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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-13

Study Completion Date

2024-12-31

Brief Summary

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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.

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Depression

UNKNOWN

Detailed Description

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Conditions

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Major Depressive Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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)

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ST-arm

one-third of the patients is randomized to schema therapy

Group Type EXPERIMENTAL

schema therapy

Intervention Type 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

CBT-arm

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

Group Type ACTIVE_COMPARATOR

cognitive behavioral therapy

Intervention Type BEHAVIORAL

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

IST-arm

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

Group Type PLACEBO_COMPARATOR

individualized supportive therapy

Intervention Type 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.

Interventions

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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

Intervention Type BEHAVIORAL

cognitive behavioral therapy

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

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No