Zum Umgang Mit Aufdringlichen Gedanken Bei Der Zwangsstörung - Zwei Behandlungsstrategien im Vergleich
| Registry | NCT03002753 |
|---|---|
| Status | Completed |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: double, treatment |
| Enrollment | 43 (Actual) |
| Sponsor | Christoph-Dornier-Stiftung für Klinische Psychologie (Other); collaborators: Universität Münster |
| Conditions | Obsessive-Compulsive Disorder |
| Interventions | detached mindfulness, cognitive restructuring (Behavioral) |
| Dates | start 2016-12-01, primary completion 2018-07-12, completion 2018-07-12, first posted 2016-12-26, last updated 2019-04-16 |
| Locations | 1 site in Germany |
Related Papers Related Patents Related Grants Related Experts
All trials for Obsessive-Compulsive Disorder All trials of detached mindfulness All trials of cognitive restructuring
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| DM | Experimental | Behavioral: detached mindfulness | Group of patients receiving detached mindfulness (for details, see detailed description of the study) |
| CR | Active comparator | Behavioral: cognitive restructuring | Group of patients receiving cognitive restructuring (for details, see detailed description of the study) |
| 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). |
Sex: All, ages: 18 Years to any
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
| Milestone | Detached Mindfulness | Cognitive Restructuring | Waitlist |
|---|---|---|---|
| Started | 10 | 12 | 21 |
| Completed | 9 | 11 | 21 |
| Not completed | 1 | 1 | 0 |
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.
| Arm | Deaths | Serious adverse events | Other adverse events |
|---|---|---|---|
| Detached Mindfulness (DM) | 0 | 0 | 0 |
| Cognitive Restructuring (CR) | 0 | 0 | 0 |
| Waitlist (WL) | 0 | 0 | 0 |
| Facility | City | Country | Status |
|---|---|---|---|
| Christoph-Dornier-Stiftung für Klinische Psychologie | Münster, North Rhine-Westphalia | Germany |