Lowering Stress Levels of Women in Lebanon

Not Applicable

Completed

• Conditions: Happiness; Stress; Resilience; Self Efficacy
• Interventions: Behavioral: Transcendental Meditation (TM) practice; Other: Stress reduction class (online)

• Registration Number: NCT05836129
• Lead Sponsor: Maharishi International University

Brief Summary

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:

1. Do women in rural Lebanon who practice the TM technique experience lower stress levels compared to those who do not.

2. 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

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 Timeline

• Study First Submitted: 2023-04-18
• Study First Submitted QC: 2023-04-18
• Study Start: 2023-05-01
• Study First Posted: 2023-05-01
• Primary Completion: 2023-11-30
• Study Completion: 2023-11-30
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-11
• Last Update Posted: 2024-03-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 109

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TM Group	Transcendental Meditation (TM) practice	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.
Active Control Group	Stress reduction class (online)	This group will be offered an online stress reduction course consisting of two 20-60 minute classes for the first month of the trial.

Primary Outcome Measures

Name	Time	Method
Change from baseline to 1 and 3-months on the Connor-Davidson Resilience Scale (CDRS-10)	Change = (week 12-baseline)	The CDRS-10 measures how well one is equipped to bounce back after stressful events, tragedy, or trauma
Change from baseline to 1 and 3-months on the New General Self-Efficacy Scale (NGSE-8)	Change = (week 12-baseline)	The New General Self-Efficacy Scale assesses how much people believe they can achieve their goals, despite difficulties.
Change from baseline to 1 and 3-months on the Arabic Scale of Happiness (ASH-20)	Change = (week 12-baseline)	The ASH-20 seeks to conduct a global, subjective assessment of whether a person is happy or unhappy
Change from baseline to 1 and 3-months on the Perceived Stress Scale(PSS-10)	Change = (week 12-baseline)	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

Trial Locations

Locations (1)

TM Home of Pure Knowledge Center; 🇱🇧 Beirut, Lebanon