Behavioral ResiliencePhase 3NCT01592188
Cognitively-Based Compassion Training and Mindfulness Attention Training Program
A Phase 3 study testing Cognitively-Based Compassion Training (CBCT) and Mindfulness training in people with Behavioral Resilience and Biological Resilience, run by Emory University at 1 site in United States.
Trial summary
This project will explore the effect of Cognitively-Based Compassion Training or mindfulness training on behavior and saliva stress hormones in elementary school-age children. Read more about this study
- Who is it for?
- Ages 7 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Behavioral Resilience, Biological Resilience
- What is being tested?
- Cognitively-Based Compassion Training (CBCT) and Mindfulness training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2012to Nov 2013
- Phase
- Phase 3
- 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 7 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- age 7-12
- enrollment at the Paideia School.
Who cannot join
- poor physical health
- enrollment at a school other than the Paideia school.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cognitively-Based Compassion Training and Mindfulness Attention Training for Elementary School Students
This project will explore the effect of Cognitively-Based Compassion Training or mindfulness training on behavior and saliva stress hormones in elementary school-age children.
Read the detailed description
This project will explore the effect of Cognitively-Based Compassion Training (CBCT) or mindfulness training (MT) on different aspects of behavior and stress-related biology in elementary school-age children. The program will consist of 12 weeks of CBCT or MT, and various social behavioral assessments will be conducted. Participants will also provide saliva in which concentrations of stress hormones including cortisol and the inflammatory biomarkers C-reactive protein will be measured.
- Conditions
- Behavioral Resilience, Biological Resilience
- Being tested
- Cognitively-Based Compassion Training (CBCT), Mindfulness training
- Keywords
- meditation, inflammation, children, attention
- Medical subject headings
- Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitively-Based Compassion Training (CBCT)Behavioural
Also called Compassion Meditation
CBCT is a 12 week program that begins by teaching mindfulness and attention. It then goes on to use new mindfulness skills to consider topics of compassion, or unbiased acceptance and compassion for all other people, both friends, unfamiliar people, and enemies.
Mindfulness trainingBehavioural
Also called Mindfulness meditation
Mindfulness training will consist of 6 weeks training in mindfulness meditation.
| Study group | Role | What they receive |
|---|---|---|
| MT | Active comparator | Mindfulness training. Participants will be provided with once per week training in mindfulness meditation. Receives: Behavioral: Mindfulness training |
| CBCT | Experimental | Cognitively-based compassion training. Participants in this arm will be provided with once weekly training on the cognitively-based compassion training program. Receives: Behavioral: Cognitively-Based Compassion Training (CBCT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Interpersonal behaviors assessed using standardized protocols of social behavior, social cognition, and empathy.
Assessments before and after CBCT or MT interventions will be conducted to see if these practices lead to changes in interpersonal behavior. Participants will be asked to respond to questions related to social behavior in the lab setting, with the Social Circle Task, Mind In The Eyes Task, and the Implicit Association Task.
Measured: 12 weeks
Concentrations of stress system biomarkers in saliva
Assessments before and after CBCT or MT interventions will be conducted to see if these practices lead to changes in stress system activity, as measured by key biomarkers (cortisol, C-reactive protein) in saliva samples.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2012 (estimated)
- Study startJan 2012
- Primary completionNov 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Behavioral ResilienceStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe 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 3
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thaddeus Pace, PhD, Emory University
- Investigators
- Philippe Rochat, PhD, Principal investigator, Emory UniversityThaddeus Pace, PhD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01592188
- Sponsor's protocol ID
- IRB00054782
- Other IDs
- CBCT-Paideia
- Status last verified
- Nov 2013
- First submitted
- 2 May 2012
- Last updated
- 14 Nov 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitively-Based Compassion Training and Mindfulness Attention Training for Elementary School Students
- ClinicalTrials.gov ID
- NCT01592188
- Acronym / sponsor ID
- IRB00054782
- Conditions
- Behavioral Resilience, Biological Resilience
- Keywords
- meditation, inflammation, children, attention
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 7 May 2012 (estimated)
- 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.
This project will explore the effect of Cognitively-Based Compassion Training or mindfulness training on behavior and saliva stress hormones in elementary school-age children.
Detailed description
This project will explore the effect of Cognitively-Based Compassion Training (CBCT) or mindfulness training (MT) on different aspects of behavior and stress-related biology in elementary school-age children. The program will consist of 12 weeks of CBCT or MT, and various social behavioral assessments will be conducted. Participants will also provide saliva in which concentrations of stress hormones including cortisol and the inflammatory biomarkers C-reactive protein will be measured.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MT | Active comparator | Behavioral: Mindfulness trainingMindfulness training. Participants will be provided with once per week training in mindfulness meditation. |
| CBCT | Experimental | Behavioral: Cognitively-Based Compassion Training (CBCT)Cognitively-based compassion training. Participants in this arm will be provided with once weekly training on the cognitively-based compassion training program. |
Who may qualify
- Ages
- 7 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- age 7-12
- enrollment at the Paideia School.
Key exclusion criteria (2 listed)
- poor physical health
- enrollment at a school other than the Paideia school.
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 |
|---|---|---|
| Cognitively-Based Compassion Training (CBCT)Also: Compassion MeditationCBCT is a 12 week program that begins by teaching mindfulness and attention. It then goes on to use new mindfulness skills to consider topics of compassion, or unbiased acceptance and compassion for all other people, both friends, unfamiliar people, and enemies. | Behavioural | CBCT |
| Mindfulness trainingAlso: Mindfulness meditationMindfulness training will consist of 6 weeks training in mindfulness meditation. | Behavioural | MT |
Primary outcome
Interpersonal behaviors assessed using standardized protocols of social behavior, social cognition, and empathy.
Time frame: 12 weeks
Assessments before and after CBCT or MT interventions will be conducted to see if these practices lead to changes in interpersonal behavior. Participants will be asked to respond to questions related to social behavior in the lab setting, with the Social Circle Task, Mind In The Eyes Task, and the Implicit Association Task.
Concentrations of stress system biomarkers in saliva
Time frame: 12 weeks
Assessments before and after CBCT or MT interventions will be conducted to see if these practices lead to changes in stress system activity, as measured by key biomarkers (cortisol, C-reactive protein) in saliva samples.
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 14 Nov 2013.
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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.
Philippe Rochat, PhD principal investigator
Emory University
Thaddeus Pace, PhD principal investigator
Emory University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Cognitively-Based Compassion Training (CBCT) and Mindfulness training in people with Behavioral Resilience and Biological Resilience, run by Emory University 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 2 inclusion and 2 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 14 Nov 2013. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Interpersonal behaviors assessed using standardized protocols of social behavior, social cognition, and empathy. (time frame: 12 weeks). The study lists 2 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 14 Nov 2013.