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Internet-administrated Treatment of Anxiety Disorders (NOVA II)

Primary Purpose

Anxiety Disorders, Depression

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Tailored Internet-administrated CBT-Treatment
Waitlist
Sponsored by
Umeå University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anxiety Disorders

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • ongoing psychological treatment
  • suicidal prone
  • ongoing alcohol addiction

Sites / Locations

  • Department of Behavioural Sciences and Learning, Linköping University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

tailored internet-administrated CBT

waitlist

Arm Description

Behavioral: tailored internet-administrated CBT

waitlist

Outcomes

Primary Outcome Measures

Change from baseline in Clinical Outcome in Routine Evaluation - Outcome Measure (CORE-OM)
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)
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)
Measures depressive symptoms. Change from baseline in depressive symptoms expected between time frames.
Change from baseline in Quality of Life Inventory (QOLI)
Measures quality of life. Change from baseline in quality of life expected between time frames.

Full Information

First Posted
July 1, 2011
Last Updated
March 4, 2013
Sponsor
Umeå University
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1. Study Identification

Unique Protocol Identification Number
NCT01390168
Brief Title
Internet-administrated Treatment of Anxiety Disorders
Acronym
NOVA II
Official Title
Tailored Internet-administrated Treatment of Anxiety Disorders - A Randomised Controlled Trial (NOVA II)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2013
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Umeå University

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety Disorders, Depression

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
tailored internet-administrated CBT
Arm Type
Experimental
Arm Description
Behavioral: tailored internet-administrated CBT
Arm Title
waitlist
Arm Type
Active Comparator
Arm Description
waitlist
Intervention Type
Behavioral
Intervention Name(s)
Tailored Internet-administrated CBT-Treatment
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Waitlist
Intervention Description
active waitlist
Primary Outcome Measure Information:
Title
Change from baseline in Clinical Outcome in Routine Evaluation - Outcome Measure (CORE-OM)
Description
Measures anxiety and depressive symptoms. Change from baseline in anxiety and depressive symptoms expected between time frames.
Time Frame
Two weeks pre treatment (baseline), two weeks post treatment, and 12 months post treatment
Secondary Outcome Measure Information:
Title
Change from baseline in Beck Anxiety Inventory (BAI)
Description
Measures anxiety symtoms. Change from baseline in anxiety symptoms expected between time frames.
Time Frame
Two weeks pre treatment (baseline), two weeks post treatment, 12 months post treatment
Title
Change from baseline in Montgomery Åsberg Depression Rating Scale-Self Rated (MADRS-S)
Description
Measures depressive symptoms. Change from baseline in depressive symptoms expected between time frames.
Time Frame
Two weeks pre treatment (baseline), two weeks post treatment, and 12 months post treatment
Title
Change from baseline in Quality of Life Inventory (QOLI)
Description
Measures quality of life. Change from baseline in quality of life expected between time frames.
Time Frame
Two weeks pre treatment (baseline), two weeks post treatment, and 12 months post treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Per Carlbring, Professor
Organizational Affiliation
Umeå University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Gerhard Andersson, Professor
Organizational Affiliation
Linkoeping University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Lise Bergman Nordgren, Ph D Student
Organizational Affiliation
Linkoeping University
Official's Role
Study Chair
Facility Information:
Facility Name
Department of Behavioural Sciences and Learning, Linköping University
City
Linköping
State/Province
Östergötland
ZIP/Postal Code
581 83
Country
Sweden

12. IPD Sharing Statement

Citations:
PubMed Identifier
24933451
Citation
Nordgren LB, Hedman E, Etienne J, Bodin J, Kadowaki A, Eriksson S, Lindkvist E, Andersson G, Carlbring P. Effectiveness and cost-effectiveness of individually tailored Internet-delivered cognitive behavior therapy for anxiety disorders in a primary care population: a randomized controlled trial. Behav Res Ther. 2014 Aug;59:1-11. doi: 10.1016/j.brat.2014.05.007. Epub 2014 Jun 2.
Results Reference
derived
PubMed Identifier
22321916
Citation
Nordgren LB, Andersson G, Kadowaki A, Carlbring P. Tailored internet-administered treatment of anxiety disorders for primary care patients: study protocol for a randomised controlled trial. Trials. 2012 Feb 9;13:16. doi: 10.1186/1745-6215-13-16.
Results Reference
derived

Learn more about this trial

Internet-administrated Treatment of Anxiety Disorders

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