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

Major Depressive Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03287362
• Other study ID #: 17-395
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 13, 2017
• Est. completion date: December 2024

Study information

• Verified date: March 2024
• Source: Max-Planck-Institute of Psychiatry
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 300
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Intervention

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

Locations

Country	Name	City	State
Germany	Max Planck Institute of Psychiatry	Munich

Sponsors (2)

Lead Sponsor	Collaborator
Max-Planck-Institute of Psychiatry	Ludwig-Maximilians - University of Munich

Country where clinical trial is conducted

Germany, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.
Other	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.
Other	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.
Other	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.
Other	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.
Other	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.
Other	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.
Other	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.
Other	MCTQ	Munich ChronoType Questionnaire	Assessed in week 4.
Other	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.
Other	endocrine parameters		Assessed as baseline measure after informed consent was given, in week 4 and 7 of the treatment.
Other	ECG		Assessed at baseline and in week 7.
Other	circadian rhythms		continuous measurement using a wearable actimeter during the whole therapy program of seven weeks
Other	imaging (MRT)		Assessed at baseline and in week 7.
Primary	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	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	Decreased need for psychopharmacological medication		Comparison between baseline measurement before treatment start and end of therapy treatment of seven weeks
Secondary	Dropout rate from therapeutic treatment		Assessed after all participants were recruited, enrolled, treated and finished their final measurements (approx. after eight years)
Secondary	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.