<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/NCT03268434</url>
  </required_header>
  <id_info>
    <org_study_id>LJ05207</org_study_id>
    <nct_id>NCT03268434</nct_id>
  </id_info>
  <brief_title>Evaluation of Metacognitive Training for Depression (D-MCT) in Outpatient Care</brief_title>
  <official_title>Evaluation of Metacognitive Training for Depression (D-MCT) in Outpatient Psychiatric-psychotherapeutic Care: Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universitätsklinikum Hamburg-Eppendorf</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Asklepios Kliniken Hamburg GmbH</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Universitätsklinikum Hamburg-Eppendorf</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>
      Aim of the current study is to investigate the acceptance and efficacy of Metacognitive&#xD;
      Training for Depression (D-MCT) compared to cognitive remediation in outpatients with major&#xD;
      depressive disorders in a randomized, controlled, assessor-blind, group trial.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Evidence-based treatments for depression include pharmacological and psychological&#xD;
      interventions. Within psychological interventions, cognitive behavioral therapy (CBT) is one&#xD;
      of the most extensively researched evidence-based approaches for depression (Cuijpers, 2015).&#xD;
      However, even if optimal treatment and access to services were available to all patients, the&#xD;
      burden of depression would be reduced by only 30% (Andrews et al., 2004). Moreover, as&#xD;
      depression represents the disorder with the highest drop-out rates during CBT treatment&#xD;
      (36.4%) (Fernandez et al., 2015), and a relapse rate of 54% for treatment responders within&#xD;
      the two years after treatment termination (Vittengl et al., 2007), it is pivotal to improve&#xD;
      treatment for depression. It has been argued that this is less a question of developing novel&#xD;
      psychological treatments as of determining how existing treatments may be improved (Cuijpers,&#xD;
      2015) and better disseminated to increase retention rates and to use the waiting phase to&#xD;
      rise interest in therapy (Fernandez et al., 2015). Due to hopelessness and the discouraging&#xD;
      character of the disorder, this poses a particular challenge.&#xD;
&#xD;
      To meet this aim, Metacognitive Training for Depression (D-MCT) has been developed as a&#xD;
      low-threshold, highly standardized and yet easy to administer group concept for the treatment&#xD;
      of depression. It is conceptualized as a variant of CBT that adopts a metacognitive&#xD;
      perspective focusing on the modification of cognitive biases, and is compatible with a&#xD;
      general CBT treatment approach. Use of standardized presentations reduces time needed for&#xD;
      preparation and administration of the training; moreover, this &quot;packaging&quot; increases the&#xD;
      accessibility of D-MCT to a wide range of health care providers, and encourages&#xD;
      standardization across therapists. The training seeks to enable group members to recognize&#xD;
      and correct the often automatic and unconscious thought patterns that accompany depression.&#xD;
      To this end, it attempts to challenge cognitive biases through the use of creative and&#xD;
      engaging exercises supported by a multimedia presentation (e.g., insight based on &quot;aha&quot;&#xD;
      effects rather than psychoeducation) and to encourage patients to take a metacognitive&#xD;
      perspective (&quot;think about one's thinking&quot;). The training is highly flexible with regard to&#xD;
      depth and intensity. Patients do not need to (but may) discuss their own problems, and can&#xD;
      still experience how cognitive biases work and influence one's mood in a playful atmosphere.&#xD;
      The training is conceptualized as an open group: New patients can join the group in every&#xD;
      session. Thus, the threshold for administration of and participation in this intervention is&#xD;
      low.&#xD;
&#xD;
      The general structure of and exercises in D-MCT were inspired by Metacognitive Training for&#xD;
      psychosis (Moritz et al., 2014); however, contents were modified upon to suit the specific&#xD;
      problems of individuals with depression. Beside depressive thought patterns already targeted&#xD;
      in CBT (e.g., overgeneralization, &quot;mind reading&quot;), a number of general cognitive biases,&#xD;
      which have been identified by basic cognitive research, form the core of D-MCT (e.g.,&#xD;
      mood-congruent memory (Mathews and MacLeod, 2005)). Finally, as in Metacognitive Therapy&#xD;
      (MCT) sensu Adrian Wells (Wells, 2011) dysfunctional coping strategies (i.e., thought&#xD;
      suppression, rumination as problem-solving) are challenged. D-MCT thus blends established&#xD;
      elements from CBT and MCT as well as newly developed and evidence-based exercises in one&#xD;
      coherent metacognitive approach.&#xD;
&#xD;
      D-MCT was positively evaluated with regard to feasibility and acceptance in a non-randomized&#xD;
      pilot study (Jelinek et al., 2013). Moreover, efficacy of D-MCT was suggested in a randomized&#xD;
      controlled trail (RCT) in comparison to an active control intervention (Jelinek et al.,&#xD;
      2016). In this trial patients with depressive disorder were completing a psychosomatic&#xD;
      outpatient treatment program and were randomly assigned to either D-MCT or general health&#xD;
      training. Severity of depression and cognitive biases were assessed at baseline (t0), post&#xD;
      treatment (t1) and 6 months (t2) later by raters blind to diagnostic status.&#xD;
      Intention-to-treat analyses demonstrated that at the end of treatment, as well as 6 months&#xD;
      later, improvement in depression was significantly greater in the D-MCT relative to the&#xD;
      health training group at medium effect sizes. A significantly greater number of patients in&#xD;
      the D-MCT group were in remission at 6-month follow-up. Moreover, the decrease in cognitive&#xD;
      biases and increase in psychological well-being/quality of life was larger in the D-MCT than&#xD;
      the health training group over time. Patients' subjective appraisal of D-MCT was also&#xD;
      positive (Jelinek et al., 2017).&#xD;
&#xD;
      Aim of the current study is to investigate the acceptance and efficacy of D-MCT in&#xD;
      outpatients.The Hamilton Depression Rating Scale (HDRS, 17-item version) total score as well&#xD;
      as the Quick Inventory of Depressive Symptomatology (QIDS) serve as primary outcome.&#xD;
      Self-assessed depression, dysfunctional beliefs, self-esteem, quality of life, rumination,&#xD;
      remission rate as well as neuropsychological functioning serve as secondary outcomes.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 10, 2017</start_date>
  <completion_date type="Actual">September 24, 2019</completion_date>
  <primary_completion_date type="Actual">August 22, 2019</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Investigator, Outcomes Assessor)</masking>
    <masking_description>Double Blind (Investigator, Outcome Assessor)</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Quick Inventory of Depressive Symptomatology (QIDS)</measure>
    <time_frame>eight months from baseline (t0) to 6-months follow up (t2)</time_frame>
    <description>Primary outcome is change on the Quick Inventory of Depressive Symptomatology (QIDS) from baseline to follow-up (t0 - t2)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Hamilton Depression Rating Scale</measure>
    <time_frame>[Time Frame: eight months from baseline (t0) to 6-months follow up (t2)]</time_frame>
    <description>Change on the Hamilton Depression Rating Scale (HDRS, 17-item version) from baseline to follow-up (t0 - t2)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-assessed depression</measure>
    <time_frame>[Time Frame: eight months from baseline (t0) to 6-months follow up (t2)]</time_frame>
    <description>Change in self-assessed depression as measured by the Patient Health Questionnaire (PHQ-9) from baseline to follow-up (t0 to t2)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quick Inventory of Depressive Symptomatology (QIDS)</measure>
    <time_frame>from baseline (t0) to post intervention assessment at 8 weeks (t1) [time frame: 8 weeks]</time_frame>
    <description>Change on the Quick Inventory of Depressive Symptomatology (QIDS) from baseline to post intervention assessment (t0 - t1)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hamilton Depression Rating Scale</measure>
    <time_frame>from baseline (t0) to post intervention assessment at 8 weeks (t1) [time frame: 8 weeks]</time_frame>
    <description>Change on the Hamilton Depression Rating Scale from baseline to post intervention assessment (t0 - t1)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Health Questionnaire (PHQ-9)</measure>
    <time_frame>from baseline (t0) to post intervention assessment at 8 weeks (t1) [time frame: 8 weeks]</time_frame>
    <description>Change on the Patient Health Questionnaire (PHQ-9) from baseline to post intervention assessment (t0 - t1)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Dysfunctional beliefs</measure>
    <time_frame>eight months from baseline (t0) to 6-months follow up (t2</time_frame>
    <description>Change in dysfunctional beliefs as measured by the Dysfunctional Attitude Scale (DAS) from baseline to follow-up (t0 to t2)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life</measure>
    <time_frame>eight months from baseline (t0) to 6-months follow up (t2)</time_frame>
    <description>Change in quality of life as measured by the World Health Organization Quality of Life Assessment (WHOQOL-BREF) from baseline to follow-up (t0 to t2)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Dysfunctional metacognitive beliefs</measure>
    <time_frame>eight months from baseline (t0) to 6-months follow up (t2)</time_frame>
    <description>Change in metacognitive beliefs as measured by the Metacognitions Questionnaire (MCQ-30) from baseline to follow-up (t0 to t2)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rumination</measure>
    <time_frame>eight months from baseline (t0) to 6-months follow up (t2)</time_frame>
    <description>Rumination measured by the Ruminative Response Scale (RRS) from baseline to follow-up (t0 to t2)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-esteem</measure>
    <time_frame>eight months from baseline (t0) to 6-months follow up (t2)</time_frame>
    <description>Change in self-esteem as measured by the Rosenberg Self-Esteem Scale (RSE) from from baseline to follow-up (t0 to t2)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Remission rate</measure>
    <time_frame>eight months from baseline (t0) to 6-months follow up (t2)</time_frame>
    <description>Remission rate at T2 as measured by the Hamilton Depression Rating Scale (HDRS score ≤ 8)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Information processing</measure>
    <time_frame>from baseline (t0) to post intervention assessment at 8 weeks (t1) [time frame: 8 weeks]</time_frame>
    <description>Information processing as measured by the Trail-Making Test A (TMT-A) from baseline to post treatment assessment (t0 to t1)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Subjective appraisal of the training</measure>
    <time_frame>each week (session data) [time frame: 8 weeks] and six months from post treatment assessment (t1) to 6 months follow up (t1 to t2) [time frame: 6 months]</time_frame>
    <description>Subjective appraisal of the training after each session as well as at post treatment and follow up assessment (for questionnaire see Jelinek et al., 2017)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Executive functioning</measure>
    <time_frame>from baseline (t0) to post intervention assessment at 8 weeks (t1) [time frame: 8 weeks]</time_frame>
    <description>Executive functions as measured by the Trail-Making Test B (TMT-B) from baseline to post treatment assessment (t0 to t1)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Verbal memory</measure>
    <time_frame>from baseline (t0) to post intervention assessment at 8 weeks (t1) [time frame: 8 weeks]</time_frame>
    <description>Memory functioning as measured by Rivermead Behavioral Memory Test from baseline to post treatment assessment (t0 to t1)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">86</enrollment>
  <condition>Unipolar Depression</condition>
  <arm_group>
    <arm_group_label>D-MCT Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Metacognitive Training for Depression (D-MCT), 8 sessions (60min); once a week over a period of 8 weeks. Metacognitive Training for depression (D-MCT) is a low-threshold, easy to administer group intervention. It aims at the reduction of depressive symptoms by changing cognitive biases; not only biases targeted in cognitive behavioral therapy but also those identified by basic research.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cognitive remediation</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>A computerized cognitive remediation program that covers several cognitive domains, such as attention, visuomotor skills, and Memory.The difficulty level adapts automatically to the performance level of each patient. At the end of each session, the patient receives individual feedback on his or her performance.; 8 sessions (60min), once a week over a period of 8 weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>D-MCT</intervention_name>
    <description>Metacognitive Training for Depression (D-MCT), 8 sessions (60min); once a week over a period of 8 weeks. Metacognitive Training for depression (D-MCT) is a low-threshold, easy to administer group intervention. It aims at the reduction of depressive symptoms by changing cognitive biases; not only biases targeted in cognitive behavioral therapy but also those identified by basic research.</description>
    <arm_group_label>D-MCT Group</arm_group_label>
    <other_name>Metacognitive Training for Depression</other_name>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Cognitive remediation</intervention_name>
    <description>A computerized cognitive remediation program that covers several cognitive domains, such as attention, visuomotor skills, and Memory. The difficulty level adapts automatically to the performance level of each patient. At the end of each session, the patient receives individual feedback on his or her performance; 8 sessions (60min), once a week over a period of 8 weeks</description>
    <arm_group_label>Cognitive remediation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  informed consent&#xD;
&#xD;
          -  age between 18 and 70 years&#xD;
&#xD;
          -  diagnosis of a single Episode or recurrent Major depressive disorder (MDD) or&#xD;
             dysthymia (verified by the MINI)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  lifetime psychotic symptoms (i.e., hallucinations, delusions, or mania), suicidality&#xD;
             (Suicidal Behaviors Questionnaire-Revised ≥ 7), intellectual disability (estimated IQ&#xD;
             &lt; 70) or dementia.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Marion Hagemann-Goebel, Dr.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Asklepios Klinik Nord-Ochsenzoll</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Asklepios Klinik Nord-Ochsenzoll</name>
      <address>
        <city>Hamburg</city>
        <zip>22419</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <reference>
    <citation>Moritz S, Veckenstedt R, Andreou C, Bohn F, Hottenrott B, Leighton L, Kother U, Woodward TS, Treszl A, Menon M, Schneider BC, Pfueller U, Roesch-Ely D. Sustained and &quot;sleeper&quot; effects of group metacognitive training for schizophrenia: a randomized clinical trial. JAMA Psychiatry. 2014 Oct;71(10):1103-11. doi: 10.1001/jamapsychiatry.2014.1038.</citation>
    <PMID>25103718</PMID>
  </reference>
  <reference>
    <citation>Jelinek L, Hauschildt M, Wittekind CE, Schneider BC, Kriston L, Moritz S. Efficacy of Metacognitive Training for Depression: A Randomized Controlled Trial. Psychother Psychosom. 2016;85(4):231-4. doi: 10.1159/000443699. Epub 2016 May 27. No abstract available.</citation>
    <PMID>27230865</PMID>
  </reference>
  <reference>
    <citation>Jelinek L, Otte C, Arlt S, &amp; Hauschildt M. Denkverzerrungen erkennen und korrigieren: Eine Machbarkeitsstudie zum Metakognitiven Training bei Depressionen (D-MKT). [Identifying and correcting cognitive biases: A Pilot study on the Metacognitive Training for Depression (D-MCT)] Zeitschrift für Psychiatrie, Psychologie und Psychotherapie, 61, 247-254, 2013.</citation>
  </reference>
  <reference>
    <citation>Jelinek L, Moritz S, Hauschildt M. Patients' perspectives on treatment with Metacognitive Training for Depression (D-MCT): Results on acceptability. J Affect Disord. 2017 Oct 15;221:17-24. doi: 10.1016/j.jad.2017.06.003. Epub 2017 Jun 7.</citation>
    <PMID>28628763</PMID>
  </reference>
  <reference>
    <citation>Andrews G, Issakidis C, Sanderson K, Corry J, Lapsley H. Utilising survey data to inform public policy: comparison of the cost-effectiveness of treatment of ten mental disorders. Br J Psychiatry. 2004 Jun;184:526-33. doi: 10.1192/bjp.184.6.526.</citation>
    <PMID>15172947</PMID>
  </reference>
  <reference>
    <citation>Cuijpers P. Psychotherapies for adult depression: recent developments. Curr Opin Psychiatry. 2015 Jan;28(1):24-9. doi: 10.1097/YCO.0000000000000121.</citation>
    <PMID>25415495</PMID>
  </reference>
  <reference>
    <citation>Fernandez E, Salem D, Swift JK, Ramtahal N. Meta-analysis of dropout from cognitive behavioral therapy: Magnitude, timing, and moderators. J Consult Clin Psychol. 2015 Dec;83(6):1108-22. doi: 10.1037/ccp0000044. Epub 2015 Aug 24.</citation>
    <PMID>26302248</PMID>
  </reference>
  <reference>
    <citation>Mathews A, MacLeod C. Cognitive vulnerability to emotional disorders. Annu Rev Clin Psychol. 2005;1:167-95. doi: 10.1146/annurev.clinpsy.1.102803.143916.</citation>
    <PMID>17716086</PMID>
  </reference>
  <reference>
    <citation>Vittengl JR, Clark LA, Dunn TW, Jarrett RB. Reducing relapse and recurrence in unipolar depression: a comparative meta-analysis of cognitive-behavioral therapy's effects. J Consult Clin Psychol. 2007 Jun;75(3):475-88. doi: 10.1037/0022-006X.75.3.475.</citation>
    <PMID>17563164</PMID>
  </reference>
  <reference>
    <citation>Wells, A., 2011. Metacognitive Therapy for anxiety and depression. The Guilford Press, New York.</citation>
  </reference>
  <verification_date>September 2019</verification_date>
  <study_first_submitted>August 3, 2017</study_first_submitted>
  <study_first_submitted_qc>August 28, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 31, 2017</study_first_posted>
  <last_update_submitted>September 26, 2019</last_update_submitted>
  <last_update_submitted_qc>September 26, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">September 27, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Depression</keyword>
  <keyword>Metacognition</keyword>
  <keyword>CBT</keyword>
  <keyword>D-MCT</keyword>
  <keyword>cognitive bias</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Depression</mesh_term>
    <mesh_term>Depressive Disorder</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/NCT03268434
org study id: LJ05207
nct id: NCT03268434
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Aim of the current study is to investigate the acceptance and efficacy of Metacognitive
      Training for Depression (D-MCT) compared to cognitive remediation in outpatients with major
      depressive disorders in a randomized, controlled, assessor-blind, group trial.
Evidence-based treatments for depression include pharmacological and psychological
      interventions. Within psychological interventions, cognitive behavioral therapy (CBT) is one
      of the most extensively researched evidence-based approaches for depression (Cuijpers, 2015).
      However, even if optimal treatment and access to services were available to all patients, the
      burden of depression would be reduced by only 30% (Andrews et al., 2004). Moreover, as
      depression represents the disorder with the highest drop-out rates during CBT treatment
      (36.4%) (Fernandez et al., 2015), and a relapse rate of 54% for treatment responders within
      the two years after treatment termination (Vittengl et al., 2007), it is pivotal to improve
      treatment for depression. It has been argued that this is less a question of developing novel
      psychological treatments as of determining how existing treatments may be improved (Cuijpers,
      2015) and better disseminated to increase retention rates and to use the waiting phase to
      rise interest in therapy (Fernandez et al., 2015). Due to hopelessness and the discouraging
      character of the disorder, this poses a particular challenge.

      To meet this aim, Metacognitive Training for Depression (D-MCT) has been developed as a
      low-threshold, highly standardized and yet easy to administer group concept for the treatment
      of depression. It is conceptualized as a variant of CBT that adopts a metacognitive
      perspective focusing on the modification of cognitive biases, and is compatible with a
      general CBT treatment approach. Use of standardized presentations reduces time needed for
      preparation and administration of the training; moreover, this "packaging" increases the
      accessibility of D-MCT to a wide range of health care providers, and encourages
      standardization across therapists. The training seeks to enable group members to recognize
      and correct the often automatic and unconscious thought patterns that accompany depression.
      To this end, it attempts to challenge cognitive biases through the use of creative and
      engaging exercises supported by a multimedia presentation (e.g., insight based on "aha"
      effects rather than psychoeducation) and to encourage patients to take a metacognitive
      perspective ("think about one's thinking"). The training is highly flexible with regard to
      depth and intensity. Patients do not need to (but may) discuss their own problems, and can
      still experience how cognitive biases work and influence one's mood in a playful atmosphere.
      The training is conceptualized as an open group: New patients can join the group in every
      session. Thus, the threshold for administration of and participation in this intervention is
      low.

      The general structure of and exercises in D-MCT were inspired by Metacognitive Training for
      psychosis (Moritz et al., 2014); however, contents were modified upon to suit the specific
      problems of individuals with depression. Beside depressive thought patterns already targeted
      in CBT (e.g., overgeneralization, "mind reading"), a number of general cognitive biases,
      which have been identified by basic cognitive research, form the core of D-MCT (e.g.,
      mood-congruent memory (Mathews and MacLeod, 2005)). Finally, as in Metacognitive Therapy
      (MCT) sensu Adrian Wells (Wells, 2011) dysfunctional coping strategies (i.e., thought
      suppression, rumination as problem-solving) are challenged. D-MCT thus blends established
      elements from CBT and MCT as well as newly developed and evidence-based exercises in one
      coherent metacognitive approach.

      D-MCT was positively evaluated with regard to feasibility and acceptance in a non-randomized
      pilot study (Jelinek et al., 2013). Moreover, efficacy of D-MCT was suggested in a randomized
      controlled trail (RCT) in comparison to an active control intervention (Jelinek et al.,
      2016). In this trial patients with depressive disorder were completing a psychosomatic
      outpatient treatment program and were randomly assigned to either D-MCT or general health
      training. Severity of depression and cognitive biases were assessed at baseline (t0), post
      treatment (t1) and 6 months (t2) later by raters blind to diagnostic status.
      Intention-to-treat analyses demonstrated that at the end of treatment, as well as 6 months
      later, improvement in depression was significantly greater in the D-MCT relative to the
      health training group at medium effect sizes. A significantly greater number of patients in
      the D-MCT group were in remission at 6-month follow-up. Moreover, the decrease in cognitive
      biases and increase in psychological well-being/quality of life was larger in the D-MCT than
      the health training group over time. Patients' subjective appraisal of D-MCT was also
      positive (Jelinek et al., 2017).

      Aim of the current study is to investigate the acceptance and efficacy of D-MCT in
      outpatients.The Hamilton Depression Rating Scale (HDRS, 17-item version) total score as well
      as the Quick Inventory of Depressive Symptomatology (QIDS) serve as primary outcome.
      Self-assessed depression, dysfunctional beliefs, self-esteem, quality of life, rumination,
      remission rate as well as neuropsychological functioning serve as secondary outcomes.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Investigator, Outcomes Assessor)
masking description: Double Blind (Investigator, Outcome Assessor)
measure: Quick Inventory of Depressive Symptomatology (QIDS)
time frame: eight months from baseline (t0) to 6-months follow up (t2)
description: Primary outcome is change on the Quick Inventory of Depressive Symptomatology (QIDS) from baseline to follow-up (t0 - t2)
measure: Hamilton Depression Rating Scale
time frame: [Time Frame: eight months from baseline (t0) to 6-months follow up (t2)]
description: Change on the Hamilton Depression Rating Scale (HDRS, 17-item version) from baseline to follow-up (t0 - t2)
measure: Self-assessed depression
time frame: [Time Frame: eight months from baseline (t0) to 6-months follow up (t2)]
description: Change in self-assessed depression as measured by the Patient Health Questionnaire (PHQ-9) from baseline to follow-up (t0 to t2)
measure: Quick Inventory of Depressive Symptomatology (QIDS)
time frame: from baseline (t0) to post intervention assessment at 8 weeks (t1) [time frame: 8 weeks]
description: Change on the Quick Inventory of Depressive Symptomatology (QIDS) from baseline to post intervention assessment (t0 - t1)
measure: Hamilton Depression Rating Scale
time frame: from baseline (t0) to post intervention assessment at 8 weeks (t1) [time frame: 8 weeks]
description: Change on the Hamilton Depression Rating Scale from baseline to post intervention assessment (t0 - t1)
measure: Patient Health Questionnaire (PHQ-9)
time frame: from baseline (t0) to post intervention assessment at 8 weeks (t1) [time frame: 8 weeks]
description: Change on the Patient Health Questionnaire (PHQ-9) from baseline to post intervention assessment (t0 - t1)
measure: Dysfunctional beliefs
time frame: eight months from baseline (t0) to 6-months follow up (t2
description: Change in dysfunctional beliefs as measured by the Dysfunctional Attitude Scale (DAS) from baseline to follow-up (t0 to t2)
measure: Quality of life
time frame: eight months from baseline (t0) to 6-months follow up (t2)
description: Change in quality of life as measured by the World Health Organization Quality of Life Assessment (WHOQOL-BREF) from baseline to follow-up (t0 to t2)
measure: Dysfunctional metacognitive beliefs
time frame: eight months from baseline (t0) to 6-months follow up (t2)
description: Change in metacognitive beliefs as measured by the Metacognitions Questionnaire (MCQ-30) from baseline to follow-up (t0 to t2)
measure: Rumination
time frame: eight months from baseline (t0) to 6-months follow up (t2)
description: Rumination measured by the Ruminative Response Scale (RRS) from baseline to follow-up (t0 to t2)
measure: Self-esteem
time frame: eight months from baseline (t0) to 6-months follow up (t2)
description: Change in self-esteem as measured by the Rosenberg Self-Esteem Scale (RSE) from from baseline to follow-up (t0 to t2)
measure: Remission rate
time frame: eight months from baseline (t0) to 6-months follow up (t2)
description: Remission rate at T2 as measured by the Hamilton Depression Rating Scale (HDRS score ≤ 8)
measure: Information processing
time frame: from baseline (t0) to post intervention assessment at 8 weeks (t1) [time frame: 8 weeks]
description: Information processing as measured by the Trail-Making Test A (TMT-A) from baseline to post treatment assessment (t0 to t1)
measure: Subjective appraisal of the training
time frame: each week (session data) [time frame: 8 weeks] and six months from post treatment assessment (t1) to 6 months follow up (t1 to t2) [time frame: 6 months]
description: Subjective appraisal of the training after each session as well as at post treatment and follow up assessment (for questionnaire see Jelinek et al., 2017)
measure: Executive functioning
time frame: from baseline (t0) to post intervention assessment at 8 weeks (t1) [time frame: 8 weeks]
description: Executive functions as measured by the Trail-Making Test B (TMT-B) from baseline to post treatment assessment (t0 to t1)
measure: Verbal memory
time frame: from baseline (t0) to post intervention assessment at 8 weeks (t1) [time frame: 8 weeks]
description: Memory functioning as measured by Rivermead Behavioral Memory Test from baseline to post treatment assessment (t0 to t1)
arm group label: D-MCT Group
arm group type: Experimental
description: Metacognitive Training for Depression (D-MCT), 8 sessions (60min); once a week over a period of 8 weeks. Metacognitive Training for depression (D-MCT) is a low-threshold, easy to administer group intervention. It aims at the reduction of depressive symptoms by changing cognitive biases; not only biases targeted in cognitive behavioral therapy but also those identified by basic research.
arm group label: Cognitive remediation
arm group type: Active Comparator
description: A computerized cognitive remediation program that covers several cognitive domains, such as attention, visuomotor skills, and Memory.The difficulty level adapts automatically to the performance level of each patient. At the end of each session, the patient receives individual feedback on his or her performance.; 8 sessions (60min), once a week over a period of 8 weeks
intervention type: Behavioral
intervention name: D-MCT
description: Metacognitive Training for Depression (D-MCT), 8 sessions (60min); once a week over a period of 8 weeks. Metacognitive Training for depression (D-MCT) is a low-threshold, easy to administer group intervention. It aims at the reduction of depressive symptoms by changing cognitive biases; not only biases targeted in cognitive behavioral therapy but also those identified by basic research.
arm group label: D-MCT Group
other name: Metacognitive Training for Depression
intervention type: Behavioral
intervention name: Cognitive remediation
description: A computerized cognitive remediation program that covers several cognitive domains, such as attention, visuomotor skills, and Memory. The difficulty level adapts automatically to the performance level of each patient. At the end of each session, the patient receives individual feedback on his or her performance; 8 sessions (60min), once a week over a period of 8 weeks
arm group label: Cognitive remediation
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Marion Hagemann-Goebel, Dr.
role: Principal Investigator
affiliation: Asklepios Klinik Nord-Ochsenzoll
facility: 
country: Germany
citation: Moritz S, Veckenstedt R, Andreou C, Bohn F, Hottenrott B, Leighton L, Kother U, Woodward TS, Treszl A, Menon M, Schneider BC, Pfueller U, Roesch-Ely D. Sustained and "sleeper" effects of group metacognitive training for schizophrenia: a randomized clinical trial. JAMA Psychiatry. 2014 Oct;71(10):1103-11. doi: 10.1001/jamapsychiatry.2014.1038.
PMID: 25103718
citation: Jelinek L, Hauschildt M, Wittekind CE, Schneider BC, Kriston L, Moritz S. Efficacy of Metacognitive Training for Depression: A Randomized Controlled Trial. Psychother Psychosom. 2016;85(4):231-4. doi: 10.1159/000443699. Epub 2016 May 27. No abstract available.
PMID: 27230865
citation: Jelinek L, Otte C, Arlt S, & Hauschildt M. Denkverzerrungen erkennen und korrigieren: Eine Machbarkeitsstudie zum Metakognitiven Training bei Depressionen (D-MKT). [Identifying and correcting cognitive biases: A Pilot study on the Metacognitive Training for Depression (D-MCT)] Zeitschrift für Psychiatrie, Psychologie und Psychotherapie, 61, 247-254, 2013.
citation: Jelinek L, Moritz S, Hauschildt M. Patients' perspectives on treatment with Metacognitive Training for Depression (D-MCT): Results on acceptability. J Affect Disord. 2017 Oct 15;221:17-24. doi: 10.1016/j.jad.2017.06.003. Epub 2017 Jun 7.
PMID: 28628763
citation: Andrews G, Issakidis C, Sanderson K, Corry J, Lapsley H. Utilising survey data to inform public policy: comparison of the cost-effectiveness of treatment of ten mental disorders. Br J Psychiatry. 2004 Jun;184:526-33. doi: 10.1192/bjp.184.6.526.
PMID: 15172947
citation: Cuijpers P. Psychotherapies for adult depression: recent developments. Curr Opin Psychiatry. 2015 Jan;28(1):24-9. doi: 10.1097/YCO.0000000000000121.
PMID: 25415495
citation: Fernandez E, Salem D, Swift JK, Ramtahal N. Meta-analysis of dropout from cognitive behavioral therapy: Magnitude, timing, and moderators. J Consult Clin Psychol. 2015 Dec;83(6):1108-22. doi: 10.1037/ccp0000044. Epub 2015 Aug 24.
PMID: 26302248
citation: Mathews A, MacLeod C. Cognitive vulnerability to emotional disorders. Annu Rev Clin Psychol. 2005;1:167-95. doi: 10.1146/annurev.clinpsy.1.102803.143916.
PMID: 17716086
citation: Vittengl JR, Clark LA, Dunn TW, Jarrett RB. Reducing relapse and recurrence in unipolar depression: a comparative meta-analysis of cognitive-behavioral therapy's effects. J Consult Clin Psychol. 2007 Jun;75(3):475-88. doi: 10.1037/0022-006X.75.3.475.
PMID: 17563164
citation: Wells, A., 2011. Metacognitive Therapy for anxiety and depression. The Guilford Press, New York.
responsible party type: Sponsor
mesh term: Depression
mesh term: Depressive Disorder
sharing ipd: No