Trial Summary
What is the purpose of this trial?Urgency urinary incontinence (UUI) is common in older people and vastly reduces quality of life, yet the cause and mechanism of disease are not well understood. This study will investigate the role of adding behavioral sleep intervention to the standard pharmacotherapy in treatment of UUI among older adults, and the brain mechanisms involved in continence by evaluating brain changes. This will expand the current knowledge of how the sleep affects bladder control, and better characterize the brain mechanisms in maintaining continence.
What safety data exists for Behavioral Sleep Treatment and Mirabegron for Urinary Incontinence?The provided research primarily discusses the efficacy and acceptability of Cognitive Behavioral Therapy for Insomnia (CBT-I) and its variants, such as Brief Behavioral Treatment for Insomnia (BBTI), in various populations, including military personnel and veterans. While these studies highlight the effectiveness and patient preferences for CBT-I, they do not specifically address the safety data for the combination of Behavioral Sleep Treatment and Mirabegron for Urinary Incontinence. Therefore, the safety data for this specific combination treatment is not covered in the provided research.124910
Is the treatment Brief Behavioral Treatment for Insomnia a promising treatment for urinary incontinence?Yes, Brief Behavioral Treatment for Insomnia, also known as Cognitive Behavioral Therapy for Insomnia (CBT-I), is a promising treatment. It has been shown to be effective in improving sleep in various groups, including those with traumatic brain injuries, asthma, and veterans with sleep difficulties. This suggests it could be beneficial for urinary incontinence as well, as better sleep can improve overall health and well-being.13468
What data supports the idea that Behavioral Sleep Treatment + Mirabegron for Urinary Incontinence is an effective treatment?The available research shows that Cognitive Behavioral Therapy for Insomnia (CBT-I) is effective for improving sleep-related issues, such as reducing the time it takes to fall asleep and decreasing awakenings during the night. Studies have shown that CBT-I is feasible, acceptable, and effective, with improvements maintained over time. However, the research provided does not specifically address the combination of Behavioral Sleep Treatment and Mirabegron for Urinary Incontinence, nor does it compare this combination to other treatments for urinary incontinence.13567
Do I have to stop taking my current medications for the trial?If you are currently using anticholinergic medications, you must go through a washout period of at least 4 weeks. The protocol does not specify other medication restrictions, but you should discuss your current medications with the trial team.
Eligibility Criteria
This trial is for ambulatory women aged 60 and older who experience frequent urgency urinary incontinence or urge-predominant mixed incontinence, despite treatment. Participants should have nocturia (waking up to urinate) at least twice each night and be willing to stop any anticholinergic medications for four weeks before the study.Inclusion Criteria
I get up to urinate 2 or more times each night.
I have had frequent urgent or mixed incontinence for over 3 months despite treatment.
I am a woman over 60 years old and can walk.
Exclusion Criteria
I do not have specific conditions like spinal injury, severe bladder issues, MS, or uncontrolled high blood pressure.
I am allergic or cannot take certain medications like mirabegron.
I have had Botox injections or nerve stimulation therapy for bladder control.
Treatment Details
The study tests whether adding a behavioral sleep intervention improves bladder control in older women with urinary issues when combined with standard drug therapy using Mirabegron. It also examines brain changes related to continence through fMRI scans.
2Treatment groups
Experimental Treatment
Group I: Mirabegron plus Brief Behavioral Treatment for Insomnia (BBTI)Experimental Treatment2 Interventions
Mirabegron for 8 weeks and a 4 week behavioral intervention for insomnia
Group II: MirabegronExperimental Treatment1 Intervention
Mirabegron for 8 weeks
Find a clinic near you
Research locations nearbySelect from list below to view details:
University of PittsburghPittsburgh, PA
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Who is running the clinical trial?
Shachi TyagiLead Sponsor
National Institute on Aging (NIA)Collaborator
References
Cognitive behavioral therapy for insomnia associated with traumatic brain injury: a single-case study. [2018]To test the efficacy of a cognitive behavioral therapy (CBT) for insomnia with a patient with traumatic brain injury (TBI).
Cognitive behavior therapy for chronic insomnia occurring within the context of medical and psychiatric disorders. [2022]Insomnia is a pervasive problem for many patients suffering from medical and psychiatric conditions. Even when the comorbid disorders are successfully treated, insomnia often fails to remit. In addition to compromising quality of life, untreated insomnia may also aggravate and complicate recovery from the comorbid disease. Cognitive behavior therapy for insomnia (CBT-I) has an established efficacy for primary insomnia, but less is known about its efficacy for insomnia occurring in the context of medical and psychiatric conditions. The purpose of this article is to present a rationale for using CBT-I in medical and psychiatric disorders, review the extant outcome literature, highlight considerations for adapting CBT-I procedures in specific populations, and suggest directions for future research. Outcome studies were identified for CBT-I in mixed medical and psychiatric conditions, cancer, chronic pain, HIV, depression, posttraumatic stress disorder, and alcoholism. Other disorders discussed include: bipolar disorder, eating disorders, generalized anxiety, and obsessive compulsive disorder. The available data demonstrate moderate to large treatment effects (Cohen's d, range=0.35-2.2) and indicate that CBT-I is a promising treatment for individuals with medical and psychiatric comorbidity. Although the literature reviewed here is limited by a paucity of randomized, controlled studies, the available data suggest that by improving sleep, CBT-I might also indirectly improve medical and psychological endpoints. This review underscores the need for future research to test the efficacy of adaptations of CBT-I to disease specific conditions and symptoms.
Efficacy of cognitive-behavioral therapy for insomnia associated with traumatic brain injury: a single-case experimental design. [2015]To test the efficacy of a cognitive-behavioral therapy (CBT) for insomnia in persons having sustained traumatic brain injury (TBI).
Insomnia treatment acceptability and preferences of male Iraq and Afghanistan combat veterans and their healthcare providers. [2019]Sleep difficulty is a prevalent problem among returning Veterans. Although there is strong evidence for the efficacy and durability of cognitive-behavioral treatment for insomnia (CBT-I) in the general population, the interventions require motivation, attention, and adherence from patients to achieve successful outcomes. Given the unique characteristics of Operation Iraqi Freedom/Operation Enduring Freedom (OIF/OEF) Veterans who have experienced blast-related injuries and other trauma, CBT-I for these patients may require modification, including alternative delivery methods, to ensure effective implementation and positive outcomes. We interviewed 18 OIF/OEF Veterans who screened positive for mild traumatic brain injury and 19 healthcare providers to determine the acceptability of insomnia treatments and preferences for the interventions and treatment delivery. Veterans and providers had distinct preferences for insomnia treatment and its delivery. The treatments the Veterans found most acceptable were also the ones they preferred: relaxation treatment and pharmacotherapy. The providers identified relaxation therapy as the most acceptable treatment. Veterans preferred the individual treatment format as well as electronic methods of treatment delivery. Despite some differences between patients and providers, a compromise through modification of empirically supported behavioral treatments is feasible, and implications for preference-based insomnia intervention development and testing are discussed.
[Cognitive behavioral therapy for chronic insomnia]. [2018]To evaluate the efficacy of cognitive behavioral therapy (CBT-I) in chronic insomnia treatment.
Feasibility and preliminary real-world promise of a manualized group-based cognitive behavioral therapy for insomnia protocol for veterans. [2018]Insomnia is increasingly common among the general population, even more so among veterans. Given the adverse impact of insomnia on both mental and physical health of veterans, it is important to provide effective treatments within the Veterans Health Administration (VHA) system. Group-based cognitive behavioral therapy for insomnia (CBT-I) provides a viable option for treatment. This study reports the feasibility, acceptability, initial effectiveness, and durability of group-based CBT-I in a clinical sample of veterans with comorbid medical and mental health diagnoses; the treatment was provided in a real-world VHA hospital setting using a manualized protocol that was explicitly adapted from the existing 1:1 CBT-I VHA protocol. Overall, we found the treatment to be feasible and acceptable to veterans, as well as effective. We found medium to large effect sizes for both questionnaire and sleep diary measures, including sleep onset latency, awakenings during the night, sleep efficiency, insomnia scores, and dysfunctional beliefs about sleep. Improvements in insomnia symptoms were maintained over 1 month.
Long-term clinical effect of group cognitive behavioral therapy for insomnia: a case series study. [2019]Cognitive-behavioral therapy for insomnia (CBT-I) is recognized as the first-choice intervention for insomnia. One of the best-known advantages of CBT-I in comparison with pharmacotherapy is its long-term effect. However, only few studies have assessed its benefits with follow-up periods of longer than three years. In this clinical case series study we aimed to describe the long-term effects of group CBT-I after a mean 7.8 ± 1.6 years of follow-up (range 4-10 years).
Solving insomnia electronically: Sleep treatment for asthma (SIESTA): A study protocol for a randomized controlled trial. [2023]Chronic insomnia is associated with poor asthma control. Cognitive-behavioral treatment for insomnia (CBT-I) is an efficacious and durable treatment for comorbid insomnia in medical and psychiatric disorders. However, the efficacy and potential accompanying mechanisms of CBT-I have not been examined in asthma. The purpose of this study is to test the efficacy of a CBT-I intervention on sleep and asthma control in adults with insomnia and asthma. We will also explore airway inflammation (i.e., exhaled nitric oxide, blood eosinophils) as a potential biological mechanism linking improvements in sleep with improvements in asthma control.
Cognitive behavioral therapy for insomnia among active duty military personnel. [2021]Insomnia is one of the most frequent sleep complaints among veterans and military personnel. This retrospective study investigated whether cognitive-behavioral therapy for insomnia (CBT-I) improved sleep and reduced insomnia symptoms in an active duty military population. The study consisted of 98 military personnel (mean age = 31.0, SD = 7.4; 70% male) who experienced insomnia and completed CBT-I in a military sleep disorders clinic. Assessments of sleep were completed analyzing pre- and posttreatment variables from the sleep diary, Insomnia Severity Index (ISI), and Epworth Sleepiness Scale (ESS). At baseline, the mean ISI was 16.63 (SD = 4.36) with a total sleep time (TST) of approximately 5.90 hr (SD = 1.32). After CBT-I, the ISI was 14.50 (SD = 5.19) and TST was 5.62 hr (SD = 1.32). There was no significant change over time for patients who received fewer than 4 sessions, but change over time was significant for patients who received 4 or more sessions. Over the course of treatment, patients' overall sleep improved across metrics with 20% achieving clinically meaningful improvement in insomnia symptoms. CBT-I improves insomnia symptoms in some military personnel. However, everyone does not respond successfully to CBT-I treatment. (PsycInfo Database Record (c) 2021 APA, all rights reserved).
Survey of Resources in Behavioral Sleep Medicine Across the Department of Defense, Defense Health Agency. [2023]Insomnia affects approximately 40% of active duty service members and adversely affects health, readiness, and safety. The VA/DoD Clinical Practice Guideline for the management of insomnia recommends cognitive-behavioral treatment of insomnia (CBTI) or its abbreviated version (brief behavioral treatment of insomnia [BBTI]) as the first-line insomnia treatment. The goal of this study was to assess CBTI/BBTI resources at MTFs, perceived facilitators and barriers for CBTI/BBTI, and gaps in these treatments across the Defense Health Agency.