StressTMLNCT05836129
Lowering Stress Levels of Women in Lebanon
A study testing Transcendental Meditation (TM) practice and Stress reduction class (online) in people with Stress and Resilience, run by Maharishi International University at 1 site in Lebanon.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 95 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Stress, Resilience, Self Efficacy
- What is being tested?
- Transcendental Meditation (TM) practice and Stress reduction class (online)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 109 participants
- Where
- 1 siteLebanon
- Study dates
- 1 May 2023to 30 Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 95 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
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.
-
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Stress, Resilience, Self Efficacy, Happiness
- Being tested
- Transcendental Meditation (TM) practice, Stress reduction class (online)
- Keywords
- Transcendental Meditation, Rural women in Lebanon
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcendental Meditation (TM) practiceBehavioural
See previous description
Stress reduction class (online)Other
See previous description
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Stress reduction class (online) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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.
Measured: Change = (week 12-baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2023
- Study start1 May 2023
- Primary completion30 Nov 2023
- Study completion30 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a randomized controlled trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 109 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maharishi International University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marie Loiselle, Maharishi International University
- Investigators
- Ghada Fakhreddine, BA, Study director, Chouf Development Council and the Ladies Foundation for Pure Knowledge
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05836129
- Sponsor's protocol ID
- 30-62050-3816
- Acronym
- TML
- Status last verified
- Mar 2024
- First submitted
- 18 Apr 2023
- Last updated
- 13 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Transcendental Meditation on Rural Women of Lebanon
- ClinicalTrials.gov ID
- NCT05836129
- Acronym / sponsor ID
- TML / 30-62050-3816
- Conditions
- Stress, Resilience, Self Efficacy, Happiness
- Keywords
- Transcendental Meditation, Rural women in Lebanon
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 109 participants (actual)
- Lead sponsor
- Maharishi International UniversityUniversity, hospital or other
- Study start
- 1 May 2023 (actual)
- Primary completion
- 30 Nov 2023 (actual)
- Study completion
- 30 Nov 2023 (actual)
- First posted
- 1 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This is a randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| TM Group | Experimental | Behavioral: Transcendental Meditation (TM) practiceThe 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 | Active comparator | Other: 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. |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcendental Meditation (TM) practiceSee previous description | Behavioural | TM Group |
| Stress reduction class (online)See previous description | Other | Active Control Group |
Primary outcome
Change from baseline to 1 and 3-months on the Perceived Stress Scale(PSS-10)
Time frame: 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
Change from baseline to 1 and 3-months on the Connor-Davidson Resilience Scale (CDRS-10)
Time frame: 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 Arabic Scale of Happiness (ASH-20)
Time frame: 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 New General Self-Efficacy Scale (NGSE-8)
Time frame: Change = (week 12-baseline)
The New General Self-Efficacy Scale assesses how much people believe they can achieve their goals, despite difficulties.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ghada Fakhreddine, BA study director
Chouf Development Council and the Ladies Foundation for Pure Knowledge
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcendental Meditation (TM) practice and Stress reduction class (online) in people with Stress and Resilience, run by Maharishi International University at 1 site in Lebanon.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Lebanon. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline to 1 and 3-months on the Perceived Stress Scale(PSS-10) (time frame: Change = (week 12-baseline)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2024.