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Insomnia clinical trials

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NCT ID: NCT06361914 Recruiting - Chronic Pain Clinical Trials

Digital CBT-I for Patients With Chronic Pain and Insomnia

Back2Sleep
Start date: April 12, 2024
Phase: N/A
Study type: Interventional

Chronic pain constitutes an increasing health and social burden. More than 50% of patients with chronic pain report insomnia, and patients with comorbid insomnia often report stronger and widespread pain, compared to those who are sleeping well. Sleep disturbances are often considered a consequence to chronic pain. This means that insomnia is often overlooked or ineffectively managed with hypnotics or advice on sleep hygiene. Therefore, efficacious, easily accessible, and safe alternatives to the current pharmacological treatments for patients with chronic pain and insomnia are needed. Cognitive behavioral therapy for insomnia (CBT-I) is a cost-effective and safe treatment for insomnia and is recommended as first-line treatment. While highly efficacious, the challenge is to deliver CBT-I to those in need. The main barriers of face-to-face delivered CBT-I are availability of trained therapists, costs, as well as physical and geographical constraints. The primary aim of this randomized controlled clinical superiority trial is to investigate whether digitally-delivered CBT-I has a greater effect on insomnia and pain than digitally-delivered sleep hygiene education in patients with chronic pain and comorbid insomnia. Secondary objectives are to a) explore whether the pain-relieving effect is mediated by a change in physiological markers of sleep quality, b) whether health care cost and use of medications at 12 months are reduced after digital CBT-I, and c) to explore the effectiveness of digital CBT-I compared with sleep hygiene education on: 1. Physiological sleep metrics (recorded with ear EEG in subsample of 60 patients). 2. Self-reported sleep quality. 3. Quality of life. 4. Physical and mental health. 5. Thoughts and beliefs about sleep and pain.

NCT ID: NCT06361368 Not yet recruiting - Insomnia Clinical Trials

Efficacy Assessment of Probiotics in Improving Sleep Indices

Start date: April 2024
Phase: N/A
Study type: Interventional

To determine whether PS150 (1) reduces insomnia symptoms, (2) improves sleep quality, (3) adjusts autonomic nervous system functioning, (4) reduces the severity of anxiety and depressive symptoms, and (5) adjusts microbiome and endocrine functions.

NCT ID: NCT06358898 Not yet recruiting - Depression Clinical Trials

Digital Mood-enhanced CBT-I to Improve Depressive Symptoms in Adolescents

Start date: April 18, 2024
Phase: N/A
Study type: Interventional

Emerging encouraging evidence showed that sleep focused treatment can simultaneously improve sleep and depression in adult with comorbid conditions. Although these favorable changes in depressed adults is encouraging, little is known in the potential efficacy of CBT-I in altering depression trajectory in adolescent population. This current study aims to compare the effect of digitally delivered, mood enhanced cognitive behavioral therapy for insomnia (M-dCBT-I) and standard digital cognitive behavioral therapy for insomnia (dCBT-I) in improving depressive symptoms in adolescents, and to examine the potential sustained treatment effect in mood outcomes following M-dCBT-I or dCBT-I treatment.

NCT ID: NCT06358495 Not yet recruiting - Insomnia Clinical Trials

Improving Sleep to Prevent Depression & Anxiety in Adolescents at High Risk

Start date: May 1, 2024
Phase: N/A
Study type: Interventional

Emerging evidence has shown that sleep interventions such as Cognitive Behavioral Therapy for Insomnia (CBT-I) improve depressive and anxiety symptoms in adults, even when the intervention is brief, such as four to six sessions. The overarching aim of the proposed research is to conduct a pilot trial to evaluate whether a brief intervention for insomnia adapted for improves sleep and subthreshold depressive and anxiety symptoms in adolescents at risk (i.e., with a parental history of depressive or anxiety disorders).

NCT ID: NCT06353919 Not yet recruiting - Anxiety Clinical Trials

Remote Yoga Nidra for Deprescribing BZRAs

Start date: June 1, 2024
Phase: N/A
Study type: Interventional

The overall goal of this application is to assess feasibility and impact of a remotely delivered guided meditation practice called Yoga Nidra, for reducing or stopping use of Benzodiazepine Receptor Agonists (BZRAs) for insomnia and anxiety in a population of older adults recruited from within the Birmingham VA medical system.

NCT ID: NCT06353100 Active, not recruiting - Chronic Pain Clinical Trials

Chronic Pain in the General Population of Chile

RDC
Start date: January 1, 2023
Phase:
Study type: Observational

The present study seeks to follow up the cohort of adults representative of Chile's urban population whose levels of chronic pain were evaluated in March 2023 (baseline) as part of the Mental Health Thermometer (MHT) study. The study consists of a 12 month follow-up telephone interview to assess parameters of chronic pain (CP) and subtypes, mental and physical health, lifestyle and adversity and work characteristics. The study objectives are as follows: 1. Estimate the prevalence of CP and subtypes in the general population 2. Explore the association between mental health indicators, perceived work stress and presence of CP in the population. 3. Investigate the impact of CP (functional, occupational and social) among the subset of participants reporting CP 4. Describe the use of management strategies in those who suffer from CP.

NCT ID: NCT06351930 Recruiting - Insomnia Clinical Trials

CBT for Insomnia in Adolescents With ADHD

Start date: January 1, 2023
Phase: N/A
Study type: Interventional

Insomnia and attention deficit hyperactivity disorder (ADHD) are highly comorbid conditions with an intricate, bidirectional relationship. In particular, insomnia and ADHD often co-occur, with 22.9-34.6% of adolescents with insomnia having clinically significant ADHD, and 22-33.5% of adolescents with ADHD experiencing comorbid insomnia symptoms. Insomnia is not only associated with increased ADHD severity, but also linked to an increased risk for other mental health problems and poorer treatment response in young people with ADHD. Behavioural sleep interventions have shown promise in improving sleep in young children with comorbid ADHD and insomnia. Nonetheless, when treating adolescent insomnia, especially those with ADHD, there is a need to consider the unique sleep and circadian features as well as psychosocial factors associated with not only ADHD but also adolescence, a challenging developmental stage. To date, there is a paucity of research to test the efficacy of cognitive behavioural therapy for insomnia (CBT-I) in adolescents with comorbid ADHD and insomnia. To address the limitations in the existing literature, this study aims to conduct a randomised controlled trial (RCT) to examine the effects of CBT-I relative to a usual care (UC) condition in adolescents with ADHD, on improving sleep and ADHD symptoms, and other clinical and daytime symptoms as well as overall functional improvement.

NCT ID: NCT06348082 Not yet recruiting - Insomnia Clinical Trials

Project Women's Insomnia Sleep Health Equity Study (WISHES)

Project WISHES
Start date: September 2025
Phase: N/A
Study type: Interventional

The purpose of this study is to achieve health and healthcare equity by implementing an equity-focused, mindfulness-based sleep intervention to reduce stress and sleep deficiency-related cardiometabolic disease burden in Black women.

NCT ID: NCT06339853 Completed - Insomnia Clinical Trials

Study of Efficacy of Digital Cognitive Behavioral Therapy With Wearable Device for Insomnia

Start date: September 7, 2023
Phase: N/A
Study type: Interventional

The purpose of the study was to examine safety and efficacy of cognitive behavioral therapy (CBT)-based wearable integrated digital therapeutics for insomnia patients

NCT ID: NCT06336551 Not yet recruiting - Insomnia Clinical Trials

Acceptance and Commitment Therapy for Insomnia

Start date: April 1, 2024
Phase: N/A
Study type: Interventional

Insomnia is a common sleep problem that impacts both physical and mental health. Acceptance and Commitment Therapy for Insomnia (ACT-I) is proposed as a promising new treatment for insomnia. However, its effectiveness without overlapping behavioral components of the current standard treatment, cognitive behavioral therapy, remains largely unknown. The main goal of this clinical trial is to test the efficacy of stand-alone ACT-I in adults with insomnia, compared to a waitlist control group. The second goal is to explore the potential working mechanisms of ACT-I, using network intervention analysis. Adults with insomnia will be randomized to an ACT-I or waitlist group. Both the ACT-I treatment and waiting period span 7 weeks. Assessments take place at baseline (pre), after 4 weeks (mid), and after 8 weeks (post), followed by a 3- and 6-month follow-up for the ACT-I group. The main questions this RCT aims to answer are: - Is ACT-I superior to a waitlist control group in improving insomnia severity (primary outcome) in addition to sleep diary measures, anxiety, depression, general mental health, and sleep-related quality of life (secondary outcomes)? - How do networks of insomnia symptoms or potential treatment processes (i.e., psychological (in)flexibility, sleep-related arousal, dysfunctional cognitions, and sleep-related safety behaviors) develop during and following ACT-I?