Please select the outcome measures 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: Pittsburgh Sleep Quality Index (PSQI) (8 weeks and 5 months); Insomnia Severity Index (8 weeks and 5 months); Actigraphy (8 weeks)
B: Overall Incidence of Adverse Events (12 Months (from the 1st dose to the end of study))
C: Daily Living and Role Functioning (DLRF) Basis-32 Subscale Ratings (9 weeks); Relation to Self/Others (RSO) Basis-32 Subscale Ratings (9 weeks); Quality of Life Ratings, as Measured by the Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) (9 weeks)
D: diagnostic yield of PSG (during overnight study); total sleep time (during overnight study); wake after sleep onset (during overnight study); sleep latency (during overnight study); sleep efficiency (during overnight study); total arousal index (during overnight study); respiratory disturbance index at highest CPAP level (during overnight study)

Answer: A