<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03287362</url>
  </required_header>
  <id_info>
    <org_study_id>17-395</org_study_id>
    <nct_id>NCT03287362</nct_id>
  </id_info>
  <brief_title>Effects of Schema Therapy vs. Cognitive Behavioral Therapy vs. Individual Supportive Therapy</brief_title>
  <official_title>The OPTIMA-Study: Optimized Treatment Identification at the Max Planck Institute of Psychiatry</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Max-Planck-Institute of Psychiatry</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Ludwig-Maximilians - University of Munich</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Max-Planck-Institute of Psychiatry</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The OPTIMA-Study: Optimized Treatment Identification at the Max Planck Institute of&#xD;
      Psychiatry: An outline&#xD;
&#xD;
      Depressive disorders represent one of the most frequent diseases worldwide. Schema therapy,&#xD;
      which was originally developed for patients with personality disorders and focuses on emotion&#xD;
      activating techniques, became popular in the field of psychotherapy in the recent years and&#xD;
      was also applied on axis-I-disorders such as depression.&#xD;
&#xD;
      The current study aims to close the gap of increasing popularity of ST and missing empirical&#xD;
      evidence of its effectiveness. This aim breaks down into three main research questions&#xD;
      dealing with (1) general effectiveness of ST measured by multiple operationalizations (i.e.&#xD;
      depressive symptoms, biological markers, relapse prevention, or need for medication), (2)&#xD;
      specific effectiveness of ST (i.e. interpersonal problems and emotion regulation), and (3)&#xD;
      the identification of parameters in the sense of an individualized psychotherapy approach in&#xD;
      order to fit patient needs with certain psychotherapy offers.&#xD;
&#xD;
      After participants have given informed consent, they undergo a comprehensive baseline&#xD;
      measurement which covers psychometric measures (such as questionnaires and clinical ratings),&#xD;
      biological parameters (blood samples, endocrine activity), neuropsychological testing (such&#xD;
      as word fluency), and actimetry measures (circadian rhythms).&#xD;
&#xD;
      After finishing the diagnostic procedure, participants will be randomized to three different&#xD;
      experimental conditions: (1) a schema therapy condition, (2) a cognitive behavioral therapy&#xD;
      condition, and (3) an individualized supportive therapy condition. After undergoing a&#xD;
      comprehensive baseline measurement process in study week one, patients participate in an&#xD;
      intensive seven-week-treatment-program, in addition to the regular pharmacological treatment,&#xD;
      which is not object of the study. The measures are repeated during the fourth and seventh&#xD;
      week of psychotherapeutical treatment and on the occasion of a follow-up visit six months&#xD;
      after discharge from the clinic.&#xD;
&#xD;
      Additionally, the investigators test among sub-samples the effects of psychotherapeutical&#xD;
      interventions on psychophysiological outcomes, sleep-patterns, and neuronal substrates in the&#xD;
      context of emotional regulation and social interaction.&#xD;
&#xD;
      Thus, the study will give valuables insights in the effectiveness of an innovative&#xD;
      psychotherapy approach and breaks new ground in the field of individualized psychotherapy and&#xD;
      its biological implications.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">September 13, 2017</start_date>
  <completion_date type="Anticipated">August 2025</completion_date>
  <primary_completion_date type="Anticipated">August 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <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)</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>BDI-II (Beck-Depression-Inventory-II)</measure>
    <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.</time_frame>
    <description>Decrease in depression symptoms, measured by &quot;benefit&quot; 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</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>MADRS (Montgomery-Åsberg Depression Rating Scale)</measure>
    <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.</time_frame>
    <description>Decrease in depression symptoms, &quot;benefit&quot; changes from baseline to week 4 and 7 of treatment up to six months after discharge from the clinic, clinical rating</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CIDI (Composite International Diagnostic Interview)</measure>
    <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.</time_frame>
    <description>Decrease in symptoms or recovery from DSM-5 diagnosis of depression, &quot;benefit&quot; changes from baseline to week 7 of treatment and up to six months after discharge from the clinic</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>BSI (Brief Symptom Inventory)</measure>
    <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.</time_frame>
    <description>Decrease in general psychopathology, &quot;benefit&quot; changes from baseline over the course of seven weeks of treatment up to six months after discharge from the clinic</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>WHOQOL (WHO - Quality of Life)</measure>
    <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.</time_frame>
    <description>Increase in quality of life, &quot;benefit&quot; changes from baseline to week 4 and 7 of treatment and up to six months after discharge from the clinic</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Neuropsychological testing (including sections on episodic memory, working memory, inhibition, cognitive flexibility, word fluency, sensitivity to interference, and attention)</measure>
    <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.</time_frame>
    <description>Increase of cognitive functioning, &quot;benefit&quot; changes from baseline to week 4 and 7 of treatment and up to six months after discharge from the clinic</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Decreased need for psychopharmacological medication</measure>
    <time_frame>Comparison between baseline measurement before treatment start and end of therapy treatment of seven weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Dropout rate from therapeutic treatment</measure>
    <time_frame>Assessed after all participants were recruited, enrolled, treated and finished their final measurements (approx. after eight years)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>WHODAS (WHO-Disability Assessment Schedule)</measure>
    <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.</time_frame>
    <description>Decrease in symptoms or recovery from DSM-5 diagnosis of depression, &quot;benefit&quot; changes from baseline to week 7 of treatment and up to six months after discharge from the clinic</description>
  </secondary_outcome>
  <other_outcome>
    <measure>PID-5</measure>
    <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.</time_frame>
    <description>The Personality Inventory for DSM-5</description>
  </other_outcome>
  <other_outcome>
    <measure>YSQ-S2</measure>
    <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.</time_frame>
    <description>Young Schema Questionnaire</description>
  </other_outcome>
  <other_outcome>
    <measure>ATQ</measure>
    <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.</time_frame>
    <description>Automatic Thought questionnaire</description>
  </other_outcome>
  <other_outcome>
    <measure>DAS</measure>
    <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.</time_frame>
    <description>Dysfunctional Attitude Scale</description>
  </other_outcome>
  <other_outcome>
    <measure>NAQ</measure>
    <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.</time_frame>
    <description>Need for Affect Questionnaire</description>
  </other_outcome>
  <other_outcome>
    <measure>IE-4</measure>
    <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.</time_frame>
    <description>a short scale to assess internal and external control beliefs</description>
  </other_outcome>
  <other_outcome>
    <measure>ERQ</measure>
    <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.</time_frame>
    <description>Emotion Regulation Questionnaire</description>
  </other_outcome>
  <other_outcome>
    <measure>RSQ-D</measure>
    <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.</time_frame>
    <description>Response Styles Questionnaire</description>
  </other_outcome>
  <other_outcome>
    <measure>MCTQ</measure>
    <time_frame>Assessed in week 4.</time_frame>
    <description>Munich ChronoType Questionnaire</description>
  </other_outcome>
  <other_outcome>
    <measure>blood samples</measure>
    <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.</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>endocrine parameters</measure>
    <time_frame>Assessed as baseline measure after informed consent was given, in week 4 and 7 of the treatment.</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>ECG</measure>
    <time_frame>Assessed at baseline and in week 7.</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>circadian rhythms</measure>
    <time_frame>continuous measurement using a wearable actimeter during the whole therapy program of seven weeks</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>imaging (MRT)</measure>
    <time_frame>Assessed at baseline and in week 7.</time_frame>
  </other_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">300</enrollment>
  <condition>Major Depressive Disorder</condition>
  <arm_group>
    <arm_group_label>ST-arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>one-third of the patients is randomized to schema therapy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>CBT-arm</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>one-third of the patients is randomized to cognitive behavioral therapy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>IST-arm</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>one-third of the patients is randomized to individualized supportive therapy</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>schema therapy</intervention_name>
    <description>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</description>
    <arm_group_label>ST-arm</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>cognitive behavioral therapy</intervention_name>
    <description>The intervention consists of a seven-week program of cognitive behavioral therapy, which is the current gold standard of treatment</description>
    <arm_group_label>CBT-arm</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>individualized supportive therapy</intervention_name>
    <description>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.</description>
    <arm_group_label>IST-arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Main diagnosis of major depressive disorder, single episode or recurrent, moderate or&#xD;
             severe without psychotic symptoms according to DSM-5 criteria (F32.1, F32.2, F33.1,&#xD;
             F33.2 according to ICD-10)&#xD;
&#xD;
          2. age between 18 and 75 years&#xD;
&#xD;
          3. informed consent to the study procedures and assessments (in written form)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Major depressive disorder, single episode or recurrent, severe with psychotic symptoms&#xD;
             (F32.3, F33.3 according to ICD-10)&#xD;
&#xD;
          2. Severe mutism or stupor&#xD;
&#xD;
          3. lifetime history of any psychotic or bipolar disorder&#xD;
&#xD;
          4. severe neurological or internal concomitant diseases&#xD;
&#xD;
          5. IQ &lt; 80; severe learning disability, brain damage or pervasive developmental disorder&#xD;
&#xD;
          6. current alcohol or any illicit drug withdrawal syndrome according to DSM-5&#xD;
&#xD;
          7. mental disorders secondary to a medical conditions or substance use disorders&#xD;
&#xD;
          8. acute suicidality&#xD;
&#xD;
          9. pregnancy and lactation period&#xD;
&#xD;
         10. Missing eligibility for psychotherapy because of missing language skills&#xD;
&#xD;
         11. Electroconvulsive therapy (ECT) in preparation&#xD;
&#xD;
         12. Participation in further scientific studies&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Johannes M. Kopf-Beck, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Max-Planck-Institute of Psychiatry</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Max Planck Institute of Psychiatry</name>
      <address>
        <city>Munich</city>
        <zip>80804</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <reference>
    <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>
    <PMID>23778056</PMID>
  </reference>
  <reference>
    <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>
    <PMID>24223526</PMID>
  </reference>
  <verification_date>March 2021</verification_date>
  <study_first_submitted>August 25, 2017</study_first_submitted>
  <study_first_submitted_qc>September 18, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 19, 2017</study_first_posted>
  <last_update_submitted>March 22, 2021</last_update_submitted>
  <last_update_submitted_qc>March 22, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">March 23, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>major depressive disorder</keyword>
  <keyword>cognitive behavioral therapy</keyword>
  <keyword>supportive therapy</keyword>
  <keyword>schema therapy</keyword>
  <keyword>biomarkers</keyword>
  <keyword>neuropsychology</keyword>
  <keyword>circadian rhythm</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Depressive Disorder</mesh_term>
    <mesh_term>Depression</mesh_term>
    <mesh_term>Depressive Disorder, Major</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03287362
org study id: 17-395
nct id: NCT03287362
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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)
primary purpose: Treatment
masking: None (Open Label)
measure: 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.
description: 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
measure: 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.
description: 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
measure: 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.
description: 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
measure: 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.
description: 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
measure: 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.
description: 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
measure: 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.
description: 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
measure: Decreased need for psychopharmacological medication
time frame: Comparison between baseline measurement before treatment start and end of therapy treatment of seven weeks
measure: Dropout rate from therapeutic treatment
time frame: Assessed after all participants were recruited, enrolled, treated and finished their final measurements (approx. after eight years)
measure: 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.
description: 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
measure: 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.
description: The Personality Inventory for DSM-5
measure: 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.
description: Young Schema Questionnaire
measure: 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.
description: Automatic Thought questionnaire
measure: 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.
description: Dysfunctional Attitude Scale
measure: 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.
description: Need for Affect Questionnaire
measure: 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.
description: a short scale to assess internal and external control beliefs
measure: 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.
description: Emotion Regulation Questionnaire
measure: 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.
description: Response Styles Questionnaire
measure: MCTQ
time frame: Assessed in week 4.
description: Munich ChronoType Questionnaire
measure: 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.
measure: endocrine parameters
time frame: Assessed as baseline measure after informed consent was given, in week 4 and 7 of the treatment.
measure: ECG
time frame: Assessed at baseline and in week 7.
measure: circadian rhythms
time frame: continuous measurement using a wearable actimeter during the whole therapy program of seven weeks
measure: imaging (MRT)
time frame: Assessed at baseline and in week 7.
arm group label: ST-arm
arm group type: Experimental
description: one-third of the patients is randomized to schema therapy
arm group label: CBT-arm
arm group type: Active Comparator
description: one-third of the patients is randomized to cognitive behavioral therapy
arm group label: IST-arm
arm group type: Placebo Comparator
description: one-third of the patients is randomized to individualized supportive therapy
intervention type: Behavioral
intervention name: schema therapy
description: 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
arm group label: ST-arm
intervention type: Behavioral
intervention name: cognitive behavioral therapy
description: The intervention consists of a seven-week program of cognitive behavioral therapy, which is the current gold standard of treatment
arm group label: CBT-arm
intervention type: Behavioral
intervention name: individualized supportive therapy
description: 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 group label: IST-arm
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Johannes M. Kopf-Beck, PhD
role: Principal Investigator
affiliation: Max-Planck-Institute of Psychiatry
facility: 
country: Germany
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.
PMID: 23778056
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.
PMID: 24223526
responsible party type: Sponsor
mesh term: Depressive Disorder
mesh term: Depression
mesh term: Depressive Disorder, Major
sharing ipd: No