scholarly journals SleepUp, a Digital Therapeutics Platform for Insomnia

2021 ◽  
Author(s):  
Gabriel Natan Pires ◽  
Ksdy Maiara Moura Sousa ◽  
Thábita Maganete ◽  
Paula Villena Redondo ◽  
Renata Redondo Bonaldi
Keyword(s):  
Early Stage ◽  
Behavioral Therapy ◽  
Sleep Hygiene ◽  
Regulatory Agencies ◽  
Evidence Based Treatment ◽  
Sleep Log ◽  
Additional Therapy ◽  
High Treatment ◽  
Insomnia Symptoms ◽  
Accessible Format

Background: Cognitive-Behavioral Therapy for Insomnia (CBTi) is the gold-standard treatment for chronic insomnia. Although effective, CBTi is not easily accessible due to a shortage of specialized professionals and high treatment costs. Online CBTi (CBTi-O) has been proposed as a more accessible and affordable treatment option. CBTi and CBTi-O are equally effective, and some apps have already been approved by regulatory agencies in USA (Somryst™) and UK (Sleepio™). Objetives: SleepUp is a digital therapeutics solution for insomnia, intended to provide evidence-based treatment in an easily accessible format. Methods: The treatment program is based on CBTi-O, composed by seven therapeutic modules (sleep hygiene, relaxation and meditation, psychoeducation, stimulus control, cognitive restructuring, sleep restriction and paradoxical intention). Users are monitored with a sleep log and validated questionnaires assessing insomnia symptoms, sleepiness, sleep quality and sleep hygiene. Additional therapy modules are included, encompassing mindfulness and other meditation techniques. For refractory cases or for those with comorbidities, remote appointments with medical doctors and psychologists specialized in sleep medicine are available. Results: SleepUp is an early-stage startup and its solutions for sleep and insomnia are being constantly developed and improved. The app is already available in Brazil and USA, both for Android™ and IOS™ devices. Preliminary results demonstrate that the treatment is effective, reducing insomnia symptoms in 28%, (n=1700), improving sleep hygiene scores in 32% (n=100) and increasing sleep efficiency in 16% (n=2500). Conclusion: SleepUp aims at providing a more accessible alternative to the treatment of insomnia, based on CBTI-O, an effective and safe therapeutic approach.

scholarly journals 0517 Integrated Cognitive Behavioral Therapy (CBT) and Mindfulness Group Treatment Protocol for Insomnia and Chronic Pain

SLEEP ◽  
2020 ◽  
Vol 43 (Supplement_1) ◽  
pp. A198-A198
Author(s):  
F Barwick ◽  
H Poupore-King ◽  
D You
Keyword(s):  
Chronic Pain ◽  
Group Treatment ◽  
Pain Catastrophizing ◽  
Behavioral Therapy ◽  
Treatment Protocol ◽  
Sleep Hygiene ◽  
Post Treatment ◽  
Pain Acceptance ◽  
Time In Bed ◽  
Insomnia Symptoms

Abstract Introduction Chronic pain and insomnia are highly comorbid, and CBT is a recommended treatment for both. CBT protocols that treat these conditions together, however, show improvements in sleep but not pain. As mindfulness, an acceptance-based approach, has been used successfully to treat chronic pain, integrating mindfulness into a combined CBT treatment protocol may help improve outcomes for chronic pain as well as insomnia. Methods An integrated CBT/Mindfulness weekly 6-session group protocol for chronic pain and insomnia was developed and piloted. Treatment components included education about pain neuroscience as well as sleep and circadian biology, relaxation, time-based pacing, tracking 24-hour time in bed, sleep compression, stimulus control, cognitive reframing, and mindfulness. Pre-post measures evaluating insomnia symptoms, sleep hygiene, pain acceptance, pain catastrophizing, and unhelpful beliefs about sleep and pain were analyzed using frequency analyses and paired sample t-tests. Results Two groups were completed for a total of 16 participants, 94% of whom attended at least 5 sessions. Average age was 56 years, 75% of the sample was female, 88% were White, 6% Asian, and 6% Latino. Post-treatment outcomes showed significant improvement in insomnia symptoms (ISI Mdiff=6.6, SDdiff=5.3, p=.01, ES=1.2), sleep hygiene (SHI Mdiff=3.8, SDdiff=4.6, p=.02, ES=.83), pain acceptance (CPAQ Mdiff=5.2, SDdiff=7.8, p=.03, ES=.67), pain catastrophizing (PCS Mdiff=5.1, SDdiff=7.5, p=.03, ES=.68), and unhelpful beliefs about sleep (DBAS Mdiff=31.4, SDdiff=21.2, p=.009, ES=1.5) and pain (PBAS Mdiff=11.6, SDdiff=10.7, p=.02, ES=1.1). Conclusion An integrated CBT/Mindfulness group protocol for chronic pain and insomnia showed significant improvements in post-treatment sleep and pain measures. As previous combined CBT-only protocols showed pre-post improvement in sleep but not pain, the current study demonstrates that including mindfulness might improve outcomes for chronic pain. Future studies should compare CBT protocols for chronic pain and insomnia with and without mindfulness to determine the clinical benefits of including an acceptance-based component. Support Poster presented as part of collaborative conversation with Skye Margolies, PhD, Department of Anesthesiology, University of North Carolina School of Medicine.

scholarly journals 0389 Prevalent Insomnia Symptoms and Need for an Intervention Among Oncology Nurses

SLEEP ◽  
2020 ◽  
Vol 43 (Supplement_1) ◽  
pp. A149-A149
Author(s):  
S Lee ◽  
T F Vigoureux ◽  
B D Gonzalez ◽  
B J Small
Keyword(s):  
Cognitive Behavioral Therapy ◽  
Behavioral Therapy ◽  
Sleep Hygiene ◽  
Oncology Nurses ◽  
South Florida ◽  
Cognitive Behavioral ◽  
Full Time ◽  
Public Health Burden ◽  
Hygiene Education ◽  
Insomnia Symptoms

Abstract Introduction Insomnia is prevalent in the working population. Nurses may be particularly vulnerable to insomnia due to demands with shift work, limited recovery between shifts, lack of control over their work, and stress associated with proximity to life-threatening health conditions. Insomnia in nurses is a significant public health burden, because it can lead to degraded quality of patient care. This study examined the prevalence of insomnia symptoms among oncology nurses and the need for an intervention to improve insomnia symptoms. Methods Participants were 62 nurses working full-time at a cancer hospital (Mage=35.26±11.69). Participants were asked about their (1) main sleep-related complaint, (2) willingness to participate in a sleep-focused intervention, (3) preferred delivery forms of the intervention (i.e., group-based, online, and/or one-on-one), and (4) preference for content to include in the intervention (e.g., sleep hygiene education, mindfulness, cognitive-behavioral therapy). We used content analysis to analyze open-ended responses as well as descriptive statistics to summarize data. Results Most (74%) reported difficulty falling or staying asleep or not feeling rested upon awakening as their primary or secondary sleep concerns. Nearly all nurses (95%) expressed interest in participating in a future sleep-focused intervention. In terms of preferred delivery forms of the intervention, an online intervention was most preferred (56%), followed by group meetings at the workplace (50%), and one-on-one meetings at the clinic (29%). Mindfulness strategies were preferred by most nurses (73%), followed by cognitive-behavioral therapy (48%), and sleep hygiene education (34%). Conclusion Most oncology nurses report insomnia symptoms and the majority are interested in participating in an intervention to improve their insomnia symptoms either online or in group sessions at the workplace. The information obtained from this pilot study will serve as the basis for developing a future intervention to improve insomnia and overall sleep health in oncology nurses. Support This work was supported, in part, by the University of South Florida College of Behavioral & Community Sciences Internal Grant Program (PI: Lee, Grant No. 0134930).

361 Relative Effectiveness of Cognitive Behavioral Therapy and its Components in Improving Insomnia Symptoms in Older Adults

SLEEP ◽  
2021 ◽  
Vol 44 (Supplement_2) ◽  
pp. A144-A144
Author(s):  
Kathleen O’Hora ◽  
Beatriz Hernandez ◽  
Laura Lazzeroni ◽  
Jamie Zeitzer ◽  
Leah Friedman ◽  
...  
Keyword(s):  
Older Adults ◽  
Cognitive Behavioral Therapy ◽  
Behavioral Therapy ◽  
Sleep Onset ◽  
Post Treatment ◽  
Cognitive Behavioral ◽  
Sleep Onset Latency ◽  
Significant Group ◽  
Time Interaction ◽  
Insomnia Symptoms

Abstract Introduction The prevalence of insomnia complaints in older adults is 30–48%, compared to 10–15% in the general population. Cognitive Behavioral Therapy for Insomnia (CBT-I) is a first-line, non-pharmacological sleep treatment for Insomnia. However, the relative impact of Behavioral (BT) and Cognitive (CT) components compared to that of CBT-I in older adults is unknown. Methods 128 older adults with insomnia were randomized to receive CBT-I, BT, or CT. Sleep diaries and the Insomnia Severity Index (ISI) were collected pre- and post-treatment and at a 6-month follow-up. We conducted split-plot linear mixed models with age and sex as covariates to assess within and between subject changes to test effects of group, time, and their interaction on ISI, sleep onset latency (SOL), wake after sleep onset (WASO), total sleep time (TST), time in bed (TIB), sleep efficiency (SE), and percent of treatment responders (ISI decrease>7) and remitters (ISI<8). Effect size (d) was calculated by dividing the difference between means by the root-mean-squared error of the mixed effects model. Results All treatments lead to a significant improvement across outcome measures at post-treatment (p’s<0.001) and 6-months (p’s<0.01), with the exception of TIB, response, and remission. For TIB, there was a significant Group x Time interaction (p<0.001): while all treatments significantly reduced TIB post-treatment relative to baseline, CBT-I (p<0.001,d=-2.26) and BT (p<0.001,d=-1.59) performed significantly better than CT (p=0.003, d=-0.68). In contrast, at 6-months CBT-I (p<0.001,d=-1.16) performed significantly better at reducing TIB than CT (p=0.195,d=-0.24) or BT (p=0.023,d=-0.61) relative to baseline. There was also a non-significant trend for a Group x Time interaction for remission status (p=0.062). Whereas, the percentage of remitters within all groups post-treatment did not differ from chance (p>0.234), at 6 months, the percentage of remitters was significantly higher than chance in CBT-I (73.63%,p=0.026) and BT (78.08%,p=0.012), but not CT (47.85%,p=0.826). There were no other significant time or interaction effects (all p>0.05). Conclusion CBT-I and its components are effective in improving subjective insomnia symptoms in older adults. Evidence suggests CBT-I may be superior to either CT or BT alone in improving TIB in older adults. Support (if any) NIMHR01MH101468; MIRECC at VAPAHCS

scholarly journals Current hurdles to the translation of nanomedicines from bench to the clinic

2021 ◽  
Author(s):  
Snežana Đorđević ◽  
María Medel Gonzalez ◽  
Inmaculada Conejos-Sánchez ◽  
Barbara Carreira ◽  
Sabina Pozzi ◽  
...  
Keyword(s):  
Drug Product ◽  
Early Stage ◽  
Regulatory Agencies ◽  
Important Process ◽  
Close Collaboration ◽  
Critical Quality Attributes ◽  
Research Areas ◽  
Physical Chemical ◽  
Clinical Models ◽  
Further Development

AbstractThe field of nanomedicine has significantly influenced research areas such as drug delivery, diagnostics, theranostics, and regenerative medicine; however, the further development of this field will face significant challenges at the regulatory level if related guidance remains unclear and unconsolidated. This review describes those features and pathways crucial to the clinical translation of nanomedicine and highlights considerations for early-stage product development. These include identifying those critical quality attributes of the drug product essential for activity and safety, appropriate analytical methods (physical, chemical, biological) for characterization, important process parameters, and adequate pre-clinical models. Additional concerns include the evaluation of batch-to-batch consistency and considerations regarding scaling up that will ensure a successful reproducible manufacturing process. Furthermore, we advise close collaboration with regulatory agencies from the early stages of development to assure an aligned position to accelerate the development of future nanomedicines. Graphical abstract

scholarly journals Efficacy of Psychiatric Treatment to Treat a Specific Phobia of Intravitreal Injections in a Patient with Neovascular Age-Related Macular Degeneration

2021 ◽  
pp. 48-56
Author(s):  
Atsuta Ozaki ◽  
Hisashi Matsubara ◽  
Masahiko Sugimoto ◽  
Manami Kuze ◽  
Mineo Kondo ◽  
...  
Keyword(s):  
Macular Degeneration ◽  
Macular Edema ◽  
Psychiatric Treatment ◽  
Early Stage ◽  
Behavioral Therapy ◽  
Specific Phobia ◽  
Age Related Macular Degeneration ◽  
Intravitreal Injections ◽  
Anti Vegf ◽  
Age Related

Intravitreal injection of anti-vascular endothelial growth factor (anti-VEGF) is essential for the treatment of macular diseases such as wet age-related macular degeneration and macular edema. Although continued treatment is needed to maintain good vision, some patients cannot continue such injections for various reasons, including specific phobias. Here, we report a case of a patient with a specific phobia of intravitreal injections who could resume treatment after undergoing combined drug and cognitive-behavioral therapy (CBT). A 74-year-old Japanese man diagnosed with retinal angiomatous proliferation by fluorescein angiography and indocyanine green angiography was treated with intravitreal anti-VEGF injection. However, at 8 months after the first treatment, he became difficult to treat because of a phobia of injections. He was treated with photodynamic therapy, but his macular edema did not improve. After a psychiatric consultation, he was diagnosed with a specific phobia of intravitreal injections. Combined drug and CBT enabled him to resume receiving intravitreal injections. This case demonstrates that a specific phobia of intravitreal injections may benefit from combined drug and CBT. In this regard, some patients with high anxiety and fear of intravitreal injections should be referred to a psychiatrist at an early stage.

scholarly journals The Relationship between Sleep Hygiene, Mood, and Insomnia Symptoms in Men with Prostate Cancer

2021 ◽  
Author(s):  
Kathleen T. Galvin ◽  
Sheila N. Garland ◽  
Erik Wibowo
Keyword(s):  
Prostate Cancer ◽  
Depressive Symptoms ◽  
Daytime Sleepiness ◽  
Online Survey ◽  
Psychological Symptoms ◽  
Sleep Hygiene ◽  
Psychological Conditions ◽  
Mailing Lists ◽  
Anxiety Depression ◽  
Insomnia Symptoms

Abstract PurposeInsomnia symptoms are commonly experienced by men after prostate cancer (PCa) treatment. Here we explored how sleep hygiene behaviours and psychological symptoms are associated with insomnia symptoms in PCa patients.MethodsAn online survey was posted on social media and sent to mailing lists of PCa and general cancer organisations. The survey collected information on demographic, sleep hygiene and psychological symptoms using validated questionnaires. ResultsData from 142 participants were compared based on the absence (age = 68.3 ± 8.9 years) and presence (age = 66.6 ± 9.0 years) of insomnia symptoms. Participants with insomnia symptoms had significantly higher levels of anxiety, depression, fatigue, and daytime sleepiness as well as poorer sleep hygiene than those without insomnia symptoms. Control variables (age, comorbidities, ADT experience and BMI) accounted for 12.5% of the variance in insomnia symptoms. Adding sleepiness, fatigue, anxiety, depressive symptoms to the model explained an additional 45.1% of the variance in insomnia symptoms. Further, including the sleep hygiene item “I think, plan, or worry when I am in bed” and “I sleep in an uncomfortable bedroom” explained an additional 3.6% of the variance in insomnia symptoms. ConclusionsPoor sleep hygiene, fatigue, daytime sleepiness, anxiety, depressive symptoms were all associated with worse insomnia symptoms in PCa patients. Improving sleep hygiene and treating psychological conditions may potentially help prevent and/or alleviate insomnia symptoms in PCa patients.

scholarly journals Rewriting One Patient’s Story of Disrupted Sleep

2019 ◽  
pp. 161-172
Author(s):  
Samantha Domingo ◽  
Michelle L. Drerup
Keyword(s):  
Social Support ◽  
Treatment Adherence ◽  
Relaxation Training ◽  
Behavioral Therapy ◽  
Treatment Options ◽  
Cognitive Restructuring ◽  
Sleep Hygiene ◽  
Sleep Restriction ◽  
Insomnia Disorder

This chapter covers treatment options for individuals with chronic insomnia disorder. We describe the effectiveness of cognitive behavioral therapy for insomnia (CBT-i) and various modalities of delivery of the treatment. CBT-i is an alternative treatment for insomnia that has been demonstrated to be as successful as pharmacological therapies in the short term, and more effective in the long term. CBT-i comprises sleep restriction, stimulus control, relaxation training, sleep hygiene, and cognitive restructuring. The authors examine group CBT-i as a way to increase social support and enhance treatment adherence. Computerized CBT-i is a newer option to provide increased access to this treatment.

The effectiveness of short-term cognitive behavioral therapy in the complex treatment of idiopathic restless legs syndrome with chronic insomnia

2021 ◽  
Vol LIII (2) ◽  
pp. 46-56
Author(s):  
Aleksey I. Melekhin
Keyword(s):  
Restless Legs Syndrome ◽  
Behavioral Therapy ◽  
Well Being ◽  
Sleep Hygiene ◽  
Cognitive Behavioral ◽  
Chronic Insomnia ◽  
Short Term ◽  
Restless Legs ◽  
Mental Well Being

Aim. To investigate the effectiveness of the short-term protocol of cognitive behavioral therapy RELEGS M. Hornyak et al. in complex treatment to improve the quality of sleep, reduce the symptoms of depression, anxiety, suicidal thoughts in patients with primary SBN comorbid with chronic insomnia. Methods. Study participants: 68 patients with primary restless legs syndrome with comorbid chronic insomnia. Women 56 (average age 52.110.3 years), men 12 (average age 50.39.4 years). The severity of restless legs syndrome is moderate to severe. The average age of the onset of the disease is 1848 years, the duration of the course of the disease is on average 1415 years. Taking various medications for the management of SBN for an average of 45 years. Study design: a randomized controlled trial, after screening 26 patients were assigned to the main group, underwent combined treatment, took a prolonged form of Pramipexole (Mirapex-PD, 1.5 mg.) and underwent the RELEGS CBT protocol (Restless Legs Skills program, Hornyak, Grossmann, 2018), which integrates the cognitive behavioral insomnia protocol (Morin, 2007) and Mindfulness-Based Stress therapy (Mindfulness-Based Stress Reduction, Bablas, 2016). The control group consisted of 24 people who received only general recommendations on sleep hygiene once. Both groups were treated with dopaminergic agonists under the supervision of a neurologist. Research methods: IRLS, ISI, DBAS-16, sleep diary analysis, actigraphy, BDI, SBQ-R, BAI. Results. The use of the CBT protocol in combination therapy with prolonged-acting dopaminergic agonists in patients with primary restless leg syndrome (mild and moderate severity) with comorbid chronic insomnia, in contrast to simple one-time general recommendations on sleep hygiene, is more effective for reducing dysfunctional behaviors, the spectrum of reinsurance and avoidance behavior both in relation to sleep and symptoms of restless legs. In patients with primary restless legs syndrome who underwent CBT, greater mental well-being was observed, which was expressed in a decrease in the severity of symptoms of insomnia, anxiety, and suicidal behavior after completion and persisted after 3 months of follow-up. Conclusion. As part of a personalized comprehensive approach, along with a drug-based approach and general recommendations for sleep hygiene, the use of short-term CBT (4 sessions, 60 minutes each) can significantly improve mental well-being, improve the quality of sleep of patients with restless legs syndrome with comorbid chronic insomnia.

Session 1: Stress Identification and Management

2020 ◽  
pp. 11-20
Author(s):  
Bryan D. Carter ◽  
William G. Kronenberger ◽  
Eric L. Scott
Keyword(s):  
Physical Activity ◽  
Chronic Illness ◽  
Stress Management ◽  
Management Strategies ◽  
Building Blocks ◽  
Sleep Hygiene ◽  
Hygiene Practices ◽  
Health And Illness ◽  
Sleep Log ◽  
Recovery Program

This session introduces important information on understanding just what stress is and how it can affect our bodies. Learning to identify situations that can be stressful is the first step, followed by understanding how different stressors call for different stress management strategies. One particularly important issue in managing the stress that comes from having a chronic illness is sleep. The Children’s Health and Illness Recovery Program (CHIRP) introduces the importance of improving sleep by learning healthy sleep hygiene practices and monitoring this with the help of the Sleep Log. Improvement in sleep hygiene and physical activity are emphasized as important building blocks of CHIRP.

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