NCT03002753

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
43

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2016

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

December 14, 2016

Completed
12 days until next milestone

First Posted

Study publicly available on registry

December 26, 2016

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 12, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 12, 2018

Completed
9 months until next milestone

Results Posted

Study results publicly available

April 16, 2019

Completed
Last Updated

April 16, 2019

Status Verified

April 1, 2019

Enrollment Period

1.6 years

First QC Date

December 14, 2016

Results QC Date

July 20, 2018

Last Update Submit

April 13, 2019

Conditions

Obsessive-Compulsive Disorder

Keywords

OCDobsessive-compulsive disordercognitive therapymetacognitive therapycognitive restructuringdetached mindfulnesscomparisonGermanyMuensterChristoph-Dornier-Stiftungmetacognition

Outcome Measures

Primary Outcomes (1)

  • Y-BOCS Change Score (Pre to Post Assessment)

    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.

    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.

Study Arms (3)

DM

EXPERIMENTAL

Group of patients receiving detached mindfulness (for details, see detailed description of the study)

Behavioral: detached mindfulness

CR

ACTIVE COMPARATOR

Group of patients receiving cognitive restructuring (for details, see detailed description of the study)

Behavioral: cognitive restructuring

WL

NO INTERVENTION

Waitlist control group, which, however, is again randomized after the waiting time in order to receive one of the two interventions (DM or CR).

Interventions

detached mindfulnessBEHAVIORAL

Please see detailed study description.

DM
cognitive restructuringBEHAVIORAL

Please see detailed study description.

CR

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • A diagnosis of OCD according to DSM-5
  • Minimum age of 18 years
  • Sufficient German language skills

You may not qualify if:

  • A mental disorder other then OCD constituting the primary diagnosis (such as depression)
  • Verbal IQ \<80 as measured with the MWT-B (Lehrl, 2005)
  • Presence of an acute suicidal tendency or suicidal behavior in the past 6 months
  • Presence of an acute psychosis or assured diagnosis of psychosis and related disorders
  • Presence of an acute manic episode
  • Presence of an acute borderline personality disorder
  • Presence of a comorbid addictive disorder
  • Present psychotherapeutic treatment including OCD-focused CBT elements
  • Psychotherapeutic treatment including OCD-focused CBT elements within the past 12 months
  • For individuals with psychotropic medication, a change of substance or dose within the past 8 weeks

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Christoph-Dornier-Stiftung für Klinische Psychologie

Münster, North Rhine-Westphalia, 48143, Germany

Location

Related Publications (23)

  • 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: 18922674BACKGROUND

  • 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: 19203749BACKGROUND

  • 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: 17590836BACKGROUND

  • Baer L. Alles unter Kontrolle: Zwangsgedanken und Zwangshandlungen überwinden. Bern: Hans Huber, 1993.

    BACKGROUND

  • 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.

    BACKGROUND

  • 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.

    BACKGROUND

  • Wells A, Gwilliam P, Cartwright-Hatton S. Thought-Fusion-Instrument (TFI, unpublished manuscript). University of Manchester, UK, 2002.

    BACKGROUND

  • Schulte D. Messung der Therapieerwartung und Therapieevaluation von Patienten (PATHEV). Zeitschrift für Klinische Psychologie und Psychotherapie 34(3): 176-187, 2005.

    BACKGROUND

  • Hautzinger M, Keller F, Kühner C. BDI II. Beck Depressions Inventar. Revision. Frankfurt/Main: Harcourt Test Service, 2006.

    BACKGROUND

  • Wells A, McNicol K. Beliefs About Rituals Inventory (BARI, unpublished manuscript). University of Manchester, UK, 2004.

    BACKGROUND

  • Wells A. Metacognitive therapy for anxiety and depression. Guilford press, 2011.

    BACKGROUND

  • Wilhelm S, Steketee GS. Cognitive therapy for obsessive compulsive disorder: A guide for professionals. New Harbinger Publications, 2006.

    BACKGROUND

  • American Psychiatric Association. Diagnostic and statistical manual of mental disorders, Fourth Edition, Text Revision (DSM-IV-TR). Washington, DC: American Psychiatric Association, 2000.

    BACKGROUND

  • 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.

    BACKGROUND

  • Lehrl S. MWT-B Mehrfachwahl-Wortschatz-Intelligenztest. Balingen: Spitta-Verlag, 2005.

    BACKGROUND

  • 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: 18701199BACKGROUND

  • 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.

    PMID: 21072138BACKGROUND

  • 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.

    PMID: 23421734BACKGROUND

  • 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.

    PMID: 20418053BACKGROUND

  • 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.

    PMID: 17418090BACKGROUND

  • 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.

    PMID: 18295186BACKGROUND

  • 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.

    PMID: 16785776BACKGROUND

  • 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.

    BACKGROUND

MeSH Terms

Conditions

Obsessive-Compulsive Disorder

Interventions

Cognitive Restructuring

Condition Hierarchy (Ancestors)

Anxiety DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Cognitive Behavioral TherapyBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Results Point of Contact

Title
Christian Rupp, M. Sc.
Organization
Christoph-Dornier-Stiftung Münster
rupp@cds-muenster.de
00492514183440

Study Officials

  • Ulrike Buhlmann, Prof. Dr.

    Universität Münster

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr.

Study Record Dates

First Submitted

December 14, 2016

First Posted

December 26, 2016

Study Start

December 1, 2016

Primary Completion

July 12, 2018

Study Completion

July 12, 2018

Last Updated

April 16, 2019

Results First Posted

April 16, 2019

Record last verified: 2019-04

Locations

DE(1)