Internet-based Treatment of Generalized Anxiety Disorder

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

Study Overview

• Status: Completed
• Conditions: Generalized Anxiety Disorder
• Intervention / Treatment: Behavioral: Internet-based cognitive behavioral therapy (iCBT)

• Study Type: Interventional
• Enrollment (Actual): 103
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Västerbotten
    • Umeå, Västerbotten, Sweden, 90181
      • Department of Psychology, Umeå University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Umeå University

Publications and helpful links

General Publications

• Dahlin M, Andersson G, Magnusson K, Johansson T, Sjogren J, Hakansson A, Pettersson M, Kadowaki A, Cuijpers P, Carlbring P. Internet-delivered acceptance-based behaviour therapy for generalized anxiety disorder: A randomized controlled trial. Behav Res Ther. 2016 Feb;77:86-95. doi: 10.1016/j.brat.2015.12.007. Epub 2015 Dec 21.

Study record dates

Study Major Dates

• Study Start: January 1, 2012
• Primary Completion (ACTUAL): January 1, 2016
• Study Completion (ACTUAL): February 1, 2016

Study Registration Dates

• First Submitted: March 31, 2012
• First Submitted That Met QC Criteria: April 3, 2012
• First Posted (ESTIMATE): April 4, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): November 1, 2016
• Last Update Submitted That Met QC Criteria: October 31, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Keywords: Anxiety; Cognitive behavioral therapy; Internet; Generalized anxiety disorder
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Disease; Anxiety Disorders
• Other Study ID Numbers: Oroshjalpen