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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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 August 28, 2014