Trial document




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  DRKS00012792

Trial Description

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Title

Online Interpretation Bias Modification (CBM-I) in body dysmorphic disorder: a randomized-controlled trial

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Trial Acronym

IMP-BDD

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URL of the Trial

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Brief Summary in Lay Language

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Brief Summary in Scientific Language

Negative interpretation biases are discussed as maintaining factors in body dysmorphic disorder. Targeting these processes might thus be a promising treatment or prevention add-on for this disorder.
Extending prior research, this study aims at testing the effectiveness of a so-called CBM-I intervention (Cognitive Bias Modification for Interpretation) in patients with body dysmorphic disorder. Within a randomized-controlled, double-blind trial, we are contrasting this active training group with an active control and a wait-list group. Participants will be randomized to these different groups and receive either up to 8 15-minute sessions of CBM-I or active control-training over a period of 2 weeks, or a waiting phase, respectively. We will assess symptom severity, cognitive biases, and stress vulnerability at pre- and post-treatment as well as at follow-up (1 week, 4 weeks and 3 months after treatment). Participants must be at least 18 years old, fulfill DSM-5 diagnostic criteria for body dysmorphic disorder as assessed by an independent clinician. Further, participants should currently be not suicidal or present with symptoms of psychotic disorders, bipolar disorder, or substance dependency. They should not currently receive psychotherapeutic or psychiatric treatment to rule out confound effects of these treatments.
We hypothesize that CBM-I intervention has more pronounced and long-term effects on the aforementioned dependent variables. We will further explore possible mediators and predictors of treatment response to elucidate selective indication of CBM-I as a treatment add-on.

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Organizational Data

  •   DRKS00012792
  •   2017/10/16
  •   [---]*
  •   yes
  •   Approved
  •   2017-34-FD-Ä2, Ethikkommission des FB07 Fachbereich 7 Psychologie und Sportwissenschaft Westfälische Wilhelms-Universität Münster
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Secondary IDs

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Health Condition or Problem studied

  •   F45.2 -  Hypochondriacal disorder
  •   Body dysmorphic disorder
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Interventions/Observational Groups

  •   CBM-I: active intervention;
    up to 8 15-min. online interpretation retraining sessions within 2 weeks
  •   ICC: active control condition; up to 8 15-min. active control condition (CBM-I paradigm without feedback) sessions within 2 weeks
  •   WLC: wait list; waiting period of 2 weeks
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Blinded
  •   patient/subject, investigator/therapist, assessor
  •   Active control (effective treament of control group), Control group receives no treatment
  •   Treatment
  •   Parallel
  •   II
  •   N/A
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Primary Outcome

Interpretation bias (Word Sentence Association Paradigm, WSAP; Interpretation Questionnaire; IQ),
body-dysmorphic symptom severity (BDD-Y-BOCS), insight (Brown Assessment of Belief Scale, BABS); functional impairment and clinical global impression (Clinical Global Impression Scale, CGIS; WHO Disability Assessment Schedule, WHO DAS 2.0)

Assessed at 5 Time Points:

Pre-Post (2 weeks)
FU 1 (1 week after post)
FU 2 (1 month after post)
FU 3 (3 months after post)

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Secondary Outcome

Depressive symptom severity (BDI-II - Beck Depression Inventory-II), social anxiety symptom severity (Liebowitz Social Anxiety Scale, LSAS-SR), cognitive flexibility (WCST - Wisconsin Card Sorting Test, CFI - Cognitive Flexibility Inventory), implicit associative structure (Implicit Association Task, IAT); stress vulnerability (Mirror Gazing Task; Picture Taking Task)

Assessed at 2 Time Points:
Pre-Post (after 2 weeks).
WCST, CFI, Mirror Gazing Task, Picture Taking Task.

Assessed at 5 Time Points:
Pre-Post (after 2 weeks)
FU1 (1 week after post)
FU2 (4 weeks after post)
FU3 (3 months after post)
IAT, BDI-II und LSAS-SR.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • other 
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Recruitment

  •   Planned
  •   2017/10/17
  •   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 body dysmorphic disorder based on current, at least moderate symptom severity (sum score of BDD-Y-BOCS ≥ 20) and fulfillment of DSM-5 BDD criteria (procedure according to Wilhelm et al., 2014), age > 18 years, written consent, sufficient language fluency in German to understand tasks and questionnaires; access to the internet via PC/Laptop

Inclusion and exclusion criteria will be assessed via telephone and lab-based screening, those fulfilling criteria will be invited for participation.

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Exclusion Criteria

current or previous diagnosis of substance abuse or dependence (excluding nicotine), current or previous diagnosis of schizophrenia, psychotic disorder, bipolar disorder based on SCID-I, BDI-II > 29 (i.e., severe levels of depression; Hautzinger et al., 2006); acute levels of suicidality; change in psychotropic medication within the last 8 weeks prior to study admittance; current on-going psychotherapeutic treatment

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Addresses

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    • AE Klinische Psychologie und PsychotherapieInstitut für Psychologie
    • Ms.  Prof. Dr.  Ulrike  Buhlmann 
    • Fliednerstr. 21
    • 48149  Münster
    • Germany
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    • AE Klinische Psychologie und PsychotherapieInstitut für Psychologie
    • Ms.  Dipl.-Psych.  Fanny Alexandra  Dietel 
    • Fliednerstr. 21
    • 48149  Münster
    • Germany
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    • AE Klinische Psychologie und PsychotherapieInstitut für Psychologie
    • Ms.  Dipl.-Psych.  Fanny Alexandra  Dietel 
    • Fliednerstr. 21
    • 48149  Münster
    • Germany
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Sources of Monetary or Material Support

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    • AE Klinische Psychologie und Psychotherapie
    • Prof. Dr.  Ulrike  Buhlmann 
    • Fliednerstr. 21
    • 48153  Münster
    • Germany
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Status

  •   Enrolling by invitation
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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.