Pilot Study of Internet-based Cognitive Behavior Therapy for Fibromyalgia
1 other identifier
interventional
41
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Nov 2011
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2011
CompletedFirst Submitted
Initial submission to the registry
November 8, 2011
CompletedFirst Posted
Study publicly available on registry
November 10, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2012
CompletedAugust 22, 2017
August 1, 2017
10 months
November 8, 2011
August 17, 2017
Conditions
Outcome Measures
Primary Outcomes (3)
The Fibromyalgia Impact Questionnaire
Once, 1 week before start of treatment
The Fibromyalgia Impact Questionnaire
Once, immediately after treatment
The Fibromyalgia Impact Questionnaire
Once, 6 months after treatment
Secondary Outcomes (6)
Short form 12-item Questionnaire
Once, 1 week before start of treatment
Short form 12-item Questionnaire
Once, immediately after treatment
Short form 12-item Questionnaire
Once, 6 months after treatment
Hospital Anxiety and Depression Scale
Once, 1 week before start of treatment
Hospital Anxiety and Depression Scale
Once, immediately after treatment
- +1 more secondary outcomes
Study Arms (1)
Internet-based CBT
EXPERIMENTALInterventions
10 weeks of internet-based CBT with online therapist contact
Eligibility Criteria
You may qualify if:
- Current diagnosis of fibromyalgia
You may not qualify if:
- Current diagnosis of severe psychiatric disorder
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Karolinska Institutet, Department of Clinical Neuroscience, Section of psychiatry, Karolinska Hospital Solna R5
Stockholm, 171 76, Sweden
Related Publications (1)
Ljotsson B, Atterlof E, Lagerlof M, Andersson E, Jernelov 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: 10.1080/16506073.2013.846401. Epub 2013 Nov 12.
PMID: 24215278RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate professor
Study Record Dates
First Submitted
November 8, 2011
First Posted
November 10, 2011
Study Start
November 1, 2011
Primary Completion
September 1, 2012
Study Completion
September 1, 2012
Last Updated
August 22, 2017
Record last verified: 2017-08