Internet-administrated Treatment of Anxiety Disorders

Depression Clinical Trial

— NOVA II  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01390168
• Other study ID #: PC-FAS-2008-1145
• Status: Completed
• Phase: N/A
• First received: July 1, 2011
• Last updated: March 4, 2013
• Start date: January 2010
• Est. completion date: December 2012

Study information

• Verified date: March 2013
• Source: Umeå University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anxiety Disorders
• Depression

Intervention

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.
• Waitlist
active waitlist

Locations

Country	Name	City	State
Sweden	Department of Behavioural Sciences and Learning, Linköping University	Linköping	Östergötland

Sponsors (1)

Lead Sponsor	Collaborator
Umeå University

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Two weeks pre treatment (baseline), two weeks post treatment, and 12 months post treatment	No
Secondary	Change from baseline in Beck Anxiety Inventory (BAI)	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	No
Secondary	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.	Two weeks pre treatment (baseline), two weeks post treatment, and 12 months post treatment	No
Secondary	Change from baseline in Quality of Life Inventory (QOLI)	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	No