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

Max-Planck-Institute of Psychiatry

Status: Completed

Conditions: Major Depressive Disorder

Treatments: Behavioral: individualized supportive therapy; Behavioral: schema therapy; Behavioral: cognitive behavioral therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT03287362

17-395

Details and patient eligibility

About

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.

Enrollment: 300 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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300 participants in 3 patient groups, including a placebo group

ST-arm

Experimental group

Description:

one-third of the patients is randomized to schema therapy

Treatment:

Behavioral: schema therapy

CBT-arm

Active Comparator group

Description:

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

Treatment:

Behavioral: cognitive behavioral therapy

IST-arm

Placebo Comparator group

Description:

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

Treatment:

Behavioral: individualized supportive therapy