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

Primary Purpose

Generalized Anxiety Disorder

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
iCBT
iPDT
Sponsored by
Linkoeping University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Generalized Anxiety Disorder focused on measuring Internet treatment, GAD, guided self-help

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Linköping University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Internet-delivered CBT

Internet-delivered PDT

Control condition

Arm Description

Active treatment: Internet-delivered Cognitive Behavior Therapy, 8 weeks treatment, guided self-help

Active treatment: Internet-delivered Psychodynamic Therapy Active treatment: Internet-delivered Psychodynamic Therapy, 8 weeks treatment, guided self-help

Wait-list condition, received treatment 3 months after initial treatment period

Outcomes

Primary Outcome Measures

Penn State Worry Questionnaire (PSWQ)
Change from baseline in anxiety symptoms to two weeks post treatment.

Secondary Outcome Measures

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

Full Information

First Posted
March 7, 2011
Last Updated
March 9, 2011
Sponsor
Linkoeping University
Collaborators
Stockholm University
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1. Study Identification

Unique Protocol Identification Number
NCT01312116
Brief Title
Psychodynamic Internet Treatment Versus Cognitive Behavioral Therapy (CBT) for Generalized Anxiety Disorder
Official Title
Psychodynamic Versus Cognitive Behavioral Internet-Delivered Guided Self-help for Generalized Anxiety Disorder: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2011
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
October 2009 (Actual)
Study Completion Date
December 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Linkoeping University
Collaborators
Stockholm University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Generalized Anxiety Disorder
Keywords
Internet treatment, GAD, guided self-help

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
81 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Internet-delivered CBT
Arm Type
Experimental
Arm Description
Active treatment: Internet-delivered Cognitive Behavior Therapy, 8 weeks treatment, guided self-help
Arm Title
Internet-delivered PDT
Arm Type
Experimental
Arm Description
Active treatment: Internet-delivered Psychodynamic Therapy Active treatment: Internet-delivered Psychodynamic Therapy, 8 weeks treatment, guided self-help
Arm Title
Control condition
Arm Type
No Intervention
Arm Description
Wait-list condition, received treatment 3 months after initial treatment period
Intervention Type
Behavioral
Intervention Name(s)
iCBT
Intervention Description
Internet-delivered cognitive behavior therapy, 8 weeks
Intervention Type
Behavioral
Intervention Name(s)
iPDT
Intervention Description
Internet-delivered psychodynamic therapy, 8 weeks
Primary Outcome Measure Information:
Title
Penn State Worry Questionnaire (PSWQ)
Description
Change from baseline in anxiety symptoms to two weeks post treatment.
Time Frame
Two weeks pre treatment to two weeks post treatment.
Secondary Outcome Measure Information:
Title
Montgomery Åsberg Depression Rating Scale-Self Rated (MADRS-S)
Description
Change from baseline in depressive symptoms to two weeks post treatment.
Time Frame
Two weeks pre treatment to two weeks post treatment
Title
Quality of Life Inventory (QOLI)
Description
Change from baseline in quality of life status to two weeks post treatment.
Time Frame
Two weeks pre treatment to two weeks post treatment
Title
Beck Depression Inventory (BDI)
Description
Change from baseline in depressive symptoms to two weeks post treatment.
Time Frame
Two weeks pre treatment to two weeks post treatment
Title
Beck Anxiety Inventory (BAI)
Description
Change from baseline in anxiety symptoms to two weeks post treatment.
Time Frame
Two weeks pre treatment to two weeks post treatment
Title
Trimbos and iMTA questionnaire on Costs associated with Psychiatric illness (TIC-P)
Description
Change from baseline in societal cost of illness to two weeks post treatment.
Time Frame
Two weeks pre treatment to two weeks post treatment
Title
State Trait Anxiety Inventory (STAI)
Description
Change from baseline in anxiety symptoms to two weeks post treatment.
Time Frame
Two weeks pre treatment to two weeks post treatment
Title
Generalized Anxiety Disorder Questionnaire IV (GAD-Q IV)
Description
Change from baseline in anxiety symptoms to two weeks post treatment.
Time Frame
Two weeks pre treatment to two weeks post treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gerhard Andersson, Professor
Organizational Affiliation
Linkoeping University
Official's Role
Study Director
Facility Information:
Facility Name
Linköping University
City
Linköping
State/Province
Östergötland
ZIP/Postal Code
581 83
Country
Sweden

12. IPD Sharing Statement

Links:
URL
http://www.kbt.info/origo2/
Description
Project site

Learn more about this trial

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

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