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

Participants will answer the following questions on the daily diaries: I napped for ____________ minutes yesterday. I napped ______ times yesterday. I napped in the ___morning ___afternoon ____evening (check all that apply) I went to bed last night at ____________ AM/PM. It took me ____________ minutes to fall asleep. I woke up ____________ times last night. I was awake for ____________ minutes in the middle of the night. My final wake up time was ____________ AM/PM. I got out of bed at ____________ AM/PM. I would rate my quality of sleep last night as ____________. 1. very poor 2. poor 3. fair. 4 good 5. Excellent

The Insomnia Severity Index will be administered four times - baseline, post-treatment, and 6 and 12 month follow-up. Analysis will involve examining the trend of change in the ISI.

heart rate variability (as measured by Holter-Monitoring)

measures how much self-reported stress participants experience (from 0-never to 4-very often) across various 10 situations. Higher total scores indicate greater perceived stress.

30-item self-report questionnaire designed to identify and assess various sleep/insomnia-related cognitions (e.g., beliefs, attitudes, expectations, appraisals, attributions).

The PCS instructions ask participants to reflect on past painful experiences, and to indicate the degree to which they experienced each of 13 thoughts or feelings when experiencing pain, on 5-point scales with the end points (0) not at all and (4) all the time. The PCS yields a total score and three subscale scores assessing rumination, magnification and helplessness. Total score range from 0-52, with higher scores indicating greater pain catastrophizing.

Participants will rate how much pain they experience and how unpleasant the pain is on a scale of 1 to 100 on the daily dairies. Analysis will involve examining the trend of changes in these ratings.

assessment of neural plasticity

Actiwatch-L (ACT-L; Mini Mitter, Inc.) will be used to obtain a behavioral measure of sleep outcome. ACT-L is a wristwatch-like device that provides long-term monitoring of ambient light exposure and gross motor activity in human subjects. The Actiware-Sleep software provides behavioral estimates for several sleep variables: (1) sleep onset latency-interval between bedtime and sleep start; (2) total sleep time-sum of all sleep epochs within the sleep period; (3) sleep efficiency percentage- ratio of total sleep time to total time spent in bed × 100; and (4) total wake time-sum of all wake epochs within the sleep period.

Participants will undergo quantitative sensory testing using a contact thermode applied to the volar surface of the forearm. The protocol that will assess both first pain (primarily A-delta function) and second pain (primarily C-fiber input). All thermal stimuli will be delivered using a computer-controlled Medoc Thermal Sensory Analyzer (TSA-2001, Ramat Yishai, Israel). Visual Analog Scale (VAS) ratings of 4 graded intensities (45, 47, 49, 51° C) of 5 second temperature stimuli will be obtained in the following fashion: Stimulus presentation will be timed such that no site is stimulated with less than a 3-minute interval to avoid sensitization of the site. Participants will rate 8 stimuli (2 at each intensity) using a VAS for pain intensity anchored at the right end by "the most intense pain imaginable." A second random sequence of 8 stimuli (2 at each intensity) will be rated by VAS for pain unpleasantness.

Ambulatory Polysomnography will be conducted four times at baseline, post-treatment, 6-month, and 12 month follow-up. This involves attachment of small electrodes and wires to the head and body.

The McGill Pain Questionnaire will be administered four times - baseline, post-treatment, 6 month and 12 month follow-up. Analysis will involve examining the trend of change in the scores in McGill Pain Questionnaire.

The Pain Disability Questionnaire will be administered four times - baseline, post-treatment, 6 month follow-up and 12-month follow-up. Analysis will involve examining the trend of change in the scores in Pain Disability Questionnaire.

This 21-item scale measures self-reported depressive symptoms. Total scores range from 0-63, with higher scores indicating greater maladjustment.

The STAI-Y1 contains 20 items for assessing trait anxiety and 20 for state anxiety. State anxiety items include: "I am tense; I am worried" and "I feel calm; I feel secure." Trait anxiety items include: "I worry too much over something that really doesn't matter" and "I am content; I am a steady person." All items are rated on a 4-point scale (e.g., from "Almost Never" to "Almost Always"). Higher scores indicate greater anxiety.

A 20 item self-report scale that measures the frequency (0-never, to 5-almost always) of anxiety across situations in which pain is experienced. Total scores range from 0 to 100 with higher scores indicating greater anxiety related to pain.

A 10-item scale that asks participants to rate the level of worry and/or anxiety during several situations regarding disturbed sleep. Participant rate the truthfulness of each statement according to their own experience (1-not true to 10-very true). Higher total scores indicate greater anxiety/preoccupation about sleep.

A 6-item scale that measures the degree of independence on activities of daily living (1-independent; 0-dependent; activities include bathing, dressing, toileting, transferring, continence and feeding). Higher total scores indicate greater degree of independence on ADLs

A 8-item scale that measures the degree of independence in performing instrumental activities of daily living (1-independent; 0-dependent; instrumental daily activities include ability to use telephone, shopping, food preparation, housekeeping, laundry, transportation, responsibility for own medications, and finances). Higher total scores indicate greater degree of independence on IADLs

A 25-item scale measuring subjective cognition; caregivers rate on a scale of 0 (never) to 4 (very often) how often they experience cognitive mistakes and errors in daily tasks

A 20-minute computerized battery completed in a single setting on iPad (20 in. screen); domains tested include processing speed and attention, visuospatial ability and memory, verbal learning and memory, and executive functioning and working memory

Hair sample analysis for the inflammatory and stress hormone cortisol, and sex hormones estradiol and testosterone

Blood based biomarkers and hormones will be examined at each assessment period; biomarkers include CRP & IL-6, AβB42, AβB40 & total tau and phosphorylated-Tau at threonine181 & threonine217

Blood plasma analysis of three hormones including estradiol, testosterone, and cortisol

An 11-item questionnaire that provides a measure of global cognition. Participants are asked questions related to orientation to time/place, memory immediate/ delayed recall, attention and calculation, naming, repetition, comprehension, reading, writing, and drawing. Participants are scored 0-incorrect or 1- correct on each item. Total score is computed (out of 30), with higher total scores indicating better global cognitive function.

A 30-item questionnaire that provides a measure of global cognition. Participants are asked questions related to visuospatial/executive functioning, naming, memory immediate/delayed recall, attention, language, abstraction, and orientation to time/place. Participants are scored 0-incorrect or 1-correct on each item. Total score is computed (out of 30), with higher total scores indicating better global cognitive function.