Mental Health Wellness 1NCT05490979
The Impact of Dyad Exercises on Well-being and Connection in Young Adults
A study testing Contemplative dyad meditation and Fast friends in people with Mental Health Wellness 1 and Loneliness, run by University of Pennsylvania at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Mental Health Wellness 1, Loneliness
- What is being tested?
- Contemplative dyad meditation and Fast friends
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Sep 2022to 3 Oct 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 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Current student, staff, or employee at the University of Pennsylvania (for safety reasons)
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: Effectiveness and Physiological Mechanisms of Contemplative Dyad Meditation to Increase Social Connection in Young Adults in the Aftermath of the Pandemic
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.
Read more
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.
- Conditions
- Mental Health Wellness 1, Loneliness
- Being tested
- Contemplative dyad meditation, Fast friends
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Contemplative dyad meditationBehavioural
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 friendsBehavioural
During 2 weeks, participants meet in supervised group settings to practice the 'fast friends' exercise with alternating partners for up to 6 times.
| Study group | Role | What they receive |
|---|---|---|
| Contemplative dyad meditation | Experimental | Not described Receives: Behavioral: Contemplative dyad meditation |
| Fast friends | Active comparator | Not described Receives: Behavioral: Fast friends |
| No intervention | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 3 weeks
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.
Measured: 3 weeks
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.
Measured: 3 weeks
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).
Measured: Directly after each individual meditation or "fast friends" exercise
Secondary outcomes (10)
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.
Measured: 3 weeks
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.
Measured: 3 weeks
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.
Measured: 3 weeks
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.
Measured: 3 weeks
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.
Measured: 3 weeks
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).
Measured: 3 weeks
Toronto Empathy Questionnaire
The Toronto Empathy Questionnaire consists of 16 items. Scores range from 0 to 64 with higher scores indicating higher empathy.
Measured: 3 weeks
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).
Measured: Directly after each individual meditation or "fast friends" exercise
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).
Measured: Directly after each individual meditation or "fast friends" exercise
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.
Measured: Directly after each individual meditation or "fast friends" exercise
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2022
- Study start6 Sep 2022
- Primary completion22 Jun 2023
- Study completion3 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental Health Wellness 1Studies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Platt, University of Pennsylvania
- Investigators
- Michael L Platt, PhD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05490979
- Sponsor's protocol ID
- #10085952
- Status last verified
- Oct 2023
- First submitted
- 4 Aug 2022
- Last updated
- 5 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness and Physiological Mechanisms of Contemplative Dyad Meditation to Increase Social Connection in Young Adults in the Aftermath of the Pandemic
- ClinicalTrials.gov ID
- NCT05490979
- Acronym / sponsor ID
- #10085952
- Conditions
- Mental Health Wellness 1, Loneliness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- 6 Sep 2022 (actual)
- Primary completion
- 22 Jun 2023 (actual)
- Study completion
- 3 Oct 2023 (actual)
- First posted
- 8 Aug 2022 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Contemplative dyad meditation | Experimental | Behavioral: Contemplative dyad meditation |
| Fast friends | Active comparator | Behavioral: Fast friends |
| No intervention | No intervention | – |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Current student, staff, or employee at the University of Pennsylvania (for safety reasons)
Key exclusion criteria (1 listed)
- none
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 |
|---|---|---|
| Contemplative dyad meditationParticipants 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. | Behavioural | Contemplative dyad meditation |
| Fast friendsDuring 2 weeks, participants meet in supervised group settings to practice the 'fast friends' exercise with alternating partners for up to 6 times. | Behavioural | Fast friends |
Primary outcome
Brief Inventory of Thriving
Time frame: 3 weeks
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).
Loneliness Scores on the Comprehensive Inventory of Thriving
Time frame: 3 weeks
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.
Mindfulness Score on the Five Facet Mindfulness Questionnaire
Time frame: 3 weeks
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.
Inclusion of Other in the Self Scale
Time frame: Directly after each individual meditation or "fast friends" exercise
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).
10 secondary outcomes
Positive Affect Scores on the Negative And Positive Affect Scale
Time frame: 3 weeks
Negative Affect Scores on the Negative And Positive Affect Scale
Time frame: 3 weeks
Depression Scores on the Patient Health Questionnaire-9
Time frame: 3 weeks
Generalized Anxiety Disorder-7 questionnaire
Time frame: 3 weeks
Social Interaction Anxiety Scale-6
Time frame: 3 weeks
Self-Compassion Scale Short-Form
Time frame: 3 weeks
Toronto Empathy Questionnaire
Time frame: 3 weeks
Positive Affect Scores on the Negative And Positive Affect Scale
Time frame: Directly after each individual meditation or "fast friends" exercise
Negative Affect Scores on the Negative And Positive Affect Scale
Time frame: Directly after each individual meditation or "fast friends" exercise
Emotional synchrony
Time frame: Directly after each individual meditation or "fast friends" exercise
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 5 Oct 2023.
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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.
Michael L Platt, PhD principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Contemplative dyad meditation and Fast friends in people with Mental Health Wellness 1 and Loneliness, run by University of Pennsylvania at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. 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 5 Oct 2023. 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 United States. 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?
Brief Inventory of Thriving (time frame: 3 weeks). 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 5 Oct 2023.