Trial document




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  DRKS00009734

Trial Description

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Title

Impact of thought control strategies and mindfulness on insight in obsessive compulsive disorder

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

This study is designed to investigate whether different ways of dealing with intrusive thoughts predict consecutive level of insight. It is assumed that dysfunctional thought control strategies predict lower levels of insight, whereas a mindful approach in dealing with intrusive thoughts is expected to have the reverse effect. To test these hypotheses, a total of 60 participants with a primary diagnosis of obsessive-compulsive disorder will record their current and recent experiences 10 times a day on 6 consecutive days using the experience-sampling method (ESM). Participants will be equipped with a smartphone and will be asked to fill out a form 10 times a day on 6 consecutive days between 8 am and 11 pm.

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Brief Summary in Scientific Language

Insight into the unreasonableness or excessiveness of obsessive symptoms has for a long time been regarded as an essential characteristic of obsessive-compulsive disorder (OCD). However, a growing body of research indicates that OCD is characterized by a spectrum of insight with a remarkable proportion of patients exhibiting poor or even absent insight. Since poor insight is associated with greater impairment, this phenomenon deserves more attention in clinical research. Based on clinical observations showing that level of insight varies among different obsessions as well as over time, several authors reject a stable trait-like insight concept, recommending repeated assessments of insight instead of a global, retrospective assessment conducted in a clinical interview setting. For this purpose, Ecological Momentary Assessment Method (EMA) could provide a powerful research tool, because the repeated collection of real-time data on participants’ momentary experiences or states in their natural environments guarantees the realization of ecological validity. Furthermore, unlike retrospective measures, EMA is less prone to memory distortions like recall biases, because participants are asked to record their current or very recent experiences. Up to now, the temporal variation of the level of insight, its association with anxiety level and other situational correlates have never been empirically studied using EMA. Furthermore, it is still unknown which processes lead to a consecutive increase or decrease of insight level. Several studies indicate that besides engaging in avoidance behavior and compulsions, people suffering from OCD also tend to use maladaptive thought control strategies such as worry and self-punishment in order to deal with unwanted/intrusive thoughts. There are several reasons to assume that the use of these maladaptive thought control strategies decreases consecutive level of insight, because both strategies are presumed to increase the frequency of intrusions, maintain a state of enhanced threat expectation, perceived uncontrollability and heightened distress. On the other hand, the use of mindfulness and acceptance-based strategies (characterized by a willingness to experience thoughts and feelings as temporary mental events rather than accurate reflections of reality) are assumed to improve consecutive degree of insight.
The study is designed to investigate whether worry and self-punishment on the one hand, and a mindfulness-based strategy on the other hand, predict the consecutive degree of insight. We hypothesize that both antecedent worry and punishment predict lower levels of insight in the proximal period as well as time-lagged, whereas a mindful approach in dealing with intrusive thoughts is expected to have the reverse effect. Besides corroborating the findings of previous studies suggesting that OCD patients tend to use rather maladaptive than adaptive thought control strategies, this study aims at exploring the relevance of thought control strategies in dealing with unwanted/intrusive thoughts as compared to overt and mental compulsions usually adopted to neutralize obsessions and associated distress. Moreover, it should be examined whether obsessive beliefs surrounding the importance of and the need to control thoughts predict the use of thought control strategies. A total of 60 subjects with a primary diagnosis of OCD according to DSM will record current level of insight, antecedent OC-symptoms and associated distress and antecedent use of thought control strategies as well as overt and mental compulsions 10 times a day on 6 consecutive days on a smartphone equipped with the web-based experience-sampling application movisensXS. Data will be analyzed using multilevel modelling to account for the hierarchical structure of real-time data. Besides improving insight conceptualization, the current study could help develop effective intervention strategies to directly target the processes that lead to a decline of insight in OCD e.g. by fostering those strategies that promote a detachment/disengagement from obsessive fears.

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Organizational Data

  •   DRKS00009734
  •   2015/11/30
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  •   yes
  •   Approved
  •   496/15, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
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Secondary IDs

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Health Condition or Problem studied

  •   F42 -  Obsessive-compulsive disorder
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Interventions/Observational Groups

  •   After obtaining written informed consent, socio-demographic information will be collected using a brief interview. Axis I diagnoses, OC-symptom dimensions and severity of OCD and the level of insight will be assessed in clinical interviews (M.I.N.I., Y-BOCS and BABS) by trained staff.
    Afterwards, eligible participants will fill out three questionnaires (BDI-II, TCQ, OBQ). Finally they will be trained in using the Smartphone and the experience-sampling-app movisensXS.
    During the following ecological momentary assessment period, participants will be asked about their current symptoms and about antecedent processes 10 times a day on 6 consecutive days between 8 am and 11 pm via the experience-sampling app installed on the smartphone.
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Basic research/physiological study
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

Experience-sampling method: Current obsessive symptoms, level of insight and antecedent way of dealing with intrusions (use of thought control strategies, a mindful way of dealing with intrusions, engaging in compulsions) is measured repeatedly (10 times a day on 6 consecutive days).

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Secondary Outcome

Global insight level is assessed with the Brown Assessment of Beliefs Scale before starting Ecological Momentary Assessment. The use of thought control strategies is assessed using the TCQ, depression is assessed with BDI-II, obsessive beliefs will be assessed using the OBQ.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2016/02/02
  •   60
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   65   Years
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Additional Inclusion Criteria

primary diagnosis of obsessive-compulsive disorder according to DSM, clinically relevant OC symptoms, (i.e. a Y-BOCS global score >12 or a score of >=8 in either obsession or compulsion subscale at study inclusion), underlying beliefs associated with the obsession / about the consequences of not performing their compulsions (assessed with the Brown Assessment of Beliefs Scale), age between 18 and 65 years, sufficient comprehension of the German language

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Exclusion Criteria

Comorbid generalized anxiety disorder (GAD), psychosis or mania according to DSM,
suicidal tendencies as measured according to the Suicidal Behaviors Questionnaire-Revised (SBQ-R), severe depression defined as having a BDI-II score > 29, currently undergoing inpatient therapy

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Addresses

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    • Universitätsklinikum Freiburg
    • Ms.  Dr.  Anne Katrin  Külz 
    • Hauptstr. 5
    • 79104  Freiburg
    • Germany
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    • Universitätsklinikum Freiburg
    • Ms.  Dipl. psych.  Sarah  Landmann 
    • Hauptstr. 5
    • 79104  Freiburg
    • Germany
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    • Universitätsklinikum Freiburg
    • Ms.  Dipl. psych.  Sarah  Landmann 
    • Hauptstr. 5
    • 79104  Freiburg
    • Germany
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Sources of Monetary or Material Support

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    • Wissenschaftliche Gesellschaft Freiburg
    • Hermann-Herder-Straße 9
    • 79104  Freiburg
    • Germany
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    • Universitätsklinikum Freiburg, Abteilung für Psychiatrie und Psychotherapie
    • Ms.  Dr.  Anne Katrin  Külz 
    • Hauptstr. 5
    • 79104  Freiburg
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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