Sleep and Pain Interventions in Fibromyalgia

NCT02001077 | Completed

• 2 other identifiers: 627-2007R01AR055160
• Study Type: interventional
• Target: 113
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Insomnia; Fibromyalgia

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Change in self-report of pain experience.

  Change from baseline to the two follow-up periods (immediately and 3-months following treatment)

• Change in mood.

  Change from baseline to the two follow-up periods (immediately and 3-months following treatment).

Study Arms (3)

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.

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.

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.

Interventions

Cognitive Behavioral Therapy for Insomnia (CBT-I) BEHAVIORAL

CBT-I

Cognitive Behavioral Therapy for Pain (CBT-P) BEHAVIORAL

CBT-P

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Sleep disorder other than insomnia
• Bipolar disorder
• Seizure disorder
• Severe untreated psychopathology
• Cognitive impairment

Sponsors & Collaborators

• University of Florida: lead
• National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS): collaborator

Study Sites (1)

University of Florida

Gainesville, Florida, 32610, United States

Location

Related Publications (11)

• 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.

  PMID: 22381437 RESULT

• McGovney 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.

  PMID: 35856908 DERIVED

• 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.

  PMID: 34310276 DERIVED

• 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.

  PMID: 33226334 DERIVED

• 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.

  PMID: 32126156 DERIVED

• 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.

  PMID: 31180977 DERIVED

• 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.

  PMID: 30496533 DERIVED

• 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.

  PMID: 30296735 DERIVED

• 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.

  PMID: 30176973 DERIVED

• 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.

  PMID: 30062746 DERIVED

• 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.

  PMID: 28940629 DERIVED

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Fibromyalgia

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Christina S McCrae, PhD

  University of Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 27, 2013
• First Posted: December 4, 2013
• Study Start: February 1, 2009
• Primary Completion: September 1, 2013
• Study Completion: September 1, 2013
• Last Updated: December 4, 2013

Record last verified: 2013-11

Locations

US (1)