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

Primary Purpose

Anxiety Disorders, Depression

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

About this trial

This is an interventional treatment trial for Anxiety Disorders

Eligibility Criteria

16 Years - 25 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Behavioral Sciences and Learning, Linköping UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Tailored Internet-delivered CBT

Arm Description

Behavioral: Tailored Internet-delivered CBT

Outcomes

Primary Outcome Measures

Beck Anxiety Inventory (BAI)- Change from baseline
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
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
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
Change from baseline in anxiety and depressive symptoms two weeks post treatment, at six months and at 12 months post treatment.

Full Information

First Posted
July 1, 2011
Last Updated
April 26, 2013
Sponsor
Linkoeping University
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1. Study Identification

Unique Protocol Identification Number
NCT01402258
Brief Title
Internet-administrated Treatment of Anxiety Symptoms for Young Adults
Acronym
NOVA-IV
Official Title
Tailored Internet-administrated Treatment of Anxiety Symptoms for Young Adults
Study Type
Interventional

2. Study Status

Record Verification Date
April 2013
Overall Recruitment Status
Unknown status
Study Start Date
April 2011 (undefined)
Primary Completion Date
December 2014 (Anticipated)
Study Completion Date
June 2015 (Anticipated)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

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
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Tailored Internet-delivered CBT
Arm Type
Experimental
Arm Description
Behavioral: Tailored Internet-delivered CBT
Intervention Type
Behavioral
Intervention Name(s)
Tailored Internet-administrated CBT-Treatment
Intervention Description
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.
Primary Outcome Measure Information:
Title
Beck Anxiety Inventory (BAI)- Change from baseline
Description
Change from baseline in anxiety symptoms two weeks post treatment, at six months and at 12 months post treatment.
Time Frame
Two weeks pre treatment, two weeks post treatment, six months and 12 months post treatment
Secondary Outcome Measure Information:
Title
Quality of Life Inventory (QOLI)- Change from baseline
Description
Change from baseline in quality of life statements two weeks post treatment, at six months and at 12 months post treatment.
Time Frame
Two weeks pre treatment, two weeks post treatment, six months and 12 months post treatment
Title
Montgomery Åsberg Depression Rating Scale-Self Rated (MADRS-S)- Change from baseline
Description
Change from baseline in depressive symptoms two weeks post treatment, at six months and at 12 months post treatment.
Time Frame
Two weeks pre treatment, two weeks post treatment, six months and 12 months post treatment
Title
Clinical Outcome in Routine Evaluation - Outcome Measure (CORE-OM)- Change from baseline
Description
Change from baseline in anxiety and depressive symptoms two weeks post treatment, at six months and at 12 months post treatment.
Time Frame
Two weeks pre treatment, two weeks post treatment, six months and 12 months post treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gerhard Andersson, Professor
Phone
+46 13 285840
Email
gerhard.andersson@liu.se
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gerhard Andersson, PhD
Organizational Affiliation
Department of Behavioral Sciences and Learning, Linköping University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Behavioral Sciences and Learning, Linköping University
City
Linköping
State/Province
Östergötland
ZIP/Postal Code
58183
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gerhard Andersson, PhD
Phone
+4613285840
Email
gerhard.andersson@liu.se

12. IPD Sharing Statement

Learn more about this trial

Internet-administrated Treatment of Anxiety Symptoms for Young Adults

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