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Completed

NCT Number: NCT02001077

Sleep and Pain Interventions in Fibromyalgia

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Florida

Gainesville, Florida, 32610, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cognitive Behavioral Therapy for Insomnia (CBT-I)

Behavioral

Cognitive Behavioral Therapy for Pain (CBT-P)

Behavioral

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. Change in self-report of pain experience.

    Time frame: 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Collaborators

  • National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Registry information

Official study title

Sleep and Pain Interventions in Fibromyalgia: Hyperalgesia and Central Sensitization

Acronym: SPIN

Important dates

Study start
2009
Primary completion
2013
Study completion
2013
First posted
Dec 4, 2013
Registry last updated
Dec 4, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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