跳至主要内容
临床试验/NCT03002753
NCT03002753已完成不适用

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

Christoph-Dornier-Stiftung für Klinische Psychologie2 个研究点 分布在 1 个国家目标入组 43 人开始时间: 2016年12月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
43
试验地点
2
主要终点
Y-BOCS Change Score (Pre to Post Assessment)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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

研究组 & 干预措施

DM

Experimental

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

干预措施: detached mindfulness (Behavioral)

CR

Active Comparator

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

干预措施: cognitive restructuring (Behavioral)

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).

结局指标

主要结局

Y-BOCS Change Score (Pre to Post Assessment)

时间窗: 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.

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.

次要结局

未报告次要终点

研究者

发起方
Christoph-Dornier-Stiftung für Klinische Psychologie
申办方类型
Other
责任方
Principal Investigator
主要研究者

Prof. Dr. Ulrike Buhlmann

Prof. Dr.

Universität Münster

研究点 (2)

Loading locations...

相似试验

Dealing With Intrusive Thoughts in OCD - a... | 临床试验