Behavioral Insomnia Therapy Trial Recruiting FM Patients at Duke

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Duke University Medical Center’s Insomnia & Sleep Research Program in Durham, North Carolina, is recruiting patients diagnosed with both FM and insomnia (“sleep initiation and maintenance disorders”) for a trial of behavioral insomnia therapy. It will also analyze the use of sleep electroencephalogram (EEG) as a means of measuring improvements in FM symptoms.

The researchers are recruiting both men and women, ages 21 through 65. And, because the study will entail about 15 clinic visits over a 9-month period, only patients within traveling distance of Durham will be considered. It will be randomized, single blinded and placebo controlled – meaning patients will be randomly assigned to receive either the therapy being tested or a placebo (fake) therapy, as a means of comparison. All participants will receive “basic FM care,” including medical advice and medication prescriptions, and apparently will be screened for conditions such as sleep apnea and restless legs syndrome.

The study – sponsored by the NIH’s National Institute of Arthritis, Musculoskeletal and Skin Diseases (NIAMS) – is officially titled “Behavioral Insomnia Therapy with Fibromyalgia.” number NCT00321451.

Study Objectives & Rationale
The purpose of this study is to evaluate the effectiveness of cognitive behavioral insomnia therapy in reducing sleep disturbances and improving FM-related pain, fatigue, mood, and quality of life among individuals with FM. Another important aspect of the study will be analysis of the sleep electroencephalogram (EEG) as a way to measure improvements in FM symptoms.

The study rationale is that:
n The majority of individuals with FM report sleep problems, including delayed sleep onset, extended awakenings, and non-restorative sleep. These sleep disturbances may worsen FM-related pain, fatigue, low mood, and low energy.
n Current treatment involves symptom-focused interventions such as antidepressants, behavioral stress management, coping skills training, and exercise programs.
n However, there are no interventions specifically designed to reduce sleep disturbances in people with FM.
n Past research has shown that individuals with FM experience the same behavioral and psychological factors that individuals suffering from insomnia experience. Cognitive behavioral insomnia therapy, a form of psychotherapy that aims to eliminate factors that disrupt sleep, may prove useful for people with FM.

Primary outcomes measured: Total wake time; total sleep time; sleep efficiency, measured at outset and completion of 9-month treatment period and 6 months post-treatment.

Secondary outcomes measured: Sleep onset latency [delay]; wake time after sleep onset; score on an insomnia rating scale; score on a fatigue rating scale; score on a mood rating scale; subjective pain ratings; score on a health-related quality of life scale.

Procedural Details
Study length 9 months, including approximately 16 study visits. Specifically:
n An initial 2-week screening period will include a physical examination, blood collection, a mental status exam, a tender-point exam, a sleep history questionnaire, and structured sleep and psychiatric interviews.
n Participants will complete a 1-week sleep log and one overnight polysomnogram test, in which several body functions (brain activity, eye movement, heart rate, etc.) are recorded.
n If an FM diagnosis is confirmed, an additional 2-week assessment period will take place, followed by an 8-week treatment period.
n During treatment, participants will be randomly assigned to one of the following three treatment groups:

  1. Usual FM care (medical advice and medication prescription),
  2. Usual FM care plus psychological treatment to decrease insomnia, and
  3. Usual FM care plus placebo psychological treatment to decrease insomnia.

n Groups 2 and 3 will attend four bi-weekly individual therapy sessions with a sleep psychologist.
n Participants will meet with a rheumatologist at least once.
n Throughout treatment, nightly sleep logs and medication questionnaires will be completed, and participants will wear a wrist-watch sized device that will record their day- and night-time activity.
n A therapy evaluation questionnaire will be completed during the first and last weeks of treatment and an outcome questionnaire packet will be completed after 4 weeks of treatment.
n All participants will be evaluated following the end of treatment and again 6 months later.

Inclusion Criteria:
n History of insomnia complaints for more than 1 month
n Diagnosis of primary FM
n Diagnosis of insomnia

Exclusion Criteria:
n Terminal illness or acute serious medical illness
n Secondary FM or condition other than FM that seriously compromises sleep
n Current psychiatric illness or currently suicidal
n Substance abuse or dependence
n Other primary sleep disorder (e.g., sleep apnea or restless legs syndrome)

Location & Contact Information:
Please refer to this study by identifier NCT00321451

Duke University Medical Center, Durham, North Carolina
Contact Research Associate Meg Lineberger, PhD:
Phone: 919-668-3267; Fax: 919-681-3267
Mail Address: Duke Insomnia and Sleep Research Program; DUMC Box 2908, Durham NC 27710

Principal Investigator Jack D. Edinger, PhD
Health Authority: U.S. Federal Government

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