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
Recruitment status was Active, not recruiting
Sponsor:
Karolinska Institutet
Information provided by:
Karolinska Institutet
ClinicalTrials.gov Identifier:
NCT01468961
First received: November 8, 2011
Last updated: February 9, 2012
Last verified: November 2011
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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 (Adult, Senior) |
| 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
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 |
| 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 September 30, 2016