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Insomnia is a prevalent health concern which is often associated with functional impairments, reduced quality of life, and increased health-care costs. The proposed study may provide useful information about optimal models for integrating behavioral and pharmacological therapies for the clinical management of insomnia.
Participants are randomly assigned to CBT or CBT plus medication. After the 6-week acute treatment phase, participants enter into a 6-month extended treatment phase. Of those treated with CBT alone initially, responders are randomized to extended CBT or no treatment. Of those receiving the combined CBT plus medication approach initially, responders are randomized to an extended treatment consisting of either CBT plus medication (used on an as needed schedule) or CBT alone (plus medication tapering). Outcome is evaluated across measures of sleep, clinical ratings, and several indices of daytime functioning. The measures are administered at baseline, at the end of the acute and extended treatment phases, and at 6, 12, and 24-month follow-up.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Sleep Initiation and Maintenance Disorders
Cognitive-behavior therapy, zolpidem
National Institute of Mental Health (NIMH)
Published on BioPortfolio: 2014-07-23T21:52:41-0400
To evaluate the efficacy of zolpidem for adolescent insomniacs with polysomnography
The purpose of this study is to investigate the efficacy and safety of FK199B (Zolpidem MR Tablet) in patients with insomnia by a randomized, double-blind, group-comparison study using zol...
This study will determine how sleeping pills can be combined with nondrug treatments to maximize the benefits of therapy for insomnia.
Primary objective: To show that the combination of Zolpidem + antidepressant therapy is more effective in the treatment of the secondary insomnia of depressive and dysthimic patients than...
This study is to investigate the efficacy and safety of FK199B (Zolpidem MR Tablet) by polysomnography in patients with insomnia, excluding patients with schizophrenia or manic-depressive ...
Among people with chronic pain, insomnia is highly prevalent, closely related to the mechanism of central sensitization, characterized by low-grade neuroinflammation, and commonly associated with stre...
Cognitive bias to sleep-related information is thought to be a core feature of sleep disturbances. The bias may enhance pre-sleep arousal, such as excessive worry about sleeplessness, which prevents p...
Sleep disturbances, including delayed sleep phase disorder (DSPD) and disorders of sleep initiation and maintenance (DIMS), have repeatedly been identified in adult obsessive-compulsive disorder (OCD)...
The aim of this study was to test whether a cognitive-behavioral and mindfulness-based group sleep intervention would improve behavior problems in at-risk adolescents, and whether these improvements w...
Insomnia disorder is present in as much as 30% of the general adult population. Given the significant adverse effects of pharmacotherapy, cognitive behavioral therapy (CBT) has been found to be an eff...
Drugs used to induce SLEEP, prevent SLEEPLESSNESS, or treat SLEEP INITIATION AND MAINTENANCE DISORDERS.
Disorders characterized by impairment of the ability to initiate or maintain sleep. This may occur as a primary disorder or in association with another medical or psychiatric condition.
Movements or behaviors associated with sleep, sleep stages, or partial arousals from sleep that may impair sleep maintenance. Parasomnias are generally divided into four groups: arousal disorders, sleep-wake transition disorders, parasomnias of REM sleep, and nonspecific parasomnias. (From Thorpy, Sleep Disorders Medicine, 1994, p191)
Conditions characterized by disturbances of usual sleep patterns or behaviors. Sleep disorders may be divided into three major categories: DYSSOMNIAS (i.e. disorders characterized by insomnia or hypersomnia), PARASOMNIAS (abnormal sleep behaviors), and sleep disorders secondary to medical or psychiatric disorders. (From Thorpy, Sleep Disorders Medicine, 1994, p187)
Dyssomnias (i.e., insomnias or hypersomnias) associated with dysfunction of internal sleep mechanisms or secondary to a sleep-related medical disorder (e.g., sleep apnea, post-traumatic sleep disorders, etc.). (From Thorpy, Sleep Disorders Medicine, 1994, p187)
Depression is a serious mental health condition, where sad feelings carry on for weeks or months and interfere with your life. The symptoms include feeling unhappy most of the time (but may feel a little better in the evenings), loosing interest in lif...
Sleep disorders disrupt sleep during the night, or cause sleepiness during the day, caused by physiological or psychological factors. The common ones include snoring and sleep apnea, insomnia, parasomnias, sleep paralysis, restless legs syndrome, circa...