Psychodynamic Internet Treatment Versus Cognitive Behavioral Therapy (CBT) for Generalized Anxiety Disorder
This study has been completed.
Sponsor:
Linkoeping University
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
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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 May 23, 2013