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Insomnia clinical trials

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NCT ID: NCT05157386 Active, not recruiting - Depression Clinical Trials

Physical Exercise as Adjunctive Therapy for Affective Disorder and Anxiety

Start date: December 20, 2021
Phase:
Study type: Observational

"Braining" is a clinical method for physical exercise as adjunctive therapy in psychiatric care. The core components are personnel-led group training sessions and motivating contact with psychiatric staff, as well as measurement and evaluation before and after the training period of 12 weeks. Objective. This study aims to describe the clinical and demographic variables in the population of patients who participated in Braining 2017-2020, investigate the feasibility of Braining, and analyse perceived short-term effects and side effects of Braining regarding psychiatric and somatic symptoms. Method. The project is a retrospective, descriptive study. Patients at Psykiatri Sydväst (PSV, Psychiatric Clinic Psychiatry Southwest, Stockholm) who participated in Braining 2017-2020 during at least 3 training sessions, will be asked for inclusion. Medical and demographic data, as well as patient treatment evaluations, are already available in medical records. Additionally, an extended 2-year long-term follow-up will be carried out. This includes blood and hair sample, physical examination as well as qualitative interviews with a representative subgroup.

NCT ID: NCT05067569 Active, not recruiting - Insomnia Clinical Trials

App-delivered Sleep ThERapy for Older Individuals With Insomnia

ASTEROID
Start date: October 1, 2022
Phase: N/A
Study type: Interventional

This randomised, open, parallel controlled trial aims to compare the efficacy of a digital brief behavioural therapy for insomnia (dBBTi) against online sleep health education on insomnia symptom severity in older adults aged 60 years and over. The trial will be totally online with participants recruited from the community across Australia.

NCT ID: NCT05065502 Active, not recruiting - Insomnia Clinical Trials

MIDAS Cluster Randomized Controlled Trial of Implementation Strategies to Optimize Use of Medications in VA Clinical Settings

MIDAS cRCT
Start date: May 3, 2021
Phase: N/A
Study type: Interventional

Scientific advances are constantly leading to better treatments. However, it is quite challenging for healthcare systems, including VA, to ask very busy providers to change the way they practice. The MIDAS QUERI program will help providers improve the way they treat VA patients for three common conditions, using specific strategies to ensure the reliable delivery of these treatments. The first project will focus on reducing potentially inappropriate medication (PIM) use using the VIONE practice, developed in VA. The second project will focus on better use of drugs called direct oral anticoagulants (DOACs) for patients with a history of severe blood clots or an abnormal heart rhythm. The third project will focus on increasing the use of cognitive behavioral therapy for insomnia as the first-line treatment for insomnia instead of sleep medications. The investigators will test two implementation approaches to improve medication use within these topics.

NCT ID: NCT05027438 Active, not recruiting - Insomnia Clinical Trials

Reducing Use of Sleep Medications Assisted by a Digital Insomnia Intervention

SEDATIVE
Start date: September 22, 2022
Phase: N/A
Study type: Interventional

Chronic insomnia is one of the most common health problems among Veterans and significantly impacts their health, function, and quality of life. Sedative-hypnotic medications are the most common treatment despite mixed effectiveness and are associated with numerous risks that can further impact Veteran function. An intervention combining evidence-based interventions for deprescribing sedative-hypnotics and behavioral interventions for insomnia can help to optimize sleep and functional outcomes for Veterans with a desire to reduce or stop using these medications. Furthermore, by delivering these interventions through an easy to use and highly accessible digital platform can provide additional benefits to Veterans, especially those with limited time and access to engage in traditional in-person interventions. The Clinician Operated Assistive Sleep Technology (COAST) is an efficient, scalable, and adaptable platform that can help providers to reach more Veterans and provide evidence-based care that translates to improved health and function. Aim 1: To assess the feasibility of recruiting Veterans with chronic sedative-hypnotic use to participate in a 12-week combined deprescribing and CBT-I intervention, delivered through the COAST digital platform. Aim 2: To assess Veteran acceptability and usability of the COAST platform. Aim 3: To assess change in Veteran sleep, sedative-hypnotic use, and function pre- to post-intervention.

NCT ID: NCT04949360 Active, not recruiting - Insomnia Clinical Trials

SleepUp Digital CBTi-based Platform for Insomnia

Start date: May 5, 2022
Phase: N/A
Study type: Interventional

Cognitive-Behavioral Therapy for insomnia (CBTi) is a well-established therapeutic intervention for insomnia. SleepUp provides a digital therapeutics platform based on CBTi and additional features. This clinical trial aims at analyzing the efficacy of the CBTi-based platform offered by SleepUp in reducing symptoms of insomnia. The sample will be composed of 160 individuals, both males and females, from 20 to 60 years old, with insomnia symptoms considered as at least mild. Those who accept to participate will be randomized and distributed in four groups: - Standard CBTi (CBTi-S): This treatment consists of an eight-week treatment composed by weekly and structure appointments with board-certified sleep psychologists. The appointments will be made remotely (video calls with psychologists). - Minimal intervention - Sleep hygiene (MI-SH): This group informative material regarding normal sleep pattern and sleep hygiene (through regular mail and e-mail). This procedure is more adequate as a control than the commonly used no treatment or waiting list controls, due to the behavioral nature of insomnia. - Online CBTI (CBTI-O): This group will receive access to an eight-month CBTi-based treatment through the SleepUp app. The platform will be updated into a non-commercial version, and all features other than the CBTi track, the sleep log and the clinical tests will be removed. This way, the participants of this group will receive interventions equivalent to the standard in-person CBTi, but provided through a digital platform. The treatment last eight weeks. - Online CBTi + additional features (CBTi-O+): This group will have access to the complete premium version of SleepUp platform. It includes those presented in the CBTi-O group and other therapeutic and complementary features (including meditation audios and videos, mindfulness therapy, relaxation soundtracks, sleep hygiene tips, virtual assistant, and telehealth. All participants in all groups will be assessed periodically throughout the eight weeks of intervention with standard sleep questionnaires and sleep logs. Additionally, follow ups will be made at two, four and six months after the end of the intervention. Equivalent intervals will be applied to the SH-MI group.

NCT ID: NCT04936321 Active, not recruiting - Insomnia Clinical Trials

Intervention for Sleep and Pain in Youth: A Randomized Controlled Trial

I-SPY-RCT
Start date: October 1, 2021
Phase: N/A
Study type: Interventional

Insomnia is a common comorbidity among adolescents with migraine. This randomized controlled clinical trial aims to determine efficacy of cognitive-behavioral therapy (CBT) for insomnia, as well as the combined effect of CBT insomnia and pain interventions, on reducing insomnia symptoms and headache-related disability in adolescents with migraine. The long-term goal is to offer effective, tailored self-management interventions that can address migraine and co-morbid sleep problems in adolescence and disrupt a cycle of persistent, disabling migraine from continuing into adulthood.

NCT ID: NCT04682197 Active, not recruiting - Anxiety Clinical Trials

Cereset Research In Healthcare Workers During COVID-19

Start date: December 14, 2021
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate the use of Cereset Research to improve the symptoms of stress in healthcare workers in an open label, waitlist controlled pilot clinical trial, during the period of COVID-19.

NCT ID: NCT04627480 Active, not recruiting - Insomnia Clinical Trials

Evaluation of a Neurostimulation Device for Insomnia: A Randomized Trial

Start date: October 1, 2020
Phase: Phase 4
Study type: Interventional

Examine the safety and effectiveness of the Fisher Wallace Cranial Electrotherapy Stimulator Device (CES) for the treatment of insomnia characterized by difficulties with sleep maintenance using a 20-minute treatment right before bedtime.

NCT ID: NCT04621643 Active, not recruiting - Insomnia Clinical Trials

Digital Cognitive Behavior Therapy for Insomnia Compared With Digital Patient Education About Insomnia in Individuals Referred to Public Mental Health Services in Norway

Norse4
Start date: November 24, 2020
Phase: N/A
Study type: Interventional

Sleep is a fundamental human need with large impact on both psychological and somatic functioning. However, for patients with mental disorders, sleep is often disturbed. Across all diagnostic groups, sleep disturbance is one of the most common and disruptive symptoms. For decades it has been assumed that the sleep disturbance these patients experience was a secondary symptom of a primary mental disorder, but recently this has changed. Experimental and clinical data now suggest that there is a reciprocal relationship between sleep disturbance and mental disorders where they perpetuate and aggravate each other. This makes sleep disturbance a potential therapeutic target in the treatment of mental disorders. Evidence emerging the last decade indicate that providing Cognitive Behavior Therapy for Insomnia (CBT-I) to patients with mental disorders not only improves sleep, but also has clinically meaningful effects on their primary mental disorder. However, a major problem has been disseminating CBT-I and few therapists are trained in this intervention. Consequently, most patients receive sleep medication although evidence clearly indicate that CBT-I is more effective and should be the treatment of choice. In this study, the investigators will use a fully automated digital version of CBT-I that might be used to treat a large number of patients while they are still on the waiting list to receive ordinary outpatient treatment in secondary mental health care clinics in Norway. The main goal is to test the effectiveness of digital CBT-I for this patient group.

NCT ID: NCT04598672 Active, not recruiting - Insomnia Clinical Trials

Cognitive Behavioral Therapy for Insomnia (CBTi) in Patients With Somatic Disease

Start date: January 1, 2018
Phase: N/A
Study type: Interventional

Insomnia is common with co-morbid somatic disease, e.g. rheumatic disease, cancer, heart and lung disease or gastrointestinal disorders. Pain, breathing difficulties and other symptoms of disease can worsen sleep problems and cause insomnia. In turn, insomnia may aggravate pain, fatigue and reduce quality of life in patients with somatic disorders. This project aims to evaluate a course offered to patients with insomnia and somatic disease at Diakonhjemmet Hospital. The course is based on cognitive behavioral therapy, a documented treatment for insomnia.