Pilot Study of Internet-based Cognitive Behavior Therapy for Fibromyalgia

August 17, 2017 updated by: Brjann Ljotsson, Karolinska Institutet
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

41

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Stockholm, Sweden, 171 76
        • Karolinska Institutet, Department of Clinical Neuroscience, Section of psychiatry, Karolinska Hospital Solna R5

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Current diagnosis of fibromyalgia

Exclusion Criteria:

  • Current diagnosis of severe psychiatric disorder

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The Fibromyalgia Impact Questionnaire
Time Frame: Once, 1 week before start of treatment
Once, 1 week before start of treatment
The Fibromyalgia Impact Questionnaire
Time Frame: Once, immediately after treatment
Once, immediately after treatment
The Fibromyalgia Impact Questionnaire
Time Frame: Once, 6 months after treatment
Once, 6 months after treatment

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Karolinska Institutet

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2011

Primary Completion (Actual)

September 1, 2012

Study Completion (Actual)

September 1, 2012

Study Registration Dates

First Submitted

November 8, 2011

First Submitted That Met QC Criteria

November 9, 2011

First Posted (Estimate)

November 10, 2011

Study Record Updates

Last Update Posted (Actual)

August 22, 2017

Last Update Submitted That Met QC Criteria

August 17, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FIBRO-P

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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