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Insomnia clinical trials

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NCT ID: NCT01655797 Completed - Insomnia Clinical Trials

Cognitive Behavior Therapy for Insomnia in Primary Care

TIRED
Start date: May 2008
Phase: N/A
Study type: Interventional

The aim of this study was to investigate the clinical effectiveness of protocol-driven cognitive behavioral therapy (CBT) for insomnia delivered by ordinary primary care personnel (primary care nurses and social workers) in general medical practice with unselected patients, in line with a stepped care approach. The study design was a randomised controlled parallel group design, with allocation to CBT and waiting list control group (WL). Following an active treatment-control period, the control group were re-assigned to CBT. The study hypothesis was that the CBT group would experience less symptoms of insomnia after treatment compared with the WL group. Primary outcome measure was a brief self-report screening form, Insomnia severity index.

NCT ID: NCT01648062 Completed - Insomnia Clinical Trials

Sleep Self-Regulation Using Mental Imagery

Start date: October 2008
Phase: N/A
Study type: Interventional

This randomised controlled trial assessed the efficacy of four mental imagery techniques for improving sleep and its related behaviour: (1) imagery focused on reducing arousal levels; (2) imagery incorporating implementation intentions (a strategy designed to link specified behaviour with the anticipated context) for sleep-related behaviour; (3) a combination of imagery using arousal reduction and implementation intention strategies; or (4) a condition where participants were asked to imagine their typical post work activities.

NCT ID: NCT01603381 Completed - Insomnia Clinical Trials

The Effect of Family History on Insomnia During Sobriety in Alcoholics

Start date: June 2012
Phase: N/A
Study type: Interventional

The investigators intend to assess the following: - the efficacy of CBTi in treating insomnia during recovery, - does a family history of alcoholism moderate the insomnia symptoms, - does an improvement in insomnia lead to a decrease in impulsivity.

NCT ID: NCT01577290 Completed - Depression Clinical Trials

An Internet-administered, Mindfulness Training Program for the Treatment of Anxiety

Start date: March 2012
Phase: N/A
Study type: Interventional

The purpose of this study is to examine the effects of a 10 week mindfulness training program -- without therapist-support -- as treatment of anxiety. Effects on depression, quality of life, and insomnia symptoms will also be studied.

NCT ID: NCT01571115 Completed - Insomnia Clinical Trials

Effects of Resistance Physical Exercise in Patients With Chronic Primary Insomnia

IER
Start date: January 2012
Phase: N/A
Study type: Interventional

INTRODUCTION: The primary insomnia, according to the concepts of the DSM IV, is a disorder characterized by difficulty initiating or maintaining sleep, waking early or by non-restorative sleep, resulting in losses in the daily functioning of patients, such as lack of attention, concentration and memory, fatigue, moodiness and irritability that are potentially associated with changes in sleep architecture, especially the reduction in slow-wave sleep. The most widely used therapy for the treatment of insomnia is the drug, but currently the resistive exercise is an important non-pharmacological intervention known to provide enough increase in slow wave sleep, and improve other parameters of sleep, as well as reducing symptoms of anxiety that are directly associated with the framework of insomnia. OBJECTIVE: To evaluate the effect of chronic resistive exercise in sleep patterns, the profile of mood and quality of life of patients with chronic primary insomnia. METHODOLOGY: 30 patients will be selected (male and female) with chronic primary insomnia. (Clinical diagnosis based on DSM-IV) referred for ambulatory sleep disorders Sleep Institute - AFIP. The protocol will be conducted at the Center for Psychobiology and Exercise (CEPE) of the AFIP and the Sleep Institute. Volunteers will be randomized into 2 groups of 15 participants, which will hold a resistive exercise and the other stretching exercise. This study will consist of three assessments: Pre-intervention (baseline), intermediate Rating (2 months) and post-intervention (at the end of 4 months). In the program of resistive exercise will be held 48 sessions that involve upper and lower limbs, abdominal and paraspinal region. It will be initially used a relative intensity 50% 1-RM. After 2 months of training intensity will be increased to 60% of 1-RM. Each exercise will be conducted in three sets of 12 repetitions, at intervals of 30 seconds between sets and one minute between each exercise. The total duration of the training session will be approximately 50 minutes. Before starting the training, participants will hold for 5 minutes stretching and warming on a bicycle ergometer (Life Cycle 9100) or treadmill (Life Fitness 9100) for the same period. After the session, the volunteers performed repeated stretches at the start of training. The group submitted to follow the practice of stretching protocol performed by Tworoger et al. that consist of 48 sessions of stretching for 60 minutes of low intensity, three times a week. The session will begin with 5 minutes of walking around the room, followed by 45 minutes of stretching exercises that involve the upper and lower limbs, 8 to 10 types for each region and end with 10 minutes of relaxation. STATISTICAL ANALYSIS: The variables of sleep, body composition and maximal repetition test will be analyzed using the software Statistica 7.0 (StaSoft, INC). The appropriate statistical test, parametric or nonparametric, will be chosen according to the data of the sample groups.

NCT ID: NCT01558180 Completed - Insomnia Clinical Trials

Telephone Care Management to Address Sleep Problems in Young Children With Autism

Start date: April 2012
Phase: Phase 2
Study type: Interventional

The investigators will conduct a randomized controlled trial comparing a telephone based intervention (TCM) to usual care (UC). TCM will feature a registered nurse providing a series of phone calls to assist caregivers in learning and modifying behavioral strategies that may help young children with autism to sleep better. Objective (activity monitors) and subjective (rating scales) data will be collected by an independent research assistant at the end of the project. The investigators hypothesize that TCM improves sleep duration and decreases sleep problems relative to a usual care control condition (UC).

NCT ID: NCT01556074 Completed - Insomnia Clinical Trials

Evaluation of Yoga for Sleep Disturbances in Post Traumatic Stress Disorder (PTSD)

Start date: June 2012
Phase: N/A
Study type: Interventional

The primary objective of this preliminary study is to estimate sleep outcome effect sizes and determine feasibility for a novel yoga treatment of insomnia in participants with post traumatic stress disorder (PTSD). Additional objectives are to evaluate relationships of sleep outcomes with measures of other PTSD symptoms, psychosocial health and possible mechanisms of action.

NCT ID: NCT01549899 Completed - Insomnia Clinical Trials

Comparing Internet and In-Person Brief Cognitive Behavioral Therapy of Insomnia

Start date: March 2012
Phase: Phase 3
Study type: Interventional

The objective of this study is to directly compare 6 sessions of in-person and Internet administered Cognitive-Behavior Therapy for Insomnia (CBTi) to a Minimal Contact control (MC), within an active duty military population to determine the comparative benefits of these interventions on improvement in sleep as well as domains strongly related to insomnia such as depression, substance abuse, and PTSD symptoms. A total of 189 military personnel with chronic insomnia, aged 18-65, will be recruited and randomized to receive 6-sessions (over 6 weeks) of CBTi (n=77), ICBTi (n=35), or a MC control (n=77) condition. The investigators will compare these three groups on subjective and objective measures of sleep. The CBTi and MC control groups will be compared on other variables of interest (e.g., depression, substance abuse, and PTSD symptoms) and predictors of outcomes.

NCT ID: NCT01545414 Completed - Depression Clinical Trials

Internet-CBT (Cognitive Behavioral Therapy) for Depression and Anxiety in Parkinsons Disease

Start date: February 2012
Phase: Phase 3
Study type: Interventional

The purpose of this project is to develop and evaluate Internet-based Cognitive Behavioral Therapy (ICBT) for Parkinson's Disease (PD) patients with concurrent depression or anxiety symptoms. All treatment in this project is given as an adjunct to Standard Medical Treatment (SMT). ICBT will be compared to an Internet-based active control treatment (ICONTROL) and to SMT alone. It is hypothesized that both active treatments will be superior to SMT, and that ICBT will be superior to ICONTROL, in reducing symptoms of depression and anxiety.

NCT ID: NCT01508741 Completed - Stress Clinical Trials

Use Of The Dietary Supplement 5-ALA And Its Relationship With Sleep And Mood

Start date: January 2012
Phase: N/A
Study type: Interventional

PURPOSE: The purpose of this investigation is to determine if a relationship exists between the administration of a dietary supplement containing 5-ALA and sleep and mood. HYPOTHESIS: There are several possible mechanisms for improvement in sleep and mood. In one study involving test mice, researchers found that the regular administration of 5-ALA appeared to raise serotonin levels in the brain. One hypothesis is by increasing serotonin levels, 5-ALA may contribute to improvements with sleep, along with additional improvements in mood, calmness, irritability and coping abilities. 5-ALA may also support hormonal regulation, including melatonin, in the pineal gland and corticosteroid regulation in the adrenal glands. Another hypothesis is that 5-ALA may have an impact on increasing the energy and metabolism of cells, such that its own circadian rhythms are better defined. 5-ALA may support neuronal function and assistance with "mental energy" needed to deal with stress in daily life, producing better feelings of "coping", "less irritability" and lowering an individual's feelings of "fatigue", all of which may contribute to a reduction of "pessimism" regarding the ability to deal with daily tasks. DESIGN: This will be a double-blinded, randomized parallel-group comparison study. SAMPLE: 40 participants will be randomized to the following 2 study groups for each outcome variable (Sleep and Mood): Control Group - 20 participants and Intervention Group - 20 participants. A table of random numbers will be used to assign the participants.