Dealing With Intrusive Thoughts in OCD - a Comparison of Detached Mindfulness and Cognitive Restructuring
Primary Purpose
Obsessive-Compulsive Disorder
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
detached mindfulness
cognitive restructuring
Sponsored by

About this trial
This is an interventional treatment trial for Obsessive-Compulsive Disorder focused on measuring OCD, obsessive-compulsive disorder, cognitive therapy, metacognitive therapy, cognitive restructuring, detached mindfulness, comparison, Germany, Muenster, Christoph-Dornier-Stiftung, metacognition
Eligibility Criteria
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
Sites / Locations
- Christoph-Dornier-Stiftung für Klinische Psychologie
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
No Intervention
Arm Label
DM
CR
WL
Arm Description
Group of patients receiving detached mindfulness (for details, see detailed description of the study)
Group of patients receiving cognitive restructuring (for details, see detailed description of the study)
Waitlist control group, which, however, is again randomized after the waiting time in order to receive one of the two interventions (DM or CR).
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT03002753
First Posted
December 14, 2016
Last Updated
April 13, 2019
Sponsor
Christoph-Dornier-Stiftung für Klinische Psychologie
Collaborators
Westfälische Wilhelms-Universität Münster
1. Study Identification
Unique Protocol Identification Number
NCT03002753
Brief Title
Dealing With Intrusive Thoughts in OCD - a Comparison of Detached Mindfulness and Cognitive Restructuring
Official Title
Zum Umgang Mit Aufdringlichen Gedanken Bei Der Zwangsstörung - Zwei Behandlungsstrategien im Vergleich
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
December 2016 (Actual)
Primary Completion Date
July 12, 2018 (Actual)
Study Completion Date
July 12, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Christoph-Dornier-Stiftung für Klinische Psychologie
Collaborators
Westfälische Wilhelms-Universität Münster
4. Oversight
5. Study Description
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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obsessive-Compulsive Disorder
Keywords
OCD, obsessive-compulsive disorder, cognitive therapy, metacognitive therapy, cognitive restructuring, detached mindfulness, comparison, Germany, Muenster, Christoph-Dornier-Stiftung, metacognition
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
43 (Actual)
8. Arms, Groups, and Interventions
Arm Title
DM
Arm Type
Experimental
Arm Description
Group of patients receiving detached mindfulness (for details, see detailed description of the study)
Arm Title
CR
Arm Type
Active Comparator
Arm Description
Group of patients receiving cognitive restructuring (for details, see detailed description of the study)
Arm Title
WL
Arm Type
No Intervention
Arm 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(s)
detached mindfulness
Intervention Description
Please see detailed study description.
Intervention Type
Behavioral
Intervention Name(s)
cognitive restructuring
Intervention Description
Please see detailed study description.
Primary Outcome Measure Information:
Title
Y-BOCS Change Score (Pre to Post Assessment)
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.
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ulrike Buhlmann, Prof. Dr.
Organizational Affiliation
Westfälische Wilhelms-Universität Münster
Official's Role
Principal Investigator
Facility Information:
Facility Name
Christoph-Dornier-Stiftung für Klinische Psychologie
City
Muenster
State/Province
NRW
ZIP/Postal Code
48143
Country
Germany
12. IPD Sharing Statement
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Dealing With Intrusive Thoughts in OCD - a Comparison of Detached Mindfulness and Cognitive Restructuring
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