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Internet-administrated Treatment of Anxiety Symptoms for Young Adults (NOVA-IV)

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2013 by Linkoeping University
Sponsor:
Information provided by (Responsible Party):
Gerhard Andersson, Linkoeping University
ClinicalTrials.gov Identifier:
NCT01402258
First received: July 1, 2011
Last updated: April 26, 2013
Last verified: April 2013
  Purpose

The purpose of this study is to determine whether tailored internet-administrated CBT is a feasible approach in the treatment of anxiety symptoms and comorbid anxiety and depressive symptoms in a clinical setting.


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

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Tailored Internet-administrated Treatment of Anxiety Symptoms for Young Adults

Resource links provided by NLM:


Further study details as provided by Linkoeping University:

Primary Outcome Measures:
  • Beck Anxiety Inventory (BAI)- Change from baseline [ Time Frame: Two weeks pre treatment, two weeks post treatment, six months and 12 months post treatment ] [ Designated as safety issue: No ]
    Change from baseline in anxiety symptoms two weeks post treatment, at six months and at 12 months post treatment.


Secondary Outcome Measures:
  • Quality of Life Inventory (QOLI)- Change from baseline [ Time Frame: Two weeks pre treatment, two weeks post treatment, six months and 12 months post treatment ] [ Designated as safety issue: No ]
    Change from baseline in quality of life statements two weeks post treatment, at six months and at 12 months post treatment.

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

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


Estimated Enrollment: 30
Study Start Date: April 2011
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Tailored Internet-delivered CBT
Behavioral: Tailored Internet-delivered CBT
Behavioral: Tailored Internet-administrated CBT-Treatment
This intervention contains 6-8 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.

  Eligibility

Ages Eligible for Study:   16 Years to 25 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Be between the ages of 16-25 years old
  • Have anxiety symptoms and/or anxiety syndrome

Exclusion Criteria:

  • Suicide prone
  • Alcohol addiction
  • Ongoing psychological treatment
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01402258

Contacts
Contact: Gerhard Andersson, Professor +46 13 285840 gerhard.andersson@liu.se

Locations
Sweden
Department of Behavioral Sciences and Learning, Linköping University Recruiting
Linköping, Östergötland, Sweden, 58183
Contact: Gerhard Andersson, PhD    +4613285840    gerhard.andersson@liu.se   
Sponsors and Collaborators
Linkoeping University
Investigators
Principal Investigator: Gerhard Andersson, PhD Department of Behavioral Sciences and Learning, Linköping University
  More Information

No publications provided

Responsible Party: Gerhard Andersson, Professor, Linkoeping University
ClinicalTrials.gov Identifier: NCT01402258     History of Changes
Other Study ID Numbers: GA-FORSS-2011-150291
Study First Received: July 1, 2011
Last Updated: April 26, 2013
Health Authority: Sweden: Regional Ethical Review Board

Additional relevant MeSH terms:
Anxiety Disorders
Depression
Behavioral Symptoms
Mental Disorders

ClinicalTrials.gov processed this record on November 20, 2014