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

Primary Purpose

Primary Insomnia

Status

Completed

Phase

Not Applicable

Locations

Brazil

Study Type

Interventional

Intervention

mindfulness training

About this trial

This is an interventional treatment trial for Primary Insomnia focused on measuring insomnia,menopause, polysomnography, mindfulness

Eligibility Criteria

50 Years - 66 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

mindfulness training

polysomnography and actigraphy

Arm Description

mindfulness training for patients with insomnia

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT01593436

First Posted

April 23, 2012

Last Updated

April 30, 2018

Sponsor

University of Sao Paulo

Collaborators

Associação Fundo de Incentivo à Pesquisa

1. Study Identification

Unique Protocol Identification Number

NCT01593436

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2018

Overall Recruitment Status

Completed

Study Start Date

July 2011 (Actual)

Primary Completion Date

November 2011 (Actual)

Study Completion Date

July 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Sao Paulo

Collaborators

Associação Fundo de Incentivo à Pesquisa

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Primary Insomnia

Keywords

insomnia,menopause, polysomnography, mindfulness

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Investigator

Allocation

Randomized

Enrollment

54 (Actual)

8. Arms, Groups, and Interventions

Arm Title

mindfulness training

Arm Type

Active Comparator

Arm Description

mindfulness training for patients with insomnia

Arm Title

polysomnography and actigraphy

Arm Type

No Intervention

Arm Description

Intervention Type

Behavioral

Intervention Name(s)

mindfulness training

Other Intervention Name(s)

mindfulness,, meditation,, sleep pattern in meditators women in menopause

Intervention Description

mindfulness interventions for 8 weeks for a group of menopausal insomniacs

Primary Outcome Measure Information:

Title

The investigators intend to evaluate the effectiveness of mindfulness training in postmenopausal women with insomnia

Description

Time Frame

two years

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

50 Years

Maximum Age & Unit of Time

66 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Helena hachul Campos, advisor

Organizational Affiliation

UNIFESP-Federal University of Sao Paulo

Official's Role

Study Director

Facility Information:

Facility Name

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

City

Sao Paulo

State/Province

ZIP/Postal Code

04017-001

Country

Brazil

12. IPD Sharing Statement

Citations:

PubMed Identifier

29787483

Citation

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.

Results Reference

derived

Learn more about this trial

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

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