Lowering Stress Levels of Women in Lebanon

Study Overview
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Brief Summary
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The goal of this clinical trial is to compare the experiences of women who learn the TM technique to those who do not. The main questions it aims to answer are: Do women in rural Lebanon who practice the TM technique experience lower stress levels compared to those who do not. Do women in rural Lebanon who practice the TM technique experience increased happiness, self-efficacy, and resilience levels compared to those who do not. Participants will: complete baseline surveys be divided into experimental and active-control groups those in the experimental group will learn the TM technique, the control group will be offered an online didactic course on stress reduction both groups will complete post-test surveys at the end of 1 and 3 months Researchers will compare experimental and control groups to see if the intervention effects stress levels.

Detailed Description
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Methods: We will measure the effects of TM on 62+ women of the Chouf region of Lebanon using the following measures: Perceived Stress Scale, Connor-Davidson Resiliency Scale, New General Self-Efficacy Scale, and the Arabic Scale of Happiness. This is a randomized controlled trial with an experimental group and an active wait-list control group. Measurements will be taken at baseline (pre-test) and at 1 and 3 months post-test.

Official Title
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Effects of Transcendental Meditation on Rural Women of Lebanon

Conditions
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Stress, Resilience, Self Efficacy, Happiness

Intervention / Treatment
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* Behavioral: Transcendental Meditation (TM) practice
* Other: Stress reduction class (online)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Females living in the Chouf region of Lebanon between the ages of 18-95. - Exclusion Criteria: Anyone: not female, under 18 or over 95, not in sound mental condition. -

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 95 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The randomization will be done by villages versus participants.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TM Group<br>The intervention used for this group is instruction in the Transcendental Meditation practice. It is a four day course of instruction with 1.5 hours of instruction over four consecutive days, followed by an additional 1.5 hours of instruction ten days later. | Behavioral: Transcendental Meditation (TM) practice<br>* See previous description<br>|
| Active Comparator: Active Control Group<br>This group will be offered an online stress reduction course consisting of two 20-60 minute classes for the first month of the trial. | Other: Stress reduction class (online)<br>* See previous description<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline to 1 and 3-months on the Perceived Stress Scale(PSS-10) | The PSS measures the degree to which situations in one's life are appraised as stressful. Possible scores range from 0=never to 4=very often | Change = (week 12-baseline) | 
| Change from baseline to 1 and 3-months on the Connor-Davidson Resilience Scale (CDRS-10) | The CDRS-10 measures how well one is equipped to bounce back after stressful events, tragedy, or trauma | Change = (week 12-baseline) | 
| Change from baseline to 1 and 3-months on the Arabic Scale of Happiness (ASH-20) | The ASH-20 seeks to conduct a global, subjective assessment of whether a person is happy or unhappy | Change = (week 12-baseline) | 
| Change from baseline to 1 and 3-months on the New General Self-Efficacy Scale (NGSE-8) | The New General Self-Efficacy Scale assesses how much people believe they can achieve their goals, despite difficulties. | Change = (week 12-baseline) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Transcendental Meditation, Rural women in Lebanon