Lowering Stress Levels of Women in Lebanon

NCT05836129 | Completed DMC

• 1 other identifier: 30-62050-3816
• Study Type: interventional
• Target: 109
• Locations: 1 country
• Sites: 1

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:

• 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.

Conditions

Stress; Resilience; Self Efficacy; Happiness

Keywords

Transcendental Meditation; Rural women in Lebanon

Outcome Measures

Primary Outcomes (4)

• 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)

Study Arms (2)

TM Group

EXPERIMENTAL

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

Active Control Group

ACTIVE COMPARATOR

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)

Interventions

Transcendental Meditation (TM) practice BEHAVIORAL

See previous description

TM Group

Stress reduction class (online) OTHER

See previous description

Active Control Group

Eligibility Criteria

• Age: 18 Years - 95 Years
• Gender Eligibility Details: Those who present as females.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• Maharishi International University: lead

Study Sites (1)

TM Home of Pure Knowledge Center

Beirut, 0000, Lebanon

Location

MeSH Terms

Interventions

Meditation

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Spiritual Therapies; Relaxation Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Ghada Fakhreddine, BA

  Chouf Development Council and the Ladies Foundation for Pure Knowledge

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The statistician will not be aware of which arm the participants are in.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Evaluation, Assistant Professor

Model Details: This is a randomized controlled trial

Study Record Dates

• First Submitted: April 18, 2023
• First Posted: May 1, 2023
• Study Start: May 1, 2023
• Primary Completion: November 30, 2023
• Study Completion: November 30, 2023
• Last Updated: March 13, 2024

Record last verified: 2024-03

Locations

LE (1)