TML: Lowering Stress Levels of Women in Lebanon

Sponsor
Maharishi International University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05836129
Collaborator
(none)
62
2
7

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Transcendental Meditation (TM) practice
  • Other: Stress reduction class (online)
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
62 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
The randomization will be done by villages versus participants.The randomization will be done by villages versus participants.
Masking:
Single (Outcomes Assessor)
Masking Description:
The statistician will not be aware of which arm the participants are in.
Primary Purpose:
Basic Science
Official Title:
Effects of Transcendental Meditation on Rural Women of Lebanon
Anticipated Study Start Date :
Apr 1, 2023
Anticipated Primary Completion Date :
Sep 15, 2023
Anticipated Study Completion Date :
Nov 1, 2023

Arms and Interventions

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.

Behavioral: Transcendental Meditation (TM) practice
See previous description

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.

Other: Stress reduction class (online)
See previous description

Outcome Measures

Primary Outcome Measures

  1. 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

  2. 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

  3. 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

  4. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 95 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes

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.

-

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Maharishi International University

Investigators

  • Study Director: Ghada Fakhreddine, BA, Chouf Development Council and the Ladies Foundation for Pure Knowledge

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Marie Loiselle, Director of Evaluation, Assistant Professor, Maharishi International University
ClinicalTrials.gov Identifier:
NCT05836129
Other Study ID Numbers:
  • 30-62050-3816
First Posted:
May 1, 2023
Last Update Posted:
May 1, 2023
Last Verified:
Apr 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Marie Loiselle, Director of Evaluation, Assistant Professor, Maharishi International University

Study Results

No Results Posted as of May 1, 2023