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Pilot Study of Internet-based Cognitive Behavior Therapy for Fibromyalgia

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ClinicalTrials.gov Identifier: NCT01468961
Recruitment Status : Completed
First Posted : November 10, 2011
Last Update Posted : August 22, 2017
Sponsor:
Information provided by (Responsible Party):
Brjann Ljotsson, Karolinska Institutet

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
This pilot trial will include 30-40 participants with a diagnosis of fibromyalgia. The purpose of the study is to evaluate an internet-based treatment protocol based on cognitive behavioral therapeutic principles. Participants are required to have a previous diagnosis of fibromyalgia before entering into the trial. The treatment will be 10 weeks long and all included participants will be given treatment, i.e. there is no randomization to a comparison group.

Condition or disease Intervention/treatment Phase
Fibromyalgia Behavioral: Internet-based CBT Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 41 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pilot Study of Internet-based Cognitive Behavior Therapy for Fibromyalgia
Study Start Date : November 2011
Actual Primary Completion Date : September 2012
Actual Study Completion Date : September 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fibromyalgia
U.S. FDA Resources

Arms and Interventions
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Internet-based CBT Behavioral: Internet-based CBT
10 weeks of internet-based CBT with online therapist contact


Outcome Measures
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Primary Outcome Measures :
  1. The Fibromyalgia Impact Questionnaire [ Time Frame: Once, 1 week before start of treatment ]
  2. The Fibromyalgia Impact Questionnaire [ Time Frame: Once, immediately after treatment ]
  3. The Fibromyalgia Impact Questionnaire [ Time Frame: Once, 6 months after treatment ]

Secondary Outcome Measures :
  1. Short form 12-item Questionnaire [ Time Frame: Once, 1 week before start of treatment ]
  2. Short form 12-item Questionnaire [ Time Frame: Once, immediately after treatment ]
  3. Short form 12-item Questionnaire [ Time Frame: Once, 6 months after treatment ]
  4. Hospital Anxiety and Depression Scale [ Time Frame: Once, 1 week before start of treatment ]
  5. Hospital Anxiety and Depression Scale [ Time Frame: Once, immediately after treatment ]
  6. Hospital Anxiety and Depression Scale [ Time Frame: Once, 6 months after treatment ]

Eligibility Criteria
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Current diagnosis of fibromyalgia

Exclusion Criteria:

  • Current diagnosis of severe psychiatric disorder
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT01468961


Locations
Sweden
Karolinska Institutet, Department of Clinical Neuroscience, Section of psychiatry, Karolinska Hospital Solna R5
Stockholm, Sweden, 171 76
Sponsors and Collaborators
Karolinska Institutet
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications of Results:

Responsible Party: Brjann Ljotsson, Associate professor, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT01468961     History of Changes
Other Study ID Numbers: FIBRO-P
First Posted: November 10, 2011    Key Record Dates
Last Update Posted: August 22, 2017
Last Verified: August 2017

Additional relevant MeSH terms:
Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
 Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases