Trial document




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  DRKS00015626

Trial Description

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Title

imagin - online intervention for people with appearance related concerns

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Trial Acronym

imagin

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URL of the Trial

http://www.studicare.com/imagin

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Brief Summary in Lay Language

The present study examines the efficacy of a therapist guided online intervention for people with appearance related concerns. For this purpose one group receiving the treatment is compared to a second group which is waiting at the same time. The treatment is offered to the waiting group after the waiting period.

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Brief Summary in Scientific Language

The present study investigates the efficacy of a therapist guided cognitive-behavioural online intervention for people with appearance related concerns. The study is organised in two study parts. One part includes only people with a diagnosis of Body Dysmorphic Disorder (main study), the other part examines a subclinical population (side study).

Various studies confirm the efficacy of online interventions for different mental illnesses. One study showed an efficacious online treatment of people with Body Dysmorphic Disorder which was superior to a supportive therapy.

The intervention “imagin” encompasses seven modules including the topics information about the disorder, attention focus, safety seeking behaviour, thoughts, self-esteem, body image and relapse prevention. The study protocol in both study parts is based on a randomised-controlled design, comparing an intervention group to a waiting list control group. The randomised group allocation is done by an independent third-party institution after verification of inclusion and exclusion criteria. People in the control group are offered the treatment after the waiting time (cross-over). The assessor is blind to the treatment condition. We hypothesise a stronger reduction in symptom severity in the intervention in comparison to the waiting group. Besides we expect related variables to differ between groups after the treatment and waiting period respectively.

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Organizational Data

  •   DRKS00015626
  •   2018/11/15
  •   [---]*
  •   yes
  •   Approved
  •   MS/JE 180806_Schoenenberg, Ethikkommission der Bergischen Universität Wuppertal Gaußstraße 20, 42119 Wuppertal
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Secondary IDs

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Health Condition or Problem studied

  •   F45.2 -  Hypochondriacal disorder
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Interventions/Observational Groups

  •   Intervention – directly receives a seven modules internet-based therapist guided program (over a period of 10 - 12 weeks)
  •   Control group – waits for three months and receives the same internet-based therapist guided intervention after a second diagnostic assessment
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Blinded
  •   assessor
  •   Control group receives no treatment
  •   Treatment
  •   Crossover
  •   II
  •   N/A
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Primary Outcome

Severity measured with a semi-structured clinical interview: Yale-Brown Obsessive-Compulsive Scale Modified for Body Dysmorphic Disorder (BDD-YBOCS)

Measurements: baseline, post-treatment /post-waiting period and follow-up (3 months after treatment termination)

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Secondary Outcome

1. BDD symptoms and related constructs:
“Fragebogen körperdysmorpher Symptome” (FKS),
Dysmorphic Concerns Questionnaire (DCQ),
BDD-State (six items of the BDD-YBOCS modified for self-assessment),
List of safety seeking behaviours (LSV),
Physical Appearance Comparison Scale (PACS)
Brown Assessment of Beliefs Scale in Body Dysmorphic Disorder (BABS; Interview)

2. General Psychopathology:
affect: affect scale
depressive symptoms: „Gesundheitsfragbogen für Pat“ (PHQ-9)
rumination: Screening-Instrument for Rumination-Suppression (RS-8)
obsessive-compulsive symptoms: Zohar-Fineberg Obsessive Compulsive Screening 5+1 (ZF-OCS)
self-efficacy: „Allgemeiner Selbstwirksamkeits Kurzskala“ (ASKU)

3. Quality of life: EUROHIS-QOL

4. Adverse Events

5. Acceptability:
Credibility and Expectancy questionnaire (CEQ),
Visual Aesthetics of Websites Inventory (VisAWI-S),
Website - Clarity, Likeability, Informativeness, and Credibility (Web-CLIC)
Perceived Website Usability - german (PWU-g)

6. Further Instruments / Mediators
„Technikbereitschaft“ (TB)
Appearance based rejection Sensitivity (ARS-D)

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • other 
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Recruitment

  •   Actual
  •   2018/11/16
  •   42
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

- main diagnosis body dysmophic disorder (main study) / central problem appearance related concerns (side study)
- at least 18 years old
- at least 14 points in the “Fragebogen körperdysmorpher Symptome (FKS)”

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Exclusion Criteria

- current psychotherapeutic treatment (outpatient/inpatient);
- cognitive-behavioural treatment of the Body Dysmorphic Disorder within the last 6 months;
- instable psychopharmacological medication within the last two months
- severe suicidality
- current Substance-related Addiction, current severe Major Depression, Bipolar Disorder, pre-diagnosed Schizophrenic Disorder or Borderline Personality Disorder

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Addresses

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    • Bergische Universität Wuppertal
    • Gaußstraße 20
    • 42119  Wuppertal
    • Germany
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    • Bergische Universität WuppertalKlinische Psychologie und Psychotherapie
    • Ms.  Prof. Dr.  Alexandra  Martin 
    • Gaußstraße 20
    • 42119  Wuppertal
    • Germany
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    • Bergische Universität WuppertalKlinische Psychologie und Psychotherapie
    • Ms.  Dr.  Katrin  Schoenenberg 
    • Gaußstraße 20
    • 42119  Wuppertal
    • Germany
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Sources of Monetary or Material Support

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    • Bergische Universität Wuppertal
    • Gaußstraße 20
    • 42119  Wuppertal
    • Germany
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Status

  •   Recruiting ongoing
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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.