<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/NCT03002753</url>
  </required_header>
  <id_info>
    <org_study_id>CDS-MS-JR-2016</org_study_id>
    <nct_id>NCT03002753</nct_id>
  </id_info>
  <brief_title>Dealing With Intrusive Thoughts in OCD - a Comparison of Detached Mindfulness and Cognitive Restructuring</brief_title>
  <official_title>Zum Umgang Mit Aufdringlichen Gedanken Bei Der Zwangsstörung - Zwei Behandlungsstrategien im Vergleich</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Christoph-Dornier-Stiftung für Klinische Psychologie</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Westfälische Wilhelms-Universität Münster</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Christoph-Dornier-Stiftung für Klinische Psychologie</source>
  <brief_summary>
    <textblock>
      The purpose of this study is to assess and compare the overall efficacy and differential&#xD;
      effects of detached mindfulness and cognitive restructuring in the treatment of patients with&#xD;
      obsessive-compulsive disorder.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of this study is to assess and compare the overall efficacy and differential&#xD;
      effects of two interventions for patients suffering from obsessive-compulsive disorder (OCD)&#xD;
      according to DSM-5. The interventions to be compared are detached mindfulness (DM) and&#xD;
      cognitive restructuring (CR). Whereas the efficacy of CR for the treatment of OCD has been&#xD;
      proven in various studies, the efficacy of DM as a single intervention so far has only been&#xD;
      shown within a case study and within a non-clinical sample. By contrast, the efficacy of&#xD;
      complex metacognitive protocols (of which DM constitutes one of several single interventions)&#xD;
      has been shown multiple times. So far, however, little is known about the efficacy of DM as a&#xD;
      single intervention in a clinical sample and the differential working mechanisms of DM vs.&#xD;
      CR.&#xD;
&#xD;
      Whereas DM is supposed to modify metacognitions by teaching patients to solely observe their&#xD;
      intrusive thoughts, CR aims at teaching the patients to actively question and modify their&#xD;
      distorted interpretations of their intrusions. Since previous research has shown that symptom&#xD;
      reduction is mediated by a change in metacognition but not by a change of distorted&#xD;
      interpretations, the investigators hypothesize that, while expecting both interventions to be&#xD;
      similarly effective on an overall scale, DM will lead to a change in both metacognitions and&#xD;
      distorted interpretations whereas CR will predominantly have an effect on distorted&#xD;
      interpretations while influencing metacognitions to a lesser extent. Further research&#xD;
      questions address differences concerning the applicability of the two interventions in&#xD;
      patients' everyday life and the degree to which an intense psychoeducation can already have&#xD;
      an effect on the participants' overall symptom burden.&#xD;
&#xD;
      The intervention (both DM and CR) is spread over four sessions of 100 min each taking place&#xD;
      within two weeks (i.e. two sessions per week) and includes intensive homework assignments for&#xD;
      the patients. The intervention will be delivered by MSc-level clinical psychologists&#xD;
      completing the clinical training for becoming a licenced psychotherapist in Germany&#xD;
      (&quot;Psychologischer Psychotherapeut&quot;). The diagnostic assessment involves clinical interviews&#xD;
      and a number of questionnaires and will be conducted by independent assessors who have a&#xD;
      qualification similar to the study therapists. Assessment involves pre-, post- and follow-up&#xD;
      assessment. Additionally, assessment comprises data collection via ecological momentary&#xD;
      assessment (EMA) in order to measure OCD symptoms (intrusions, emotions and coping&#xD;
      strategies), the degree to which participants apply the newly learned strategy (DM or CR) in&#xD;
      everyday life and the amount of relief experienced from applying it. There will be one EMA&#xD;
      before (Pre-EMA) and one after the intervention (Post-EMA). For EMA, participants receive a&#xD;
      smartphone for four days each (Friday to Monday) and are randomly prompted ten times per day&#xD;
      to fill in a short questionnaire. The average amount of time necessary to fill in the&#xD;
      questionnaire is assumed to be less than 2 min, based on a sample trial with mentally healthy&#xD;
      participants.&#xD;
&#xD;
      Participants will be randomly assigned to one of three groups: 1) DM, 2) CR, and 3) a&#xD;
      waitlist control group. The waitlist control group will wait for two weeks (i.e., as long as&#xD;
      the intervention in the other two groups last), before participants will be once more&#xD;
      randomly assigned to one of the two active conditions (DM and CR), which they will then&#xD;
      regularly participate in. Thus, all participants enrolled in the study receive one of the two&#xD;
      treatments sooner or later. For participants who are initially assigned to the waitlist&#xD;
      group, there will be a second pre-assessment prior to the start of the intervention.&#xD;
&#xD;
      The study is going to be sponsored by the Christoph-Dornier-Stiftung für Klinische&#xD;
      Psychologie, which is a non-profit organization that supports research in clinical psychology&#xD;
      and awards PhD scholarships to clinical psychologists. The study at hand is the major part of&#xD;
      the PhD project of Christian Rupp, M. Sc., and Charlotte Juergens, M. Sc., who are currently&#xD;
      holding a PhD scholarship by the Christoph-Dornier-Stiftung für Klinische Psychologie. The&#xD;
      Christoph-Dornier-Stiftung für Klinische Psychologie collaborates with Department of Clinical&#xD;
      Psychology at the University of Muenster (Westfälische Wilhelms-Universität). The The PhD&#xD;
      project is being supervised scientifically by Principal Investigator Prof. Dr. Ulrike&#xD;
      Buhlmann, who is a professor of clinical psychology at the University of Muenster&#xD;
      (Westfälische Wilhelms-Universität), Germany.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 2016</start_date>
  <completion_date type="Actual">July 12, 2018</completion_date>
  <primary_completion_date type="Actual">July 12, 2018</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 (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Y-BOCS Change Score (Pre to Post Assessment)</measure>
    <time_frame>Difference score resulting from (a) first baseline minus post-treatment (non-waitlist) or (b) first baseline minus second baseline (waitlist). In both cases, there are 2 weeks between the two measurements.</time_frame>
    <description>German version of the Yale-Brown Obsessive Compulsive Scale (Hand &amp; Büttner-Westphal, 1991). The mininum value is 0, the maximal value is 40. Higher scores indicate a higher symptom severity of obsessive-compulsive disorder.</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">43</enrollment>
  <condition>Obsessive-Compulsive Disorder</condition>
  <arm_group>
    <arm_group_label>DM</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Group of patients receiving detached mindfulness (for details, see detailed description of the study)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>CR</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Group of patients receiving cognitive restructuring (for details, see detailed description of the study)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>WL</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Waitlist control group, which, however, is again randomized after the waiting time in order to receive one of the two interventions (DM or CR).</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>detached mindfulness</intervention_name>
    <description>Please see detailed study description.</description>
    <arm_group_label>DM</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>cognitive restructuring</intervention_name>
    <description>Please see detailed study description.</description>
    <arm_group_label>CR</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  A diagnosis of OCD according to DSM-5&#xD;
&#xD;
          -  Minimum age of 18 years&#xD;
&#xD;
          -  Sufficient German language skills&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  A mental disorder other then OCD constituting the primary diagnosis (such as&#xD;
             depression)&#xD;
&#xD;
          -  Verbal IQ &lt;80 as measured with the MWT-B (Lehrl, 2005)&#xD;
&#xD;
          -  Presence of an acute suicidal tendency or suicidal behavior in the past 6 months&#xD;
&#xD;
          -  Presence of an acute psychosis or assured diagnosis of psychosis and related disorders&#xD;
&#xD;
          -  Presence of an acute manic episode&#xD;
&#xD;
          -  Presence of an acute borderline personality disorder&#xD;
&#xD;
          -  Presence of a comorbid addictive disorder&#xD;
&#xD;
          -  Present psychotherapeutic treatment including OCD-focused CBT elements&#xD;
&#xD;
          -  Psychotherapeutic treatment including OCD-focused CBT elements within the past 12&#xD;
             months&#xD;
&#xD;
          -  For individuals with psychotropic medication, a change of substance or dose within the&#xD;
             past 8 weeks&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ulrike Buhlmann, Prof. Dr.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Westfälische Wilhelms-Universität Münster</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Christoph-Dornier-Stiftung für Klinische Psychologie</name>
      <address>
        <city>Muenster</city>
        <state>NRW</state>
        <zip>48143</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <reference>
    <citation>Myers SG, Fisher PL, Wells A. An empirical test of the metacognitive model of obsessive-compulsive symptoms: fusion beliefs, beliefs about rituals, and stop signals. J Anxiety Disord. 2009 May;23(4):436-42. doi: 10.1016/j.janxdis.2008.08.007. Epub 2008 Sep 3.</citation>
    <PMID>18922674</PMID>
  </reference>
  <reference>
    <citation>Solem S, Haland AT, Vogel PA, Hansen B, Wells A. Change in metacognitions predicts outcome in obsessive-compulsive disorder patients undergoing treatment with exposure and response prevention. Behav Res Ther. 2009 Apr;47(4):301-7. doi: 10.1016/j.brat.2009.01.003. Epub 2009 Jan 17.</citation>
    <PMID>19203749</PMID>
  </reference>
  <reference>
    <citation>Gonner S, Leonhart R, Ecker W. [The German version of the obsessive-compulsive inventory-revised: a brief self-report measure for the multidimensional assessment of obsessive-compulsive symptoms]. Psychother Psychosom Med Psychol. 2007 Sep-Oct;57(9-10):395-404. doi: 10.1055/s-2007-970894. German.</citation>
    <PMID>17590836</PMID>
  </reference>
  <reference>
    <citation>Baer L. Alles unter Kontrolle: Zwangsgedanken und Zwangshandlungen überwinden. Bern: Hans Huber, 1993.</citation>
  </reference>
  <reference>
    <citation>Ertle A, Wahl K, Bohne A, Moritz S, Kordon A, Schulte D. Dimensionen zwangsspezifischer Einstellungen: Der Obsessive-Beliefs Questionnaire (OBQ) für den deutschen Sprachraum analysiert. Zeitschrift für Klinische Psychologie und Psychotherapie 37: 263-271, 2008.</citation>
  </reference>
  <reference>
    <citation>Hand I, Büttner-Westphal H. Die Yale-Brown Obsessive Compulsive Scale (Y-BOCS): Ein halbstrukturiertes Interview zur Beurteilung des Schweregrades von Denk- und Handlungszwängen. Verhaltenstherapie 1: 223-225, 1991.</citation>
  </reference>
  <reference>
    <citation>Wells A, Gwilliam P, Cartwright-Hatton S. Thought-Fusion-Instrument (TFI, unpublished manuscript). University of Manchester, UK, 2002.</citation>
  </reference>
  <reference>
    <citation>Schulte D. Messung der Therapieerwartung und Therapieevaluation von Patienten (PATHEV). Zeitschrift für Klinische Psychologie und Psychotherapie 34(3): 176-187, 2005.</citation>
  </reference>
  <reference>
    <citation>Hautzinger M, Keller F, Kühner C. BDI II. Beck Depressions Inventar. Revision. Frankfurt/Main: Harcourt Test Service, 2006.</citation>
  </reference>
  <reference>
    <citation>Wells A, McNicol K. Beliefs About Rituals Inventory (BARI, unpublished manuscript). University of Manchester, UK, 2004.</citation>
  </reference>
  <reference>
    <citation>Wells A. Metacognitive therapy for anxiety and depression. Guilford press, 2011.</citation>
  </reference>
  <reference>
    <citation>Wilhelm S, Steketee GS. Cognitive therapy for obsessive compulsive disorder: A guide for professionals. New Harbinger Publications, 2006.</citation>
  </reference>
  <reference>
    <citation>American Psychiatric Association. Diagnostic and statistical manual of mental disorders, Fourth Edition, Text Revision (DSM-IV-TR). Washington, DC: American Psychiatric Association, 2000.</citation>
  </reference>
  <reference>
    <citation>Wittchen HU, Wunderlich U, Gruschwitz S, Zaudig M. SKID I. Strukturiertes Klinisches Interview für DSM-IV. Achse I: Psychische Störungen. Interviewheft und Beurteilungsheft. Eine deutschsprachige, erweiterte Bearb. d. amerikanischen Originalversion des SKID I., 1997.</citation>
  </reference>
  <reference>
    <citation>Lehrl S. MWT-B Mehrfachwahl-Wortschatz-Intelligenztest. Balingen: Spitta-Verlag, 2005.</citation>
  </reference>
  <reference>
    <citation>Rosa-Alcazar AI, Sanchez-Meca J, Gomez-Conesa A, Marin-Martinez F. Psychological treatment of obsessive-compulsive disorder: a meta-analysis. Clin Psychol Rev. 2008 Dec;28(8):1310-25. doi: 10.1016/j.cpr.2008.07.001. Epub 2008 Jul 4.</citation>
    <PMID>18701199</PMID>
  </reference>
  <reference>
    <citation>Wilhelm S, Steketee G, Fama JM, Buhlmann U, Teachman BA, Golan E. Modular Cognitive Therapy for Obsessive-Compulsive Disorder: A Wait-List Controlled Trial. J Cogn Psychother. 2009;23(4):294-305. doi: 10.1891/0889-8391.23.4.294.</citation>
    <PMID>21072138</PMID>
  </reference>
  <reference>
    <citation>Olatunji BO, Rosenfield D, Tart CD, Cottraux J, Powers MB, Smits JA. Behavioral versus cognitive treatment of obsessive-compulsive disorder: an examination of outcome and mediators of change. J Consult Clin Psychol. 2013 Jun;81(3):415-28. doi: 10.1037/a0031865. Epub 2013 Feb 18.</citation>
    <PMID>23421734</PMID>
  </reference>
  <reference>
    <citation>Belloch A, Cabedo E, Carrio C, Larsson C. Cognitive therapy for autogenous and reactive obsessions: clinical and cognitive outcomes at post-treatment and 1-year follow-up. J Anxiety Disord. 2010 Aug;24(6):573-80. doi: 10.1016/j.janxdis.2010.03.017. Epub 2010 Apr 2.</citation>
    <PMID>20418053</PMID>
  </reference>
  <reference>
    <citation>Fisher PL, Wells A. Metacognitive therapy for obsessive-compulsive disorder: a case series. J Behav Ther Exp Psychiatry. 2008 Jun;39(2):117-32. doi: 10.1016/j.jbtep.2006.12.001. Epub 2007 Mar 7.</citation>
    <PMID>17418090</PMID>
  </reference>
  <reference>
    <citation>Rees CS, van Koesveld KE. An open trial of group metacognitive therapy for obsessive-compulsive disorder. J Behav Ther Exp Psychiatry. 2008 Dec;39(4):451-8. doi: 10.1016/j.jbtep.2007.11.004. Epub 2008 Jan 18.</citation>
    <PMID>18295186</PMID>
  </reference>
  <reference>
    <citation>Simons M, Schneider S, Herpertz-Dahlmann B. Metacognitive therapy versus exposure and response prevention for pediatric obsessive-compulsive disorder. A case series with randomized allocation. Psychother Psychosom. 2006;75(4):257-64. doi: 10.1159/000092897.</citation>
    <PMID>16785776</PMID>
  </reference>
  <reference>
    <citation>Shareh H, Gharraee B, Atef-Vahid MK, Eftekhar M. Metacognitive therapy (MCT), fluvoxamine, and combined treatment in improving obsessive-compulsive, depressive and anxiety symptoms in patients with obsessive-compulsive disorder (OCD). Iranian Journal of Psychiatry and Behavioral Sciences, 4(2): 17-25, 2010.</citation>
  </reference>
  <verification_date>April 2019</verification_date>
  <study_first_submitted>December 14, 2016</study_first_submitted>
  <study_first_submitted_qc>December 21, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 26, 2016</study_first_posted>
  <results_first_submitted>July 20, 2018</results_first_submitted>
  <results_first_submitted_qc>April 13, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">April 16, 2019</results_first_posted>
  <last_update_submitted>April 13, 2019</last_update_submitted>
  <last_update_submitted_qc>April 13, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">April 16, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Westfälische Wilhelms-Universität Münster</investigator_affiliation>
    <investigator_full_name>Prof. Dr. Ulrike Buhlmann</investigator_full_name>
    <investigator_title>Prof. Dr.</investigator_title>
  </responsible_party>
  <keyword>OCD</keyword>
  <keyword>obsessive-compulsive disorder</keyword>
  <keyword>cognitive therapy</keyword>
  <keyword>metacognitive therapy</keyword>
  <keyword>cognitive restructuring</keyword>
  <keyword>detached mindfulness</keyword>
  <keyword>comparison</keyword>
  <keyword>Germany</keyword>
  <keyword>Muenster</keyword>
  <keyword>Christoph-Dornier-Stiftung</keyword>
  <keyword>metacognition</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Compulsive Personality Disorder</mesh_term>
    <mesh_term>Obsessive-Compulsive Disorder</mesh_term>
  </condition_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>July 12, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/53/NCT03002753/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>July 12, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/53/NCT03002753/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Participants were recruited between December 2016 and June 2018.</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>Detached Mindfulness</title>
          <description>Group of patients receiving detached mindfulness (for details, see detailed description of the study)</description>
        </group>
        <group group_id="P2">
          <title>Cognitive Restructuring</title>
          <description>Group of patients receiving cognitive restructuring (for details, see detailed description of the study)</description>
        </group>
        <group group_id="P3">
          <title>Waitlist</title>
          <description>Group of patients who are re-randomized to either Detached Mindfulness or Cognitive Restructuring after a delay of 2 weeks.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>First Randomization</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="10"/>
                <participants group_id="P2" count="12"/>
                <participants group_id="P3" count="21"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
                <participants group_id="P2" count="11"/>
                <participants group_id="P3" count="21"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
        <period>
          <title>Second Randomization (Re-randomization)</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="11"/>
                <participants group_id="P2" count="10"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="11"/>
                <participants group_id="P2" count="9"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Please note that in contrast to the previous version of this document, we now listed the data for the intention-to-treat (ITT) sample, which is n = 43 (DM: n = 21, CR: n = 22), whereas the completer sample is n = 40 (DM: n = 20, CR: n = 20). We chose to do this because we also report the ITT sample in the article submitted for publication.</population>
      <group_list>
        <group group_id="B1">
          <title>Detached Mindfulness</title>
          <description>Group of patients receiving detached mindfulness (for details, see detailed description of the study)</description>
        </group>
        <group group_id="B2">
          <title>Cognitive Restructuring</title>
          <description>Group of patients receiving cognitive restructuring (for details, see detailed description of the study)</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="21"/>
            <count group_id="B2" value="22"/>
            <count group_id="B3" value="43"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="30.81" spread="9.48"/>
                    <measurement group_id="B2" value="31.23" spread="10.96"/>
                    <measurement group_id="B3" value="31.02" spread="10.02"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="25"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="21"/>
                    <measurement group_id="B2" value="22"/>
                    <measurement group_id="B3" value="43"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Germany</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="21"/>
                    <measurement group_id="B2" value="22"/>
                    <measurement group_id="B3" value="43"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Number of participants under parallel psychopharmacological medication</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Y-BOCS Change Score (Pre to Post Assessment)</title>
        <description>German version of the Yale-Brown Obsessive Compulsive Scale (Hand &amp; Büttner-Westphal, 1991). The mininum value is 0, the maximal value is 40. Higher scores indicate a higher symptom severity of obsessive-compulsive disorder.</description>
        <time_frame>Difference score resulting from (a) first baseline minus post-treatment (non-waitlist) or (b) first baseline minus second baseline (waitlist). In both cases, there are 2 weeks between the two measurements.</time_frame>
        <population>People with obsessive-compulsive disorder</population>
        <group_list>
          <group group_id="O1">
            <title>Detached Mindfulness</title>
            <description>Group of patients receiving detached mindfulness (for details, see detailed description of the study)</description>
          </group>
          <group group_id="O2">
            <title>Cognitive Restructuring</title>
            <description>Group of patients receiving cognitive restructuring (for details, see detailed description of the study)</description>
          </group>
          <group group_id="O3">
            <title>Waitlist</title>
            <description>Waitlist control group, which, however, is again randomized after the waiting time in order to receive one of the two interventions (DM or CR).</description>
          </group>
        </group_list>
        <measure>
          <title>Y-BOCS Change Score (Pre to Post Assessment)</title>
          <description>German version of the Yale-Brown Obsessive Compulsive Scale (Hand &amp; Büttner-Westphal, 1991). The mininum value is 0, the maximal value is 40. Higher scores indicate a higher symptom severity of obsessive-compulsive disorder.</description>
          <population>People with obsessive-compulsive disorder</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
                <count group_id="O2" value="11"/>
                <count group_id="O3" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.11" spread="5.80"/>
                    <measurement group_id="O2" value="5.09" spread="5.43"/>
                    <measurement group_id="O3" value="0.25" spread="2.15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>All-Cause Mortality, Serious, and Other (Not Including Serious) Adverse Events were not monitored/assessed because this trial eomployed a purely behavioral intervention for obsessive-compulsive disorder which from our point of view did not imply any potential side effects leading to a participant's death.</time_frame>
      <desc>All-Cause Mortality, Serious, and Other (Not Including Serious) Adverse Events were not monitored/assessed because this trial eomployed a purely behavioral intervention for obsessive-compulsive disorder which from our point of view did not imply any potential side effects leading to a participant's death.</desc>
      <group_list>
        <group group_id="E1">
          <title>Detached Mindfulness (DM)</title>
          <description>Group of patients receiving detached mindfulness (for details, see detailed description of the study)</description>
        </group>
        <group group_id="E2">
          <title>Cognitive Restructuring (CR)</title>
          <description>Group of patients receiving cognitive restructuring (for details, see detailed description of the study)</description>
        </group>
        <group group_id="E3">
          <title>Waitlist (WL)</title>
          <description>Waitlist control group, which, however, is again randomized after the waiting time in order to receive one of the two interventions (DM or CR).</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Christian Rupp, M. Sc.</name_or_title>
      <organization>Christoph-Dornier-Stiftung Münster</organization>
      <phone>00492514183440</phone>
      <email>rupp@cds-muenster.de</email>
    </point_of_contact>
  </clinical_results>
</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/NCT03002753
org study id: CDS-MS-JR-2016
nct id: NCT03002753
lead sponsor: 
collaborator: 
The purpose of this study is to assess and compare the overall efficacy and differential
      effects of detached mindfulness and cognitive restructuring in the treatment of patients with
      obsessive-compulsive disorder.
The purpose of this study is to assess and compare the overall efficacy and differential
      effects of two interventions for patients suffering from obsessive-compulsive disorder (OCD)
      according to DSM-5. The interventions to be compared are detached mindfulness (DM) and
      cognitive restructuring (CR). Whereas the efficacy of CR for the treatment of OCD has been
      proven in various studies, the efficacy of DM as a single intervention so far has only been
      shown within a case study and within a non-clinical sample. By contrast, the efficacy of
      complex metacognitive protocols (of which DM constitutes one of several single interventions)
      has been shown multiple times. So far, however, little is known about the efficacy of DM as a
      single intervention in a clinical sample and the differential working mechanisms of DM vs.
      CR.

      Whereas DM is supposed to modify metacognitions by teaching patients to solely observe their
      intrusive thoughts, CR aims at teaching the patients to actively question and modify their
      distorted interpretations of their intrusions. Since previous research has shown that symptom
      reduction is mediated by a change in metacognition but not by a change of distorted
      interpretations, the investigators hypothesize that, while expecting both interventions to be
      similarly effective on an overall scale, DM will lead to a change in both metacognitions and
      distorted interpretations whereas CR will predominantly have an effect on distorted
      interpretations while influencing metacognitions to a lesser extent. Further research
      questions address differences concerning the applicability of the two interventions in
      patients' everyday life and the degree to which an intense psychoeducation can already have
      an effect on the participants' overall symptom burden.

      The intervention (both DM and CR) is spread over four sessions of 100 min each taking place
      within two weeks (i.e. two sessions per week) and includes intensive homework assignments for
      the patients. The intervention will be delivered by MSc-level clinical psychologists
      completing the clinical training for becoming a licenced psychotherapist in Germany
      ("Psychologischer Psychotherapeut"). The diagnostic assessment involves clinical interviews
      and a number of questionnaires and will be conducted by independent assessors who have a
      qualification similar to the study therapists. Assessment involves pre-, post- and follow-up
      assessment. Additionally, assessment comprises data collection via ecological momentary
      assessment (EMA) in order to measure OCD symptoms (intrusions, emotions and coping
      strategies), the degree to which participants apply the newly learned strategy (DM or CR) in
      everyday life and the amount of relief experienced from applying it. There will be one EMA
      before (Pre-EMA) and one after the intervention (Post-EMA). For EMA, participants receive a
      smartphone for four days each (Friday to Monday) and are randomly prompted ten times per day
      to fill in a short questionnaire. The average amount of time necessary to fill in the
      questionnaire is assumed to be less than 2 min, based on a sample trial with mentally healthy
      participants.

      Participants will be randomly assigned to one of three groups: 1) DM, 2) CR, and 3) a
      waitlist control group. The waitlist control group will wait for two weeks (i.e., as long as
      the intervention in the other two groups last), before participants will be once more
      randomly assigned to one of the two active conditions (DM and CR), which they will then
      regularly participate in. Thus, all participants enrolled in the study receive one of the two
      treatments sooner or later. For participants who are initially assigned to the waitlist
      group, there will be a second pre-assessment prior to the start of the intervention.

      The study is going to be sponsored by the Christoph-Dornier-Stiftung für Klinische
      Psychologie, which is a non-profit organization that supports research in clinical psychology
      and awards PhD scholarships to clinical psychologists. The study at hand is the major part of
      the PhD project of Christian Rupp, M. Sc., and Charlotte Juergens, M. Sc., who are currently
      holding a PhD scholarship by the Christoph-Dornier-Stiftung für Klinische Psychologie. The
      Christoph-Dornier-Stiftung für Klinische Psychologie collaborates with Department of Clinical
      Psychology at the University of Muenster (Westfälische Wilhelms-Universität). The The PhD
      project is being supervised scientifically by Principal Investigator Prof. Dr. Ulrike
      Buhlmann, who is a professor of clinical psychology at the University of Muenster
      (Westfälische Wilhelms-Universität), Germany.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Y-BOCS Change Score (Pre to Post Assessment)
time frame: Difference score resulting from (a) first baseline minus post-treatment (non-waitlist) or (b) first baseline minus second baseline (waitlist). In both cases, there are 2 weeks between the two measurements.
description: German version of the Yale-Brown Obsessive Compulsive Scale (Hand & Büttner-Westphal, 1991). The mininum value is 0, the maximal value is 40. Higher scores indicate a higher symptom severity of obsessive-compulsive disorder.
arm group label: DM
arm group type: Experimental
description: Group of patients receiving detached mindfulness (for details, see detailed description of the study)
arm group label: CR
arm group type: Active Comparator
description: Group of patients receiving cognitive restructuring (for details, see detailed description of the study)
arm group label: WL
arm group type: No Intervention
description: Waitlist control group, which, however, is again randomized after the waiting time in order to receive one of the two interventions (DM or CR).
intervention type: Behavioral
intervention name: detached mindfulness
description: Please see detailed study description.
arm group label: DM
intervention type: Behavioral
intervention name: cognitive restructuring
description: Please see detailed study description.
arm group label: CR
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Ulrike Buhlmann, Prof. Dr.
role: Principal Investigator
affiliation: Westfälische Wilhelms-Universität Münster
facility: 
country: Germany
citation: Myers SG, Fisher PL, Wells A. An empirical test of the metacognitive model of obsessive-compulsive symptoms: fusion beliefs, beliefs about rituals, and stop signals. J Anxiety Disord. 2009 May;23(4):436-42. doi: 10.1016/j.janxdis.2008.08.007. Epub 2008 Sep 3.
PMID: 18922674
citation: Solem S, Haland AT, Vogel PA, Hansen B, Wells A. Change in metacognitions predicts outcome in obsessive-compulsive disorder patients undergoing treatment with exposure and response prevention. Behav Res Ther. 2009 Apr;47(4):301-7. doi: 10.1016/j.brat.2009.01.003. Epub 2009 Jan 17.
PMID: 19203749
citation: Gonner S, Leonhart R, Ecker W. [The German version of the obsessive-compulsive inventory-revised: a brief self-report measure for the multidimensional assessment of obsessive-compulsive symptoms]. Psychother Psychosom Med Psychol. 2007 Sep-Oct;57(9-10):395-404. doi: 10.1055/s-2007-970894. German.
PMID: 17590836
citation: Baer L. Alles unter Kontrolle: Zwangsgedanken und Zwangshandlungen überwinden. Bern: Hans Huber, 1993.
citation: Ertle A, Wahl K, Bohne A, Moritz S, Kordon A, Schulte D. Dimensionen zwangsspezifischer Einstellungen: Der Obsessive-Beliefs Questionnaire (OBQ) für den deutschen Sprachraum analysiert. Zeitschrift für Klinische Psychologie und Psychotherapie 37: 263-271, 2008.
citation: Hand I, Büttner-Westphal H. Die Yale-Brown Obsessive Compulsive Scale (Y-BOCS): Ein halbstrukturiertes Interview zur Beurteilung des Schweregrades von Denk- und Handlungszwängen. Verhaltenstherapie 1: 223-225, 1991.
citation: Wells A, Gwilliam P, Cartwright-Hatton S. Thought-Fusion-Instrument (TFI, unpublished manuscript). University of Manchester, UK, 2002.
citation: Schulte D. Messung der Therapieerwartung und Therapieevaluation von Patienten (PATHEV). Zeitschrift für Klinische Psychologie und Psychotherapie 34(3): 176-187, 2005.
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citation: Wells A. Metacognitive therapy for anxiety and depression. Guilford press, 2011.
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citation: Wittchen HU, Wunderlich U, Gruschwitz S, Zaudig M. SKID I. Strukturiertes Klinisches Interview für DSM-IV. Achse I: Psychische Störungen. Interviewheft und Beurteilungsheft. Eine deutschsprachige, erweiterte Bearb. d. amerikanischen Originalversion des SKID I., 1997.
citation: Lehrl S. MWT-B Mehrfachwahl-Wortschatz-Intelligenztest. Balingen: Spitta-Verlag, 2005.
citation: Rosa-Alcazar AI, Sanchez-Meca J, Gomez-Conesa A, Marin-Martinez F. Psychological treatment of obsessive-compulsive disorder: a meta-analysis. Clin Psychol Rev. 2008 Dec;28(8):1310-25. doi: 10.1016/j.cpr.2008.07.001. Epub 2008 Jul 4.
PMID: 18701199
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PMID: 23421734
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responsible party type: Principal Investigator
investigator affiliation: Westfälische Wilhelms-Universität Münster
investigator full name: Prof. Dr. Ulrike Buhlmann
investigator title: Prof. Dr.
mesh term: Compulsive Personality Disorder
mesh term: Obsessive-Compulsive Disorder
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 