Sleep and Pain Interventions in Fibromyalgia

Study Overview
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Brief Summary
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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
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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.

Official Title
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Sleep and Pain Interventions in Fibromyalgia: Hyperalgesia and Central Sensitization

Conditions
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Insomnia, Fibromyalgia

Intervention / Treatment
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* Behavioral: Cognitive Behavioral Therapy for Insomnia (CBT-I)
* Behavioral: Cognitive Behavioral Therapy for Pain (CBT-P)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: Sleep disorder other than insomnia Bipolar disorder Seizure disorder Severe untreated psychopathology Cognitive impairment

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: CBT-I<br>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. | Behavioral: Cognitive Behavioral Therapy for Insomnia (CBT-I)<br> <br> |
| Active Comparator: CBT-P<br>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. | Behavioral: Cognitive Behavioral Therapy for Pain (CBT-P)<br> <br> |
| No Intervention: Waitlist Control (WLC)<br>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 the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | Change from baseline to the two follow-up periods (immediately and 3-months following treatment) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | Change from baseline to the two follow-up periods (immediately and 3-months following treatment). |