Psychodynamic Internet Treatment Versus Cognitive Behavioral Therapy (CBT) for Generalized Anxiety Disorder

March 9, 2011 updated by: Linkoeping University

Psychodynamic Versus Cognitive Behavioral Internet-Delivered Guided Self-help for Generalized Anxiety Disorder: A Randomized Controlled Trial

The objective is to test if Internet-delivered cognitive behavior therapy (iCBT) or Internet-delivered psychodynamic therapy (iPDT) performs better for a population with generalized anxiety disorder (GAD), compared to a wait-list control condition.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This was a non-inferiority trial within the context of a parallel group study with unrestricted randomisation in 1:1:1 ratio conducted in Sweden. Outcome assessors were blind to treatment status.

Study Type

Interventional

Enrollment (Actual)

81

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, 581 83
        • Linkoping 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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • fulfill the diagnostic criteria for GAD according to DSM-IV
  • have access to the Internet
  • have good knowledge of the Swedish language

Exclusion Criteria:

  • recent (during last 6 weeks) change in psychiatric medication
  • presently in any other psychological treatment
  • severe depression
  • suicidal ideation

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Internet-delivered CBT
Active treatment: Internet-delivered Cognitive Behavior Therapy, 8 weeks treatment, guided self-help
Behavioral: iCBT
Internet-delivered cognitive behavior therapy, 8 weeks
Experimental: Internet-delivered PDT
Active treatment: Internet-delivered Psychodynamic Therapy Active treatment: Internet-delivered Psychodynamic Therapy, 8 weeks treatment, guided self-help
Behavioral: iPDT
Internet-delivered psychodynamic therapy, 8 weeks
No Intervention: Control condition
Wait-list condition, received treatment 3 months after initial treatment period

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Penn State Worry Questionnaire (PSWQ)
Time Frame: Two weeks pre treatment to two weeks post treatment.
Change from baseline in anxiety symptoms to two weeks post treatment.
Two weeks pre treatment to two weeks post treatment.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Montgomery Åsberg Depression Rating Scale-Self Rated (MADRS-S)
Time Frame: Two weeks pre treatment to two weeks post treatment
Change from baseline in depressive symptoms to two weeks post treatment.
Two weeks pre treatment to two weeks post treatment
Quality of Life Inventory (QOLI)
Time Frame: Two weeks pre treatment to two weeks post treatment
Change from baseline in quality of life status to two weeks post treatment.
Two weeks pre treatment to two weeks post treatment
Beck Depression Inventory (BDI)
Time Frame: Two weeks pre treatment to two weeks post treatment
Change from baseline in depressive symptoms to two weeks post treatment.
Two weeks pre treatment to two weeks post treatment
Beck Anxiety Inventory (BAI)
Time Frame: Two weeks pre treatment to two weeks post treatment
Change from baseline in anxiety symptoms to two weeks post treatment.
Two weeks pre treatment to two weeks post treatment
Trimbos and iMTA questionnaire on Costs associated with Psychiatric illness (TIC-P)
Time Frame: Two weeks pre treatment to two weeks post treatment
Change from baseline in societal cost of illness to two weeks post treatment.
Two weeks pre treatment to two weeks post treatment
State Trait Anxiety Inventory (STAI)
Time Frame: Two weeks pre treatment to two weeks post treatment
Change from baseline in anxiety symptoms to two weeks post treatment.
Two weeks pre treatment to two weeks post treatment
Generalized Anxiety Disorder Questionnaire IV (GAD-Q IV)
Time Frame: Two weeks pre treatment to two weeks post treatment
Change from baseline in anxiety symptoms to two weeks post treatment.
Two weeks pre treatment to two weeks post treatment

Collaborators and Investigators

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

Sponsor

Linkoeping University

Collaborators

Stockholm University

Investigators

  • Study Director: Gerhard Andersson, Professor, Linkoeping 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

January 1, 2009

Primary Completion (Actual)

October 1, 2009

Study Completion (Actual)

December 1, 2010

Study Registration Dates

First Submitted

March 7, 2011

First Submitted That Met QC Criteria

March 9, 2011

First Posted (Estimate)

March 10, 2011

Study Record Updates

Last Update Posted (Estimate)

March 10, 2011

Last Update Submitted That Met QC Criteria

March 9, 2011

Last Verified

March 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Dnr 2007-0756

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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