InsomniaNCT03922867
Web-based CBT for Insomnia Patients With Fibromyalgia
A study testing CBT in people with Insomnia and Fibromyalgia, run by Mayo Clinic at 1 site in United States.
Trial summary
Researchers are evaluating if cognitive behavioral therapy for insomnia delivered over the internet will help with fibromyalgia symptoms. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Insomnia, Fibromyalgia
- What is being tested?
- CBT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Dec 2019to 3 Mar 2021
- 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
- Meets diagnostic criteria for fibromyalgia
- Has insomnia
- Have internet access and a device that can access the web-based program.
Who cannot join
- Active sleep disorder which is not treated (obstructive sleep apnea, obesity hypoventilation syndrome)
- Active psychiatric disorder (Bipolar affective disorder, anxiety, depression, schizophrenia) which is not optimally managed.
- Chronic fatigue syndrome
- Morbid obesity
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: Comparison of Feasibility and Efficacy of a Web-based Cognitive Behavioral Therapy Versus Usual Care for Management of Insomnia in Patients With Fibromyalgia
Researchers are evaluating if cognitive behavioral therapy for insomnia delivered over the internet will help with fibromyalgia symptoms.
Read the detailed description
The investigators are studying the effect of an internet-based cognitive behavioral therapy for insomnia, compared with usual care in fibromyalgia patients. Fibromyalgia patients will consent to study, and a determination made if the patients meet criteria. If eligible, qualifying patients will be randomized, and begin participation in randomized intervention. During participation on the study subjects will complete surveys at set intervals.
- Conditions
- Insomnia, Fibromyalgia
- Being tested
- CBT
- Keywords
- insomnia, fibromyalgia
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBTBehavioural
A web-based educational platform to deliver cognitive behavioral therapy (CBT) for insomnia
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | Subjects with receive standard of care for management of insomnia in subjects with fibromyalgia |
| Intervention Group | Active comparator | Subjects will receive standard of care and additionally complete the online cognitive behavior therapy program Receives: Behavioral: CBT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in insomnia severity
Surveying the changes in insomnia severity seen during the subjects participation in the study
Measured: through study completion, an average of 12 weeks
Change in attitude towards sleep
Surveying the subjects attitude towards sleep over the duration of their participation in the study.
Measured: through study completion, an average of 12 weeks
Secondary outcomes (1)
Change in fibromyalgia symptoms
Surveying the change in fibromyalgia symptoms that occur during study participation
Measured: through study completion, an average of 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2019
- Study start3 Dec 2019
- Primary completion28 Feb 2021
- Study completion3 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InsomniaStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ravindra Ganesh, Mayo Clinic
- Investigators
- Ravindra Ganesh, MBBS, MD, Principal investigator, Mayo ClinicSanjeev Nanda, MD, Study chair, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03922867
- Sponsor's protocol ID
- 18-011637
- Status last verified
- Mar 2021
- First submitted
- 18 Apr 2019
- Last updated
- 5 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Feasibility and Efficacy of a Web-based Cognitive Behavioral Therapy Versus Usual Care for Management of Insomnia in Patients With Fibromyalgia
- ClinicalTrials.gov ID
- NCT03922867
- Acronym / sponsor ID
- 18-011637
- Conditions
- Insomnia, Fibromyalgia
- Keywords
- insomnia, fibromyalgia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 3 Dec 2019 (actual)
- Primary completion
- 28 Feb 2021 (actual)
- Study completion
- 3 Mar 2021 (actual)
- First posted
- 22 Apr 2019 (actual)
- 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.
Researchers are evaluating if cognitive behavioral therapy for insomnia delivered over the internet will help with fibromyalgia symptoms.
Detailed description
The investigators are studying the effect of an internet-based cognitive behavioral therapy for insomnia, compared with usual care in fibromyalgia patients. Fibromyalgia patients will consent to study, and a determination made if the patients meet criteria. If eligible, qualifying patients will be randomized, and begin participation in randomized intervention. During participation on the study subjects will complete surveys at set intervals.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –Subjects with receive standard of care for management of insomnia in subjects with fibromyalgia |
| Intervention Group | Active comparator | Behavioral: CBTSubjects will receive standard of care and additionally complete the online cognitive behavior therapy program |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Meets diagnostic criteria for fibromyalgia
- Has insomnia
- Have internet access and a device that can access the web-based program.
Key exclusion criteria (4 listed)
- Active sleep disorder which is not treated (obstructive sleep apnea, obesity hypoventilation syndrome)
- Active psychiatric disorder (Bipolar affective disorder, anxiety, depression, schizophrenia) which is not optimally managed.
- Chronic fatigue syndrome
- Morbid obesity
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 |
|---|---|---|
| CBTA web-based educational platform to deliver cognitive behavioral therapy (CBT) for insomnia | Behavioural | Intervention Group |
Primary outcome
Change in insomnia severity
Time frame: through study completion, an average of 12 weeks
Surveying the changes in insomnia severity seen during the subjects participation in the study
Change in attitude towards sleep
Time frame: through study completion, an average of 12 weeks
Surveying the subjects attitude towards sleep over the duration of their participation in the study.
1 secondary outcome
Change in fibromyalgia symptoms
Time frame: through study completion, an average of 12 weeks
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 5 Mar 2021.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Ravindra Ganesh, MBBS, MD principal investigator
Mayo Clinic
Sanjeev Nanda, MD study chair
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CBT in people with Insomnia and Fibromyalgia, run by Mayo Clinic at 1 site in United States.
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 3 inclusion and 4 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 5 Mar 2021. 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 United States. 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 insomnia severity (time frame: through study completion, an average of 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Mar 2021.