Pilot Study of Internet-based Cognitive Behavior Therapy for Fibromyalgia

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.

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

History of Changes

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:

MedlinePlus related topics: Fibromyalgia

U.S. FDA Resources

Further study details as provided by 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 ]


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 (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

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


ClinicalTrials.gov Identifier:	NCT01468961 History of Changes
Other Study ID Numbers:	FIBRO-P
Study First Received:	November 8, 2011
Last Updated:	February 9, 2012

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 18, 2017

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