An Investigation of General Predictors for CBT Outcome for Anxiety Disorders in a Naturalistic Setting
1 other identifier
observational
120
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Aug 2015
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2015
CompletedFirst Submitted
Initial submission to the registry
December 16, 2015
CompletedFirst Posted
Study publicly available on registry
December 23, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2017
CompletedMay 1, 2018
April 1, 2018
2.3 years
December 16, 2015
April 30, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Beck Anxiety Inventory
Self-report questionnaire to assess level of anxiety symptoms.
9 months
Interventions
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).
Eligibility Criteria
Patients with anxiety disorders from outpatient clinics.
You may qualify if:
- meet the diagnostic criteria for an anxiety disorder (social anxiety, generalized anxiety, panic disorder and agoraphobia) as primary diagnosis whether first episode or recurrent
- are between 18 to 60 years of age
- provide written informed consent
- speak and understand Danish.
You may not qualify if:
- cognitive disabilities (assessed with sub scales from Wechsler Adult Intelligence Scale Fourth-Edition, \< 70)
- alcohol or substance abuse (assessed during the preliminary consultations)
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Copenhagenlead
- Copenhagen University Hospital, Denmarkcollaborator
Study Sites (1)
University of Copenhagen
Copenhagen, 2200, Denmark
Related Publications (1)
Nielsen SK, Vangkilde S, Wolitzky-Taylor KB, Daniel SI, Hageman I. An investigation of general predictors for cognitive-behavioural therapy outcome for anxiety disorders in a routine clinical setting. BMJ Open. 2016 Mar 25;6(3):e010898. doi: 10.1136/bmjopen-2015-010898.
PMID: 27016248DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sara KK Nielsen, MSc
Department of Psychology
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PhD Student, Clinical Psychologist
Study Record Dates
First Submitted
December 16, 2015
First Posted
December 23, 2015
Study Start
August 1, 2015
Primary Completion
December 1, 2017
Study Completion
December 1, 2017
Last Updated
May 1, 2018
Record last verified: 2018-04