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Completed

NCT Number: NCT01570374

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.

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Key information

Conditions

Generalized Anxiety Disorder Anxiety Disorders Mental Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Psychology, Umeå University

Umeå, Västerbotten County, 90181, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Internet-Based Cognitive Behavioral Therapy (iCBT)

Behavioral

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

Primary outcomes

  1. Change from baseline in Penn State Worry Questionnaire (PSWQ)

    Time frame: 24 hours

    Measures anxiety symptoms related to Generalized Anxiety Disorder. 16 items.

  2. Change from baseline in Penn State Worry Questionnaire (PSWQ)

    Time frame: 6 months

    Measures anxiety symptoms related to Generalized Anxiety Disorder. 16 items.

  3. Change from baseline in Penn State Worry Questionnaire (PSWQ)

    Time frame: 12 months

    Measures anxiety symptoms related to Generalized Anxiety Disorder. 16 items.

  4. Change from baseline in Penn State Worry Questionnaire (PSWQ)

    Time frame: 24 months

    Measures anxiety symptoms related to Generalized Anxiety Disorder. 16 items.

Secondary outcomes

  1. Change from baseline in Beck Anxiety Inventory (BAI)

    Time frame: 24 hours

    21 item rating scale for anxiety symptoms.

  2. Change from baseline in Beck Anxiety Inventory (BAI)

    Time frame: 6 months

    21 item rating scale for anxiety symptoms.

  3. Change from baseline in Beck Anxiety Inventory (BAI)

    Time frame: 12 months

    21 item rating scale for anxiety symptoms.

  4. Change from baseline in Beck Anxiety Inventory (BAI)

    Time frame: 24 months

    21 item rating scale for anxiety symptoms.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. Change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS)

    Time frame: 24 hours

    9-item depression rating scale.

  10. Change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS)

    Time frame: 6 months

    9-item depression rating scale.

  11. Change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS)

    Time frame: 12 months

    9-item depression rating scale.

  12. Change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS)

    Time frame: 24 months

    9-item depression rating scale.

  13. 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).

  14. 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).

  15. 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).

  16. 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).

  17. 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).

  18. Change from baseline in Generalized Anxiety Disorder-7 (GAD-7)

    Time frame: Weekly during treatment period

    7-item screening form for Generalized Anxiety Disorder.

  19. Change from baseline in Generalized Anxiety Disorder-7 (GAD-7)

    Time frame: 24 hours

    7-item screening form for Generalized Anxiety Disorder.

  20. Change from baseline in Generalized Anxiety Disorder-7 (GAD-7)

    Time frame: 6 months

    7-item screening form for Generalized Anxiety Disorder.

  21. Change from baseline in Generalized Anxiety Disorder-7 (GAD-7)

    Time frame: 12 months

    7-item screening form for Generalized Anxiety Disorder.

  22. Change from baseline in Generalized Anxiety Disorder-7 (GAD-7)

    Time frame: 24 months

    7-item screening form for Generalized Anxiety Disorder.

Sponsors and collaborators

Lead sponsor

Umeå University

Other

Registry information

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Apr 4, 2012
Registry last updated
Nov 1, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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