View clinical trials related to Insomnia.
Filter by:The purpose of this clinical trial is to assess the relative efficacy of two non-pharmacological interventions for insomnia in Veterans suffering from chronic mild traumatic brain injury (mTBI).
Substance use disorders (SUDs) are a prevalent and impairing condition, particularly among trauma exposed individuals. The current proposal aims to address the critical need for targeted direct SUD prevention in this population by intervening on a novel, malleable risk factor for SUD common among trauma-exposed individuals: sleep disturbance. Sleep disturbance prospectively predicts the development of SUD and may confer risk for SUD by increasing stress reactivity, decreasing decision-making abilities, and ultimately promoting substance use to relieve negative affect, a core etiological factor in SUD. However, to our knowledge, no experimental studies have determined whether improving sleep leads to reductions in SUD risk. As such, the current study will use a randomized controlled trial design to test the effects of brief behavioral treatment for insomnia (BBTI) against a waitlist control among a sample of trauma-exposed young adults with poor sleep and risk for SUD (N = 60). We aim to determine the direct and indirect effects of condition (BBTI vs. waitlist control) on SUD symptoms, substance use-related problems, coping motives, and posttraumatic stress symptoms through improvements in sleep. Furthermore, we will test direct and indirect effects of condition on theoretically proposed mechanisms underlying the association between sleep disturbance and SUD risk (i.e., stress reactivity, cravings in response to stress).
This study will use a randomized controlled design to test whether patients who use medical marijuana, compared to a waitlist control group, experience a change in health outcomes (relief of symptoms, or adverse health outcomes such as new-onset symptoms of cannabis use disorders, neurocognitive impairments) or brain-based changes.
The purpose of this study is to learn if cognitive behavioral therapy for insomnia (CBT-I) will improve sleep quality, fatigue, and quality of life in individuals with multiple sclerosis (MS) with symptoms of insomnia.
This study will compare the efficacy of an interactive internet intervention for older adults with insomnia called SHUTi OASIS (Sleep Healthy Using the Internet for Older Adult Sufferers of Insomnia and Sleeplessness) accessed at www.shutioasis.org both with and without support for adherence to that of a static educational website to improve sleep, health, mood, and overall quality of life.
Substance Use Disorders (SUDs) and insomnia are major public health concerns, and each are independently linked to reduced quality of life, disability, and high healthcare costs. Insomnia, characterized by difficulty initiating or maintaining sleep, or nonrestorative sleep, is prevalent in 10% of the general population and is co-morbid in 70% of patients with SUDs. Primary insomnia and SUDs are chronic, unremitting diseases and have a complex bidirectional relationship. Insomnia symptoms may predate the onset of SUDs and may explain high prevalence of self-treatment. Insomnia may also be a direct effect of intoxication, withdrawal, or abstinence from the substance of abuse. Subjective and objective measures of sleep disruption have been shown in various stages of abuse and recovery. Insomnia is the most well documented predictor of substance use relapse. Treatment specifically targeting chronic insomnia is essential for improved clinical outcomes. Although, chronic insomnia is a well-established, modifiable risk factor, to our knowledge, there are no interdisciplinary residential treatment programs that specifically treat chronic insomnia during acute SUDs treatment. We propose that improved treatment of insomnia as part of a comprehensive reinforcement-based outpatient treatment program will provide an efficient and cost effective opportunity to improve standard outpatient SUD. Converging evidence suggests that prophylactic CBT-I during SUD treatment may have short and long-term efficacy for sleep, and improve attrition. In the proposed study, patients with co-morbid SUDs and insomnia will engage in an 8-week group CBT-I (gCBT-I) program in addition to receiving treatment as usual for SUDs. This study may provide new hope to effectively treat insomnia in SUD and lead to a new standardization of outpatient care. We hypothesize that a CBT-I intervention can be implemented as part of an evidence-based SUD treatment program within a residential facility.
The purpose of this study is to evaluate the efficacy and effectiveness of Sleep Restriction (SR) and Cognitive Therapy (CT) in Gulf War Veterans with insomnia. The primary hypothesis is that the efficacy of these treatments will depend upon an individual subject's baseline characteristics. For SR we expect that baseline measures of "excessive time spent in bed" may predict response and for CT we expect that baseline measures of cognitive arousal and pain may predict response. Exploratory analyses using signal detection techniques will systematically compare and contrast the potential usefulness of a number of additional potential moderator measures. Insomnia is a serious health problem in Gulf War Veterans that is often associated with extensive prescription of sleeping medications. Although safer, even the latest medications can lead to cognitive impairment and risk of abuse. Thus, non-pharmacological treatments for insomnia have been pursued as alternatives to medications. Cognitive Behavior Therapy for Insomnia (CBT-I) combines behavioral and cognitive components of therapy to address symptoms of insomnia. The combined CBT-I approach has well-documented efficacy. Between 2012 and 2014 over 650 VA mental health clinicians have received extensive training in CBT-I. Although CBT-I is efficacious, the optimal target populations for its major components has not yet been well-defined for Gulf War Veterans. We propose to address this gap and develop tools for clinicians to identify the best treatment for insomnia for individual Gulf War Veterans.
Internet-based self-help programs are personalized, self-guided interventions delivered over a computer, mobile device, or other Internet platform and focused on improving knowledge, awareness, or behavior change for a mental or physical health problem. Through previous and on-going projects at VACT, the investigators are developing a general strategy for implementing Internet-based Self-help programs in VA primary care, specifically among Patient Aligned Care Teams (PACT) and Primary Care Mental Health Integration (PCMHI) providers. An implementation strategy is defined as a systematic intervention to integrate evidence-based health innovations into usual care. The strategy the investigators propose to test consists of four core components: (1) a clinical intermediary for patient support, (2) provider/staff facilitation and education, (3) patient education, and (4) stepped-care for those requiring additional treatment. In the proposed study, the investigators will compare this strategy to a low intensity (control) strategy with respect to the implementation related outcomes of patent engagement, provider adoption through referral to the program, and patient completion, over a six-month active implementation period. The investigators will target the very common clinical problem of insomnia and use the SHUTiTM program, a 6-week self-guided program utilizing standard cognitive-behavioral therapy (CBT) techniques for the treatment of chronic insomnia. The program has been shown to improve insomnia severity and other sleep related outcomes in a number of controlled trials. The clinical effectiveness of SHUTiTM will be evaluated using clinical insomnia outcomes obtained on all patients enrolled over the 6-month active implementation periods. The purpose this study is to evaluate the preliminary (1) effectiveness of an implementation strategy for Internet-based Self-help Interventions and (2) clinical outcomes of a specific Internet-based self-help program for insomnia, SHUTiTM, in VA Connecticut outpatient primary care. The primary hypothesis is that the experimental implementation strategy the investigators are developing, relative to a control strategy, will result in higher rates of program engagement by patients, greater provider adoption through referral to the program, greater program completion, and improved patient insomnia outcomes.
This study tests the feasibility, acceptability, and preliminary efficacy of a seven-session cognitive-behavioral therapy intervention to treat sleep and pain problems in youth ages 11-17 with co-morbid headache and insomnia.
This study assesses the safety, tolerability, and efficacy of suvorexant in multiple sclerosis patients. Enrolled subjects will receive 2 weeks of treatment during treatment period 1 with either suvorexant or matching placebo (1:1). After treatment period 1, subjects will undergo a washout period of 1 week then 2 weeks of the alternate treatment (either suvorexant or placebo). The primary hypothesis is that suvorexant will provide greater improvement in sleep, as measured by symptom rating scales, compared to placebo.