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

This study has been completed.
Sponsor:
Collaborator:
Stockholm University
Information provided by:
Linkoeping University
ClinicalTrials.gov Identifier:
NCT01312116
First received: March 7, 2011
Last updated: March 9, 2011
Last verified: March 2011
  Purpose

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.


Condition Intervention
Generalized Anxiety Disorder
Behavioral: iCBT
Behavioral: iPDT

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Psychodynamic Versus Cognitive Behavioral Internet-Delivered Guided Self-help for Generalized Anxiety Disorder: A Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by Linkoeping University:

Primary Outcome Measures:
  • Penn State Worry Questionnaire (PSWQ) [ Time Frame: Two weeks pre treatment to two weeks post treatment. ] [ Designated as safety issue: No ]
    Change from baseline in anxiety symptoms to two weeks post treatment.


Secondary Outcome Measures:
  • Montgomery Åsberg Depression Rating Scale-Self Rated (MADRS-S) [ Time Frame: Two weeks pre treatment to two weeks post treatment ] [ Designated as safety issue: Yes ]
    Change from baseline in depressive symptoms to two weeks post treatment.

  • Quality of Life Inventory (QOLI) [ Time Frame: Two weeks pre treatment to two weeks post treatment ] [ Designated as safety issue: No ]
    Change from baseline in quality of life status to two weeks post treatment.

  • Beck Depression Inventory (BDI) [ Time Frame: Two weeks pre treatment to two weeks post treatment ] [ Designated as safety issue: No ]
    Change from baseline in depressive symptoms to two weeks post treatment.

  • Beck Anxiety Inventory (BAI) [ Time Frame: Two weeks pre treatment to two weeks post treatment ] [ Designated as safety issue: No ]
    Change from baseline in anxiety symptoms 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 ] [ Designated as safety issue: No ]
    Change from baseline in societal cost of illness to two weeks post treatment.

  • State Trait Anxiety Inventory (STAI) [ Time Frame: Two weeks pre treatment to two weeks post treatment ] [ Designated as safety issue: No ]
    Change from baseline in anxiety symptoms to two weeks post treatment.

  • Generalized Anxiety Disorder Questionnaire IV (GAD-Q IV) [ Time Frame: Two weeks pre treatment to two weeks post treatment ] [ Designated as safety issue: No ]
    Change from baseline in anxiety symptoms to two weeks post treatment.


Enrollment: 81
Study Start Date: January 2009
Study Completion Date: December 2010
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01312116

Locations
Sweden
Linköping University
Linköping, Östergötland, Sweden, 581 83
Sponsors and Collaborators
Linkoeping University
Stockholm University
Investigators
Study Director: Gerhard Andersson, Professor Linköping University
  More Information

Additional Information:
No publications provided

Responsible Party: Gerhard Andersson, Professor, Linköping University
ClinicalTrials.gov Identifier: NCT01312116     History of Changes
Other Study ID Numbers: Dnr 2007-0756
Study First Received: March 7, 2011
Last Updated: March 9, 2011
Health Authority: Sweden: Regional Ethical Review Board

Keywords provided by Linkoeping University:
Internet treatment
GAD
guided self-help

Additional relevant MeSH terms:
Anxiety Disorders
Mental Disorders

ClinicalTrials.gov processed this record on April 23, 2014