Internet-based Treatment of Generalized Anxiety Disorder

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2012 by Umeå University.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Per Carlbring, PhD, Umeå University
ClinicalTrials.gov Identifier:
NCT01570374
First received: March 31, 2012
Last updated: April 3, 2012
Last verified: March 2012
  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:


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
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, see Learn About Clinical Studies.

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 July 28, 2014