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The goal of this clinical trial is to test the feasibility and acceptability of loving-kindness meditation among adults 50 years and older. It will also examine the benefits of this intervention and compare the outcomes between two groups (intervention and wait-list control).
The main aim of the research is to assess the feasibility and acceptability of the Loving-kindness meditation intervention among adults 50 years or older. It will also examine the intervention's preliminary impact on loneliness, self-compassion, cognitive function, and psychological well-being. The study will use a randomized controlled trial with waitlist control.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Loving kindness meditation | Experimental | Loving-kindness meditation is a contemplative practice that focuses on developing compassion for oneself and others through mindfulness. Participants will be shown the recorded loving-kindness training video during the first week of the intervention. Participants will be encouraged to use the mp3 device with guided meditation recording to practice mindfulness meditation for 20-25 minutes every day for 30 days. We will also provide participants with a diary to record their daily meditation experiences. There will be weekly check in. At 60 days we will do a follow-up data collection. |
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| Waitlist control | No Intervention | The arm will eventually get the intervention. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Loving-kindness Meditation | Behavioral | Loving-kindness meditation is a type of mindfulness practice where the focus is on love/compassion and kindness for self and others. The guided meditation will be provided via recording device. The intervention is 4 week long. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Loneliness | A 3-item modified UCLA loneliness scale will be used to measure loneliness. The scores on this scale range from 3 to 9, the highest scores indicative of a higher level of loneliness. We will measure loneliness at baseline, post-intervention and 2 follow-up periods to measure the change in loneliness level because of the loving-kindness meditation intervention. | baseline, immediately post-intervention, and week 4 and week 8 post intervention (follow-up periods). |
| Change in Self-compassion | A 12-item Self-compassion Short form Scale by Kirsten Neff will be used to measure self-compassion. The scores on this scale rages from 1-5. The highest scores are indicative of better self-compassion. We will measure self-compassion at baseline and post-intervention periods to measure the change in self-compassion because of the loving-kindness meditation intervention. | baseline, immediately post-intervention, and week 4 and week 8 post intervention. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Anxiety | A 4-item PROMIS Emotional Distress: Anxiety Scale will be used to measure anxiety. The scores on this scale range from 4 to 20, the highest scores indicative of a higher feeling of anxiety. We will measure anxiety at baseline and post-intervention periods to measure the change in anxiety level because of the loving-kindness meditation intervention. | baseline, immediately post-intervention, and week 4 and week 8 post intervention. |
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Inclusion Criteria:
• Adults 50 years or older living in Southern Nevada
Exclusion Criteria:
• Cognitive or language barrier that would make it difficult to understand and sign the informed consent
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| Name | Affiliation | Role |
|---|---|---|
| Nirmala Lekhak, PhD | University of Nevada, Las Vegas | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Nevada Las Vegas | Las Vegas | Nevada | 89154 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Loving Kindness Meditation | Loving-kindness meditation is a contemplative practice that focuses on developing compassion for oneself and others through mindfulness. Participants will be shown the recorded loving-kindness training video during the first week of the intervention. Participants will be encouraged to use the mp3 device with guided meditation recording to practice mindfulness meditation for 20-25 minutes every day for 30 days. We will also provide participants with a diary to record their daily meditation experiences. There will be weekly check in. At 60 days we will do a follow-up data collection. Loving-kindness Meditation: Loving-kindness meditation is a type of mindfulness practice where the focus is on love/compassion and kindness for self and others. The guided meditation will be provided via recording device. The intervention is 4 week long. 22 participants |
| FG001 | Waitlist Control | The arm will eventually get the intervention. 23 participants |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Loving Kindness Meditation | Loving-kindness meditation is a contemplative practice that focuses on developing compassion for oneself and others through mindfulness. Participants will be shown the recorded loving-kindness training video during the first week of the intervention. Participants will be encouraged to use the mp3 device with guided meditation recording to practice mindfulness meditation for 20-25 minutes every day for 30 days. We will also provide participants with a diary to record their daily meditation experiences. There will be weekly check in. At 60 days we will do a follow-up data collection. Loving-kindness Meditation: Loving-kindness meditation is a type of mindfulness practice where the focus is on love/compassion and kindness for self and others. The guided meditation will be provided via recording device. The intervention is 4 week long. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Loneliness | A 3-item modified UCLA loneliness scale will be used to measure loneliness. The scores on this scale range from 3 to 9, the highest scores indicative of a higher level of loneliness. We will measure loneliness at baseline, post-intervention and 2 follow-up periods to measure the change in loneliness level because of the loving-kindness meditation intervention. | Baseline population | Posted | Mean | Standard Deviation | units on a scale | baseline, immediately post-intervention, and week 4 and week 8 post intervention (follow-up periods). |
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Adverse events and deaths were not monitored, (e.g., "All-Cause Mortality, Serious, and Other [Not Including Serious] Adverse Events were not monitored/assessed").
Adverse events and deaths were **not monitored**. So no participants were at risk.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Loving Kindness Meditation | Loving-kindness meditation is a contemplative practice that focuses on developing compassion for oneself and others through mindfulness. Participants will be shown the recorded loving-kindness training video during the first week of the intervention. Participants will be encouraged to use the mp3 device with guided meditation recording to practice mindfulness meditation for 20-25 minutes every day for 30 days. We will also provide participants with a diary to record their daily meditation experiences. There will be weekly check in. At 60 days we will do a follow-up data collection. Loving-kindness Meditation: Loving-kindness meditation is a type of mindfulness practice where the focus is on love/compassion and kindness for self and others. The guided meditation will be provided via recording device. The intervention is 4 week long. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Nirmala Lekhak | University of Nevada Las Vegas | 702-895-5983 | nirmala.lekhak@unlv.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | May 12, 2023 | Jul 3, 2025 | Prot_SAP_ICF_000.pdf |
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| Change in Depressive Symptoms | A 10-item Center for Epidemiologic Studies Short Depression Scale will be used to measure depressive symptoms. The scores on this scale range from 10 to 40, the highest scores indicative of a higher feeling of depression. We will measure depressive symptoms at baseline and post-intervention periods to measure the change in depressive symptoms because of the loving-kindness meditation intervention. | baseline, immediately post-intervention, and week 4 and week 8 post intervention. |
| BG001 | Waitlist Control | The arm will eventually get the intervention. |
| BG002 | Total | Total of all reporting groups |
| Years |
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| Age, Continuous | Mean | Standard Deviation | Years |
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| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Loneliness | Mean | Standard Deviation | units on a scale |
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| OG001 | Waitlist Control | The arm will eventually get the intervention. 23 participants |
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| Primary | Change in Self-compassion | A 12-item Self-compassion Short form Scale by Kirsten Neff will be used to measure self-compassion. The scores on this scale rages from 1-5. The highest scores are indicative of better self-compassion. We will measure self-compassion at baseline and post-intervention periods to measure the change in self-compassion because of the loving-kindness meditation intervention. | Baseline | Posted | Mean | Standard Error | units on a scale | baseline, immediately post-intervention, and week 4 and week 8 post intervention. |
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| Secondary | Change in Anxiety | A 4-item PROMIS Emotional Distress: Anxiety Scale will be used to measure anxiety. The scores on this scale range from 4 to 20, the highest scores indicative of a higher feeling of anxiety. We will measure anxiety at baseline and post-intervention periods to measure the change in anxiety level because of the loving-kindness meditation intervention. | Some of participants did not enter the data for some timelines. | Posted | Mean | Standard Deviation | units on a scale | baseline, immediately post-intervention, and week 4 and week 8 post intervention. |
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| Secondary | Change in Depressive Symptoms | A 10-item Center for Epidemiologic Studies Short Depression Scale will be used to measure depressive symptoms. The scores on this scale range from 10 to 40, the highest scores indicative of a higher feeling of depression. We will measure depressive symptoms at baseline and post-intervention periods to measure the change in depressive symptoms because of the loving-kindness meditation intervention. | not all participants entered data for each timeline. | Posted | Mean | Standard Deviation | units on a scale | baseline, immediately post-intervention, and week 4 and week 8 post intervention. |
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| EG001 | Waitlist Control | The arm will eventually get the intervention. | 0 | 0 | 0 | 0 | 0 | 0 |
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| Week 8 follow-up |
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