Sleep and Pain Interventions in Fibromyalgia (SPIN)
Sleep and Pain Interventions in Fibromyalgia: Hyperalgesia and Central Sensitization
調査の概要
詳細な説明
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.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
-
-
Florida
-
Gainesville、Florida、アメリカ、32610
- University of Florida
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
アクティブコンパレータ：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.
|
|
|
アクティブコンパレータ：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.
|
|
|
介入なし：Waitlist Control (WLC)
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.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in time spent awake during the night.
時間枠：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 from baseline to the two study follow-ups (immediately and 3-months following treatment)
|
|
Change in mood.
時間枠：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.
|
Change from baseline to the two follow-up periods (immediately and 3-months following treatment)
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in self-report of pain experience.
時間枠：Change from baseline to the two follow-up periods (immediately and 3-months following treatment)
|
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.
時間枠：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.
|
Change from baseline to the two follow-up periods (immediately and 3-months following treatment).
|
協力者と研究者
スポンサー
捜査官
- 主任研究者：Christina S McCrae, PhD、University of Florida
出版物と役立つリンク
一般刊行物
- 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.
- McCrae 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.
- Miller 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.
- McCrae 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.
- Curtis 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.
- McCrae 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.
- Miller 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.
- McCrae 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.
- Curtis 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.
- Miller 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.
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。