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Internet-administrated Treatment of Anxiety Disorders (NOVA II)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Per Carlbring, PhD, Umeå University
ClinicalTrials.gov Identifier:
NCT01390168
First received: July 1, 2011
Last updated: March 4, 2013
Last verified: March 2013
History of Changes
  Purpose

The purpose of this study is to determine whether tailored internet-administered cbt is a feasible treatment for anxiety disorders in clinical settings.


Condition Intervention
Anxiety Disorders
Depression
 Behavioral: Tailored Internet-administrated CBT-Treatment
Behavioral: Waitlist

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Tailored Internet-administrated Treatment of Anxiety Disorders - A Randomised Controlled Trial (NOVA II)

Resource links provided by NLM:

MedlinePlus related topics: Anxiety Depression
U.S. FDA Resources

Further study details as provided by Umeå University:

Primary Outcome Measures:
  • Change from baseline in Clinical Outcome in Routine Evaluation - Outcome Measure (CORE-OM) [ Time Frame: Two weeks pre treatment (baseline), two weeks post treatment, and 12 months post treatment ] [ Designated as safety issue: No ]

    Measures anxiety and depressive symptoms.

    Change from baseline in anxiety and depressive symptoms expected between time frames.



Secondary Outcome Measures:
  • Change from baseline in Beck Anxiety Inventory (BAI) [ Time Frame: Two weeks pre treatment (baseline), two weeks post treatment, 12 months post treatment ] [ Designated as safety issue: No ]

    Measures anxiety symtoms.

    Change from baseline in anxiety symptoms expected between time frames.


  • Change from baseline in Montgomery Åsberg Depression Rating Scale-Self Rated (MADRS-S) [ Time Frame: Two weeks pre treatment (baseline), two weeks post treatment, and 12 months post treatment ] [ Designated as safety issue: No ]

    Measures depressive symptoms.

    Change from baseline in depressive symptoms expected between time frames.


  • Change from baseline in Quality of Life Inventory (QOLI) [ Time Frame: Two weeks pre treatment (baseline), two weeks post treatment, and 12 months post treatment ] [ Designated as safety issue: No ]

    Measures quality of life.

    Change from baseline in quality of life expected between time frames.



Enrollment: 100
Study Start Date: January 2010
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: tailored internet-administrated CBT
Behavioral: tailored internet-administrated CBT
 Behavioral: Tailored Internet-administrated CBT-Treatment
This intervention contains up to 6-10 text-based self-help modules in which 4 modules are fixed (the first three and the last) and the rest are "prescribed following the diagnostic telephone interview. These modules contain material on panic disorder, social phobia, stress management, assertiveness training, concentration, relaxation among other things.
Active Comparator: waitlist
waitlist
 Behavioral: Waitlist
active waitlist

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • over 18 years
  • fulfill the criteria for at least one anxiety syndrome

Exclusion Criteria:

  • ongoing psychological treatment
  • suicidal prone
  • ongoing alcohol addiction
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01390168

Locations
Sweden
Department of Behavioural Sciences and Learning, Linköping University
Linköping, Östergötland, Sweden, 581 83
Sponsors and Collaborators
Umeå University
Investigators
Study Director: Per Carlbring, Professor Umeå University
Study Chair: Gerhard Andersson, Professor Linköping University
Study Chair: Lise Bergman Nordgren, Ph D Student Linköping University
  More Information

No publications provided by Umeå University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Per Carlbring, PhD, Professor, Umeå University
ClinicalTrials.gov Identifier: NCT01390168     History of Changes
Other Study ID Numbers: PC-FAS-2008-1145
Study First Received: July 1, 2011
Last Updated: March 4, 2013
Health Authority: Sweden: Regional Ethical Review Board

Additional relevant MeSH terms:
Anxiety Disorders
Depression
Depressive Disorder
 Mental Disorders
Behavioral Symptoms
Mood Disorders

ClinicalTrials.gov processed this record on May 21, 2013