NCT02638363

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2015

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

December 16, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 23, 2015

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

May 1, 2018

Status Verified

April 1, 2018

Enrollment Period

2.3 years

First QC Date

December 16, 2015

Last Update Submit

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

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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

Study Sites (1)

University of Copenhagen

Copenhagen, 2200, Denmark

Location

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.

MeSH Terms

Conditions

Anxiety Disorders

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Sara KK Nielsen, MSc

    Department of Psychology

    PRINCIPAL INVESTIGATOR

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

Locations