FibromyalgiaNCT02638636
Internet-based Exposure-based Therapy for Fibromyalgia: A Randomized Controlled Trial.
A study testing Internet-based exposure therapy in people with Fibromyalgia, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
The purpose of this study is to examine if an internet-based exposure therapy is effective in reducing Fibromyalgia symptoms and impact amongst patients with Fibromyalgia. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- Internet-based exposure therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteSweden
- Study dates
- Dec 2015to Jul 2016
- 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Fibromyalgia diagnosis
- Swedish resident
- Internet connection before, under and after treatment
- Willing to refrain from other concurrent psychological treatment during the study
- Agreement to keep psychotrophic medication constant during the study
Who cannot join
- Severe depression (≥30 points on Montgomery Åsberg Depression Rating Scale - Self Rated (MADRS-S) or risk of suicide (≥4 points on the suicide item on MADRS-S)
- Ongoing alcohol or substance abuse
- Psychosis
- Other severe illness that require immediate treatment and/or was considered the participants primary concern other than FM, or bodily condition that makes treatment unfeasible (such as late pregnancy; >29 weeks gestation
- Illiteracy or poor skills in Swedish language
- Insufficient computer or language skills to manage a text-based treatment.
- Other concurrent psychological treatment
- Recent changes in psychotrophic medication (<6 weeks prior to randomization)
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to examine if an internet-based exposure therapy is effective in reducing Fibromyalgia symptoms and impact amongst patients with Fibromyalgia.
Read the detailed description
Trial Objectives: Primary objective is to investigate whether an Internet-based exposure therapy can effectively reduce the degree of Fibromyalgia symptoms and impact. Secondary objectives are to 1) investigate the treatment's ability to reduce degree of a) quality of life b) function c) insomnia and fatigue d) pain-related fear and negative thoughts e) depression and anxiety, cost-effectiveness of this treatment; and 2) to study if any variables could moderate/mediate the treatment outcome, such as a) degree of covert avoidance, b) degree of reactivity to inner sensations
Trial Design: Randomized controlled trial with waitlist control, who also will receive treatment after the first group has finished.
Duration: Ten weeks
Primary Endpoint: Change in Fibromyalgia symptoms and impact from baseline to Week 10. Long term follow-up is also investigated (potential changes from post-treatment to 6- and 12 months after treatment completion)
Efficacy Parameters: the Fibromyalgia Impact Questionnaire (FIQ)
Description of Trial Subjects: Patients > 18 years old, Fibromyalgia diagnosis, residing in Sweden.
Number of Subjects: 140
Sample size estimation: Sample size is based on a estimated effect size (measured by Cohen's d) of 0.5, based on a power of 0.8 and with room for a 10 % dropout rate.
Recruitment: Self-referral. Advertising will be made through national newspaper, social media and on patient organisations' websites.
Safety parameters: Participants will have the opportunity to report any adverse events during treatment at posttreatment and follow-up measurements.
Data collection: Data will be collected electronically via the treatment platform.
Plan for missing data: Last-observation carried forward (LOCF).
Main statistical analysis: Hierarchical linear mixed modelling.
- Conditions
- Fibromyalgia
- Being tested
- Internet-based exposure therapy
- Keywords
- Cognitive behavior therapy, Randomized controlled trial, Exposure therapy, Fibromyalgia
- 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 exposure therapyBehavioural
The treatment is a 10 week long cognitive behavior therapy. It is based mainly on the principles of exposure; i.e. the participant is instructed to approach situations they have avoided in order to reduce or avoid pain or other aversive experiences until they feel less discomfort and extended behavior repertoire in presence of pain and aversive inner experiences Other interventions include psychoeducation, mindfulness and acceptance strategies and are employed in order to facilitate exposure.
| Study group | Role | What they receive |
|---|---|---|
| Internet-based exposure therapy | Experimental | The experimental group will go through active internet-based treatment which is delivered on a safe internet platform. Treatment is divided into eight modules, each containing homework assignments. Participants in experimental group will be assigned a therapist that they can contact through a message system in the platform and expect answer within 48 hours. Receives: Behavioral: Internet-based exposure therapy |
| Waitlist | No intervention | Waitlist control, i.e. no active active intervention during waiting list period. Will be offered treatment when the first group has finished (i.e. week 10). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the Fibromyalgia Impact Questionnaire (FIQ)
Change in Fibromyalgia symptoms and impact from baseline to Week 10, and at 6- and 12 months after treatment has ended.
Measured: Week 0, week 10, Long term follow-up at 6- and 12-months after treatment has ended]
Secondary outcomes (11)
Insomnia Severity Index (ISI)
Change in sleep disturbances from baseline to Week 10, and at 6- and 12 months after treatment has ended.
Measured: Week 0, week 10, follow-up at 6- and 12-months after treatment has ended
Fatigue Severity Scale (FSS)
Change in fatigue from baseline to Week 10, and at 6- and 12 months after treatment has ended.
Measured: Week 0, week 10, follow-up at 6- and 12-months after treatment has ended
WHO Disability Assessment Schedule 2.0 (WHODAS 2)
Change in level of function from baseline to Week 10, and at 6- and 12 months after treatment has ended.
Measured: Week 0, week 10, follow-up at 6- and 12-months after treatment has ended
Brunnsviken Brief Quality of Life Inventory (BBQ)
Change in quality of life from baseline to Week 10, and at 6- and 12 months after treatment has ended.
Measured: Week 0, week 10, follow-up at 6- and 12-months after treatment has ended
The Psychological Inflexibility in Pain Scale (PIPS)
Change in covert avoidance from baseline to Week 10, and at 6- and 12 months after treatment has ended.
Measured: Week 0, week 10, follow-up at 6- and 12-months after treatment has ended
Pain Reactivity Scale (PRS)
Change in pain-related fear and negative thoughts from baseline to Week 10, and at 6- and 12 months after treatment has ended.
Measured: Week 0, week 10, follow-up at 6- and 12-months after treatment has ended
Patient Health Questionnaire-9 (PHQ-9)
Change in level of depression from baseline to Week 10, and at 6- and 12 months after treatment has ended.
Measured: Week 0, week 10, follow-up at 6- and 12-months after treatment has ended
Generalised Anxiety Disorder 7-item scale (GAD-7)
Change in level of anxiety from baseline to Week 10, and at 6- and 12 months after treatment has ended.
Measured: Week 0, week 10, follow-up at 6- and 12-months after treatment has ended
Subscale "reactivity to inner experiences" from Five Facets of Mindfulness Questionnaire (FFMQ)
Change in reactivity to inner experiences from baseline to Week 10, and at 6- and 12 months after treatment has ended.
Measured: Week 0, week 10, follow-up at 6- and 12-months after treatment has ended
Trimbos and Institute of Medical Technology Assessment Cost Questionnaire for Psychiatry (TIC-P)
Change in health-care costs and sick-leave from baseline to Week 10, and at 6- and 12 months after treatment has ended.
Measured: Week 0, week 10, follow-up at 6- and 12-months after treatment has ended
EQ5D
Change in health-related quality of life from baseline to week 10, and at 6- and 12 months after treatment has ended.
Measured: Week 0, week 10, follow-up at 6- and 12-months after treatment has ended
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2015 (estimated)
- Study startDec 2015
- Primary completionJul 2016
- Study completionJul 2016
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Erik Andersson, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02638636
- Sponsor's protocol ID
- EPN 2015/1528-31/1
- Status last verified
- Dec 2016
- First submitted
- 17 Dec 2015
- Last updated
- 14 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Hedman-Lagerlof M, Andersson E, Ljotsson B, Engelbrektsson J, Lundback K, Bjorkander D, Hedman-Lagerlof E, Flink I, Axelsson E. Effect moderators in Internet-based exposure therapy for fibromyalgia: The role of pain intensity. Eur J Pain. 2023 Apr;27(4):507-517. doi: 10.1002/ejp.2074. Epub 2023 Jan 10.
PubMed 36585933
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Internet-based Exposure-based Therapy for Fibromyalgia: A Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT02638636
- Acronym / sponsor ID
- EPN 2015/1528-31/1
- Conditions
- Fibromyalgia
- Keywords
- Cognitive behavior therapy, Randomized controlled trial, Exposure therapy, Fibromyalgia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- Dec 2015
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 23 Dec 2015 (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.
The purpose of this study is to examine if an internet-based exposure therapy is effective in reducing Fibromyalgia symptoms and impact amongst patients with Fibromyalgia.
Detailed description
Trial Objectives: Primary objective is to investigate whether an Internet-based exposure therapy can effectively reduce the degree of Fibromyalgia symptoms and impact. Secondary objectives are to 1) investigate the treatment's ability to reduce degree of a) quality of life b) function c) insomnia and fatigue d) pain-related fear and negative thoughts e) depression and anxiety, cost-effectiveness of this treatment; and 2) to study if any variables could moderate/mediate the treatment outcome, such as a) degree of covert avoidance, b) degree of reactivity to inner sensations
Trial Design: Randomized controlled trial with waitlist control, who also will receive treatment after the first group has finished.
Duration: Ten weeks
Primary Endpoint: Change in Fibromyalgia symptoms and impact from baseline to Week 10. Long term follow-up is also investigated (potential changes from post-treatment to 6- and 12 months after treatment completion)
Efficacy Parameters: the Fibromyalgia Impact Questionnaire (FIQ)
Description of Trial Subjects: Patients > 18 years old, Fibromyalgia diagnosis, residing in Sweden.
Number of Subjects: 140
Sample size estimation: Sample size is based on a estimated effect size (measured by Cohen's d) of 0.5, based on a power of 0.8 and with room for a 10 % dropout rate.
Recruitment: Self-referral. Advertising will be made through national newspaper, social media and on patient organisations' websites.
Safety parameters: Participants will have the opportunity to report any adverse events during treatment at posttreatment and follow-up measurements.
Data collection: Data will be collected electronically via the treatment platform.
Plan for missing data: Last-observation carried forward (LOCF).
Main statistical analysis: Hierarchical linear mixed modelling.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Internet-based exposure therapy | Experimental | Behavioral: Internet-based exposure therapyThe experimental group will go through active internet-based treatment which is delivered on a safe internet platform. Treatment is divided into eight modules, each containing homework assignments. Participants in experimental group will be assigned a therapist that they can contact through a message system in the platform and expect answer within 48 hours. |
| Waitlist | No intervention | –Waitlist control, i.e. no active active intervention during waiting list period. Will be offered treatment when the first group has finished (i.e. week 10). |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Fibromyalgia diagnosis
- Swedish resident
- Internet connection before, under and after treatment
- Willing to refrain from other concurrent psychological treatment during the study
- Agreement to keep psychotrophic medication constant during the study
Key exclusion criteria (8 listed)
- Severe depression (≥30 points on Montgomery Åsberg Depression Rating Scale - Self Rated (MADRS-S) or risk of suicide (≥4 points on the suicide item on MADRS-S)
- Ongoing alcohol or substance abuse
- Psychosis
- Other severe illness that require immediate treatment and/or was considered the participants primary concern other than FM, or bodily condition that makes treatment unfeasible (such as late pregnancy; >29 weeks gestation
- Illiteracy or poor skills in Swedish language
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 exposure therapyThe treatment is a 10 week long cognitive behavior therapy. It is based mainly on the principles of exposure; i.e. the participant is instructed to approach situations they have avoided in order to reduce or avoid pain or other aversive experiences until they feel less discomfort and extended behavior repertoire in presence of pain and aversive inner experiences Other interventions include psychoeducation, mindfulness and acceptance strategies and are employed in order to facilitate exposure. | Behavioural | Internet-based exposure therapy |
Primary outcome
Change in the Fibromyalgia Impact Questionnaire (FIQ)
Time frame: Week 0, week 10, Long term follow-up at 6- and 12-months after treatment has ended]
Change in Fibromyalgia symptoms and impact from baseline to Week 10, and at 6- and 12 months after treatment has ended.
11 secondary outcomes
Insomnia Severity Index (ISI)
Time frame: Week 0, week 10, follow-up at 6- and 12-months after treatment has ended
Fatigue Severity Scale (FSS)
Time frame: Week 0, week 10, follow-up at 6- and 12-months after treatment has ended
WHO Disability Assessment Schedule 2.0 (WHODAS 2)
Time frame: Week 0, week 10, follow-up at 6- and 12-months after treatment has ended
Brunnsviken Brief Quality of Life Inventory (BBQ)
Time frame: Week 0, week 10, follow-up at 6- and 12-months after treatment has ended
The Psychological Inflexibility in Pain Scale (PIPS)
Time frame: Week 0, week 10, follow-up at 6- and 12-months after treatment has ended
Pain Reactivity Scale (PRS)
Time frame: Week 0, week 10, follow-up at 6- and 12-months after treatment has ended
Patient Health Questionnaire-9 (PHQ-9)
Time frame: Week 0, week 10, follow-up at 6- and 12-months after treatment has ended
Generalised Anxiety Disorder 7-item scale (GAD-7)
Time frame: Week 0, week 10, follow-up at 6- and 12-months after treatment has ended
Subscale "reactivity to inner experiences" from Five Facets of Mindfulness Questionnaire (FFMQ)
Time frame: Week 0, week 10, follow-up at 6- and 12-months after treatment has ended
Trimbos and Institute of Medical Technology Assessment Cost Questionnaire for Psychiatry (TIC-P)
Time frame: Week 0, week 10, follow-up at 6- and 12-months after treatment has ended
EQ5D
Time frame: Week 0, week 10, follow-up at 6- and 12-months after treatment has ended
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 14 Dec 2016.
- Derived from this study: PubMed 36585933Hedman-Lagerlof M, Andersson E, Ljotsson B, Engelbrektsson J, Lundback K, Bjorkander D, Hedman-Lagerlof E, Flink I, Axelsson E. Effect moderators in Internet-based exposure therapy for fibromyalgia: The role of pain intensity. Eur J Pain. 2023 Apr;27(4):507-517. doi: 10.1002/ejp.2074. Epub 2023 Jan 10.
- Individual participant dataSharing planned: Undecided
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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 exposure therapy 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 5 inclusion and 8 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 14 Dec 2016. 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?
Change in the Fibromyalgia Impact Questionnaire (FIQ) (time frame: Week 0, week 10, Long term follow-up at 6- and 12-months after treatment has ended]). 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 NCT02638636, 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 14 Dec 2016.