Internet-administrated Treatment of Anxiety Disorders (NOVA II)

March 4, 2013 updated by: Per Carlbring, PhD, Umeå University

Tailored Internet-administrated Treatment of Anxiety Disorders - A Randomised Controlled Trial (NOVA II)

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
    • Östergötland
      • Linköping, Östergötland, Sweden, 581 83
        • Department of Behavioural Sciences and Learning, Linköping University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • ongoing psychological treatment
  • suicidal prone
  • ongoing alcohol addiction

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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
Behavioral: Waitlist
active waitlist

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Two weeks pre treatment (baseline), two weeks post treatment, and 12 months post treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Two weeks pre treatment (baseline), two weeks post treatment, 12 months post treatment
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.
Two weeks pre treatment (baseline), two weeks post treatment, and 12 months post treatment
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.
Two weeks pre treatment (baseline), two weeks post treatment, and 12 months post treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (Actual)

December 1, 2012

Study Completion (Actual)

December 1, 2012

Study Registration Dates

First Submitted

July 1, 2011

First Submitted That Met QC Criteria

July 6, 2011

First Posted (Estimate)

July 8, 2011

Study Record Updates

Last Update Posted (Estimate)

March 5, 2013

Last Update Submitted That Met QC Criteria

March 4, 2013

Last Verified

March 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PC-FAS-2008-1145

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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