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

December 8, 2023 updated by: Gerhard Andersson, Linkoeping University

Tailored Internet-administrated Treatment of Anxiety Symptoms for Young Adults

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

15

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, 58183
        • Department of Behavioral 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

16 years to 25 years (Child, Adult)

Accepts Healthy Volunteers

No

Description

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

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Beck Anxiety Inventory (BAI)- Change from baseline
Time Frame: Two weeks pre treatment, two weeks post treatment, six months and 12 months post treatment
Change from baseline in anxiety symptoms two weeks post treatment, at six months and at 12 months post treatment.
Two weeks pre treatment, two weeks post treatment, six months and 12 months post treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Change from baseline in quality of life statements two weeks post treatment, at six months and at 12 months post treatment.
Two weeks pre treatment, two weeks post treatment, six months and 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
Change from baseline in depressive symptoms two weeks post treatment, at six months and at 12 months post treatment.
Two weeks pre treatment, two weeks post treatment, six months and 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
Change from baseline in anxiety and depressive symptoms two weeks post treatment, at six months and at 12 months post treatment.
Two weeks pre treatment, two weeks post treatment, six months and 12 months post treatment

Collaborators and Investigators

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

Sponsor

Linkoeping University

Investigators

  • Principal Investigator: Gerhard Andersson, PhD, Department of Behavioral Sciences and Learning, Linköping University

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

April 1, 2011

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

June 1, 2015

Study Registration Dates

First Submitted

July 1, 2011

First Submitted That Met QC Criteria

July 25, 2011

First Posted (Estimated)

July 26, 2011

Study Record Updates

Last Update Posted (Actual)

December 14, 2023

Last Update Submitted That Met QC Criteria

December 8, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GA-FORSS-2011-150291

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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