NCT03287362

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

Completed NA Last updated 13 May 2025

What this trial tests

NA trial testing schema therapy in Major Depressive Disorder in 300 participants. Completed in 31 December 2024.

Timeline

13 September 2017

Primary endpoint
31 December 2024

31 December 2024

Quick facts

Lead sponsor	Max-Planck-Institute of Psychiatry
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	300
Start date	13 September 2017
Primary completion	31 December 2024
Estimated completion	31 December 2024
Sites	1 location across Germany

Drugs / interventions tested

• schema therapy
• cognitive behavioral therapy
• individualized supportive therapy

Conditions studied

• Major Depressive Disorder — all drugs for Major Depressive Disorder →

Sponsor

Max-Planck-Institute of Psychiatry

Who can join

Adults 18 to 75, any sex, with Major Depressive Disorder. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Transdiagnostic evaluation of epigenetic age acceleration and burden of psychiatric disorders.
   Yusupov N, Dieckmann L, Erhart M, Sauer S, et al · · 2023 · cited 24× · PMID 37069357 · DOI 10.1038/s41386-023-01579-3
2. 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.
   Kopf-Beck J, Zimmermann P, Egli S, Rein M, et al · · 2020 · cited 16× · PMID 33054737 · DOI 10.1186/s12888-020-02880-x
3. Effectiveness of Schema Therapy versus Cognitive Behavioral Therapy versus Supportive Therapy for Depression in Inpatient and Day Clinic Settings: A Randomized Clinical Trial.
   Kopf-Beck J, Müller CL, Tamm J, Fietz J, et al · · 2024 · cited 8× · PMID 38176391 · DOI 10.1159/000535492
4. DNA methylation patterns of FKBP5 regulatory regions in brain and blood of humanized mice and humans.
   Yusupov N, Roeh S, Sotillos Elliott L, Chang S, et al · · 2024 · cited 6× · PMID 38317011 · DOI 10.1038/s41380-024-02430-x
5. Ecological Momentary Assessment versus Weekly Questionnaire Assessment of Change in Depression.
   Tamm J, Takano K, Just L, Ehring T, et al · · 2024 · cited 4× · PMID 40226649 · DOI 10.1155/2024/9191823
6. The role of concreteness in repetitive negative thinking: Temporal dynamics and the predictive value for depression throughout psychological treatment.
   Kirchler SV, Müller CL, Spock Z, Ehring T, et al · · 2025 · cited 1× · PMID 40544720 · DOI 10.1016/j.brat.2025.104801
7. Comprehensive analysis of cytokines in depression: independent data from patient plasma and post-mortem ventromedial prefrontal cortex.
   Rahimian R, Hagenberg J, Belliveau C, Chen R, et al · · 2026 · PMID 42094851 · DOI 10.1016/j.bbih.2026.101245
8. Integrative gene and isoform co-expression networks reveal regulatory rewiring in stress-related psychiatric disorders.
   Rehawi G, Hagenberg J, BeCOME study group, Optima study group, et al · · 2025 · PMID 40927681 · DOI 10.1016/j.isci.2025.113342