Mindfulness and RelaxationTraining for Insomnia (MRTI) on Postmenopausal Women: a Randomized Clinical Trial.

The Effects of Mindfulness and RelaxationTraining for Insomnia (MRTI) on Postmenopausal Women: a Randomized Clinical Trial.

Summary

Introduction: Insomnia is a symptom of sleep disorders most prevalent. Primary insomnia, the investigators analyzed, often related to stress states acquired, generalized anxiety and stress, which are important factors that disrupt normal sleep. The investigators point out a fact that still intrigue the students of medicine and sleep that is distorted perception of sleep by the sleepless nights, polysomnography shows greater effectiveness than that perceived by them. On the other hand, there is evidence that mindfulness techniques may reduce symptoms of stress and anxiety as well as improve the general attention, which may contribute to a better perception of the effectiveness of sleep. In addition, there are studies showing that meditation is associated with metabolic and neurophysiological characteristics similar to normal sleep. Objectives: To compare sleepless menopausal women trained for 8 weeks in the technique of mindfulness insomniac postmenopausal untrained and also assess the quality of sleep experienced meditators menopausal comparing them to the group of healthy postmenopausal women untrained in the art.

Study Overview

• Status: Completed
• Conditions: Primary Insomnia
• Intervention / Treatment: Behavioral: mindfulness training

Detailed Description

Groups will be assessed by actigraphy, polysomnography and questionnaires for assessing stress, depression, anxiety, quality of life, self-pity, subjective states such as sedation and other physical or mental attitudes, vitality, emotional state and attentiveness. Moreover, prospective memory participants will be evaluated by means of a task as close as possible to real life conditions of the volunteers (green) and also the working memory is assessed by a test called specific counting span. Menopausal women will be evaluated for the presence or absence of bruxism compared to ordinary meditators, all postmenopausal.

• Study Type: Interventional
• Enrollment (Actual): 54
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • Sp
    • Sao Paulo, Sp, Brazil, 04017-001
      • Associacao Fundo de Incentivo a Psicofarmacologia Sao Paulo, SP, Brazil

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 66 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

Inclusion Criteria:Inclusion criteria for postmenopausal women with insomnia:

• be available to attend any training program of mindfulness (1 time per week for 8 weeks) and perform the suggested practices home.
• be available to perform the tests at home polysomnography (overnight) and other tests.
• Be available to perform the blood collection
• meet the criteria established in accordance with DSM-IV-TR for insomnia
• age 50 to 65 years.
• Women in menopause: women presenting with absence of menstruation in the past year and either FSH greater than 30.
• Have a BMI value lower than 30.
• Not having undergone any previous treatment against insomnia.
• Not having made use of hypnotics for at least 15 days.

Inclusion criteria for women without menopausal insomnia

• be available to perform the examinations polysomnographic (overnight) and other tests.
• To meditators, having trained as a practice of mindfulness meditation for at least 3 years 3 times a week.
• Age: 50 to 65 years
• Being a woman and being in menopause: women presenting failures or lack of regular menstrual periods last year.

Exclusion Criteria:Exclusion criteria for menopausal women with insomnia

• being under drug treatment, subjects will not be accepted that use of benzodiazepines, antihistamines, hypnotics, herbal sleeping pills, sedatives, antidepressants, antipsychotics, stimulants (amphetamine, caffeine, modafinil), corticosteroids, bronchodilators and beta blockers.
• being under psychological or psychiatric treatment.
• present history of neurological or psychiatric diseases such as severe psychotic disorders.
• having other sleep disorders like narcolepsy, sleep-disordered breathing, sleep apnea with an index greater than 15 / h, circadian rhythm disorder or parasomnias.
• 4 years of schooling below complete primary school

Exclusion criteria for menopausal women without complaints of insomnia:

• being under drug treatment, subjects will not be accepted that use of benzodiazepines, antihistamines, hypnotics, herbal sleeping pills, sedatives, antidepressants, antipsychotics, stimulants (amphetamine, caffeine, modafinil), corticosteroids, bronchodilators and beta blockers.
• being in psychological treatments.
• having had contact with a meditation technique.
• present history of neurological or psychiatric diseases such as severe psychotic disorders, as well as anxiety and depression.
• women presenting failures or regular period last year.
• 4 years of schooling below complete primary school
• submit any sleep disorders

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: mindfulness training; mindfulness training for patients with insomnia	Behavioral: mindfulness training; mindfulness interventions for 8 weeks for a group of menopausal insomniacs; Other Names: mindfulness,; meditation,; sleep pattern in meditators women in menopause
No Intervention: polysomnography and actigraphy; The intention is to assess the sleep architecture of meditators and non meditators women without menopausal insomnia by polysomnographic , actigraphy, and questionnaires to assess sleep quality and emotional state

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The investigators intend to evaluate the effectiveness of mindfulness training in postmenopausal women with insomnia	The insomniacs were trained for 8 weeks in mindfullness,and they had a 30-minute meditation class once a week. They also received a meditation audio,to practice three times a day for 15 minutes in their homes.The control group was not infirm intervention. The meditation group showed relief of the symptoms of insomnia, indicated by Pittsburgh Insomnia Index, actigraphy and polysomnography, improving the overall quality of sleep and decreasing number of awakening.The control group remained with the same symptoms and complaints of insomnia.	two years

Collaborators and Investigators

• Sponsor: University of Sao Paulo
• Collaborators: Associação Fundo de Incentivo à Pesquisa
• Investigators: Study Director: Helena hachul Campos, advisor, UNIFESP-Federal University of Sao Paulo

Publications and helpful links

General Publications

• Garcia MC, Kozasa EH, Tufik S, Mello LEAM, Hachul H. The effects of mindfulness and relaxation training for insomnia (MRTI) on postmenopausal women: a pilot study. Menopause. 2018 Sep;25(9):992-1003. doi: 10.1097/GME.0000000000001118.

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2011
• Primary Completion (Actual): November 1, 2011
• Study Completion (Actual): July 1, 2015

Study Registration Dates

• First Submitted: April 23, 2012
• First Submitted That Met QC Criteria: May 7, 2012
• First Posted (Estimate): May 8, 2012

Study Record Updates

• Last Update Posted (Actual): May 3, 2018
• Last Update Submitted That Met QC Criteria: April 30, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Keywords: insomnia,menopause, polysomnography, mindfulness
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Sleep Initiation and Maintenance Disorders
• Other Study ID Numbers: 0708/11