Internet-based Treatment of Generalized Anxiety Disorder

Study Overview
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Brief Summary
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The purpose of this study is to determine whether internet-administered cognitive behavior therapy is a feasible treatment for generalized anxiety disorder.

Official Title
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Internet-based Treatment of Generalized Anxiety Disorder

Conditions
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Generalized Anxiety Disorder

Intervention / Treatment
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* Behavioral: Internet-based cognitive behavioral therapy (iCBT)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Satisfy DSM-IV criteria for generalized anxiety disorder Living in Sweden and being able to read Swedish Access to computer with internet connection Exclusion Criteria: Currently receiving other psychological treatment Non-stable use of psychoactive medication Deemed suicidal Deemed to suffer from other psychological disorder, e.g. psychosis, bipolarity etc.

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: iCBT<br>Receives treatment. | Behavioral: Internet-based cognitive behavioral therapy (iCBT)<br>* 9 week internet-administered, therapist-assisted, controlled-progression cognitive behavioral therapy (iCBT). Individualized and disorder-specific.<br>|
| No Intervention: Waiting list control group<br>The waiting list control group initially receives no treatment, but do weekly screenings. After 9 weeks, the control group receives the same treatment as the other study arm. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in Penn State Worry Questionnaire (PSWQ) | Measures anxiety symptoms related to Generalized Anxiety Disorder. 16 items. | 24 hours | 
| Change from baseline in Penn State Worry Questionnaire (PSWQ) | Measures anxiety symptoms related to Generalized Anxiety Disorder. 16 items. | 6 months | 
| Change from baseline in Penn State Worry Questionnaire (PSWQ) | Measures anxiety symptoms related to Generalized Anxiety Disorder. 16 items. | 12 months | 
| Change from baseline in Penn State Worry Questionnaire (PSWQ) | Measures anxiety symptoms related to Generalized Anxiety Disorder. 16 items. | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in Beck Anxiety Inventory (BAI) | 21 item rating scale for anxiety symptoms. | 24 hours | 
| Change from baseline in Beck Anxiety Inventory (BAI) | 21 item rating scale for anxiety symptoms. | 6 months | 
| Change from baseline in Beck Anxiety Inventory (BAI) | 21 item rating scale for anxiety symptoms. | 12 months | 
| Change from baseline in Beck Anxiety Inventory (BAI) | 21 item rating scale for anxiety symptoms. | 24 months | 
| Change from baseline in Quality Of Life Inventory (QOLI) | The QOLI assessment yields an overall score and a profile of problems and strengths in 16 areas of life such as love, work and play. The QOLI test is a measure of positive psychology and positive mental health. | 24 hours | 
| Change from baseline in Quality Of Life Inventory (QOLI) | The QOLI assessment yields an overall score and a profile of problems and strengths in 16 areas of life such as love, work and play. The QOLI test is a measure of positive psychology and positive mental health. | 6 months | 
| Change from baseline in Quality Of Life Inventory (QOLI) | The QOLI assessment yields an overall score and a profile of problems and strengths in 16 areas of life such as love, work and play. The QOLI test is a measure of positive psychology and positive mental health. | 12 months | 
| Change from baseline in Quality Of Life Inventory (QOLI) | The QOLI assessment yields an overall score and a profile of problems and strengths in 16 areas of life such as love, work and play. The QOLI test is a measure of positive psychology and positive mental health. | 24 months | 
| Change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) | 9-item depression rating scale. | 24 hours | 
| Change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) | 9-item depression rating scale. | 6 months | 
| Change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) | 9-item depression rating scale. | 12 months | 
| Change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) | 9-item depression rating scale. | 24 months | 
| Change from baseline in Patient Health Questionnaire (PHQ-9) | The PHQ-9 is the nine item depression scale of the Patient Health Questionnaire. The PHQ-9 is a powerful tool for assisting primary care clinicians in diagnosing depression as well as selecting and monitoring treatment. The PHQ-9 is based directly on the diagnostic criteria for major depressive disorder in the Diagnostic and Statistical Manual Fourth Edition (DSM-IV). | Weekly during treatment period | 
| Change from baseline in Patient Health Questionnaire (PHQ-9) | The PHQ-9 is the nine item depression scale of the Patient Health Questionnaire. The PHQ-9 is a powerful tool for assisting primary care clinicians in diagnosing depression as well as selecting and monitoring treatment. The PHQ-9 is based directly on the diagnostic criteria for major depressive disorder in the Diagnostic and Statistical Manual Fourth Edition (DSM-IV). | 24 hours | 
| Change from baseline in Patient Health Questionnaire (PHQ-9) | The PHQ-9 is the nine item depression scale of the Patient Health Questionnaire. The PHQ-9 is a powerful tool for assisting primary care clinicians in diagnosing depression as well as selecting and monitoring treatment. The PHQ-9 is based directly on the diagnostic criteria for major depressive disorder in the Diagnostic and Statistical Manual Fourth Edition (DSM-IV). | 6 months | 
| Change from baseline in Patient Health Questionnaire (PHQ-9) | The PHQ-9 is the nine item depression scale of the Patient Health Questionnaire. The PHQ-9 is a powerful tool for assisting primary care clinicians in diagnosing depression as well as selecting and monitoring treatment. The PHQ-9 is based directly on the diagnostic criteria for major depressive disorder in the Diagnostic and Statistical Manual Fourth Edition (DSM-IV). | 12 months | 
| Change from baseline in Patient Health Questionnaire (PHQ-9) | The PHQ-9 is the nine item depression scale of the Patient Health Questionnaire. The PHQ-9 is a powerful tool for assisting primary care clinicians in diagnosing depression as well as selecting and monitoring treatment. The PHQ-9 is based directly on the diagnostic criteria for major depressive disorder in the Diagnostic and Statistical Manual Fourth Edition (DSM-IV). | 24 months | 
| Change from baseline in Generalized Anxiety Disorder-7 (GAD-7) | 7-item screening form for Generalized Anxiety Disorder. | Weekly during treatment period | 
| Change from baseline in Generalized Anxiety Disorder-7 (GAD-7) | 7-item screening form for Generalized Anxiety Disorder. | 24 hours | 
| Change from baseline in Generalized Anxiety Disorder-7 (GAD-7) | 7-item screening form for Generalized Anxiety Disorder. | 6 months | 
| Change from baseline in Generalized Anxiety Disorder-7 (GAD-7) | 7-item screening form for Generalized Anxiety Disorder. | 12 months | 
| Change from baseline in Generalized Anxiety Disorder-7 (GAD-7) | 7-item screening form for Generalized Anxiety Disorder. | 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anxiety, Cognitive behavioral therapy, Internet, Generalized anxiety disorder