FibromyalgiaNCT01468961
Pilot Study of Internet-based Cognitive Behavior Therapy for Fibromyalgia
A study testing Internet-based CBT in people with Fibromyalgia, run by Karolinska Institutet at 1 site in Sweden.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- Internet-based CBT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteSweden
- Study dates
- Nov 2011to Sep 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Current diagnosis of fibromyalgia
Who cannot join
- Current diagnosis of severe psychiatric disorder
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Karolinska Institutet, Department of Clinical Neuroscience, Section of psychiatry, Karolinska Hospital Solna R5
Stockholm, 171 76
About this study
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.
- Conditions
- Fibromyalgia
- Being tested
- Internet-based CBT
- Medical subject headings
- Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Internet-based CBTBehavioural
10 weeks of internet-based CBT with online therapist contact
| Study group | Role | What they receive |
|---|---|---|
| Internet-based CBT | Experimental | Not described Receives: Behavioral: Internet-based CBT |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Fibromyalgia Impact Questionnaire
Measured: Once, 1 week before start of treatment
The Fibromyalgia Impact Questionnaire
Measured: Once, immediately after treatment
The Fibromyalgia Impact Questionnaire
Measured: Once, 6 months after treatment
Secondary outcomes (6)
Short form 12-item Questionnaire
Measured: Once, 1 week before start of treatment
Short form 12-item Questionnaire
Measured: Once, immediately after treatment
Short form 12-item Questionnaire
Measured: Once, 6 months after treatment
Hospital Anxiety and Depression Scale
Measured: Once, 1 week before start of treatment
Hospital Anxiety and Depression Scale
Measured: Once, immediately after treatment
Hospital Anxiety and Depression Scale
Measured: Once, 6 months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2011 (estimated)
- Study startNov 2011
- Primary completionSep 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brjann Ljotsson, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01468961
- Sponsor's protocol ID
- FIBRO-P
- Status last verified
- Aug 2017
- First submitted
- 8 Nov 2011
- Last updated
- 22 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 24215278
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Internet-based Cognitive Behavior Therapy for Fibromyalgia
- ClinicalTrials.gov ID
- NCT01468961
- Acronym / sponsor ID
- FIBRO-P
- Conditions
- Fibromyalgia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 10 Nov 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Internet-based CBT | Experimental | Behavioral: Internet-based CBT |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Current diagnosis of fibromyalgia
Key exclusion criteria (1 listed)
- Current diagnosis of severe psychiatric disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Internet-based CBT10 weeks of internet-based CBT with online therapist contact | Behavioural | Internet-based CBT |
Primary outcome
The Fibromyalgia Impact Questionnaire
Time frame: Once, 1 week before start of treatment
The Fibromyalgia Impact Questionnaire
Time frame: Once, immediately after treatment
The Fibromyalgia Impact Questionnaire
Time frame: Once, 6 months after treatment
6 secondary outcomes
Short form 12-item Questionnaire
Time frame: Once, 1 week before start of treatment
Short form 12-item Questionnaire
Time frame: Once, immediately after treatment
Short form 12-item Questionnaire
Time frame: Once, 6 months after treatment
Hospital Anxiety and Depression Scale
Time frame: Once, 1 week before start of treatment
Hospital Anxiety and Depression Scale
Time frame: Once, immediately after treatment
Hospital Anxiety and Depression Scale
Time frame: Once, 6 months after treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2017.
- Results publication: PubMed 24215278Ljotsson 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Internet-based CBT in people with Fibromyalgia, run by Karolinska Institutet at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Fibromyalgia Impact Questionnaire (time frame: Once, 1 week before start of treatment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01468961, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2017.