Lowering Stress Levels of Women in Lebanon (TML)
Effects of Transcendental Meditation on Rural Women of Lebanon
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Beirut, Lebanon, 0000
- TM Home of Pure Knowledge Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria: Females living in the Chouf region of Lebanon between the ages of 18-95.
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Exclusion Criteria: Anyone: not female, under 18 or over 95, not in sound mental condition.
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Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: TM Group
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.
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See previous description
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Active Comparator: Active Control Group
This group will be offered an online stress reduction course consisting of two 20-60 minute classes for the first month of the trial.
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See previous description
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change from baseline to 1 and 3-months on the Perceived Stress Scale(PSS-10)
Time Frame: Change = (week 12-baseline)
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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
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Change = (week 12-baseline)
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Change from baseline to 1 and 3-months on the Connor-Davidson Resilience Scale (CDRS-10)
Time Frame: Change = (week 12-baseline)
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The CDRS-10 measures how well one is equipped to bounce back after stressful events, tragedy, or trauma
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Change = (week 12-baseline)
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Change from baseline to 1 and 3-months on the Arabic Scale of Happiness (ASH-20)
Time Frame: Change = (week 12-baseline)
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The ASH-20 seeks to conduct a global, subjective assessment of whether a person is happy or unhappy
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Change = (week 12-baseline)
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Change from baseline to 1 and 3-months on the New General Self-Efficacy Scale (NGSE-8)
Time Frame: Change = (week 12-baseline)
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The New General Self-Efficacy Scale assesses how much people believe they can achieve their goals, despite difficulties.
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Change = (week 12-baseline)
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Collaborators and Investigators
Investigators
- Study Director: Ghada Fakhreddine, BA, Chouf Development Council and the Ladies Foundation for Pure Knowledge
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 30-62050-3816
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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