MM GroupNCT06360497
The Effect of Mindfulness Meditation and Loving-kindness and Compassion Meditation on Psychological Distress
A study testing mindfulness meditation intervention and loving-kindness and compassion meditation intervention in people with MM Group and LKCM Group, run by Beijing Normal University at 1 site in China.
Trial summary
The purpose of the study is to explore the effect of of mindfulness meditation and loving-kindness and compassion meditation on psychological distress (i.e., anxiety, depression, stress), and explore the mechanism from the perspective of reinforcement sensitivity theory. Read more about this study
- Who is it for?
- Ages 18 to 56 yearsHealthy volunteers can take part
- Conditions the study is for
- MM Group, LKCM Group, Waitlist Group
- What is being tested?
- mindfulness meditation intervention and loving-kindness and compassion meditation intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 152 participants
- Where
- 1 siteChina
- Study dates
- 3 Jun 2022to 9 Oct 2022
- 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 56 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- have not attended structured meditation intervention; (2) have not diagnosed psychiatric diseases; (3) not currently receiving or has never received psychological counseling; (4) not currently taking or has never taken psychotropic medication; (5) age is less than 18.
Who cannot join
- have attended structured meditation intervention; (2) have diagnosed psychiatric diseases; (3) receiving or have received psychological counseling; (4) taking or have taken psychotropic drugs; (5) age is more than 18.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Mindfulness Meditation and Loving-kindness and Compassion Meditation on Psychological Distress: The Perspective of Reinforcement Sensitivity Theory
The purpose of the study is to explore the effect of of mindfulness meditation and loving-kindness and compassion meditation on psychological distress (i.e., anxiety, depression, stress), and explore the mechanism from the perspective of reinforcement sensitivity theory.
Read the detailed description
Participants were randomly assigned to three groups: mindfulness meditation group (MM, n = 51), loving-kindness and compassion meditation group (LKCM, n = 51), and waitlist group (n = 50). Participants in MM group and LKCM group received four weeks intervention, and data was collected before the intervention and after the intervention.
- Conditions
- MM Group, LKCM Group, Waitlist Group
- Being tested
- mindfulness meditation intervention and loving-kindness and compassion meditation intervention
- Keywords
- mindfulness, loving-kindness and compassion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mindfulness meditation intervention and loving-kindness and compassion meditation interventionOther
Also called waitlist
Interventions were conducted by two teachers separately. Mindfulness meditation group provided the knowledge and practice related with mindfulness, and loving-kindness and compassion meditation group provided knowledge and practice related with loving-kindness and compassion meditation.
| Study group | Role | What they receive |
|---|---|---|
| mindfulness meditation group | Experimental | participants in mindfulness meditation group would receive four weeks mindfulness meditation intervention. Receives: Other: mindfulness meditation intervention and loving-kindness and compassion meditation intervention |
| loving-kindness and compassion meditation group | Experimental | participants in loving-kindness and compassion meditation group would receive four weeks loving-kindness and compassion meditation meditation. Receives: Other: mindfulness meditation intervention and loving-kindness and compassion meditation intervention |
| waitlist | No intervention | participants in waitlist receive no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Depression Anxiety Stress Scale
The scalewas used to measure depression, anxiety, and stress with 21 items. Participants are required to report the degree of conformity scoring from 1 (did not apply to me at all) to 4 (applied to me very much).
Measured: 2 months
The Philadelphia Mindfulness Scale
The scale was used to measure the degree of mindfulness, with 10 items and two dimensions, scoring from 1 (never) to 5 (always).
Measured: 2 months
The Sensitivity to Punishment and Sensitivity to Reward Questionnaire
The scale included 34 items to test the sensitivity to punishment and sensitivity to reward. and participants were asked to respond yes (scoring 1) or no (scoring 0). Summing the scores of the questions was the total score for that dimension.
Measured: 2 months
Secondary outcomes (1)
The Emotional Word Lists
The scale was used to measure emotions, to test the basic effect of interventions. There were 24 emotional words, which constructed two dimensions: positive emotion and negative emotion, scoring from 1 (never) to 5 (always).
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2024
- Study start3 Jun 2022
- Primary completion9 Oct 2022
- Study completion9 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MM GroupStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 152 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Normal University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06360497
- Sponsor's protocol ID
- 202206090070
- Status last verified
- Apr 2024
- First submitted
- 8 Apr 2024
- Last updated
- 11 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Mindfulness Meditation and Loving-kindness and Compassion Meditation on Psychological Distress: The Perspective of Reinforcement Sensitivity Theory
- ClinicalTrials.gov ID
- NCT06360497
- Acronym / sponsor ID
- 202206090070
- Conditions
- MM Group, LKCM Group, Waitlist Group
- Keywords
- mindfulness, loving-kindness and compassion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 152 participants (actual)
- Lead sponsor
- Beijing Normal UniversityUniversity, hospital or other
- Study start
- 3 Jun 2022 (actual)
- Primary completion
- 9 Oct 2022 (actual)
- Study completion
- 9 Oct 2022 (actual)
- First posted
- 11 Apr 2024 (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 purpose of the study is to explore the effect of of mindfulness meditation and loving-kindness and compassion meditation on psychological distress (i.e., anxiety, depression, stress), and explore the mechanism from the perspective of reinforcement sensitivity theory.
Detailed description
Participants were randomly assigned to three groups: mindfulness meditation group (MM, n = 51), loving-kindness and compassion meditation group (LKCM, n = 51), and waitlist group (n = 50). Participants in MM group and LKCM group received four weeks intervention, and data was collected before the intervention and after the intervention.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| mindfulness meditation group | Experimental | Other: mindfulness meditation intervention and loving-kindness and compassion meditation interventionparticipants in mindfulness meditation group would receive four weeks mindfulness meditation intervention. |
| loving-kindness and compassion meditation group | Experimental | Other: mindfulness meditation intervention and loving-kindness and compassion meditation interventionparticipants in loving-kindness and compassion meditation group would receive four weeks loving-kindness and compassion meditation meditation. |
| waitlist | No intervention | –participants in waitlist receive no intervention |
Who may qualify
- Ages
- 18 to 56 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- have not attended structured meditation intervention; (2) have not diagnosed psychiatric diseases; (3) not currently receiving or has never received psychological counseling; (4) not currently taking or has never taken psychotropic medication; (5) age is less than 18.
Key exclusion criteria (1 listed)
- have attended structured meditation intervention; (2) have diagnosed psychiatric diseases; (3) receiving or have received psychological counseling; (4) taking or have taken psychotropic drugs; (5) age is more than 18.
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 |
|---|---|---|
| mindfulness meditation intervention and loving-kindness and compassion meditation interventionAlso: waitlistInterventions were conducted by two teachers separately. Mindfulness meditation group provided the knowledge and practice related with mindfulness, and loving-kindness and compassion meditation group provided knowledge and practice related with loving-kindness and compassion meditation. | Other | loving-kindness and compassion meditation group, mindfulness meditation group |
Primary outcome
The Depression Anxiety Stress Scale
Time frame: 2 months
The scalewas used to measure depression, anxiety, and stress with 21 items. Participants are required to report the degree of conformity scoring from 1 (did not apply to me at all) to 4 (applied to me very much).
The Philadelphia Mindfulness Scale
Time frame: 2 months
The scale was used to measure the degree of mindfulness, with 10 items and two dimensions, scoring from 1 (never) to 5 (always).
The Sensitivity to Punishment and Sensitivity to Reward Questionnaire
Time frame: 2 months
The scale included 34 items to test the sensitivity to punishment and sensitivity to reward. and participants were asked to respond yes (scoring 1) or no (scoring 0). Summing the scores of the questions was the total score for that dimension.
1 secondary outcome
The Emotional Word Lists
Time frame: 2 months
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 11 Apr 2024.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mindfulness meditation intervention and loving-kindness and compassion meditation intervention in people with MM Group and LKCM Group, run by Beijing Normal University at 1 site in China.
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 11 Apr 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 China. 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?
The Depression Anxiety Stress Scale (time frame: 2 months). The study lists 3 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 11 Apr 2024.