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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Major Depressive Disorder
• Intervention / Treatment: Behavioral: schema therapy; Behavioral: cognitive behavioral therapy; Behavioral: individualized supportive therapy

• Study Type: Interventional
• Enrollment (Actual): 300
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Munich, Germany, 80804
    • Max Planck Institute of Psychiatry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 73 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. 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)
2. age between 18 and 75 years
3. informed consent to the study procedures and assessments (in written form)

Exclusion Criteria:

1. Major depressive disorder, single episode or recurrent, severe with psychotic symptoms (F32.3, F33.3 according to ICD-10)
2. Severe mutism or stupor
3. lifetime history of any psychotic or bipolar disorder
4. severe neurological or internal concomitant diseases
5. IQ < 80; severe learning disability, brain damage or pervasive developmental disorder
6. current alcohol or any illicit drug withdrawal syndrome according to DSM-5
7. mental disorders secondary to a medical conditions or substance use disorders
8. acute suicidality
9. pregnancy and lactation period
10. Missing eligibility for psychotherapy because of missing language skills
11. Electroconvulsive therapy (ECT) in preparation
12. Participation in further scientific studies

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ST-arm; one-third of the patients is randomized to schema therapy	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
Active Comparator: CBT-arm; one-third of the patients is randomized to cognitive behavioral therapy	Behavioral: cognitive behavioral therapy; The intervention consists of a seven-week program of cognitive behavioral therapy, which is the current gold standard of treatment
Placebo Comparator: IST-arm; one-third of the patients is randomized to individualized supportive therapy	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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	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	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	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		Comparison between baseline measurement before treatment start and end of therapy treatment of seven weeks
Dropout rate from therapeutic treatment		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	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.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
PID-5	The Personality Inventory for DSM-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	Young Schema Questionnaire	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	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	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	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	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	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	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	Assessed in week 4.
blood samples		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		Assessed as baseline measure after informed consent was given, in week 4 and 7 of the treatment.
ECG		Assessed at baseline and in week 7.
circadian rhythms		continuous measurement using a wearable actimeter during the whole therapy program of seven weeks
imaging (MRT)		Assessed at baseline and in week 7.

Collaborators and Investigators

• Sponsor: Max-Planck-Institute of Psychiatry
• Collaborators: Ludwig-Maximilians - University of Munich
• Investigators: Principal Investigator: Johannes M. Kopf-Beck, PhD, Max-Planck-Institute of Psychiatry

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 13, 2017
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: August 25, 2017
• First Submitted That Met QC Criteria: September 18, 2017
• First Posted (Actual): September 19, 2017

Study Record Updates

• Last Update Posted (Actual): March 26, 2024
• Last Update Submitted That Met QC Criteria: March 25, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: biomarkers; cognitive behavioral therapy; major depressive disorder; neuropsychology; circadian rhythm; supportive therapy; schema therapy
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder; Depressive Disorder, Major
• Other Study ID Numbers: 17-395

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No