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Pilot Study of Internet-based Cognitive Behavior Therapy for Fibromyalgia

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01468961
First Posted: November 10, 2011
Last Update Posted: August 22, 2017
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):
Brjann Ljotsson, Karolinska Institutet
  Purpose
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 Intervention
Fibromyalgia Behavioral: Internet-based CBT

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pilot Study of Internet-based Cognitive Behavior Therapy for Fibromyalgia

Resource links provided by NLM:


Further study details as provided by Brjann Ljotsson, Karolinska Institutet:

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

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

Enrollment: 41
Study Start Date: November 2011
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Internet-based CBT Behavioral: Internet-based CBT
10 weeks of internet-based CBT with online therapist contact

  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:

  • Current diagnosis of fibromyalgia

Exclusion Criteria:

  • Current diagnosis of severe psychiatric disorder
  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): 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

Publications:
Responsible Party: Brjann Ljotsson, Associate professor, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT01468961     History of Changes
Other Study ID Numbers: FIBRO-P
First Submitted: November 8, 2011
First Posted: November 10, 2011
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