Clinical trial NCT03287362: Effects of Schema Therapy vs. Cognitive Behavioral Therapy vs. Individual Supportive Therapy
Official title: The OPTIMA-Study: Optimized Treatment Identification at the Max Planck Institute of Psychiatry
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Major Depressive Disorder
Keywords: major depressive disorder
cognitive behavioral therapy
supportive therapy
schema therapy
biomarkers
neuropsychology
circadian rhythm
Lead sponsor: Max-Planck-Institute of Psychiatry
Sponsor class: OTHER
Collaborators: name: Ludwig-Maximilians - University of Munich
First posted: 2017-09-19
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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)
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: BDI-II (Beck-Depression-Inventory-II)
timeFrame: 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 outcomes:
measure: MADRS (Montgomery-Åsberg Depression Rating Scale)
timeFrame: 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.
measure: CIDI (Composite International Diagnostic Interview)
timeFrame: 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.
measure: BSI (Brief Symptom Inventory)
timeFrame: 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.
measure: WHOQOL (WHO - Quality of Life)
timeFrame: 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.
measure: Neuropsychological testing (including sections on episodic memory, working memory, inhibition, cognitive flexibility, word fluency, sensitivity to interference, and attention)
timeFrame: 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.
measure: Decreased need for psychopharmacological medication
timeFrame: Comparison between baseline measurement before treatment start and end of therapy treatment of seven weeks
measure: Dropout rate from therapeutic treatment
timeFrame: Assessed after all participants were recruited, enrolled, treated and finished their final measurements (approx. after eight years)
measure: WHODAS (WHO-Disability Assessment Schedule)
timeFrame: 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 outcomes:
measure: PID-5
timeFrame: 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.
measure: YSQ-S2
timeFrame: 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.
measure: ATQ
timeFrame: 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.
measure: DAS
timeFrame: 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.
measure: NAQ
timeFrame: 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.
measure: IE-4
timeFrame: 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.
measure: ERQ
timeFrame: 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.
measure: RSQ-D
timeFrame: 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.
measure: MCTQ
timeFrame: Assessed in week 4.
measure: blood samples
timeFrame: 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.
measure: endocrine parameters
timeFrame: Assessed as baseline measure after informed consent was given, in week 4 and 7 of the treatment.
measure: ECG
timeFrame: Assessed at baseline and in week 7.
measure: circadian rhythms
timeFrame: continuous measurement using a wearable actimeter during the whole therapy program of seven weeks
measure: imaging (MRT)
timeFrame: Assessed at baseline and in week 7.
Locations:
city: Munich
country: Germany
facility: Max Planck Institute of Psychiatry
Study officials:
affiliation: Max-Planck-Institute of Psychiatry
name: Johannes M. Kopf-Beck, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.
citation: 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.