Internet-based Treatment of Generalized Anxiety Disorder

Generalized Anxiety Disorder Clinical Trial

Official title:

Internet-based Treatment of Generalized Anxiety Disorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01570374
• Other study ID #: Oroshjalpen
• Status: Completed
• Phase: N/A
• First received: March 31, 2012
• Last updated: October 31, 2016
• Start date: January 2012
• Est. completion date: February 2016

Study information

• Verified date: October 2016
• Source: Umeå University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 103
• Est. completion date: February 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anxiety Disorders
• Disease
• Generalized Anxiety Disorder

Intervention

Behavioral:
• Internet-based cognitive behavioral therapy (iCBT)
9 week internet-administered, therapist-assisted, controlled-progression cognitive behavioral therapy (iCBT). Individualized and disorder-specific.

Locations

Country	Name	City	State
Sweden	Department of Psychology, Umeå University	Umeå	Västerbotten

Sponsors (1)

Lead Sponsor	Collaborator
Umeå University

Country where clinical trial is conducted

Sweden, 

References & Publications (1)

Dahlin M, Andersson G, Magnusson K, Johansson T, Sjögren J, Håkansson A, Pettersson M, Kadowaki Å, Cuijpers P, Carlbring P. Internet-delivered acceptance-based behaviour therapy for generalized anxiety disorder: A randomized controlled trial. Behav Res Th — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in Penn State Worry Questionnaire (PSWQ)	Measures anxiety symptoms related to Generalized Anxiety Disorder. 16 items.	24 hours	No
Primary	Change from baseline in Penn State Worry Questionnaire (PSWQ)	Measures anxiety symptoms related to Generalized Anxiety Disorder. 16 items.	6 months	No
Primary	Change from baseline in Penn State Worry Questionnaire (PSWQ)	Measures anxiety symptoms related to Generalized Anxiety Disorder. 16 items.	12 months	No
Primary	Change from baseline in Penn State Worry Questionnaire (PSWQ)	Measures anxiety symptoms related to Generalized Anxiety Disorder. 16 items.	24 months	No
Secondary	Change from baseline in Beck Anxiety Inventory (BAI)	21 item rating scale for anxiety symptoms.	24 hours	No
Secondary	Change from baseline in Beck Anxiety Inventory (BAI)	21 item rating scale for anxiety symptoms.	6 months	No
Secondary	Change from baseline in Beck Anxiety Inventory (BAI)	21 item rating scale for anxiety symptoms.	12 months	No
Secondary	Change from baseline in Beck Anxiety Inventory (BAI)	21 item rating scale for anxiety symptoms.	24 months	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	Change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS)	9-item depression rating scale.	24 hours	No
Secondary	Change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS)	9-item depression rating scale.	6 months	No
Secondary	Change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS)	9-item depression rating scale.	12 months	No
Secondary	Change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS)	9-item depression rating scale.	24 months	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	Change from baseline in Generalized Anxiety Disorder-7 (GAD-7)	7-item screening form for Generalized Anxiety Disorder.	Weekly during treatment period	No
Secondary	Change from baseline in Generalized Anxiety Disorder-7 (GAD-7)	7-item screening form for Generalized Anxiety Disorder.	24 hours	No
Secondary	Change from baseline in Generalized Anxiety Disorder-7 (GAD-7)	7-item screening form for Generalized Anxiety Disorder.	6 months	No
Secondary	Change from baseline in Generalized Anxiety Disorder-7 (GAD-7)	7-item screening form for Generalized Anxiety Disorder.	12 months	No
Secondary	Change from baseline in Generalized Anxiety Disorder-7 (GAD-7)	7-item screening form for Generalized Anxiety Disorder.	24 months	No