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

NCT01593436 | Completed DMC

• 1 other identifier: 0708/11
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Primary Insomnia

Keywords

insomnia,menopause, polysomnography, mindfulness

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

mindfulness training

ACTIVE COMPARATOR

mindfulness training for patients with insomnia

Behavioral: mindfulness training

polysomnography and actigraphy

NO INTERVENTION

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

Interventions

mindfulness training BEHAVIORAL

mindfulness interventions for 8 weeks for a group of menopausal insomniacs

Also known as: mindfulness,, meditation,, sleep pattern in meditators women in menopause

mindfulness training

Eligibility Criteria

• Age: 50 Years - 66 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• years of schooling below complete primary school
• 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.
• years of schooling below complete primary school
• submit any sleep disorders

Sponsors & Collaborators

• University of Sao Paulo: lead
• Associação Fundo de Incentivo à Pesquisa: collaborator

Study Sites (1)

Associacao Fundo de Incentivo a Psicofarmacologia Sao Paulo, SP, Brazil

São Paulo, São Paulo, 04017-001, Brazil

Location

Related Publications (1)

• 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.

  PMID: 29787483 DERIVED

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

Mindfulness; Meditation; Menopause

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Mind-Body Therapies; Complementary Therapies; Therapeutics; Spiritual Therapies; Relaxation Therapy; Climacteric; Reproductive Physiological Phenomena; Reproductive and Urinary Physiological Phenomena; Sexual Development

Study Officials

• Helena hachul Campos, advisor

  UNIFESP-Federal University of Sao Paulo

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: April 23, 2012
• First Posted: May 8, 2012
• Study Start: July 1, 2011
• Primary Completion: November 1, 2011
• Study Completion: July 1, 2015
• Last Updated: May 3, 2018

Record last verified: 2018-04

Locations

BR (1)