Internet-based Treatment of Generalized Anxiety Disorder - Full Text View

Purpose

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

Condition	Intervention
Generalized Anxiety Disorder	Behavioral: Internet-based cognitive behavioral therapy (iCBT)

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Internet-based Treatment of Generalized Anxiety Disorder

Resource links provided by NLM:

MedlinePlus related topics: Anxiety

U.S. FDA Resources

Further study details as provided by Umeå University:

Primary Outcome Measures:

Change from baseline in Penn State Worry Questionnaire (PSWQ) [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
Measures anxiety symtoms related to Generalized Anxiety Disorder. 16 items.
Change from baseline in Penn State Worry Questionnaire (PSWQ) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Measures anxiety symtoms related to Generalized Anxiety Disorder. 16 items.
Change from baseline in Penn State Worry Questionnaire (PSWQ) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Measures anxiety symtoms related to Generalized Anxiety Disorder. 16 items.
Change from baseline in Penn State Worry Questionnaire (PSWQ) [ Time Frame: 24 months ] [ Designated as safety issue: No ]
Measures anxiety symtoms related to Generalized Anxiety Disorder. 16 items.

Secondary Outcome Measures:

Change from baseline in Beck Anxiety Inventory (BAI) [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
21 item rating scale for anxiety symptoms.
Change from baseline in Beck Anxiety Inventory (BAI) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
21 item rating scale for anxiety symptoms.
Change from baseline in Beck Anxiety Inventory (BAI) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
21 item rating scale for anxiety symptoms.
Change from baseline in Beck Anxiety Inventory (BAI) [ Time Frame: 24 months ] [ Designated as safety issue: No ]
21 item rating scale for anxiety symptoms.
Change from baseline in Quality Of Life Inventory (QOLI) [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
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.
Change from baseline in Quality Of Life Inventory (QOLI) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
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.
Change from baseline in Quality Of Life Inventory (QOLI) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
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.
Change from baseline in Quality Of Life Inventory (QOLI) [ Time Frame: 24 months ] [ Designated as safety issue: No ]
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.
Change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
9-item depression rating scale.
Change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
9-item depression rating scale.
Change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
9-item depression rating scale.
Change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) [ Time Frame: 24 months ] [ Designated as safety issue: No ]
9-item depression rating scale.
Change from baseline in Patient Health Questionnaire (PHQ-9) [ Time Frame: Weekly during treatment period ] [ Designated as safety issue: No ]
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).
Change from baseline in Patient Health Questionnaire (PHQ-9) [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
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).
Change from baseline in Patient Health Questionnaire (PHQ-9) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
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).
Change from baseline in Patient Health Questionnaire (PHQ-9) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
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).
Change from baseline in Patient Health Questionnaire (PHQ-9) [ Time Frame: 24 months ] [ Designated as safety issue: No ]
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).
Change from baseline in Generalized Anxiety Disorder-7 (GAD-7) [ Time Frame: Weekly during treatment period ] [ Designated as safety issue: No ]
7-item screening form for Generalized Anxiety Disorder.
Change from baseline in Generalized Anxiety Disorder-7 (GAD-7) [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
7-item screening form for Generalized Anxiety Disorder.
Change from baseline in Generalized Anxiety Disorder-7 (GAD-7) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
7-item screening form for Generalized Anxiety Disorder.
Change from baseline in Generalized Anxiety Disorder-7 (GAD-7) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
7-item screening form for Generalized Anxiety Disorder.
Change from baseline in Generalized Anxiety Disorder-7 (GAD-7) [ Time Frame: 24 months ] [ Designated as safety issue: No ]
7-item screening form for Generalized Anxiety Disorder.

Estimated Enrollment:	128
Study Start Date:	January 2012
Estimated Study Completion Date:	January 2014
Estimated Primary Completion Date:	January 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: iCBT Receives treatment.	Behavioral: Internet-based cognitive behavioral therapy (iCBT) 9 week internet-administered, therapist-assisted, controlled-progression cognitive behavioral therapy (iCBT). Individualized and disorder-specific.
No Intervention: Waiting list control group 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.	Behavioral: Internet-based cognitive behavioral therapy (iCBT) 9 week internet-administered, therapist-assisted, controlled-progression cognitive behavioral therapy (iCBT). Individualized and disorder-specific.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01570374

Contacts

Contact: Per Carlbring, Professor

+46 90-786 78 33

per.carlbring@psy.umu.se

Locations

Sweden
Department of Psychology, Umeå University	Recruiting
Umeå, Västerbotten, Sweden, 90181
Contact: Per Carlbring, Professor +46 90-786 78 33 per.carlbring@psy.umu.se

Sponsors and Collaborators

Umeå University

Investigators

Principal Investigator:

Per Carlbring, Professor

Department of Psychology, Umeå University

More Information

No publications provided

Responsible Party:	Per Carlbring, PhD, Professor, Umeå University
ClinicalTrials.gov Identifier:	NCT01570374 History of Changes
Other Study ID Numbers:	Oroshjalpen
Study First Received:	March 31, 2012
Last Updated:	April 3, 2012
Health Authority:	Sweden: Regional Ethical Review Board

Keywords provided by Umeå University:

Cognitive behavioral therapy
Internet
Anxiety
Generalized anxiety disorder

Additional relevant MeSH terms:

Anxiety Disorders
Mental Disorders

ClinicalTrials.gov processed this record on May 19, 2013