Pilot Study of Internet-based Cognitive Behavior Therapy for Fibromyalgia

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2011 by Karolinska Institutet.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Karolinska Institutet
ClinicalTrials.gov Identifier:
NCT01468961
First received: November 8, 2011
Last updated: February 9, 2012
Last verified: November 2011
  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: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 Karolinska Institutet:

Primary Outcome Measures:
  • The Fibromyalgia Impact Questionnaire [ Time Frame: Once, 1 week before start of treatment ] [ Designated as safety issue: No ]
  • The Fibromyalgia Impact Questionnaire [ Time Frame: Once, immediately after treatment ] [ Designated as safety issue: No ]
  • The Fibromyalgia Impact Questionnaire [ Time Frame: Once, 6 months after treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Short form 12-item Questionnaire [ Time Frame: Once, 1 week before start of treatment ] [ Designated as safety issue: No ]
  • Short form 12-item Questionnaire [ Time Frame: Once, immediately after treatment ] [ Designated as safety issue: No ]
  • Short form 12-item Questionnaire [ Time Frame: Once, 6 months after treatment ] [ Designated as safety issue: No ]
  • Hospital Anxiety and Depression Scale [ Time Frame: Once, 1 week before start of treatment ] [ Designated as safety issue: No ]
  • Hospital Anxiety and Depression Scale [ Time Frame: Once, immediately after treatment ] [ Designated as safety issue: No ]
  • Hospital Anxiety and Depression Scale [ Time Frame: Once, 6 months after treatment ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: November 2011
Estimated Study Completion Date: September 2012
Estimated 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Current diagnosis of fibromyalgia

Exclusion Criteria:

  • Current diagnosis of severe psychiatric disorder
  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: 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

No publications provided

ClinicalTrials.gov Identifier: NCT01468961     History of Changes
Other Study ID Numbers: FIBRO-P
Study First Received: November 8, 2011
Last Updated: February 9, 2012
Health Authority: Sweden: Regional Ethical Review Board

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

ClinicalTrials.gov processed this record on August 20, 2014