NCT01390168

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2010

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

July 1, 2011

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 8, 2011

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

March 5, 2013

Status Verified

March 1, 2013

Enrollment Period

2.9 years

First QC Date

July 1, 2011

Last Update Submit

March 4, 2013

Conditions

Anxiety DisordersDepression

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (3)

  • Change from baseline in Beck Anxiety Inventory (BAI)

    Two weeks pre treatment (baseline), two weeks post treatment, 12 months post treatment

  • Change from baseline in Montgomery Åsberg Depression Rating Scale-Self Rated (MADRS-S)

    Two weeks pre treatment (baseline), two weeks post treatment, and 12 months post treatment

  • Change from baseline in Quality of Life Inventory (QOLI)

    Two weeks pre treatment (baseline), two weeks post treatment, and 12 months post treatment

Study Arms (2)

tailored internet-administrated CBT

EXPERIMENTAL

Behavioral: tailored internet-administrated CBT

Behavioral: Tailored Internet-administrated CBT-Treatment

waitlist

ACTIVE COMPARATOR

waitlist

Behavioral: Waitlist

Interventions

Tailored Internet-administrated CBT-TreatmentBEHAVIORAL

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.

tailored internet-administrated CBT
WaitlistBEHAVIORAL

active waitlist

waitlist

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • ongoing psychological treatment
  • suicidal prone
  • ongoing alcohol addiction

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Behavioural Sciences and Learning, Linköping University

Linköping, Östergötland County, 581 83, Sweden

Location

Related Publications (2)

  • 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.

    PMID: 24933451DERIVED

  • 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.

    PMID: 22321916DERIVED

MeSH Terms

Conditions

Anxiety DisordersDepression

Interventions

Waiting Lists

Condition Hierarchy (Ancestors)

Mental DisordersBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Appointments and SchedulesOrganization and AdministrationHealth Services Administration

Study Officials

  • Per Carlbring, Professor

    Umeå University

    STUDY DIRECTOR

  • Gerhard Andersson, Professor

    Linkoeping University

    STUDY CHAIR

  • Lise Bergman Nordgren, Ph D Student

    Linkoeping University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 1, 2011

First Posted

July 8, 2011

Study Start

January 1, 2010

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

March 5, 2013

Record last verified: 2013-03

Locations

SE(1)