Dealing With Intrusive Thoughts in OCD - a Comparison of Detached Mindfulness and Cognitive Restructuring

Obsessive-Compulsive Disorder Clinical Trial

Official title:

Zum Umgang Mit Aufdringlichen Gedanken Bei Der Zwangsstörung - Zwei Behandlungsstrategien im Vergleich

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03002753
• Other study ID #: CDS-MS-JR-2016
• Status: Completed
• Phase: N/A
• Start date: December 2016
• Est. completion date: July 12, 2018

Study information

• Verified date: April 2019
• Source: Christoph-Dornier-Stiftung für Klinische Psychologie
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: July 12, 2018
• Est. primary completion date: July 12, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• A diagnosis of OCD according to DSM-5

• Minimum age of 18 years

• Sufficient German language skills

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Obsessive-Compulsive Disorder

Intervention

Behavioral:
• detached mindfulness
Please see detailed study description.
• cognitive restructuring
Please see detailed study description.

Locations

Country	Name	City	State
Germany	Christoph-Dornier-Stiftung für Klinische Psychologie	Muenster	NRW

Sponsors (2)

Lead Sponsor	Collaborator
Christoph-Dornier-Stiftung für Klinische Psychologie	Westfälische Wilhelms-Universität Münster

Country where clinical trial is conducted

Germany, 

References & Publications (23)

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

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

Belloch A, Cabedo E, Carrió 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. — View 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.

Fisher PL, Wells A. Metacognitive therapy for obsessive-compulsive disorder: a case series. J Behav Ther Exp Psychiatry. 2008 Jun;39(2):117-32. Epub 2007 Mar 7. — View Citation

Gönner 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. German. — View 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.

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

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

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. — View 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. — View 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. — View Citation

Rosa-Alcázar AI, Sánchez-Meca J, Gómez-Conesa A, Marín-Martínez 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. — View Citation

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

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.

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. — View Citation

Solem S, Håland 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. — View Citation

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

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

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

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. — View Citation

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

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.

* Note: There are 23 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.