Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Effects of Schema Therapy vs. Cognitive Behavioral Therapy in Patients With Depression

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03287362
Recruitment Status : Recruiting
First Posted : September 19, 2017
Last Update Posted : March 12, 2019
Sponsor:
Collaborator:
Ludwig-Maximilians - University of Munich
Information provided by (Responsible Party):
Max-Planck-Institute of Psychiatry

Brief Summary:

The MPI-PT-Study: Schema Therapy vs. Cognitive Behavioral Therapy for Patients with Major or Persistent Depressive Disorder in an Inpatient and Day Clinic Setting: 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 Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1666 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)
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The MPI-PT-Study: Schema Therapy vs. Cognitive Behavioral Therapy for Patients With Major or Persistent Depressive Disorder in an Inpatient and Day Clinic Setting: A Randomized, Controlled Trial
Actual Study Start Date : August 7, 2017
Estimated Primary Completion Date : August 2022
Estimated Study Completion Date : August 2025

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. BDI-II (Beck-Depression-Inventory-II) [ Time Frame: 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 :
  1. MADRS (Montgomery-Åsberg Depression Rating Scale) [ Time Frame: 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

  2. CIDI (Composite International Diagnostic Interview) [ Time Frame: 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

  3. BSI (Brief Symptom Inventory) [ Time Frame: 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

  4. WHOQOL (WHO - Quality of Life) [ Time Frame: 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

  5. Neuropsychological testing (including sections on episodic memory, working memory, inhibition, cognitive flexibility, word fluency, sensitivity to interference, and attention) [ Time Frame: 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

  6. Decreased need for psychopharmacological medication [ Time Frame: Comparison between baseline measurement before treatment start and end of therapy treatment of seven weeks ]
  7. Dropout rate from therapeutic treatment [ Time Frame: Assessed after all participants were recruited, enrolled, treated and finished their final measurements (approx. after eight years) ]
  8. WHODAS (WHO-Disability Assessment Schedule) [ Time Frame: 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:
  1. PID-5 [ Time Frame: 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

  2. YSQ-S2 [ Time Frame: 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

  3. ATQ [ Time Frame: 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

  4. DAS [ Time Frame: 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

  5. NAQ [ Time Frame: 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

  6. IE-4 [ Time Frame: 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

  7. ERQ [ Time Frame: 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

  8. RSQ-D [ Time Frame: 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

  9. MCTQ [ Time Frame: Assessed in week 4. ]
    Munich ChronoType Questionnaire

  10. blood samples [ Time Frame: 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. ]
  11. endocrine parameters [ Time Frame: Assessed as baseline measure after informed consent was given, in week 4 and 7 of the treatment. ]
  12. ECG [ Time Frame: Assessed at baseline and in week 7. ]
  13. circadian rhythms [ Time Frame: continuous measurement using a wearable actimeter during the whole therapy program of seven weeks ]
  14. imaging (MRT) [ Time Frame: Assessed at baseline and in week 7. ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03287362


Contacts
Layout table for location contacts
Contact: Johannes M. Kopf-Beck, PhD 0049-89-30622-209 kopf-beck@psych.mpg.de

Locations
Layout table for location information
Germany
Max Planck Institute of Psychiatry Recruiting
Munich, Germany, 80804
Sponsors and Collaborators
Max-Planck-Institute of Psychiatry
Ludwig-Maximilians - University of Munich
Investigators
Layout table for investigator information
Principal Investigator: Martin E. Keck, MD, PhD, PhD Max-Planck-Institute of Psychiatry
Principal Investigator: Johannes M. Kopf-Beck, PhD Max-Planck-Institute of Psychiatry

Publications:
Layout table for additonal information
Responsible Party: Max-Planck-Institute of Psychiatry
ClinicalTrials.gov Identifier: NCT03287362     History of Changes
Other Study ID Numbers: 17-395
First Posted: September 19, 2017    Key Record Dates
Last Update Posted: March 12, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Max-Planck-Institute of Psychiatry:
major depressive disorder
cognitive behavioral therapy
supportive therapy
schema therapy
biomarkers
neuropsychology
circadian rhythm

Additional relevant MeSH terms:
Layout table for MeSH terms
Depressive Disorder
Depression
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms