Pilot Study of Internet-based Cognitive Behavior Therapy for Fibromyalgia

Fibromyalgia Clinical Trial

Official title:

Pilot Study of Internet-based Cognitive Behavior Therapy for Fibromyalgia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01468961
• Other study ID #: FIBRO-P
• Status: Completed
• Phase: N/A
• First received: November 8, 2011
• Last updated: August 17, 2017
• Start date: November 2011
• Est. completion date: September 2012

Study information

• Verified date: August 2017
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: September 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Current diagnosis of fibromyalgia

Exclusion Criteria:

• Current diagnosis of severe psychiatric disorder

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndromes

Intervention

Behavioral:
• Internet-based CBT
10 weeks of internet-based CBT with online therapist contact

Locations

Country	Name	City	State
Sweden	Karolinska Institutet, Department of Clinical Neuroscience, Section of psychiatry, Karolinska Hospital Solna R5	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

References & Publications (1)

Ljótsson B, Atterlöf E, Lagerlöf M, Andersson E, Jernelöv S, Hedman E, Kemani M, Wicksell RK. Internet-delivered acceptance and values-based exposure treatment for fibromyalgia: a pilot study. Cogn Behav Ther. 2014;43(2):93-104. doi: 10.1080/16506073.2013 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Fibromyalgia Impact Questionnaire		Once, 1 week before start of treatment
Primary	The Fibromyalgia Impact Questionnaire		Once, immediately after treatment
Primary	The Fibromyalgia Impact Questionnaire		Once, 6 months after treatment
Secondary	Short form 12-item Questionnaire		Once, 1 week before start of treatment
Secondary	Short form 12-item Questionnaire		Once, immediately after treatment
Secondary	Short form 12-item Questionnaire		Once, 6 months after treatment
Secondary	Hospital Anxiety and Depression Scale		Once, 1 week before start of treatment
Secondary	Hospital Anxiety and Depression Scale		Once, immediately after treatment
Secondary	Hospital Anxiety and Depression Scale		Once, 6 months after treatment