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An Investigation of General Predictors for CBT Outcome for Anxiety Disorders in a Naturalistic Setting

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02638363
Recruitment Status : Completed
First Posted : December 23, 2015
Last Update Posted : May 1, 2018
Copenhagen University Hospital, Denmark
Information provided by (Responsible Party):
Sara Kerstine Kaya Nielsen, University of Copenhagen

Brief Summary:
The aim of this study is to investigate the predictive value of emotion regulation and attentional control for outcome of Cognitive Behavioural Therapy for adults with anxiety disorders in a naturalistic setting.

Condition or disease Intervention/treatment
Anxiety Disorders Behavioral: Cognitive behavioral therapy

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Study Type : Observational
Actual Enrollment : 120 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: An Investigation of General Predictors for Cognitive Behavioral Therapy Outcome for Anxiety Disorders in a Naturalistic Setting
Actual Study Start Date : August 2015
Actual Primary Completion Date : December 2017
Actual Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Intervention Details:
  • Behavioral: Cognitive behavioral therapy
    The participants will receive 12-16 sessions of manualized group-based CBT with a maximum of 8 participants in each group. The therapists are trained psychiatrists, psychologists, or nurses under supervision. The treatment manuals are developed by mental health professionals in the Capital Region of Denmark. The treatment program includes traditional CBT components (e.g., psychoeducation, identification of thoughts and feelings, exposure, cognitive restructuring, and relapse prevention).

Primary Outcome Measures :
  1. Beck Anxiety Inventory [ Time Frame: 9 months ]
    Self-report questionnaire to assess level of anxiety symptoms.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with anxiety disorders from outpatient clinics.


  1. meet the diagnostic criteria for an anxiety disorder (social anxiety, generalized anxiety, panic disorder and agoraphobia) as primary diagnosis whether first episode or recurrent
  2. are between 18 to 60 years of age
  3. provide written informed consent
  4. speak and understand Danish.


  1. cognitive disabilities (assessed with sub scales from Wechsler Adult Intelligence Scale Fourth-Edition, < 70)
  2. alcohol or substance abuse (assessed during the preliminary consultations)
  3. receiving any other psychotherapy during the study. Patients receiving medical treatment (e.g., antidepressants, Benzodiazepines) will also be included in the study and the treatment will be monitored closely.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02638363

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University of Copenhagen
Copenhagen, Denmark, 2200
Sponsors and Collaborators
University of Copenhagen
Copenhagen University Hospital, Denmark
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Principal Investigator: Sara KK Nielsen, MSc Department of Psychology
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Sara Kerstine Kaya Nielsen, PhD Student, Clinical Psychologist, University of Copenhagen Identifier: NCT02638363    
Other Study ID Numbers: Precat
First Posted: December 23, 2015    Key Record Dates
Last Update Posted: May 1, 2018
Last Verified: April 2018
Additional relevant MeSH terms:
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Anxiety Disorders
Mental Disorders