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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 300 (actual)
• Sponsor: Max-Planck-Institute of Psychiatry · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Major Depressive Disorder

Interventions

Type	Name	Description
BEHAVIORAL	schema 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
BEHAVIORAL	cognitive behavioral therapy	The intervention consists of a seven-week program of cognitive behavioral therapy, which is the current gold standard of treatment
BEHAVIORAL	individualized supportive therapy	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.

Timeline

• Start date: 2017-09-13
• Primary completion: 2024-12-31
• Completion: 2024-12-31
• First posted: 2017-09-19
• Last updated: 2025-05-13

Locations

1 site across 1 country: Germany