Trial document





This trial has been registered retrospectively.
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  DRKS00000290

Trial Description

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Title

Neurobiological Correlates and Predictors of Psychotherapeutic Processes in Patients with OCD

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Trial Acronym

[---]*

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URL of the Trial

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Brief Summary in Lay Language

A main goal of the study is to test whether neurobiological parameters are of value for predicting the course of treatment in OCD.
Patients with Obsessive-Compulsive-Disorder (OCD) were enrolled in a manual-based 12-week inpatient therapy programme . Psychotherapy treatment without psychoactive medication was based on repeated confrontation with OCD-related content/situations, with prevention of compulsions (exposure and response prevention). Symptoms, cognitive profiles and neurobiological parameters were assessed before and after treatment without use medication.

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Brief Summary in Scientific Language

A main goal of the study is to evaluate the predictive value of neurobiological parameters for the course of cognitive-behavioral therapy in OCD. Patients without comorbid Major Depression and without psychotropic medication were enrolled in a 12-week CBT programme on a specialized ward. Therapy was based on in-vivo exposure and response prevention. Before and after therapy structured diagnostics, a neuropsychological test battery and neurobiological measurements were administered to the participants. The latter involved structural, functional and neurochemical MR imaging of the brain.

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Organizational Data

  •   DRKS00000290
  •   2009/12/22
  •   [---]*
  •   yes
  •   Approved
  •   289/01, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
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Secondary IDs

  •   U1111-1112-9707 
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Health Condition or Problem studied

  •   F42 -  Obsessive-compulsive disorder
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Interventions/Observational Groups

  •   Cognitive-behavioral therapy (CBT) with in-vivo exposure and response prevention
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Characteristics

  •   Interventional
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  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Basic research/physiological study
  •   Single (group)
  •   N/A
  •   [---]*
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Primary Outcome

-Symptom Reduction (Yale-Brown-Obsessive-Compulsive Scale; Clinical Global Impression)
- Cognitive Performance (Neuropsychological Test Battery) at T0 and T2
- Concentration of neurometabolites in the brain tissue (Proton Magnetic Resonance Spectroscopy; 1H-MRS) at T0 and T2
- Fractional Anisotropy of white matter of the brain (Diffusion Tensor Imaging; T0 and T2)
- BOLD-Signal as measured with functional Magnetic Resonance Imaging (fMRI) during cognitive activation and rest

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Secondary Outcome

Change of depressive symptoms (Hamilton Depression Rating Scale and Beck Depression Inventory, at timepoints T0 and T2)

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

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Recruitment

  •   Actual
  •   2003/12/16
  •   70
  •   Multicenter trial
  •   National
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Inclusion Criteria

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

- OCD diagnosis according to DSM-IV (SCID)
- Y-BOCS total score of 16 or more
- Illness duration of at least one year
- Absence of psychoactive medication (at least 4 weeks wash-out)
- Right handedness (according to EHI)

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Exclusion Criteria

- Concurrent major depression
- Acute Suicidality
- Substance abuse or dependence (present and history of)
- History of major head trauma
- Major neurological and somatic illnesses
- Pregnancy and lactation
- Absence of contraception in fertile women
- Concurrent participation in other clinical trials, including 30 days before enrollment
- Generally accepted exclusion criteria for participation in MRI research (http://www.ismrm.org)

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Addresses

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    • Klinik für Psychiatrie und Psychotherapie Universitätsklinikum Schleswig-Holstein Campus Lübeck
    • Mr.  Prof. Dr. med.  Fritz  Hohagen 
    • Ratzeburger Allee 160
    • 23538  Lübeck
    • Germany
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    • Klinik für Psychiatrie und Psychotherapie Universitätsklinikum Schleswig-Holstein Campus Lübeck
    • Mr.  Dr. med.  Bartosz  Zurowski 
    • Ratzeburger Allee 160
    • 23538  Lübeck
    • Germany
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    • Klinik für Psychiatrie und Psychotherapie Universitätsklinikum Schleswig-Holstein Campus Lübeck
    • Mr.  Dr. med.  Andreas  Kordon 
    • Ratzeburger Allee 160
    • 23538  Lübeck
    • Germany
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Sources of Monetary or Material Support

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    • Deutsche Forschungsgemeinschaft (DFG)
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2007/01/25
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.