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

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ClinicalTrials.gov Identifier: NCT01312116
Recruitment Status : Completed
First Posted : March 10, 2011
Last Update Posted : March 10, 2011
Sponsor:
Collaborator:
Stockholm University
Information provided by:
Linkoeping University

Brief Summary:
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 or disease Intervention/treatment Phase
Generalized Anxiety Disorder Behavioral: iCBT Behavioral: iPDT Not Applicable

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  (Clinical Trial)
Actual Enrollment : 81 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Psychodynamic Versus Cognitive Behavioral Internet-Delivered Guided Self-help for Generalized Anxiety Disorder: A Randomized Controlled Trial
Study Start Date : January 2009
Actual Primary Completion Date : October 2009
Actual Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety
U.S. FDA Resources

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



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01312116


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

Responsible Party: Gerhard Andersson, Professor, Linköping University
ClinicalTrials.gov Identifier: NCT01312116     History of Changes
Other Study ID Numbers: Dnr 2007-0756
First Posted: March 10, 2011    Key Record Dates
Last Update Posted: March 10, 2011
Last Verified: March 2011

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

Additional relevant MeSH terms:
Disease
Anxiety Disorders
Pathologic Processes
Mental Disorders