title
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The OPTIMA-Study: Optimized Treatment Identification at the Max Planck Institute of Psychiatry

Conditions
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Major Depressive Disorder

Intervention / Treatment
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* Behavioral: schema therapy
* Behavioral: cognitive behavioral therapy
* Behavioral: individualized supportive therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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)
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ST-arm<br>one-third of the patients is randomized to schema therapy | Behavioral: schema therapy<br>* 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<br>|
| Active Comparator: CBT-arm<br>one-third of the patients is randomized to cognitive behavioral therapy | Behavioral: cognitive behavioral therapy<br>* The intervention consists of a seven-week program of cognitive behavioral therapy, which is the current gold standard of treatment<br>|
| Placebo Comparator: IST-arm<br>one-third of the patients is randomized to individualized supportive therapy | Behavioral: individualized supportive therapy<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| BDI-II (Beck-Depression-Inventory-II) | 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. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MADRS (Montgomery-Åsberg Depression Rating Scale) | 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. | 
| CIDI (Composite International Diagnostic Interview) | 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. | 
| BSI (Brief Symptom Inventory) | 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. | 
| WHOQOL (WHO - Quality of Life) | 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. | 
| Decreased need for psychopharmacological medication |  | Comparison between baseline measurement before treatment start and end of therapy treatment of seven weeks | 
| Dropout rate from therapeutic treatment |  | Assessed after all participants were recruited, enrolled, treated and finished their final measurements (approx. after eight years) | 
| WHODAS (WHO-Disability Assessment Schedule) | 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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schema therapy, major depressive disorder, cognitive behavioral therapy, supportive therapy, biomarkers, neuropsychology, circadian rhythm