Trial document




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  DRKS00014820

Trial Description

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Title

Transdiagnostic therapist-guided iCBT for emotional disorders: a randomized controlled trial

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

The study investigates a ten-week online therapy program for emotional disorders. Emotional disorders describe various groups of symptoms in which intense, unpleasant feelings play a role, e.g. anxiety and depression. These complaints are very common in society - often people even suffer from more than one area of complaint. The benefit of this program is that it targets all emotional disorders, so that several emotional disorders can be treated simultaneously. The study's goal is to investigate whether the program works and leads to a reduction of these complaints. To do so, we compare two groups that participants get randomly allocated to: One group starts with treatment while the other group wait for ten weeks until they gain access to the program.

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Brief Summary in Scientific Language

The study investigates a transdiagnostic guided internet-based cognitive-behavioral intervention for emotional disorders. Emotional disorders include the anxiety, depressive and somatic symptom disorders and have high prevelance and comorbidity rates. The intervention targets all emotional disorders and thus can also treat comorbid complaints. To investigate the program's efficacy a randomised-waitlist-controlled study design is realised.

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Organizational Data

  •   DRKS00014820
  •   2018/06/13
  •   [---]*
  •   yes
  •   Approved
  •   186/2018, Ethikkommission der Freien Universität Berlin, Fachbereich Erziehungswissenschaft und Psychologie
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Secondary IDs

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Health Condition or Problem studied

  •   F40.1 -  Social phobias
  •   F41.1 -  Generalized anxiety disorder
  •   F40.01 -  [generalization F40.0: Agoraphobia]
  •   F40.0 -  Agoraphobia
  •   F41.0 -  Panic disorder [episodic paroxysmal anxiety]
  •   F32 -  Depressive episode
  •   F33 -  Recurrent depressive disorder
  •   F34.1 -  Dysthymia
  •   F45.2 -  Hypochondriacal disorder
  •   F45.0 -  Somatization disorder
  •   F45.1 -  Undifferentiated somatoform disorder
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Interventions/Observational Groups

  •   Transdiagnostic cognitive-behavioral online treatment, 10-week guided self-help program
  •   Waitlist control group
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Other
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

BSI-18 total score at post-assessment

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Secondary Outcome

The following measures will be applied at 6 time points, pre-, mid- and posttreatment and at follow-up (1-month, 6-months, 12-months):

Overall Symptom Severity -> BSI-18
Social Anxiety -> LSAS
Generalized Anxiety Disorder -> GAD-7
Panic Disorder/ Agoraphobia -> PAS
Depressive symptoms -> PHQ-9
Somatoform complaints -> PHQ-15
Health Anxiety -> SHAI
Life Satisfaction -> SWLS
Positive and Negative Affect -> PANAS

The following process measures will also be assessed:
Therapeutic Alliance -> WAI
Expectations -> CEQ
Mindfulness -> SMQ
Cognitive Flexibility -> ERQ
Anxiety Sensitivity -> ASI
Emotional Avoidance -> BEAQ, BADS

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • other 
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Recruitment

  •   Actual
  •   2018/12/17
  •   180
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

very good knowledge of German, access to the internet, participation in a telephone interview, at least one of the following disorders, diagnosed with the DIPS: Sozial Anxiety Disorder, Generalized Anxiety Disorder, Panic Disorder, Agoraphobie, Major Depression, Dysthymia, Ilnness Anxiety Disorder or Somatic Symptom Disorder

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Exclusion Criteria

currently in psychotherapeutic treatment or counselling, acute psychotic symptoms, severe substance use disorder, acute suicidality, if on medication dose rate changes in the last 3 months

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Addresses

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    • Freie Universitaet Berlin
    • 14195  Berlin
    • Germany
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    • Freie Universitaet BerlinClinical Psychology and Psychotherapy
    • Ms.  Dr.  Johanna  Boettcher 
    • Habelschwerdter Allee 45
    • 14195  Berlin
    • Germany
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    • Freie Universitaet BerlinClinical Psychology and Psychotherapy
    • Ms.  Dr.  Johanna  Boettcher 
    • Habelschwerdter Allee 45
    • 14195  Berlin
    • Germany
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Sources of Monetary or Material Support

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    • Freie UniversitaetClinical Psychology and Psychotherapy
    • 14195  Berlin
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

  •   Ethikvotum
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