An interventional study of schema therapy and cognitive behavioral therapy in Major Depressive Disorder, sponsored by Max-Planck-Institute of Psychiatry. Completed at 1 site in Germany. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-05-13.
Sponsored by Max-Planck-Institute of Psychiatry · Not applicable, Interventional, and Treatment
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.
Exclusion Criteria:
one-third of the patients is randomized to schema therapy
Behavioral: schema therapy
one-third of the patients is randomized to cognitive behavioral therapy
Behavioral: cognitive behavioral therapy
one-third of the patients is randomized to individualized supportive therapy
Behavioral: individualized 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.
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
Time frame: 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.
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Comparison between baseline measurement before treatment start and end of therapy treatment of seven weeks
Dropout rate from therapeutic treatment
Time frame: 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
Time frame: 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.
PID-5
The Personality Inventory for DSM-5
Time frame: 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.
YSQ-S2
Young Schema Questionnaire
Time frame: 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.
ATQ
Automatic Thought questionnaire
Time frame: 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.
DAS
Dysfunctional Attitude Scale
Time frame: 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.
NAQ
Need for Affect Questionnaire
Time frame: 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.
IE-4
a short scale to assess internal and external control beliefs
Time frame: 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.
ERQ
Emotion Regulation Questionnaire
Time frame: 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.
RSQ-D
Response Styles Questionnaire
Time frame: 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.
MCTQ
Munich ChronoType Questionnaire
Time frame: Assessed in week 4.
blood samples
Time frame: 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.
endocrine parameters
Time frame: Assessed as baseline measure after informed consent was given, in week 4 and 7 of the treatment.
ECG
Time frame: Assessed at baseline and in week 7.
circadian rhythms
Time frame: continuous measurement using a wearable actimeter during the whole therapy program of seven weeks
imaging (MRT)
Time frame: Assessed at baseline and in week 7.
Plan to share: No
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Max-Planck-Institute of Psychiatry