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

Generalized Anxiety Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01312116
• Other study ID #: Dnr 2007-0756
• Status: Completed
• Phase: N/A
• First received: March 7, 2011
• Last updated: March 9, 2011
• Start date: January 2009
• Est. completion date: December 2010

Study information

• Verified date: March 2011
• Source: Linkoeping University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 81
• Est. completion date: December 2010
• Est. primary completion date: October 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anxiety Disorders
• Generalized Anxiety Disorder

Intervention

Behavioral:
• iCBT
Internet-delivered cognitive behavior therapy, 8 weeks
• iPDT
Internet-delivered psychodynamic therapy, 8 weeks

Locations

Country	Name	City	State
Sweden	Linköping University	Linköping	Östergötland

Sponsors (2)

Lead Sponsor	Collaborator
Linkoeping University	Stockholm University

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Penn State Worry Questionnaire (PSWQ)	Change from baseline in anxiety symptoms to two weeks post treatment.	Two weeks pre treatment to two weeks post treatment.	No
Secondary	Montgomery Åsberg Depression Rating Scale-Self Rated (MADRS-S)	Change from baseline in depressive symptoms to two weeks post treatment.	Two weeks pre treatment to two weeks post treatment	Yes
Secondary	Quality of Life Inventory (QOLI)	Change from baseline in quality of life status to two weeks post treatment.	Two weeks pre treatment to two weeks post treatment	No
Secondary	Beck Depression Inventory (BDI)	Change from baseline in depressive symptoms to two weeks post treatment.	Two weeks pre treatment to two weeks post treatment	No
Secondary	Beck Anxiety Inventory (BAI)	Change from baseline in anxiety symptoms to two weeks post treatment.	Two weeks pre treatment to two weeks post treatment	No
Secondary	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.	Two weeks pre treatment to two weeks post treatment	No
Secondary	State Trait Anxiety Inventory (STAI)	Change from baseline in anxiety symptoms to two weeks post treatment.	Two weeks pre treatment to two weeks post treatment	No
Secondary	Generalized Anxiety Disorder Questionnaire IV (GAD-Q IV)	Change from baseline in anxiety symptoms to two weeks post treatment.	Two weeks pre treatment to two weeks post treatment	No