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Internet-based Treatment of Generalized Anxiety Disorder

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01570374
First Posted: April 4, 2012
Last Update Posted: November 1, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Per Carlbring, PhD, Umeå University
  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: None (Open Label)
Primary Purpose: Treatment
Official Title: Internet-based Treatment of Generalized Anxiety Disorder

Resource links provided by NLM:


Further study details as provided by Per Carlbring, PhD, Umeå University:

Primary Outcome Measures:
  • Change from baseline in Penn State Worry Questionnaire (PSWQ) [ Time Frame: 24 hours ]
    Measures anxiety symptoms related to Generalized Anxiety Disorder. 16 items.

  • Change from baseline in Penn State Worry Questionnaire (PSWQ) [ Time Frame: 6 months ]
    Measures anxiety symptoms related to Generalized Anxiety Disorder. 16 items.

  • Change from baseline in Penn State Worry Questionnaire (PSWQ) [ Time Frame: 12 months ]
    Measures anxiety symptoms related to Generalized Anxiety Disorder. 16 items.

  • Change from baseline in Penn State Worry Questionnaire (PSWQ) [ Time Frame: 24 months ]
    Measures anxiety symptoms related to Generalized Anxiety Disorder. 16 items.


Secondary Outcome Measures:
  • Change from baseline in Beck Anxiety Inventory (BAI) [ Time Frame: 24 hours ]
    21 item rating scale for anxiety symptoms.

  • Change from baseline in Beck Anxiety Inventory (BAI) [ Time Frame: 6 months ]
    21 item rating scale for anxiety symptoms.

  • Change from baseline in Beck Anxiety Inventory (BAI) [ Time Frame: 12 months ]
    21 item rating scale for anxiety symptoms.

  • Change from baseline in Beck Anxiety Inventory (BAI) [ Time Frame: 24 months ]
    21 item rating scale for anxiety symptoms.

  • Change from baseline in Quality Of Life Inventory (QOLI) [ Time Frame: 24 hours ]
    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 ]
    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 ]
    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 ]
    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 ]
    9-item depression rating scale.

  • Change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) [ Time Frame: 6 months ]
    9-item depression rating scale.

  • Change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) [ Time Frame: 12 months ]
    9-item depression rating scale.

  • Change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) [ Time Frame: 24 months ]
    9-item depression rating scale.

  • Change from baseline in Patient Health Questionnaire (PHQ-9) [ Time Frame: Weekly during treatment period ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    7-item screening form for Generalized Anxiety Disorder.

  • Change from baseline in Generalized Anxiety Disorder-7 (GAD-7) [ Time Frame: 24 hours ]
    7-item screening form for Generalized Anxiety Disorder.

  • Change from baseline in Generalized Anxiety Disorder-7 (GAD-7) [ Time Frame: 6 months ]
    7-item screening form for Generalized Anxiety Disorder.

  • Change from baseline in Generalized Anxiety Disorder-7 (GAD-7) [ Time Frame: 12 months ]
    7-item screening form for Generalized Anxiety Disorder.

  • Change from baseline in Generalized Anxiety Disorder-7 (GAD-7) [ Time Frame: 24 months ]
    7-item screening form for Generalized Anxiety Disorder.


Enrollment: 103
Study Start Date: January 2012
Study Completion Date: February 2016
Primary Completion Date: January 2016 (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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01570374


Locations
Sweden
Department of Psychology, Umeå University
Umeå, Västerbotten, Sweden, 90181
Sponsors and Collaborators
Umeå University
Investigators
Principal Investigator: Per Carlbring, Professor Department of Psychology, Umeå University
  More Information

Publications:
Responsible Party: Per Carlbring, PhD, Professor, Umeå University
ClinicalTrials.gov Identifier: NCT01570374     History of Changes
Other Study ID Numbers: Oroshjalpen
First Submitted: March 31, 2012
First Posted: April 4, 2012
Last Update Posted: November 1, 2016
Last Verified: October 2016

Keywords provided by Per Carlbring, PhD, Umeå University:
Cognitive behavioral therapy
Internet
Anxiety
Generalized anxiety disorder

Additional relevant MeSH terms:
Disease
Anxiety Disorders
Pathologic Processes
Mental Disorders