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Insomnia clinical trials

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NCT ID: NCT05935735 Recruiting - Insomnia Clinical Trials

Feasibility of Brief Behavioral Therapy for Insomnia (BBTI) in SUD Recovery

BBTI_SUDs
Start date: July 26, 2023
Phase: N/A
Study type: Interventional

The goal of this clinical study is to learn whether treating sleep problems is helpful in people with substance abuse problems who are living in a residential treatment program. Another goal is to study whether treating sleep problems will help individuals stay in substance abuse recovery treatment for a greater amount of time. Participants will be asked to complete surveys at the time of enrollment and every week for the next 9 weeks for a total of 8 times. Participants will be asked to wear a watch that measures sleep (sleep watch) while the participants are in the group and for a 2-week period after the participants complete the group. Participants may also be asked to participate in an interview about the experience with the group and wearing the watch. Participants will also have "homework" throughout a 4 week period. Homework is to complete a sleep diary each morning. The first group of 50 participants will be enrolled in the brief behavioral treatment for insomnia (BBTI) group where the participants receive typical treatment plus the sleep intervention program. The investigators will use qualitative and quantitative data to identify implementation facilitators and barriers, then further modify BBTI to improve feasibility. After modifying the BBTI protocol and re-training staff, study procedures will remain intact with the exception that the investigators will double the recruitment and randomize participants to the modified BBTI (N=50) or standard-of-care (SOC) (N=50). All participants will complete all assessments except the SOC group will not complete treatment satisfaction surveys.

NCT ID: NCT05935241 Recruiting - Insomnia Clinical Trials

mPATH for Low-income Older Adults

Start date: May 28, 2024
Phase: N/A
Study type: Interventional

Although empirical research suggests that physical activity interventions benefit cognition and sleep in older adults in general, the possible benefit of physical activity is understudied in low-income older adults. The study aims to test the immediate and sustaining efficacy of an mHealth-facilitated Physical Activity Toward Health (mPATH) intervention on cognitive function and sleep in low-income older adults.

NCT ID: NCT05908526 Recruiting - Insomnia Clinical Trials

Insomnia Treatment and EMA (Ecological Momentary Assessment) Outcomes

Start date: October 9, 2023
Phase: Phase 2
Study type: Interventional

The goal of this study is to examine the impact of suvorexant, an FDA-approved insomnia medication, on daytime symptoms (as measured by the Daytime Insomnia Symptoms Scale: cognition, positive mood, negative mood, and fatigue/sleepiness) among older adults with insomnia. The primary hypothesis is that relative to placebo, suvorexant will improve sleep and daytime symptoms. The word "placebo" refers to a harmless pill with no therapeutic effect.

NCT ID: NCT05870228 Recruiting - Insomnia Clinical Trials

Investigating a Sleep Intervention for Adolescents Attending Mental Health Services

Start date: October 13, 2023
Phase: N/A
Study type: Interventional

The overall objectives of the study are to: 1. To assess the feasibility of delivering the Strathclyde Sleep Intervention to adolescents with co-morbid insomnia and mental health attending a mental health services The following feasibility benchmarks will be assessed: recruitment and retention, participant attendance, staff training, intervention fidelity and participant adherence. 2. To examine participant acceptability. The researchers will conduct qualitative interviews with the participants and delivery staff to examine the acceptability of the programme. 3. To investigate the preliminary effectiveness by assessing the following: sleep parameters, insomnia symptoms, Circadian phase preference (baseline only) and mental health symptoms. Data will be collected at baseline, post-intervention and 3 month follow-up.

NCT ID: NCT05867290 Recruiting - Stroke Clinical Trials

Music for Sleep After Stroke

MUSAS
Start date: February 22, 2023
Phase: N/A
Study type: Interventional

Sleep difficulties are common following stroke yet effective evidence-based interventions for improving sleep in this population are lacking. A small number of studies have investigated the use of music listening as a way to improve sleep in adults with insomnia. This study aims to examine whether a mindful music-listening intervention can reduce subjective and objective insomnia symptoms and improve mood and fatigue post-stroke. Six adults with a clinical diagnosis of stroke presenting with an insomnia disorder will be recruited from stroke services within NHS Greater Glasgow and Clyde. A multiple baseline single case experimental design will be employed. Participants will be randomly allocated to a baseline phase of 7, 11 or 15 days, followed by a five-week mindful music-listening intervention incorporating sleep hygiene. Changes in subjective and objective sleep will be measured using questionnaires and actigraphy, respectively. Mood and fatigue will also be measured. The data will be analysed using visual inspection, Tau-U and multi-level modelling.

NCT ID: NCT05855421 Recruiting - Depression Clinical Trials

Efficacy and Safety of Auricular Acupuncture in Depression During the Covid 19 Pandemic

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

Participants with moderate depressive symptoms measured by PHQ-9 will be randomized to receive auricular acupuncture. The triple blinded procedure will be conducted in 12 sessions (6 weeks). The primary outcome is the response to the treatment 3 months after inclusion.

NCT ID: NCT05846087 Recruiting - Insomnia Clinical Trials

Mobile App-delivered Sleep Therapy (SleepFix) for Individuals With Chronic Low Back Pain and Insomnia

SleepBack
Start date: September 13, 2023
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to assess the efficacy of a digital behavioral therapy for insomnia (dBTi) in people with chronic low back pain and insomnia. The main question it aims to answer is whether a 3 week period of dBTi can improve pain-related interference 6 weeks from commencement. Researchers will compare the treatment (dBTi) to an active control (Sleep health education modules) to see if there is a significant difference in outcomes at baseline and end-of-study (6 weeks).

NCT ID: NCT05838430 Recruiting - Insomnia Clinical Trials

Solriamfetol and CBT-I in Patients With Insomnia Disorder

Start date: July 31, 2023
Phase: Phase 4
Study type: Interventional

Medication is FDA approved. The objective of this project is to test the efficacy of solriamfetol for treating insomnia (alone and in combination with Cognitive Behavioral Therapy for Insomnia [CBT-I]). Ultimately, this study will test whether wake extension (regardless of how it is achieved) will consolidate sleep and improve sleep continuity.

NCT ID: NCT05814822 Recruiting - Insomnia Clinical Trials

Targeting Insomnia to Improve Outcomes in Adults With Problematic Cannabis Use

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

This study will compare the efficacy of telemedicine-delivered cognitive behavioral therapy for insomnia tailored for people using cannabis for sleep (CBTi-CB-TM) to telemedicine-delivered sleep hygiene education (SHE-TM) on sleep, cannabis use, and daytime functioning. We will also evaluate the effects of CBTi-CB-TM on fundamental sleep regulatory system - homeostatic sleep drive - and its association with clinical outcomes.

NCT ID: NCT05814783 Recruiting - Insomnia Clinical Trials

Clinician Training Program to Integrate Digital CBTI Into Routine Psychotherapy

Start date: August 24, 2023
Phase: N/A
Study type: Interventional

The goal of this study is to pilot test and refine a training program for licensed therapists to promote the integration of digital cognitive behavior therapy for insomnia (dCBTi) into their routine mental health care services.