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Internet-based Treatment of Generalized Anxiety Disorder

Primary Purpose

Generalized Anxiety Disorder

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Internet-based cognitive behavioral therapy (iCBT)
Sponsored by
Umeå University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Generalized Anxiety Disorder focused on measuring Cognitive behavioral therapy, Internet, Anxiety, Generalized anxiety disorder

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Department of Psychology, Umeå University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

iCBT

Waiting list control group

Arm Description

Receives treatment.

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.

Outcomes

Primary Outcome Measures

Change from baseline in Penn State Worry Questionnaire (PSWQ)
Measures anxiety symptoms related to Generalized Anxiety Disorder. 16 items.
Change from baseline in Penn State Worry Questionnaire (PSWQ)
Measures anxiety symptoms related to Generalized Anxiety Disorder. 16 items.
Change from baseline in Penn State Worry Questionnaire (PSWQ)
Measures anxiety symptoms related to Generalized Anxiety Disorder. 16 items.
Change from baseline in Penn State Worry Questionnaire (PSWQ)
Measures anxiety symptoms related to Generalized Anxiety Disorder. 16 items.

Secondary Outcome Measures

Change from baseline in Beck Anxiety Inventory (BAI)
21 item rating scale for anxiety symptoms.
Change from baseline in Beck Anxiety Inventory (BAI)
21 item rating scale for anxiety symptoms.
Change from baseline in Beck Anxiety Inventory (BAI)
21 item rating scale for anxiety symptoms.
Change from baseline in Beck Anxiety Inventory (BAI)
21 item rating scale for anxiety symptoms.
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.
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.
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.
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.
Change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS)
9-item depression rating scale.
Change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS)
9-item depression rating scale.
Change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS)
9-item depression rating scale.
Change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS)
9-item depression rating scale.
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).
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).
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).
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).
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).
Change from baseline in Generalized Anxiety Disorder-7 (GAD-7)
7-item screening form for Generalized Anxiety Disorder.
Change from baseline in Generalized Anxiety Disorder-7 (GAD-7)
7-item screening form for Generalized Anxiety Disorder.
Change from baseline in Generalized Anxiety Disorder-7 (GAD-7)
7-item screening form for Generalized Anxiety Disorder.
Change from baseline in Generalized Anxiety Disorder-7 (GAD-7)
7-item screening form for Generalized Anxiety Disorder.
Change from baseline in Generalized Anxiety Disorder-7 (GAD-7)
7-item screening form for Generalized Anxiety Disorder.

Full Information

First Posted
March 31, 2012
Last Updated
October 31, 2016
Sponsor
Umeå University
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1. Study Identification

Unique Protocol Identification Number
NCT01570374
Brief Title
Internet-based Treatment of Generalized Anxiety Disorder
Official Title
Internet-based Treatment of Generalized Anxiety Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
January 2016 (Actual)
Study Completion Date
February 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Umeå University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Generalized Anxiety Disorder
Keywords
Cognitive behavioral therapy, Internet, Anxiety, Generalized anxiety disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
103 (Actual)

8. Arms, Groups, and Interventions

Arm Title
iCBT
Arm Type
Experimental
Arm Description
Receives treatment.
Arm Title
Waiting list control group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Internet-based cognitive behavioral therapy (iCBT)
Intervention Description
9 week internet-administered, therapist-assisted, controlled-progression cognitive behavioral therapy (iCBT). Individualized and disorder-specific.
Primary Outcome Measure Information:
Title
Change from baseline in Penn State Worry Questionnaire (PSWQ)
Description
Measures anxiety symptoms related to Generalized Anxiety Disorder. 16 items.
Time Frame
24 hours
Title
Change from baseline in Penn State Worry Questionnaire (PSWQ)
Description
Measures anxiety symptoms related to Generalized Anxiety Disorder. 16 items.
Time Frame
6 months
Title
Change from baseline in Penn State Worry Questionnaire (PSWQ)
Description
Measures anxiety symptoms related to Generalized Anxiety Disorder. 16 items.
Time Frame
12 months
Title
Change from baseline in Penn State Worry Questionnaire (PSWQ)
Description
Measures anxiety symptoms related to Generalized Anxiety Disorder. 16 items.
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Change from baseline in Beck Anxiety Inventory (BAI)
Description
21 item rating scale for anxiety symptoms.
Time Frame
24 hours
Title
Change from baseline in Beck Anxiety Inventory (BAI)
Description
21 item rating scale for anxiety symptoms.
Time Frame
6 months
Title
Change from baseline in Beck Anxiety Inventory (BAI)
Description
21 item rating scale for anxiety symptoms.
Time Frame
12 months
Title
Change from baseline in Beck Anxiety Inventory (BAI)
Description
21 item rating scale for anxiety symptoms.
Time Frame
24 months
Title
Change from baseline in Quality Of Life Inventory (QOLI)
Description
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.
Time Frame
24 hours
Title
Change from baseline in Quality Of Life Inventory (QOLI)
Description
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.
Time Frame
6 months
Title
Change from baseline in Quality Of Life Inventory (QOLI)
Description
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.
Time Frame
12 months
Title
Change from baseline in Quality Of Life Inventory (QOLI)
Description
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.
Time Frame
24 months
Title
Change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS)
Description
9-item depression rating scale.
Time Frame
24 hours
Title
Change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS)
Description
9-item depression rating scale.
Time Frame
6 months
Title
Change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS)
Description
9-item depression rating scale.
Time Frame
12 months
Title
Change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS)
Description
9-item depression rating scale.
Time Frame
24 months
Title
Change from baseline in Patient Health Questionnaire (PHQ-9)
Description
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).
Time Frame
Weekly during treatment period
Title
Change from baseline in Patient Health Questionnaire (PHQ-9)
Description
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).
Time Frame
24 hours
Title
Change from baseline in Patient Health Questionnaire (PHQ-9)
Description
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).
Time Frame
6 months
Title
Change from baseline in Patient Health Questionnaire (PHQ-9)
Description
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).
Time Frame
12 months
Title
Change from baseline in Patient Health Questionnaire (PHQ-9)
Description
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).
Time Frame
24 months
Title
Change from baseline in Generalized Anxiety Disorder-7 (GAD-7)
Description
7-item screening form for Generalized Anxiety Disorder.
Time Frame
Weekly during treatment period
Title
Change from baseline in Generalized Anxiety Disorder-7 (GAD-7)
Description
7-item screening form for Generalized Anxiety Disorder.
Time Frame
24 hours
Title
Change from baseline in Generalized Anxiety Disorder-7 (GAD-7)
Description
7-item screening form for Generalized Anxiety Disorder.
Time Frame
6 months
Title
Change from baseline in Generalized Anxiety Disorder-7 (GAD-7)
Description
7-item screening form for Generalized Anxiety Disorder.
Time Frame
12 months
Title
Change from baseline in Generalized Anxiety Disorder-7 (GAD-7)
Description
7-item screening form for Generalized Anxiety Disorder.
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Per Carlbring, Professor
Organizational Affiliation
Department of Psychology, Umeå University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Psychology, Umeå University
City
Umeå
State/Province
Västerbotten
ZIP/Postal Code
90181
Country
Sweden

12. IPD Sharing Statement

Citations:
PubMed Identifier
26731173
Citation
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.
Results Reference
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Learn more about this trial

Internet-based Treatment of Generalized Anxiety Disorder

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