An interventional study of detached mindfulness and cognitive restructuring in Obsessive-Compulsive Disorder, sponsored by Christoph-Dornier-Stiftung für Klinische Psychologie. Completed at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-04-16.
Sponsored by Christoph-Dornier-Stiftung für Klinische Psychologie · Not applicable, Interventional, and Treatment
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.
626 studies on the registry are indexed under Obsessive-Compulsive Disorder; 162 are open to participants now.
This study's enrollment of 43 is close to the median of 45 across 510 interventional studies indexed under Obsessive-Compulsive Disorder.
Browse Obsessive-Compulsive Disorder studies →This is the only study on the registry with Christoph-Dornier-Stiftung für Klinische Psychologie as lead sponsor.
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Exclusion Criteria:
Group of patients receiving detached mindfulness (for details, see detailed description of the study)
Behavioral: detached mindfulness
Group of patients receiving cognitive restructuring (for details, see detailed description of the study)
Behavioral: cognitive restructuring
Waitlist control group, which, however, is again randomized after the waiting time in order to receive one of the two interventions (DM or CR).
Please see detailed study description.
Please see detailed study description.
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.
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.
Participants were recruited between December 2016 and June 2018.
| Milestone | Detached Mindfulness | Cognitive Restructuring | Waitlist |
|---|---|---|---|
| Started | 10 | 12 | 21 |
| Completed | 9 | 11 | 21 |
| Not completed | 1 | 1 | 0 |
| Milestone | Detached Mindfulness | Cognitive Restructuring | Waitlist |
|---|---|---|---|
| Started | 11 | 10 | 0 |
| Completed | 11 | 9 | 0 |
| Not completed | 0 | 1 | 0 |
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.
| units on a scale | Detached Mindfulness | Cognitive Restructuring | Waitlist |
|---|---|---|---|
| Y-BOCS Change Score (Pre to Post Assessment) | 5.11 ± 5.80 | 5.09 ± 5.43 | 0.25 ± 2.15 |
Collected over 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.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Detached Mindfulness (DM) | — | — | — |
| Cognitive Restructuring (CR) | — | — | — |
| Waitlist (WL) | — | — | — |
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.
| Age, Continuous(years) | Detached Mindfulness | Cognitive Restructuring | Total |
|---|---|---|---|
| Mean | 30.81 ± 9.48 | 31.23 ± 10.96 | 31.02 ± 10.02 |
| Sex: Female, Male(Participants) | Detached Mindfulness | Cognitive Restructuring | Total |
|---|---|---|---|
| Female | 15 | 10 | 25 |
| Male | 6 | 12 | 18 |
| Ethnicity (NIH/OMB)(Participants) | Detached Mindfulness | Cognitive Restructuring | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 |
| Not Hispanic or Latino | 21 | 22 | 43 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Detached Mindfulness | Cognitive Restructuring | Total |
|---|---|---|---|
| Germany | 21 | 22 | 43 |
| Number of participants under parallel psychopharmacological medication(Participants) | Detached Mindfulness | Cognitive Restructuring | Total |
|---|---|---|---|
| Count of participants | 8 | 11 | 19 |
Documents are hosted by the registry — open the source record to download them.
Ran from Dec 2016 to primary completion in Jul 2018, 19 months.
Results were first posted in Apr 2019, 9 months after primary completion.
Of 230 non-industry interventional studies with no phase under Obsessive-Compulsive Disorder, half reached primary completion within 43 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 68. This study's 19 months is below that.
Counting every sponsor, half of 232 studies reached it within 43 months; a quarter within 22 and three quarters within 65.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.
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