InsomniaSPINNCT02001077
Sleep and Pain Interventions in Fibromyalgia
A study testing Cognitive Behavioral Therapy for Insomnia (CBT-I) and Cognitive Behavioral Therapy for Pain (CBT-P) in people with Insomnia and Fibromyalgia, run by University of Florida at 1 site in United States.
Trial summary
This is a single-center, randomized controlled trial study design. Enrolled participants had comorbid fibromyalgia and chronic insomnia. Participants were randomized to a behavioral intervention for pain, a behavioral intervention for insomnia, or a waitlist control. The study intervention period lasted eight weeks. 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?
- Cognitive Behavioral Therapy for Insomnia (CBT-I) and Cognitive Behavioral Therapy for Pain (CBT-P)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 113 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2009to Sep 2013
- 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
- Diagnosis of fibromyalgia
- Diagnosis of insomnia
- No sleep medications for at least 1 month, or stable on medications for at least 6 months
- Willing to be randomly assigned to a treatment
- Able to read and understand English
Who cannot join
- Sleep disorder other than insomnia
- Bipolar disorder
- Seizure disorder
- Severe untreated psychopathology
- Cognitive impairment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Sleep and Pain Interventions in Fibromyalgia: Hyperalgesia and Central Sensitization
This is a single-center, randomized controlled trial study design. Enrolled participants had comorbid fibromyalgia and chronic insomnia. Participants were randomized to a behavioral intervention for pain, a behavioral intervention for insomnia, or a waitlist control. The study intervention period lasted eight weeks. The objective of the study is to examine the impact of two behavioral treatments on sleep and pain and to better understand what causes chronic pain and chronic sleep disturbance.
Read the detailed description
Participants will be asked to review the informed consent and consent to the study prior to any study procedure.
There are six phases of this study: 1. a telephone interview, 2. an in-home single night sleep recording, 3. a two-week baseline period, 4. an 8-week treatment period, 5. a two-week follow-up period, and 6. another two week follow-up period 6-months after the treatment period.
During the telephone interview, participants will be asked question about their sleep and pain history. Participants with poor sleep will visit the University of Florida for a medical history and will be connected to a machine which will monitor their sleep. Participants will return home to sleep while still connected to the machine and will return the machine to the University of Florida the next day. A third visit will consist of completing questionnaires and measuring response to a range of temperatures. Participants will complete brief daily questionnaires and wear an actigraph (wristwatch-like device) that measures arm movements for two weeks.
Participants will then be randomized to one of three groups: a pain treatment group, an insomnia treatment group or a waitlist control group. Both treatments consist of weekly therapy sessions for 8 consecutive weeks. Participants assigned to waitlist control will be offered therapy at no cost at the end of the study. Throughout these 8 weeks, participants in all three groups will be asked to complete daily sleep diaries.
The study consists of two follow-up periods consisting of two weeks, during which participants will wear the actigraph and complete daily sleep diaries. Participants will travel to the University two times during each follow-up period. One follow-up period will occur immediately following treatment, and the other will occur approximately 6 months following treatment. During each follow-up period, the first visits will involve being connected to the machine that monitors their sleep. Participants will then return home with the machine to sleep in their own beds. The second of these visits will occur the following day and will involve the return of the machine, completion of questionnaires, and measurement of participants' responses to a range of temperatures applied to their arm.
- Conditions
- Insomnia, Fibromyalgia
- Being tested
- Cognitive Behavioral Therapy for Insomnia (CBT-I), Cognitive Behavioral Therapy for Pain (CBT-P)
- 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.
Cognitive Behavioral Therapy for Insomnia (CBT-I)Behavioural
Cognitive Behavioral Therapy for Pain (CBT-P)Behavioural
| Study group | Role | What they receive |
|---|---|---|
| CBT-I | Active comparator | Participants will complete 8 weekly therapy sessions focused on improving sleep. A multicomponent CBT-I (Cognitive Behavioral Therapy for Insomnia) protocol will involve: sleep hygiene, stimulus control, sleep restriction, relaxation, and cognitive restructuring. Receives: Behavioral: Cognitive Behavioral Therapy for Insomnia (CBT-I) |
| CBT-P | Active comparator | Participants will complete 8 weekly therapy sessions focused on improving pain. A multicomponent CBT-P (Cognitive Behavioral Therapy for Pain) protocol will involve: pain education, relaxation, activity pacing, and cognitive restructuring. Receives: Behavioral: Cognitive Behavioral Therapy for Pain (CBT-P) |
| Waitlist Control (WLC) | No intervention | Participants in the WLC group will not receive any treatment between the baseline and post-treatment assessments. After the final follow-up assessment, they will be offered the opportunity to receive therapy which combines aspects of both CBT-I and CBT-P. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in time spent awake during the night.
The change in the time participants report spending awake during the night. Sleep will be measured with daily diaries and, means of the 14 days collected at baseline, immediately, and 6 months following treatment will be calculated.
Measured: Change from baseline to the two study follow-ups (immediately and 3-months following treatment)
Change in mood.
The change in reported mood as assessed by questionnaires from baseline to immediately and 6 months following treatment.
Measured: Change from baseline to the two follow-up periods (immediately and 3-months following treatment)
Secondary outcomes (2)
Change in self-report of pain experience.
The change in participants' report of their pain experience from baseline to the two follow-up periods. Pain will be assessed by daily diaries, and means of the 14 days collected at baseline, immediately, and 6 months following treatment will be calculated.
Measured: Change from baseline to the two follow-up periods (immediately and 3-months following treatment)
Change in mood.
The change in reported mood as assessed by questionnaires from baseline to immediately and 6 months following treatment.
Measured: Change from baseline to the two follow-up periods (immediately and 3-months following treatment).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2013 (estimated)
- Study startFeb 2009
- Primary completionSep 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for InsomniaStudies of the same condition, open and under way.
- More trials run by University of FloridaThe 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
- 113 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Responsible party
- Sponsor
- Investigators
- Christina S McCrae, PhD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02001077
- Sponsor's protocol ID
- 627-2007
- Other IDs
- R01AR055160
- Acronym
- SPIN
- Status last verified
- Nov 2013
- First submitted
- 27 Nov 2013
- Last updated
- 4 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Anderson RJ, McCrae CS, Staud R, Berry RB, Robinson ME. Predictors of clinical pain in fibromyalgia: examining the role of sleep. J Pain. 2012 Apr;13(4):350-8. doi: 10.1016/j.jpain.2011.12.009. Epub 2012 Mar 3.
PubMed 22381437McGovney KD, Curtis AF, McCrae CS. Actigraphic Physical Activity, Pain Intensity, and Polysomnographic Sleep in Fibromyalgia. Behav Sleep Med. 2023 Jul-Aug;21(4):383-396. doi: 10.1080/15402002.2022.2102009. Epub 2022 Jul 20.
PubMed 35856908McCrae CS, Craggs JG, Curtis AF, Nair N, Kay D, Staud R, Berry RB, Robinson ME. Neural activation changes in response to pain following cognitive behavioral therapy for patients with comorbid fibromyalgia and insomnia: a pilot study. J Clin Sleep Med. 2022 Jan 1;18(1):203-215. doi: 10.5664/jcsm.9540.
PubMed 34310276Miller MB, Curtis AF, Chan WS, Deroche CB, McCrae CS. Daily associations between sleep and opioid use among adults with comorbid symptoms of insomnia and fibromyalgia. J Clin Sleep Med. 2021 Apr 1;17(4):729-737. doi: 10.5664/jcsm.9002.
PubMed 33226334McCrae CS, Curtis AF, Miller MB, Nair N, Rathinakumar H, Davenport M, Berry JR, McGovney K, Staud R, Berry R, Robinson M. Effect of cognitive behavioural therapy on sleep and opioid medication use in adults with fibromyalgia and insomnia. J Sleep Res. 2020 Dec;29(6):e13020. doi: 10.1111/jsr.13020. Epub 2020 Mar 3.
PubMed 32126156Curtis AF, Miller MB, Rathinakumar H, Robinson M, Staud R, Berry RB, McCrae CS. Opioid use, pain intensity, age, and sleep architecture in patients with fibromyalgia and insomnia. Pain. 2019 Sep;160(9):2086-2092. doi: 10.1097/j.pain.0000000000001600.
PubMed 31180977McCrae CS, Williams J, Roditi D, Anderson R, Mundt JM, Miller MB, Curtis AF, Waxenberg LB, Staud R, Berry RB, Robinson ME. Cognitive behavioral treatments for insomnia and pain in adults with comorbid chronic insomnia and fibromyalgia: clinical outcomes from the SPIN randomized controlled trial. Sleep. 2019 Mar 1;42(3):zsy234. doi: 10.1093/sleep/zsy234.
PubMed 30496533Miller MB, Chan WS, Curtis AF, Boissoneault J, Robinson M, Staud R, Berry RB, McCrae CS. Pain intensity as a moderator of the association between opioid use and insomnia symptoms among adults with chronic pain. Sleep Med. 2018 Dec;52:98-102. doi: 10.1016/j.sleep.2018.08.015. Epub 2018 Sep 5.
PubMed 30296735McCrae CS, Mundt JM, Curtis AF, Craggs JG, O'Shea AM, Staud R, Berry RB, Perlstein WM, Robinson ME. Gray Matter Changes Following Cognitive Behavioral Therapy for Patients With Comorbid Fibromyalgia and Insomnia: A Pilot Study. J Clin Sleep Med. 2018 Sep 15;14(9):1595-1603. doi: 10.5664/jcsm.7344.
PubMed 30176973Curtis AF, Miller MB, Boissoneault J, Robinson M, Staud R, Berry RB, McCrae CS. Discrepancies in sleep diary and actigraphy assessments in adults with fibromyalgia: Associations with opioid dose and age. J Sleep Res. 2019 Oct;28(5):e12746. doi: 10.1111/jsr.12746. Epub 2018 Jul 31.
PubMed 30062746Miller MB, Chan WS, Boissoneault J, Robinson M, Staud R, Berry RB, McCrae CS. Dynamic daily associations between insomnia symptoms and alcohol use in adults with chronic pain. J Sleep Res. 2018 Jun;27(3):e12604. doi: 10.1111/jsr.12604. Epub 2017 Sep 22.
PubMed 28940629
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sleep and Pain Interventions in Fibromyalgia: Hyperalgesia and Central Sensitization
- ClinicalTrials.gov ID
- NCT02001077
- Acronym / sponsor ID
- SPIN / 627-2007
- Conditions
- Insomnia, Fibromyalgia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 113 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Study start
- Feb 2009
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 4 Dec 2013 (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 is a single-center, randomized controlled trial study design. Enrolled participants had comorbid fibromyalgia and chronic insomnia. Participants were randomized to a behavioral intervention for pain, a behavioral intervention for insomnia, or a waitlist control. The study intervention period lasted eight weeks. The objective of the study is to examine the impact of two behavioral treatments on sleep and pain and to better understand what causes chronic pain and chronic sleep disturbance.
Detailed description
Participants will be asked to review the informed consent and consent to the study prior to any study procedure.
There are six phases of this study: 1. a telephone interview, 2. an in-home single night sleep recording, 3. a two-week baseline period, 4. an 8-week treatment period, 5. a two-week follow-up period, and 6. another two week follow-up period 6-months after the treatment period.
During the telephone interview, participants will be asked question about their sleep and pain history. Participants with poor sleep will visit the University of Florida for a medical history and will be connected to a machine which will monitor their sleep. Participants will return home to sleep while still connected to the machine and will return the machine to the University of Florida the next day. A third visit will consist of completing questionnaires and measuring response to a range of temperatures. Participants will complete brief daily questionnaires and wear an actigraph (wristwatch-like device) that measures arm movements for two weeks.
Participants will then be randomized to one of three groups: a pain treatment group, an insomnia treatment group or a waitlist control group. Both treatments consist of weekly therapy sessions for 8 consecutive weeks. Participants assigned to waitlist control will be offered therapy at no cost at the end of the study. Throughout these 8 weeks, participants in all three groups will be asked to complete daily sleep diaries.
The study consists of two follow-up periods consisting of two weeks, during which participants will wear the actigraph and complete daily sleep diaries. Participants will travel to the University two times during each follow-up period. One follow-up period will occur immediately following treatment, and the other will occur approximately 6 months following treatment. During each follow-up period, the first visits will involve being connected to the machine that monitors their sleep. Participants will then return home with the machine to sleep in their own beds. The second of these visits will occur the following day and will involve the return of the machine, completion of questionnaires, and measurement of participants' responses to a range of temperatures applied to their arm.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CBT-I | Active comparator | Behavioral: Cognitive Behavioral Therapy for Insomnia (CBT-I)Participants will complete 8 weekly therapy sessions focused on improving sleep. A multicomponent CBT-I (Cognitive Behavioral Therapy for Insomnia) protocol will involve: sleep hygiene, stimulus control, sleep restriction, relaxation, and cognitive restructuring. |
| CBT-P | Active comparator | Behavioral: Cognitive Behavioral Therapy for Pain (CBT-P)Participants will complete 8 weekly therapy sessions focused on improving pain. A multicomponent CBT-P (Cognitive Behavioral Therapy for Pain) protocol will involve: pain education, relaxation, activity pacing, and cognitive restructuring. |
| Waitlist Control (WLC) | No intervention | –Participants in the WLC group will not receive any treatment between the baseline and post-treatment assessments. After the final follow-up assessment, they will be offered the opportunity to receive therapy which combines aspects of both CBT-I and CBT-P. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosis of fibromyalgia
- Diagnosis of insomnia
- No sleep medications for at least 1 month, or stable on medications for at least 6 months
- Willing to be randomly assigned to a treatment
- Able to read and understand English
Key exclusion criteria (5 listed)
- Sleep disorder other than insomnia
- Bipolar disorder
- Seizure disorder
- Severe untreated psychopathology
- Cognitive impairment
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 |
|---|---|---|
| Cognitive Behavioral Therapy for Insomnia (CBT-I) | Behavioural | CBT-I |
| Cognitive Behavioral Therapy for Pain (CBT-P) | Behavioural | CBT-P |
Primary outcome
Change in time spent awake during the night.
Time frame: Change from baseline to the two study follow-ups (immediately and 3-months following treatment)
The change in the time participants report spending awake during the night. Sleep will be measured with daily diaries and, means of the 14 days collected at baseline, immediately, and 6 months following treatment will be calculated.
Change in mood.
Time frame: Change from baseline to the two follow-up periods (immediately and 3-months following treatment)
The change in reported mood as assessed by questionnaires from baseline to immediately and 6 months following treatment.
2 secondary outcomes
Change in self-report of pain experience.
Time frame: Change from baseline to the two follow-up periods (immediately and 3-months following treatment)
Change in mood.
Time frame: Change from baseline to the two follow-up periods (immediately and 3-months following 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 4 Dec 2013.
- Results publication: PubMed 22381437Anderson RJ, McCrae CS, Staud R, Berry RB, Robinson ME. Predictors of clinical pain in fibromyalgia: examining the role of sleep. J Pain. 2012 Apr;13(4):350-8. doi: 10.1016/j.jpain.2011.12.009. Epub 2012 Mar 3.
- Derived from this study: PubMed 35856908McGovney KD, Curtis AF, McCrae CS. Actigraphic Physical Activity, Pain Intensity, and Polysomnographic Sleep in Fibromyalgia. Behav Sleep Med. 2023 Jul-Aug;21(4):383-396. doi: 10.1080/15402002.2022.2102009. Epub 2022 Jul 20.
- Derived from this study: PubMed 34310276McCrae CS, Craggs JG, Curtis AF, Nair N, Kay D, Staud R, Berry RB, Robinson ME. Neural activation changes in response to pain following cognitive behavioral therapy for patients with comorbid fibromyalgia and insomnia: a pilot study. J Clin Sleep Med. 2022 Jan 1;18(1):203-215. doi: 10.5664/jcsm.9540.
- Derived from this study: PubMed 33226334Miller MB, Curtis AF, Chan WS, Deroche CB, McCrae CS. Daily associations between sleep and opioid use among adults with comorbid symptoms of insomnia and fibromyalgia. J Clin Sleep Med. 2021 Apr 1;17(4):729-737. doi: 10.5664/jcsm.9002.
- Derived from this study: PubMed 32126156McCrae CS, Curtis AF, Miller MB, Nair N, Rathinakumar H, Davenport M, Berry JR, McGovney K, Staud R, Berry R, Robinson M. Effect of cognitive behavioural therapy on sleep and opioid medication use in adults with fibromyalgia and insomnia. J Sleep Res. 2020 Dec;29(6):e13020. doi: 10.1111/jsr.13020. Epub 2020 Mar 3.
- Derived from this study: PubMed 31180977Curtis AF, Miller MB, Rathinakumar H, Robinson M, Staud R, Berry RB, McCrae CS. Opioid use, pain intensity, age, and sleep architecture in patients with fibromyalgia and insomnia. Pain. 2019 Sep;160(9):2086-2092. doi: 10.1097/j.pain.0000000000001600.
- Derived from this study: PubMed 30496533McCrae CS, Williams J, Roditi D, Anderson R, Mundt JM, Miller MB, Curtis AF, Waxenberg LB, Staud R, Berry RB, Robinson ME. Cognitive behavioral treatments for insomnia and pain in adults with comorbid chronic insomnia and fibromyalgia: clinical outcomes from the SPIN randomized controlled trial. Sleep. 2019 Mar 1;42(3):zsy234. doi: 10.1093/sleep/zsy234.
- Derived from this study: PubMed 30296735Miller MB, Chan WS, Curtis AF, Boissoneault J, Robinson M, Staud R, Berry RB, McCrae CS. Pain intensity as a moderator of the association between opioid use and insomnia symptoms among adults with chronic pain. Sleep Med. 2018 Dec;52:98-102. doi: 10.1016/j.sleep.2018.08.015. Epub 2018 Sep 5.
- Derived from this study: PubMed 30176973McCrae CS, Mundt JM, Curtis AF, Craggs JG, O'Shea AM, Staud R, Berry RB, Perlstein WM, Robinson ME. Gray Matter Changes Following Cognitive Behavioral Therapy for Patients With Comorbid Fibromyalgia and Insomnia: A Pilot Study. J Clin Sleep Med. 2018 Sep 15;14(9):1595-1603. doi: 10.5664/jcsm.7344.
- Derived from this study: PubMed 30062746Curtis AF, Miller MB, Boissoneault J, Robinson M, Staud R, Berry RB, McCrae CS. Discrepancies in sleep diary and actigraphy assessments in adults with fibromyalgia: Associations with opioid dose and age. J Sleep Res. 2019 Oct;28(5):e12746. doi: 10.1111/jsr.12746. Epub 2018 Jul 31.
- Derived from this study: PubMed 28940629Miller MB, Chan WS, Boissoneault J, Robinson M, Staud R, Berry RB, McCrae CS. Dynamic daily associations between insomnia symptoms and alcohol use in adults with chronic pain. J Sleep Res. 2018 Jun;27(3):e12604. doi: 10.1111/jsr.12604. Epub 2017 Sep 22.
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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.
Christina S McCrae, PhD principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Behavioral Therapy for Insomnia (CBT-I) and Cognitive Behavioral Therapy for Pain (CBT-P) in people with Insomnia and Fibromyalgia, run by University of Florida 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 5 inclusion and 5 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 4 Dec 2013. 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 time spent awake during the night. (time frame: Change from baseline to the two study follow-ups (immediately and 3-months following treatment)). 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?
On the ClinicalTrials.gov record for NCT02001077, which also lists 11 linked publications.
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 4 Dec 2013.