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Completed

NCT Number: NCT01468961

Pilot Study of Internet-based Cognitive Behavior Therapy for Fibromyalgia

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.

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Key information

Conditions

Fibromyalgia Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neuromuscular Diseases Rheumatic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Karolinska Institutet, Department of Clinical Neuroscience, Section of psychiatry, Karolinska Hospital Solna R5

Stockholm, 171 76, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Current diagnosis of fibromyalgia

Exclusion criteria

  • Current diagnosis of severe psychiatric disorder

Treatment and study plan

Internet-based CBT

Behavioral

10 weeks of internet-based CBT with online therapist contact

Primary outcomes

  1. The Fibromyalgia Impact Questionnaire

    Time frame: Once, 1 week before start of treatment

  2. The Fibromyalgia Impact Questionnaire

    Time frame: Once, immediately after treatment

  3. The Fibromyalgia Impact Questionnaire

    Time frame: Once, 6 months after treatment

Secondary outcomes

  1. Short form 12-item Questionnaire

    Time frame: Once, 1 week before start of treatment

  2. Short form 12-item Questionnaire

    Time frame: Once, immediately after treatment

  3. Short form 12-item Questionnaire

    Time frame: Once, 6 months after treatment

  4. Hospital Anxiety and Depression Scale

    Time frame: Once, 1 week before start of treatment

  5. Hospital Anxiety and Depression Scale

    Time frame: Once, immediately after treatment

  6. Hospital Anxiety and Depression Scale

    Time frame: Once, 6 months after treatment

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Registry information

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Nov 10, 2011
Registry last updated
Aug 22, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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