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

Sponsor

Max-Planck-Institute of Psychiatry (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT03287362

Collaborator

Ludwig-Maximilians - University of Munich (Other)

300

Enrollment

Location

Arms

94.6

Anticipated Duration (Months)

3.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Major Depressive Disorder	Behavioral: schema therapy Behavioral: cognitive behavioral therapy Behavioral: individualized supportive therapy	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

300 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

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)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)

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Sep 13, 2017

Anticipated Primary Completion Date :

Aug 1, 2022

Anticipated Study Completion Date :

Aug 1, 2025

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

BDI-II (Beck-Depression-Inventory-II) [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.]
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

Secondary Outcome Measures

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.]
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
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.]
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
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.]
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
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.]
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
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.]
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
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) [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.]
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

Other Outcome Measures

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.]
The Personality Inventory for DSM-5
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.]
Young Schema Questionnaire
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.]
Automatic Thought questionnaire
DAS [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.]
Dysfunctional Attitude Scale
NAQ [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.]
Need for Affect Questionnaire
IE-4 [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.]
a short scale to assess internal and external control beliefs
ERQ [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.]
Emotion Regulation Questionnaire
RSQ-D [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.]
Response Styles Questionnaire
MCTQ [Assessed in week 4.]
Munich ChronoType Questionnaire
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.]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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)

Exclusion Criteria:

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