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Clinical Trials/NCT01468961
NCT01468961CompletedNot Applicable

Pilot Study of Internet-based Cognitive Behavior Therapy for Fibromyalgia

Karolinska Institutet1 site in 1 country41 target enrollmentStarted: November 1, 2011Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
41
Locations
1
Primary Endpoint
The Fibromyalgia Impact Questionnaire

Study Overview

Brief Summary

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 Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Current diagnosis of fibromyalgia

Exclusion Criteria

  • •Current diagnosis of severe psychiatric disorder

Arms & Interventions

Internet-based CBT

Experimental

Intervention: Internet-based CBT (Behavioral)

Outcomes

Primary Outcomes

The Fibromyalgia Impact Questionnaire

Time Frame: Once, 6 months after treatment

The Fibromyalgia Impact Questionnaire

Time Frame: Once, 1 week before start of treatment

The Fibromyalgia Impact Questionnaire

Time Frame: Once, immediately after treatment

Secondary Outcomes

  • Short form 12-item Questionnaire(Once, 6 months after treatment)
  • Hospital Anxiety and Depression Scale(Once, 6 months after treatment)
  • Short form 12-item Questionnaire(Once, 1 week before start of treatment)
  • Short form 12-item Questionnaire(Once, immediately after treatment)
  • Hospital Anxiety and Depression Scale(Once, 1 week before start of treatment)
  • Hospital Anxiety and Depression Scale(Once, immediately after treatment)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Brjann Ljotsson

Associate professor

Karolinska Institutet

Study Sites (1)

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