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Internet-administrated Treatment of Anxiety Disorders (NOVA II)

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ClinicalTrials.gov Identifier: NCT01390168
Recruitment Status : Completed
First Posted : July 8, 2011
Last Update Posted : March 5, 2013
Sponsor:
Information provided by (Responsible Party):
Per Carlbring, PhD, Umeå University

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

Condition or disease Intervention/treatment Phase
Anxiety Disorders Depression Behavioral: Tailored Internet-administrated CBT-Treatment Behavioral: Waitlist Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Tailored Internet-administrated Treatment of Anxiety Disorders - A Randomised Controlled Trial (NOVA II)
Study Start Date : January 2010
Actual Primary Completion Date : December 2012
Actual Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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 ]

    Measures anxiety and depressive symptoms.

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



Secondary Outcome Measures :
  1. Change from baseline in Beck Anxiety Inventory (BAI) [ Time Frame: Two weeks pre treatment (baseline), two weeks post treatment, 12 months post treatment ]

    Measures anxiety symtoms.

    Change from baseline in anxiety symptoms expected between time frames.


  2. 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 ]

    Measures depressive symptoms.

    Change from baseline in depressive symptoms expected between time frames.


  3. 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 ]

    Measures quality of life.

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




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

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 ClinicalTrials.gov identifier (NCT number): 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 Linkoeping University
Study Chair: Lise Bergman Nordgren, Ph D Student Linkoeping University