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Insomnia clinical trials

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NCT ID: NCT04866914 Completed - Insomnia Clinical Trials

Acceptance and Commitment Therapy for Insomnia

ACT-I
Start date: March 15, 2021
Phase: N/A
Study type: Interventional

Insomnia is a frequent complaint and is associated with impairments in physical and psychological health. Although Cognitive-Behavioral Therapy (CBT) demonstrates effective results for insomnia, there are those who do not respond to this type of intervention or present difficulties in adherence. Acceptance and Commitment Therapy (ACT) presents itself as a potentially useful intervention for the treatment of insomnia, for which, instead of focusing on controlling the symptoms, the respective approach focuses on accepting the feelings and thoughts associated, through value-based actions. The aim of this study is to evaluate the effectiveness of ACT for chronic insomnia in adults. Participants will be 150 adults aged between 18 and 59 years, diagnosed with chronic insomnia who will be randomly assigned to the ACT, CBT and wait list (WL) groups. For both groups (ACT and CBT), the intervention will be performed in six group and weekly sessions. Assessments of sleep patterns, insomnia, depression, anxiety, psychological flexibility, acceptance of sleep, beliefs about sleep, personality traits will be performed in the pre-treatment, post-treatment and six-month follow-up. After the intervention is completed, participants will respond to an inventory of compliance and satisfaction. Treatment effects will assessed using the fixed effects of group variables (ACT vs. CBT-I and ACT vs. waitlist) and their interaction with time (pre-test vs. post-test and pretest vs. six-month follow-up). Estimated pairwise contrasts to examine changes across time within groups will be used. Variables will analyzed using generalized mixed models (GMM).

NCT ID: NCT04863157 Completed - Insomnia Clinical Trials

Survivor-Sleep Health Information Program

Start date: May 24, 2021
Phase: N/A
Study type: Interventional

The purpose of the study is to learn if an educational program delivered to parents/guardians can help improve the sleep of children experiencing sleep problems after completing cancer treatment. The name of the intervention is Survivor-SHIP (Sleep Health Information Program).

NCT ID: NCT04827459 Completed - Breast Cancer Clinical Trials

Sleep Coach: A Mobile App to Address Insomnia Symptoms Among Cancer Survivors

Start date: May 12, 2021
Phase: N/A
Study type: Interventional

This clinical trial will evaluate the adherence, usefulness, satisfaction and effect size for the Sleep Coach app as an intervention for insomnia in 30 adult post-treatment cancer survivors.

NCT ID: NCT04808713 Completed - Depression Clinical Trials

RESILIENT - An Online Multidimensional Treatment to Promote Resilience After a Disaster: Randomized Controlled Trial Protocol

RESILIENT
Start date: May 9, 2017
Phase: N/A
Study type: Interventional

Background. The wildfires on May 1, 2016 in Fort McMurray, Alberta (Canada), destroyed approximately 2,400 homes and buildings and led to massive displacement of approximately 88,000 people. Many individuals faced direct or potential threat to their life or health, or significant losses, and many months later, families were still living through ongoing adversity and uncertainty as they adapted to new or temporary homes, schools and workplaces. Alberta Health Services estimated in August 2016 that mental health staff in the city had received 20,000 referrals since May, compared to 1,200 referrals each year. Objectives. The overarching aim of this project is to understand the needs of the Fort McMurray population in terms of mental health and to widely disseminate evidence-based tools to promote resilience. More specifically, we will assess the efficacy of an online self-help intervention targeting post-traumatic resilience on specific symptoms (post-traumatic stress disorder [PTSD], insomnia, depression). Method. 1,510 phone surveys have been conducted in May-July 2017 to assess the prevalence of PTSD, insomnia and depression in the evacuees from the Fort McMurray wildfires (T0). After the survey, 697 participants expressed interest to participate in the longitudinal arm of the study, which will include four in-depth assessments with online questionnaires (T1 to T4) and a diagnostic interview (T1 only). A period of six months will separate all four times of assessment. Participants with post-traumatic stress symptoms (expected n = 150) will be randomised either to the treatment condition (n = 75) or to a waitlist control condition (n = 75) after completion of T2. Data Analyses. Primary outcomes will be post-traumatic, depressive and insomnia symptom severity, measured with validated self-report questionnaires. Secondary outcomes will include cognitive, behavioural and social indicators, as well as general mental health and post-traumatic growth. Several probable moderators of treatment will be examined, including sociodemographic characteristics, level of exposure, and continuing stressors. Foreseen Impacts. If found effective in reducing symptoms, the results of this study have the potential to impact positively the Fort McMurray community. Indeed, a direct and concrete deliverable of this research project will be to provide an extended (at least two years) and free access to the online intervention specifically tailored to this population's needs.

NCT ID: NCT04783519 Completed - Insomnia Clinical Trials

Research Evaluating Sleep & Trends for Universal Prevention

REST-UP
Start date: August 17, 2021
Phase: N/A
Study type: Interventional

This study is designed to develop an integrated intervention to reduce alcohol and marijuana use and consequences and improve sleep among young adults with comorbid heavy episodic drinking, marijuana use, and sleep impairment.

NCT ID: NCT04766229 Completed - Cancer Clinical Trials

The Menopause After Cancer Study

MACS
Start date: June 21, 2021
Phase: Phase 2
Study type: Interventional

This study will recruit women with vasomotor symptoms of menopause and a prior cancer diagnosis, for whom conventional menopausal hormone therapy (MHT) is contraindicated for any reason. This study will examine if the addition of psycho-social support and digital cognitive behavioral therapy (CBT) for insomnia to standard non-hormonal pharmacotherapy can improve quality of life for these women.

NCT ID: NCT04751019 Completed - Insomnia Clinical Trials

The Use of Amber Glasses in Improving Sleep

Start date: March 11, 2019
Phase: N/A
Study type: Interventional

The use of amber glasses will aid the patient to fall asleep without the need for the use of hypnotic medication.

NCT ID: NCT04750681 Completed - Stress Clinical Trials

Evaluation of the Effects of Saffron Extract on Sleep Quality and Stress

Start date: August 12, 2019
Phase: N/A
Study type: Interventional

Therefore, the aim of this study was to confirm by a randomized double-blind controlled study the beneficial effects of saffron extract (Saffr'activ®) on sleep quality in subjects presenting mild to moderate sleep disorder associated with anxiety.

NCT ID: NCT04742699 Completed - Insomnia Clinical Trials

An Open-label, Multicenter Study to Evaluate the Efficacy and Safety of Transitioning to Lemborexant in Japanese Subjects With Insomnia

Start date: March 24, 2021
Phase: Phase 4
Study type: Interventional

This study will be conducted to evaluate whether the approach of direct transitioning to lemborexant (LEM) is supported for insomnia patients who are unsatisfied with current medication. Transition from Following 4 regimens of interest will be investigated; Z-Drug monotherapy, suvorexant (SUV) monotherapy, SUV and benzodiazepine receptor agonists (BZRA) combination therapy, and ramelteon (RMT) and BZRA combination therapy. Patients with insomnia who have been treated with one of the regimens but do not have treatment satisfaction will be enrolled. As a comprehensive indicator of patient satisfaction including treatment efficacy and safety, the proportion of patients with successful transitioning will be evaluated at 2 weeks after transitioning; thus important initial response after transitioning will be evaluated as a primary endpoint. In addition, as a secondary purpose, the treatment continuation, efficacy and tolerability, and the treatment impression for insomnia (Patient Global Impression of Insomnia) for 14 weeks after transitioning will be assessed.

NCT ID: NCT04721067 Completed - Hiv Clinical Trials

HIV-related Insomnia and Inflammation

Start date: December 2, 2021
Phase: N/A
Study type: Interventional

This randomized trial will determine the effects of internet cognitive behavioral therapy on measures of systemic inflammation in HIV-positive people receiving antiretroviral therapy.