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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05490979
Other study ID # #10085952
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 6, 2022
Est. completion date October 3, 2023

Study information

Verified date October 2023
Source University of Pennsylvania
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Many people are experiencing low well-being and loneliness, particularly due to the COVID-19 pandemic. As the world is opening back up, it is crucial to determine methods to help people grow closer again and boost subjective well-being. One promising method is contemplative dyad meditation, which has hardly been studied. This is a method in which two people have a structured dialogue with each other while contemplating a prompt, as they alternate between listening and speaking. It is related to but different from other methods that have previously been shown to increase connection, such as the "fast friends" exercise. In "fast friends", two people answer a series of increasingly personal questions in a dialogue. Here, 180 participants between 18-35 years will be randomly allocated to three conditions (stratified by gender): (a) contemplative dyad meditation training, (b) "fast friends", or (c) no-intervention. Participants in the dyad meditation group will receive professional meditation training followed by 2 weeks of regular meditation practice. Participants in the "fast friends" group will meet regularly during 2 weeks to practice "fast friends" exercises. The impact of the interventions on well-being, loneliness, mindfulness, and related measures will be investigated. After the interventions have finished, participants' physiology (heart rate) and brain waves (using electroencephalography [EEG]) during the respective exercises will also be measured to explore potential biological mechanisms. Of particular interest are heart rate variability (HRV, often linked with higher well-being), frontal alpha asymmetry in the EEG (linked with positive affect and approach), and biological synchrony in these variables between the two interacting individuals. Both dyad meditations and "fast friends" exercises are predicted to improve closeness, thriving, loneliness, affect, depression, anxiety, and social interaction anxiety compared to no-intervention. Moreover, dyad meditation is predicted to have stronger effects than "fast friends" in terms of increasing mindfulness, self-compassion, and empathy. Dyad meditation and fast friends will show differential physiological signatures (e.g., lower heart rate and higher averaged alpha power for meditation). This study may reveal effective methods to improve well-being and connection and provide insights into their biological mechanisms.


Recruitment information / eligibility

Status Completed
Enrollment 120
Est. completion date October 3, 2023
Est. primary completion date June 22, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 35 Years
Eligibility Inclusion Criteria: - Current student, staff, or employee at the University of Pennsylvania (for safety reasons) Exclusion Criteria: - none

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Contemplative dyad meditation
Participants take part in a 3-hour group meditation training led by a professional meditation teacher. They receive detailed instructions and also practice contemplative dyad meditation for at least 30 minutes with another participant. During the 2 weeks following the training, participants meet in supervised group settings to practice the meditation method with alternating partners for up to 6 times.
Fast friends
During 2 weeks, participants meet in supervised group settings to practice the 'fast friends' exercise with alternating partners for up to 6 times.

Locations

Country Name City State
United States University of Pennsylvania Philadelphia Pennsylvania

Sponsors (1)

Lead Sponsor Collaborator
University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Heart rate measured using electrocardiogram, by Bitalino 3 weeks
Other Heart rate variability measured using electrocardiogram, by Bitalino, calculated as Root Mean Square of Successive Differences (RMSSD) 3 weeks
Other Respiration measured using respiration belts by Bitalino 3 weeks
Other EEG measured using Emotiv-EEG 3 weeks
Primary Brief Inventory of Thriving The Brief Inventory of Thriving (Su, Tay, & Diener, 2014) is a questionnaire consisting of 10 items, measuring psychological well-being. Scores range from 1 to 5 with a higher score indicating more thriving (i.e., higher well-being). 3 weeks
Primary Loneliness Scores on the Comprehensive Inventory of Thriving The Loneliness sub-scale from the Comprehensive Inventory of Thriving (Su, Tay, & Diener, 2014) consists of 3 items. Scores range from 1 to 5 with a higher score indicating higher loneliness. 3 weeks
Primary Mindfulness Score on the Five Facet Mindfulness Questionnaire The Five Facet Mindfulness Questionnaire (Baer et al., 2006) consists of 39 items. Scores for mindfulness range between 1 and 5 with a higher score indicating more mindfulness. 3 weeks
Primary Inclusion of Other in the Self Scale The Inclusion of Other in the Self Scale (Aron, Aron, & Smollan, 1992) consists of 7 response options measuring closeness to another person (here: the meditation or exercise partner). The response options each show two circles labeled as" "Self" and "Other", which vary in terms of overlap, from barely touching (1, i.e., not close at all) to almost completely overlapping (7, i.e., extremely close). Directly after each individual meditation or "fast friends" exercise
Secondary Positive Affect Scores on the Negative And Positive Affect Scale The 10-item version of the Negative And Positive Affect Scale by Joshanloo (2017) contains 5 items measuring positive affect. Scores for positive affect from these 5 items range from 5 to 25 with 25 indicating higher positive affect. The scale is used here with the following adaptation: it asks about the previous 14 days rather than 30 days. 3 weeks
Secondary Negative Affect Scores on the Negative And Positive Affect Scale The 10-item version of the Negative And Positive Affect Scale (NAPAS) by Joshanloo (2017) contains 5 items measuring negative affect. Scores for negative affect from these 5 items range from 5 to 25 with 25 indicating higher negative affect. The scale is used here with the following adaptation: it asks about the previous 14 days rather than 30 days. 3 weeks
Secondary Depression Scores on the Patient Health Questionnaire-9 The Patient Health Questionnaire-9 consists of 9 items and measures the severity of depression. Scores range from 0 to 27 with a higher score indicating more severe depression. 3 weeks
Secondary Generalized Anxiety Disorder-7 questionnaire The Generalized Anxiety Disorder 7-item questionnaire screens for general anxiety disorder. Scores range from 0 to 21 with higher scores indicating more severe anxiety. 3 weeks
Secondary Social Interaction Anxiety Scale-6 The Social Interaction Anxiety Scale-6 (Peters et al., 2012) is a 6-item measure assessing social interaction anxiety. Scores range from 0 to 24 with 24 indicating more severe social anxiety. 3 weeks
Secondary Self-Compassion Scale Short-Form The short form of the Self-Compassion Scale (Raes et al., 2011) includes 12 items. Scores range from 1 to 5 with higher scores indicating more self-compassion. Change = (Week 3 Score - Baseline Score). 3 weeks
Secondary Toronto Empathy Questionnaire The Toronto Empathy Questionnaire consists of 16 items. Scores range from 0 to 64 with higher scores indicating higher empathy. 3 weeks
Secondary Positive Affect Scores on the Negative And Positive Affect Scale The 10-item version of the Negative And Positive Affect Scale by Joshanloo (2017) contains 5 items measuring positive affect. Scores for positive affect from these 5 items range from 5 to 25 with 25 indicating higher positive affect. The scale is used here with the following adaptation: it asks about the current moment rather than the past 30 days. Response options are adapted to vary from 1 (not at all) to 5 (extremely). Directly after each individual meditation or "fast friends" exercise
Secondary Negative Affect Scores on the Negative And Positive Affect Scale The 10-item version of the Negative And Positive Affect Scale (NAPAS) by Joshanloo (2017) contains 5 items measuring negative affect. Scores for negative affect from these 5 items range from 5 to 25 with 25 indicating higher negative affect. The scale is used here with the following adaptation: it asks about the current moment rather than the past 30 days. Response options are adapted to vary from 1 (not at all) to 5 (extremely). Directly after each individual meditation or "fast friends" exercise
Secondary Emotional synchrony Average correlation between emotions of the 2 people doing the exercise together, as reported with regards to the last 5 minutes of the meditation or the "fast friends" exercise. The following emotions (taken from the short version of the Negative and Positive Affect scale by Joshanloo) will be rated by both participants: restless/fidgety, hopeless, that everything was an effort, in good spirits, calm and peaceful, full of life. Directly after each individual meditation or "fast friends" exercise
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