Skip to main content
OpenTrials
Completed

NCT Number: NCT03287362

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Major Depressive Disorder Depressive Disorder Depressive Disorder, Major Mental Disorders Mood Disorders

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Max Planck Institute of Psychiatry

Munich, 80804, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

schema therapy

Behavioral

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

Cognitive behavioral therapy

Behavioral

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

individualized supportive therapy

Behavioral

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.

Primary outcomes

  1. BDI-II (Beck-Depression-Inventory-II)

    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.

    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

Secondary outcomes

  1. MADRS (Montgomery-Åsberg Depression Rating Scale)

    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.

    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

  2. CIDI (Composite International Diagnostic Interview)

    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.

    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

  3. BSI (Brief Symptom Inventory)

    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.

    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

  4. WHOQOL (WHO - Quality of Life)

    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.

    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

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

    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.

    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

  6. Decreased need for psychopharmacological medication

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

  7. Dropout rate from therapeutic treatment

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

  8. WHODAS (WHO-Disability Assessment Schedule)

    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.

    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

Other outcomes

  1. PID-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.

    The Personality Inventory for DSM-5

  2. YSQ-S2

    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.

    Young Schema Questionnaire

  3. ATQ

    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.

    Automatic Thought questionnaire

  4. DAS

    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.

    Dysfunctional Attitude Scale

  5. NAQ

    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.

    Need for Affect Questionnaire

  6. IE-4

    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.

    a short scale to assess internal and external control beliefs

  7. ERQ

    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.

    Emotion Regulation Questionnaire

  8. RSQ-D

    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.

    Response Styles Questionnaire

  9. MCTQ

    Time frame: Assessed in week 4.

    Munich ChronoType Questionnaire

  10. 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.

  11. endocrine parameters

    Time frame: Assessed as baseline measure after informed consent was given, in week 4 and 7 of the treatment.

  12. ECG

    Time frame: Assessed at baseline and in week 7.

  13. circadian rhythms

    Time frame: continuous measurement using a wearable actimeter during the whole therapy program of seven weeks

  14. imaging (MRT)

    Time frame: Assessed at baseline and in week 7.

Sponsors and collaborators

Lead sponsor

Max-Planck-Institute of Psychiatry

Other

Collaborators

  • Ludwig-Maximilians - University of Munich

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2024
Study completion
2024
First posted
Sep 19, 2017
Registry last updated
May 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.