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MMIA Trial of Mindfulness Meditation for Chronic Insomnia

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Qué se está evaluando

Mindfulness Meditation

Otro
Quiénes están siendo reclutados

Trastornos Mentales+1

+ Trastornos de inicio y mantenimiento del sueño

+ Enfermedades del sistema nervioso

A partir de 18 años
+11 Criterios de eligibilidad
Ver todos los criterios de elegibilidad
Cómo está diseñado el estudio

Estudio de Prevención

Intervencional
Inicio del estudio: mayo de 2018
Ver detalles del protocolo

Resumen

Patrocinador PrincipalGuy's and St Thomas' NHS Foundation Trust
Última actualización: 28 de enero de 2026
Extraido de una base de datos validada por el gobierno.Reclamar como socio

Fecha de inicio: 1 de mayo de 2018

Fecha en la que se inscribió al primer participante.

Sleep complaints are amongst the commonest in medical practice, and insomnia, the commonest of these affecting transiently 1/3 of the population at some point in the year and 1/3 of this population that is 1 in 10 persisting as chronic insomnia. There are significant consequences on the quality of life for individuals and significant economic burden for society. Insomnia disorder is characterized as persistent difficulty in falling or staying asleep with resulting daytime dysfunction. Once physical and psychiatric causes have been excluded, current treatment guidelines include pharmacological and behavioural approaches. Hypnotic therapy will reduce sleep latency and increase total sleep time, but there are concerns about drug dependency and side effects (residual day time sleepiness and road traffic accidents and impaired balance). Behavioural treatment (CBTi) has been shown to be effective, but availability is scarce and less than 50% of patients achieve full remission, making alternative approaches desirable. To optimize availability and to improve outcomes, approaches have included group sessions, single treatment sessions and internet sessions, but these are still limited in the NHS by availability of resources or by expense. Mindfulness meditation, focused non-judgmental awareness and attention on the present moment experience, can promote calmness and relaxation. Several health benefits have been shown across stress related conditions, including sleep disturbance, and its universal availability and ease of application make it an attractive alternative to conventional CBTi. A randomized controlled trial compared Mindfulness-Based Stress Reduction (MBSR), Mindfulness-Based Therapy for Insomnia (MBTI), and Self-monitoring (SM) in the treatment of chronic insomnia . Results indicate that those receiving mindfulness-based interventions (MBSR or MBTI) had significant reductions in total wake time and pre-sleep arousal from baseline-to-post compared to SM. The study concluded that mindfulness meditation appears to be a viable treatment option for adults with chronic insomnia and could provide an alternative to traditional treatments for insomnia. A recent meta-analysis of 6 randomised controlled trials demonstrated that mindfulness meditation may contribute to improving sleep in subjects with insomnia compared to a control group. Specifically, mindfulness meditation was found to significantly reduce total wake time, sleep onset latency and sleep quality . The present study builds upon this work, using a small-scale randomized controlled trial to gather preliminary evidence for the treatment efficacy of a brief mindfulness intervention delivered through a mobile application. Headspace (www.headspace.com) mindfulness app will be used to deliver the meditation content. Headspace currently has over 7 million users worldwide and was recently rated in a systematic review as being the highest quality mindfulness app on the market . Participants are adults with insomnia recruited through a sleep centre, recruited for management of their insomnia. The potential risks of the study are low, as participants will be exposed to a low dose of mindfulness (10 minutes daily). Adverse effects of meditation have been reported in people with a predisposition to psychiatric illness that underwent extensive mindfulness training, such as a 10-day silent retreat. Negative effects have not been reported from 8-week mindfulness interventions. The benefits from this study include improvement in or resolution of insomnia.

Título OficialA Trial of Mindfulness Meditation for Chronic Insomnia
Patrocinador PrincipalGuy's and St Thomas' NHS Foundation Trust
Última actualización: 28 de enero de 2026
Extraido de una base de datos validada por el gobierno.Reclamar como socio

Protocolo

Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.

Estudio de Prevención

Los estudios de prevención buscan evitar que se desarrolle una enfermedad. A menudo incluyen a personas en riesgo y evalúan vacunas, cambios en el estilo de vida o medicamentos preventivos.



Elegibilidad

Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.
Condiciones
Criterios

Cualquier sexo

Sexo biológico de los participantes elegibles para inscribirse.

A partir de 18 años

Rango de edades de los participantes que pueden unirse al estudio.

Voluntarios sanos no permitidos

Indica si personas sanas, sin la condición que se estudia, pueden participar.

Condiciones

Patología

Trastornos MentalesTrastornos de inicio y mantenimiento del sueñoEnfermedades del sistema nerviosoTrastornos del sueño-vigilia

Criterios

4 criterios de inclusión requeridos para participar
Over the age of 18

Meet the diagnostic criteria for an insomnia disorder. Defined as difficulty initiating or maintaining sleep despite adequate opportunity, with at least one symptom of an associated daytime impairment. Additional quantitative insomnia criteria following research recommendations include frequency (defined as sleep onset latency (SOL) or wake after sleep onset (WASO) > 30 minutes at least 3 nights per week and for chronicity, defined as symptoms lasting > 6 months.

Have access to an iOS or Android smartphone or a desktop computer with Internet access

Participants will be required to sign an informed consent form

7 criterios de exclusión impiden participar
Uncontrolled medical condition suspected to interfere with sleep or requiring immediate treatment outside of the study

Uncontrolled psychiatric conditions requiring immediate treatment outside of the study, including current major depressive episode

Comorbid sleep disorders including obstructive sleep apnea

Current use of hypnotic or sedating medications for the purpose of insomnia

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Plan de Estudio

Conoce todos los tratamientos administrados en este estudio, su descripción detallada y en qué consisten.
Grupos de Tratamiento
Objetivos del Estudio

Un solo grupo de intervención está designado en este estudio

0% de probabilidad de ser asignado al grupo placebo

Grupos de Tratamiento

Grupo I

Experimental
This arm will receive mindfulness-based interventions through a mobile application

Objetivos del Estudio

Objetivos Primarios

Objetivos Secundarios

Centros del Estudio

Estos son los hospitales, clínicas o centros de investigación donde se lleva a cabo el estudio. Puedes encontrar la ubicación más cercana a ti y su estado de reclutamiento.
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