Sleep Disturbance and Bipolar Disorder
Bipolar DisorderDyssomniasThe study aims to evaluate a psychological intervention for individuals who suffer from sleep disturbance and bipolar disorder. We are hoping that this treatment will: (1) improve the quality of life of individuals with bipolar disorder who are suffering from sleep disturbance and (2) reduce the risk of, or help prevent, episodes.
Trazodone for Sleep Disturbance in Early Alcohol Recovery
AlcoholismThis study is a randomized, double-blind clinical trial comparing trazodone (Desyrel) and placebo among sleep-disturbed, alcohol-dependent individuals shortly after discharge from an inpatient detoxification program. Subjects will undergo a baseline assessment and random assignment to trazodone or identical placebo for 12 weeks. All persons completing the alcohol detoxification at Stanley Street Treatment and Resources (SSTAR) will be screened. (SSTAR of Rhode Island provides detoxification services to non/underinsured persons of Rhode Island.)
MsFLASH-04: Pilot Trial: Telephone Behavioral Therapy for Menopause-related Sleep Disturbance
Hot FlashesMenopause2 moreSelf-reported sleep complaints are common in peri- and postmenopausal women and have been identified as a key symptom of the menopausal transition. The MsFLASH study, A Pilot Trial of Telephone-Based Cognitive-Behavioral Therapy for Midlife Women with Menopause-related Sleep Disturbance, is a randomized, single-blind, placebo-controlled, two arm clinical trial. The target population will include women in general good health, aged 40-65 years, who report symptoms of insomnia (trouble sleeping) and who are bothered by hot flashes. We plan to enroll 100 women from Seattle, Washington and surrounding areas into the trial. Half of the women will be randomly assigned to receive the behavioral intervention and half to receive the behavioral control. The intervention arm participants will receive 6 sessions of a telephone-based, cognitive-behavioral therapy intervention for insomnia (CBT-I), based on state-of-the-art methods and specifically targeted to women with menopause-related sleep disturbance (CBT-I). The control arm participants will receive telephone-based Menopause Education Control (MEC) that includes elements of sleep hygiene. Assessments for both groups will be collected at baseline (pre-randomization), 8-week post-randomization, and 6-month post-randomization. The inclusion/exclusion criteria are designed to target broadly those midlife women who have menopause-related sleep disturbance and also report being bothered by vasomotor symptoms. This target population defines the clinical population seeking treatment for relief of menopause-related sleep problems. Exclusion criteria are kept minimal and intended only to exclude women with significant medical problems likely to account for their sleep problems (instead of menopause), or likely to interfere with their ability to participate in the intervention. We include women taking hormone therapy or other medication who meet these criteria because they are part of the population seeking clinical care for relief of sleep disturbances. Our primary objective is to develop an intervention that is generalizable to the greatest number of women and maximally translatable into real-world primary care practice.
Cognitive Behavioral Therapy for Insomnia (CBTi) in Patients With Mental Illness
InsomniaInsomnia Chronic10 moreInsomnia is common in patients with co-morbid mental illness and sleeping difficulties is a frequent complaint in most psychological disorders. Mental illness may cause sleep problems, however, sleep problems like insomnia, may also cause or exacerbate mental illness. Insomnia may aggravate symptoms of depression, anxiety and fatigue, and reduce daily functioning in patients with co-morbid insomnia and mental illness. This project aims to evaluate a course offered to patients with insomnia and mental illness at Diakonhjemmet Hospital. The course is based on cognitive behavioral therapy, a documented treatment for insomnia.
Implementing Behavioral Sleep Intervention in Urban Primary Care
Sleep DisturbanceSleep Deprivation1 moreInvestigators will enroll up to 20 participants from 3 Children's Hospital of Philadelphia (CHOP) primary care locations. The primary objective is to determine the whether the Sleep Well! behavioral sleep intervention is feasible to be implemented in primary care offices and acceptable to families. The direction and magnitude of change in child sleep from pre-intervention to post-intervention will also be examined.
MyCompass in a Swedish Context - an Automated Self-help Intervention Targeting Mental Health Problems...
Mild DepressionAnxiety State3 moreThe study present findings from the implementation of myCompass, a fully automated self-help intervention of Australian origin for mild to moderate anxiety and depression, in a Swedish context. The study also investigates the usage of a specially designed research platform aimed at handling informed consent and online surveys.
Targeting Worry to Improve Sleep
AnxietySleep DisturbanceThe purpose of this study is to test an app-based mindfulness training program for worry to see if it can help individuals decrease worry and improve sleep.
Medical Management of Sleep Disturbance During Opioid Tapering
Opioid DependenceOpioid Withdrawal1 moreThis study will evaluate whether a dual orexin-receptor antagonist approved by the FDA for sleep disturbance, suvorexant (SUVO; Belsomra), will increase total sleep time in patients with opioid use disorder (OUD) undergoing supervised withdrawal. This study is designed as a dose-finding study of SUVO compared to placebo. Briefly, OUD patients seeking supervised withdrawal will be admitted into a clinical research unit and stabilized onto buprenorphine for three days before being randomly assigned to study condition. All participants will then undergo a routine four-day buprenorphine taper, followed by a four-day post-taper phase. Participants will be randomized to receive either placebo, Low Dose SUVO, or High Dose SUVO and the investigators hypothesize that one or both doses of SUVO will improve total sleep time relative to placebo. Patients will attend a single follow-up session, 5-10 days following discharge.
Digital Psychological Self-care for Sleep Problems
Chronic InsomniaIn this non-randomized treatment feasibility pilot we want to explore if a simplified version of CBT-i as a non-therapist-guided digital tool can work; if the digital tool is perceived as user friendly and if participants' insomnia severity is improved following four weeks of treatment.
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Efficacy Study Comparing 4 Weeks of...
Gastroesophageal Reflux Disease (GERD)This study includes patients with sleep disturbances associated with gastroesophageal reflux disease (GERD) and has 3 treatment arms. Patients will receive only one of the following treatment arms: esomeprazole 20 mg once daily, esomeprazole 40 mg once daily, matching placebo once daily. The relief to the sleep disturbances will be assessed.