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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Generalized Anxiety Disorder

Intervention / Treatment
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* Behavioral: iCBT
* Behavioral: iPDT


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Internet-delivered CBT<br>Active treatment: Internet-delivered Cognitive Behavior Therapy, 8 weeks treatment, guided self-help | Behavioral: iCBT<br>* Internet-delivered cognitive behavior therapy, 8 weeks<br>|
| Experimental: Internet-delivered PDT<br>Active treatment: Internet-delivered Psychodynamic Therapy Active treatment: Internet-delivered Psychodynamic Therapy, 8 weeks treatment, guided self-help | Behavioral: iPDT<br>* Internet-delivered psychodynamic therapy, 8 weeks<br>|
| No Intervention: Control condition<br>Wait-list condition, received treatment 3 months after initial treatment period | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| Beck Depression Inventory (BDI) | Change from baseline in depressive symptoms to two weeks post treatment. | Two weeks pre treatment to two weeks post treatment | 
| Beck Anxiety Inventory (BAI) | Change from baseline in anxiety symptoms to two weeks post treatment. | Two weeks pre treatment 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. | Two weeks pre treatment to two weeks post treatment | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Internet treatment, GAD, guided self-help