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

NCT03287362 | Completed

• 1 other identifier: 17-395
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

major depressive disorder; cognitive behavioral therapy; supportive therapy; schema therapy; biomarkers; neuropsychology; circadian rhythm

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• MADRS (Montgomery-Åsberg Depression Rating Scale)

  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)

  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)

  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)

  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)

  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.

Other Outcomes (14)

• PID-5

  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

  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

  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.

Study Arms (3)

ST-arm

EXPERIMENTAL

one-third of the patients is randomized to schema therapy

Behavioral: schema therapy

CBT-arm

ACTIVE COMPARATOR

one-third of the patients is randomized to cognitive behavioral therapy

Behavioral: cognitive behavioral therapy

IST-arm

PLACEBO COMPARATOR

one-third of the patients is randomized to individualized supportive therapy

Behavioral: individualized supportive therapy

Interventions

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

ST-arm

cognitive behavioral therapy BEHAVIORAL

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

CBT-arm

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.

IST-arm

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Max-Planck-Institute of Psychiatry: lead
• Ludwig-Maximilians - University of Munich: collaborator

Study Sites (1)

Max Planck Institute of Psychiatry

Munich, 80804, Germany

Location

Related Publications (6)

• Renner F, van Goor M, Huibers M, Arntz A, Butz B, Bernstein D. Short-term group schema cognitive-behavioral therapy for young adults with personality disorders and personality disorder features: associations with changes in symptomatic distress, schemas, schema modes and coping styles. Behav Res Ther. 2013 Aug;51(8):487-92. doi: 10.1016/j.brat.2013.05.011. Epub 2013 May 31.

  PMID: 23778056 BACKGROUND

• Ferrari AJ, Charlson FJ, Norman RE, Patten SB, Freedman G, Murray CJ, Vos T, Whiteford HA. Burden of depressive disorders by country, sex, age, and year: findings from the global burden of disease study 2010. PLoS Med. 2013 Nov;10(11):e1001547. doi: 10.1371/journal.pmed.1001547. Epub 2013 Nov 5.

  PMID: 24223526 BACKGROUND

• Kirchler SV, Muller CL, Spock Z, Ehring T, Kopf-Beck J, Tamm J. The role of concreteness in repetitive negative thinking: Temporal dynamics and the predictive value for depression throughout psychological treatment. Behav Res Ther. 2025 Sep;192:104801. doi: 10.1016/j.brat.2025.104801. Epub 2025 Jun 11.

  PMID: 40544720 DERIVED

• Tamm J, Takano K, Just L, Ehring T, Rosenkranz T, Kopf-Beck J. Ecological Momentary Assessment versus Weekly Questionnaire Assessment of Change in Depression. Depress Anxiety. 2024 Jul 11;2024:9191823. doi: 10.1155/2024/9191823. eCollection 2024.

  PMID: 40226649 DERIVED

• Kopf-Beck J, Muller CL, Tamm J, Fietz J, Rek N, Just L, Spock ZI, Weweck K, Takano K, Rein M, Keck ME, Egli S. Effectiveness of Schema Therapy versus Cognitive Behavioral Therapy versus Supportive Therapy for Depression in Inpatient and Day Clinic Settings: A Randomized Clinical Trial. Psychother Psychosom. 2024;93(1):24-35. doi: 10.1159/000535492. Epub 2024 Jan 4.

  PMID: 38176391 DERIVED

• Kopf-Beck J, Zimmermann P, Egli S, Rein M, Kappelmann N, Fietz J, Tamm J, Rek K, Lucae S, Brem AK, Samann P, Schilbach L, Keck ME. 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. BMC Psychiatry. 2020 Oct 14;20(1):506. doi: 10.1186/s12888-020-02880-x.

  PMID: 33054737 DERIVED

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Schema Therapy; Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities; Behavior Therapy

Study Officials

• Johannes M. Kopf-Beck, PhD

  Max-Planck-Institute of Psychiatry

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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)

Study Record Dates

• First Submitted: August 25, 2017
• First Posted: September 19, 2017
• Study Start: September 13, 2017
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: May 13, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)