Please select the eligibility criteria that correspond to the clinical trial below.
Title: Mindfulness Versus Pharmacotherapy for Chronic Insomnia: A Pilot Study
Brief Summary: Chronic insomnia is a major public health problem that affects about 10% of adults and is associated with serious and distressful health consequences such as depression, anxiety and reduced quality of life. Sleep medications are effective, but side effects, costs and uncertain long term efficacy call for non-pharmacologic alternatives. Mindfulness-Based Stress Reduction (MBSR), a standardized program of training in mindfulness meditation and yoga, is a promising new approach for treating chronic insomnia. MBSR was developed to facilitate adaptation to the stressors of medical illness. It is hypothesized that mindfulness training reduces arousal and unhelpful cognitions that promote and sustain chronic insomnia. The Mindfulness Versus Pharmacotherapy trial (MVP#1) is a pilot study designed to establish the feasibility and determine the optimal design for a full-scale trial comparing MBSR to prescribed sleep medication for treatment of chronic insomnia. For this pilot, we will randomize persons with primary chronic insomnia (actual sample of 30 persons) to 2 groups : 1) MBSR (8-weeks of group instruction followed by 3-months of home practice); and 2) PCT (3 mg of LUNESTA(eszopiclone) nightly for 8-weeks followed by 3-months of "as needed" use). Both groups will have telephone monitoring for side effects, adherence tracking, and objective sleep assessment by actigraphy. The primary outcomes are sleep quality, sleep quantity and insomnia severity assessed by well-validated self-report scales, objective sleep parameters measured by wrist actigraphy, depression and anxiety symptoms, health-related quality of life and workplace productivity. We hypothesize that those in the MBSR group will have improved sleep outcomes. Outcomes will be assessed at 8-weeks (the end of the active intervention phase) and 5 months follow-up. Outcomes will be compared to baseline values and measures reflecting proposed mechanisms of action to determine if clinically important impacts are likely to be obtainable in a full-scale trial. After follow-up data have been collected, participants will be invited to participate in focus groups to share their impressions of the study interventions to identify issues that could be addressed in a full-scale trial. Our long-range goal is to provide evidence-based recommendations for safe, practical and cost-effective non-pharmacologic treatment options for chronic insomnia.


Options:
A: Inclusion Criteria:

* Chronic insomnia defined as a) sleep onset latency and/or wake after sleep onset longer than 30 minutes per night, at least 3 nights per week; and b) Insomnia duration of at least 6 months, by self-report; and c) minimum of 1 daytime complaint by self-report (e.g. fatigue, mood disturbance);
* Between 18 and 65 years of age;
* English-speaking;
* Literate;
* Mentally intact;
* Interested in either medication or mind-body interventions;
* Able to attend weekly classes in a Minnesota Metro area;
* Able to comply with study sleep monitoring requirements;
* Willing to complete the informed consent process.

Exclusion Criteria:

* Sleep apnea or other primary sleep disorder suspected of being responsible for insomnia;
* Mental disorder or substance (including medications) suspected of being responsible for insomnia;
* General medical condition suspected of being responsible for the insomnia;
* Medically unstable (a hospital admission for non-elective purposes in the last 3 months or major surgery planned in the next 3 months);
* Serious preexisting mental health issues: suicidality or thought disorder/psychosis; or delirium or substance abuse;
* Treatment for depression or anxiety with initiation of therapy or dosage change within the last 6 months;
* Use of non-prescription sleep aids and unwilling or unable to discontinue these during the study;
* Use of prescription sleep medications or other medications known to affect sleep or be contraindicated with use of hypnotics, and unwilling or unable to discontinue these during the study;
* Known allergy to eszopiclone;
* Shift worker;
* Pregnant , breast-feeding or planning pregnancy in next 6 months;
* Previous cognitive behavioral therapy for insomnia or current psychotherapy;
* Prior MBSR class or regularly practicing mindfulness meditation.
B: Inclusion Criteria:

Inclusion Criteria:

* Subject is male or female 6 17 years of age, inclusive, at the time of consent.
* Subject must have a diagnosis of ADHD as defined by DSM-IV criteria • The diagnosis for Rollover subjects will be taken from the Screening visit of Study 190 246. Treatment naïve subjects will have these assessments performed at the Screening visit.
* Subject must have documented ADHD associated insomnia, defined as the subject or subject's parent/legal guardian having reported repeated difficulty with sleep initiation (sleep latency \>30 minutes) or consolidation (wake time after sleep onset \> 45 minutes),\>despite adequate age appropriate time and opportunity for sleep.
* Subject has either \>30 minutes latency to persistent sleep (LPS) or \>45 minutes wake time after sleep onset (WASO) demonstrated by PSG.
* Subject or subject's parent/legal guardian should have reported daytime functional impairment as a result of sleep problems.
* Subject or subject's parent/legal guardian should have reported attempted and failed behavioral interventions for sleep problems, including a regular bedtime and rise time.
* Subject's sleep disturbance must not be attributable to either the direct physiologic effect of a drug of abuse or misuse of a prescribed medication whether it is being used as intended or in an illicit manner.
* Female subjects ≥8 years of age must have a negative serum pregnancy test at screening
* Subject must be in good general health.
* Subject must be able to swallow tablets.
* If subjects are currently taking medication for ADHD, they must be on a stable dose and regimen for at least one month, and preferably for at least 3 months prior to the time of consent

Exclusion Criteria:

* Subject with weight \<10th percentile for age and gender
* Subject has any clinically significant or unstable medical abnormality/illness
* Subject has a documented history of Bipolar I or II Disorder, major depression, conduct disorder, generalized anxiety disorder (other than obsessive-compulsive disorder) or any history of psychosis, as determined by medical or psychiatric history or as determined by clinical interview using the MINI-Kid at Visit 1.
* Subject has periodic limb movement \>5 times per hour, as demonstrated on PSG.
* Subject has sleep disordered breathing, as demonstrated on PSG.
* Subject has another primary sleep disorder (or secondary sleep disorder that is causing clinical impairment or any other known or suspected medical or psychiatric condition that has affected or may affect sleep
* Subject has a history of circadian rhythm disorder or will travel across ≥3 time zones more than once during the study.
* Subject has organic brain disease, or a history of febrile seizures.
* Subject is, in the opinion of the investigator, at suicidal or homicidal risk.
* Female subject who is pregnant, lactating or planning to become pregnant.
* Subject is taking any psychotropic or disallowed medications,
* Subject has a history of severe allergies to more than 1 class of medications or multiple adverse drug reactions.
* Subject has a history of allergic reaction or has a known or suspected sensitivity to racemic zopiclone, eszopiclone, or any substance that is contained in the formulation.
* Subject has a history of alcohol or substance abuse within 3 months of study participation
* Subject has participated in any investigational study within 30 days prior to study entry or is currently participating in another clinical trial, except Study 190 246.
C: Inclusion Criteria:

* Score of greater than 10 on the Primary Care Evaluation of Mental Disorders Patient Health Questionnaire (PRIME-MD-PHQ) telephone screen
* Diagnosis of major depressive episode based on the Structured Clinical Interview for DSM-IV (SCID)
* Score of greater than 20 on the Hamilton Rating Scale for Depression
* Meets research diagnostic criteria for insomnia disorder at least 4 nights per week
* Reported mean sleep latency greater than 30 minutes and mean sleep efficiency less than 85%
* Suitable for outpatient treatment

Exclusion Criteria:

* Use of any psychotropic medications within 2 weeks of initial screening
* Bipolar disorder, schizophrenia, psychotic depression, or any other psychotic disorder
* Uncontrolled asthma or chronic obstructive pulmonary disease
* Chronic pain that may be a significant sleep-disturbing factor
* Uncontrolled thyroid disease
* Poorly controlled diabetes mellitus
* Poorly compensated congestive heart failure
* Currently taking lipophilic beta blockers, opioids, glucocorticoids, theophylline, or other medications known to interfere with sleep
* History of intolerance or treatment resistance to either fluoxetine or eszopiclone
* Inability to abstain from taking any psychotropics other than the study medications during the course of the protocol, including sedating antihistamines
* Use of any herbal or naturopathic treatments for sleep or mood (i.e., St. John's wort, melatonin, kava kava, valerian root, etc.)
* Currently undergoing behavioral, cognitive-behavioral, or interpersonal therapy
* Pregnant or breastfeeding
* Agrees to use an effective form of contraception for the duration of the study
* Uncontrolled symptoms of menopause, including hot flashes
* Uncontrolled hypertension (systolic blood pressure consistently greater than 140 mm Hg, diastolic blood pressure consistently greater than 90 mm Hg)
* Diagnosis of sleep apnea, periodic limb movement disorder, or restless leg syndrome
* Reports habitual bedtime earlier than 9 PM or later than 1 AM more than 2 times per week
* Reports habitual rising time later than 9 AM more than 2 times per week
* Body mass index greater than 30
* Consumes more than 3 alcoholic beverages per day
* Consumes more than 4 caffeinated beverages per day
* Habitual smoking between 11 PM and 7 AM
* Use of illicit drugs
* Score greater than 24 on the Mini Mental State Examination
* Determined to be incompetent
* Determined to be at imminent risk for suicide
* More than 5 lifetime SCID diagnoses of major depressive episodes
* More than 3 failed antidepressant trials during the current episode of depression, as determined by the Antidepressant Treatment History Form
* A course of electroconvulsive therapy during the present depressive episode
D: Inclusion Criteria:

* All adult patients aged 18-65, evaluated by a sleep medicine provider in the Walter Reed Army Medical Center Sleep Disorders Clinic, who are referred for PSG for suspected Obstructive Sleep Apnea Syndrome

Exclusion Criteria:

* Pregnancy
* Liver dysfunction or history of EtOH abuse
* Concomitant use of benzodiazepines, narcotics or ketozonazole
* Decompensated CHF
* CVA within 3 months
* Uncontrolled psychiatric disorders
* Patients \< 18 years old
* Patients over 65

Answer: A