Loneliness
Conditions
Brief summary
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).
Detailed description
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.
Interventions
BEHAVIORALLoving-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.
Sponsors
University of Nevada, Las Vegas
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Loneliness | baseline, immediately post-intervention, and week 4 and week 8 post intervention (follow-up periods). | 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. |
| Change in Self-compassion | baseline, immediately post-intervention, and week 4 and week 8 post intervention. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Anxiety | baseline, immediately post-intervention, and week 4 and week 8 post intervention. | 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. |
| Change in Depressive Symptoms | baseline, immediately post-intervention, and week 4 and week 8 post intervention. | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 28 |
| Waitlist Control The arm will eventually get the intervention. | 31 |
| Total | 59 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 4 | 8 |
Baseline characteristics
| Characteristic | Waitlist Control | Loving Kindness Meditation | Total |
|---|---|---|---|
| Age, Continuous | 71.5 Years STANDARD_DEVIATION 6.9 | 74.1 Years STANDARD_DEVIATION 6.2 | 72.8 Years STANDARD_DEVIATION 6.6 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 5 Participants | 2 Participants | 7 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 25 Participants | 24 Participants | 49 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 2 Participants | 3 Participants |
| Loneliness | 4.7 units on a scale STANDARD_DEVIATION 1.9 | 4.6 units on a scale STANDARD_DEVIATION 1.6 | 4.7 units on a scale STANDARD_DEVIATION 1.8 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 4 Participants | 6 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 4 Participants | 0 Participants | 4 Participants |
| Race (NIH/OMB) White | 25 Participants | 20 Participants | 45 Participants |
| Region of Enrollment United States | 31 participants | 28 participants | 54 participants |
| Sex: Female, Male Female | 25 Participants | 19 Participants | 44 Participants |
| Sex: Female, Male Male | 6 Participants | 9 Participants | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
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.
Time frame: baseline, immediately post-intervention, and week 4 and week 8 post intervention (follow-up periods).
Population: Baseline population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Loving Kindness Meditation | Change in Loneliness | Baseline | 4.64 units on a scale | Standard Deviation 1.64 |
| Loving Kindness Meditation | Change in Loneliness | Post-Intervention | 4.82 units on a scale | Standard Deviation 1.68 |
| Loving Kindness Meditation | Change in Loneliness | Week 4 follow up | 4.56 units on a scale | Standard Deviation 1.48 |
| Loving Kindness Meditation | Change in Loneliness | Week 8 follow up | 4.74 units on a scale | Standard Deviation 1.85 |
| Waitlist Control | Change in Loneliness | Week 8 follow up | 4.09 units on a scale | Standard Deviation 1.63 |
| Waitlist Control | Change in Loneliness | Baseline | 4.65 units on a scale | Standard Deviation 1.85 |
| Waitlist Control | Change in Loneliness | Week 4 follow up | 4.55 units on a scale | Standard Deviation 1.82 |
| Waitlist Control | Change in Loneliness | Post-Intervention | 4.62 units on a scale | Standard Deviation 1.69 |
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.
Time frame: baseline, immediately post-intervention, and week 4 and week 8 post intervention.
Population: Baseline
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Loving Kindness Meditation | Change in Self-compassion | Baseline | 3.5 units on a scale | Standard Error 0.63 |
| Loving Kindness Meditation | Change in Self-compassion | Post-intervention | 3.29 units on a scale | Standard Error 0.75 |
| Loving Kindness Meditation | Change in Self-compassion | Week 4 follow-up | 3.43 units on a scale | Standard Error 0.66 |
| Loving Kindness Meditation | Change in Self-compassion | Week 8 follow-up | 3.6 units on a scale | Standard Error 0.75 |
| Waitlist Control | Change in Self-compassion | Week 8 follow-up | 4.03 units on a scale | Standard Error 1.02 |
| Waitlist Control | Change in Self-compassion | Baseline | 3.62 units on a scale | Standard Error 0.87 |
| Waitlist Control | Change in Self-compassion | Week 4 follow-up | 3.82 units on a scale | Standard Error 0.98 |
| Waitlist Control | Change in Self-compassion | Post-intervention | 3.61 units on a scale | Standard Error 0.92 |
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.
Time frame: baseline, immediately post-intervention, and week 4 and week 8 post intervention.
Population: Some of participants did not enter the data for some timelines.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Loving Kindness Meditation | Change in Anxiety | baseline | 8.33 units on a scale | Standard Deviation 3.34 |
| Loving Kindness Meditation | Change in Anxiety | post intervention | 8.89 units on a scale | Standard Deviation 3.2 |
| Loving Kindness Meditation | Change in Anxiety | week 8 follow-up | 8.54 units on a scale | Standard Deviation 4.01 |
| Loving Kindness Meditation | Change in Anxiety | week 4 follow-up | 7.76 units on a scale | Standard Deviation 3.26 |
| Waitlist Control | Change in Anxiety | week 8 follow-up | 7.5 units on a scale | Standard Deviation 3.64 |
| Waitlist Control | Change in Anxiety | baseline | 8.61 units on a scale | Standard Deviation 3.87 |
| Waitlist Control | Change in Anxiety | post intervention | 9.54 units on a scale | Standard Deviation 3.85 |
| Waitlist Control | Change in Anxiety | week 4 follow-up | 8.33 units on a scale | Standard Deviation 3.95 |
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.
Time frame: baseline, immediately post-intervention, and week 4 and week 8 post intervention.
Population: not all participants entered data for each timeline.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Loving Kindness Meditation | Change in Depressive Symptoms | baseline | 16.72 units on a scale | Standard Deviation 5.32 |
| Loving Kindness Meditation | Change in Depressive Symptoms | post-intervention | 18.21 units on a scale | Standard Deviation 4.79 |
| Loving Kindness Meditation | Change in Depressive Symptoms | week 4 follow-up | 16.74 units on a scale | Standard Deviation 5.01 |
| Loving Kindness Meditation | Change in Depressive Symptoms | week 8 follow-up | 18.07 units on a scale | Standard Deviation 7.09 |
| Waitlist Control | Change in Depressive Symptoms | week 8 follow-up | 15.50 units on a scale | Standard Deviation 5.73 |
| Waitlist Control | Change in Depressive Symptoms | baseline | 17.04 units on a scale | Standard Deviation 5.65 |
| Waitlist Control | Change in Depressive Symptoms | week 4 follow-up | 16.14 units on a scale | Standard Deviation 6.11 |
| Waitlist Control | Change in Depressive Symptoms | post-intervention | 18.12 units on a scale | Standard Deviation 6.34 |