Sleep and Pain Interventions in Women With Fibromyalgia (SPIN-II)

University of Missouri (MU)

Status: Enrolling

Conditions: Fibromyalgia; Insomnia; Chronic Widespread Pain

Treatments: Behavioral: Cognitive Behavioral Treatment-Insomnia; Behavioral: Sleep Hygiene Education

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03744156

1R01NR017168-01A1 (U.S. NIH Grant/Contract)

2011835

Details and patient eligibility

About

Insomnia affects 67-88% of chronic pain patients. SPIN II is a randomized controlled clinical trial that will compare the effects of two cognitive behavioral sleep treatments in women with fibromyalgia and insomnia. This trial will yield important information about the roles of sleep, arousal, and brain structure and function in the development and maintenance of chronic pain in women with fibromyalgia.

Full description

This mechanistic trial will assess sleep, pain, arousal, and neural imagining outcomes at baseline, post-8 week behavioral treatment (CBT-I or SHE), as well as at 6 and 12 month followups. This information will provide novel information about the neural structures and functional networks associated with chronic pain, and their manipulation through a cognitive behavioral intervention to improve insomnia. Demonstration that a relatively brief intervention can reverse or resolve pain related maladaptive neural plasticity, and improve or resolve clinical pain symptoms would have immediate and far-reaching implications for millions of chronic pain sufferers as well as for the US healthcare system and economy.

Enrollment: 130 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• female
• 18+ years of age
• willing to be randomized
• can read and understand English
• diagnosed with Fibromyalgia and insomnia
• no prescript or over the counter pain or sleep medicaments for 1+ month

Exclusion criteria

• unable to provide informed consent
• cognitive impairment
• sleep disorder other than insomnia (i.e., sleep apnea, periodic limb movement disorder
• bipolar or seizure disorder
• other major psychopathology (other than depression or anxiety)
• psychotropic or other medications that alter pain or sleep
• participation in non-pharmacological treatment (including CBT) for pain, sleep, or mood outside current trial
• internal metal objects or electrical devices
• pregnancy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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130 participants in 2 patient groups

Cognitive Behavioral Treatment-Insomnia

Experimental group

Description:

Cognitive Behavioral Treatment-Insomnia. 8 Session treatment focusing on behavior and cognitions related to sleep and pain.

Treatment:

Behavioral: Cognitive Behavioral Treatment-Insomnia

Sleep Hygiene Education

Experimental group

Description:

Sleep Hygiene Education. 8 Session treatment focusing on sleep hygiene education.

Treatment:

Behavioral: Sleep Hygiene Education