Cognitive ChangeNCT03466164
Neural Mechanisms of Mindfulness
A study testing Mindfulness Based Stress Reduction Program in people with Cognitive Change, run by Washington University School of Medicine at 1 site in United States.
Trial summary
This project focuses on understanding the cognitive and neural mechanisms by which mindfulness training (MT) results in positive behavioral change and enhanced psychological well-being. Read more about this study
- Who is it for?
- Ages 22 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Cognitive Change
- What is being tested?
- Mindfulness Based Stress Reduction Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Jul 2017to 31 Mar 2020
- 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 22 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- monozygotic (MZ) or dizygotic (DZ) twins
- age range 22 to 45 years
- native English speaker
Who cannot join
- current psychiatric diagnosis
- taking psychoactive medication
- medical disorder that affects cognitive or motor function
- present or past head injury with documented neurological sequelae, and/or causing loss of consciousness.
- Pregnancy
- Claustrophobia
Show all 9Show fewer
- Metallic objects
- Heart rhythm abnormalities or pacemaker
- Premature birth (before 34 weeks)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Neural Mechanisms of Mindfulness: a Discordant Twin Design
This project focuses on understanding the cognitive and neural mechanisms by which mindfulness training (MT) results in positive behavioral change and enhanced psychological well-being. Participants will complete two sets of cognitive tasks during functional magnetic resonance imaging (fMRI) and either be assigned to an MT intervention between scan sets or after scan sets.
Read the detailed description
This project focuses on understanding the cognitive and neural mechanisms by which mindfulness training (MT) results in positive behavioral change and enhanced psychological well-being. Although MT is rapidly gaining in popularity as a life-style intervention, there are still critical gaps in our understanding of its primary mechanism of action. Current theoretical frameworks suggest that MT operates by improving attentional control, emotional regulation, and self-awareness capabilities, potentially by targeting neuroplastic brain mechanisms of executive control. This suggests an important role for cognitive neuroscience research, but current work is still in its infancy, and subject to a number of well-recognized methodological and conceptual limitations. The proposed project aims to systematically remedy these limitations of prior MT research, by leveraging the unique opportunities offered by the Human Connectome Project (HCP), and on-going NIH R01-funded research. A key feature of the project is the use of a randomized, longitudinal discordant twin design, in which monozygotic (MZ; identical) twin pairs will be recruited, with one co-twin randomly assigned to the MT condition (mindfulness-based stress reduction, or MBSR; the most-validated and standardized form of MT instruction) and the other serving as a (wait-list) control. Each co-twin will undergo extensive behavioral and MRI neuroimaging assessments in a pre/post fashion, before and after the MT (or no-contact control) intervention, to test for specific MT-related effects. The discordant twin design, though never previously employed in an MT context, is widely recognized as one of the strongest for causal inference, since it avoids many of the challenges and confounds associated with inadequately matched control groups, and enables twin-pair focused analyses, which greatly increase statistical power. The investigators will use this design to investigate theoretically-focused hypotheses that stem from a guiding framework regarding the neural mechanisms of cognitive control. Specifically, using a newly developed cognitive control task battery, the investigator will test the counter-intuitive hypothesis that MT produces an enhancement in the neural mechanism and circuits associated with reactive (rather than proactive) control. An additional subset of MZ twin participants will undergo retesting with the original HCP protocol, in order to provide a comprehensive assessment and comparison of MT effect sizes across multiple domains of cognitive and brain function. Success in this project will have high relevance for public health, by providing innovative experimental tools and a novel theoretical framework from which to empirically evaluate and better understand the potential impact of MT programs as lifestyle interventions for enhancing psychological well-being in healthy populations.
- Conditions
- Cognitive Change
- Being tested
- Mindfulness Based Stress Reduction Program
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness Based Stress Reduction ProgramBehavioural
Also called MBSR
8 week, 10-session course of mindfulness training
| Study group | Role | What they receive |
|---|---|---|
| Behavioral: Mindfulness Based Stress Reduction Program | Experimental | Mindfulness-Based Stress Reduction MZ: identical (monozygotic; MZ) twins are tested in a pre-post manner, with only one twin randomly assigned to MT in between the two testing sessions Receives: Behavioral: Mindfulness Based Stress Reduction Program |
| Control MZ | No intervention | Control MZ twin will complete 2 testing sessions without intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in proactive cognitive control composite behavioral score
The proactive composite variable consists aggregates the proactive condition of 4 tasks (Stroop, Cued Task-Switching, AX-CPT, Sternberg WM). For each task, a z-score is computed for each participant from their behavioral performance score: [(participant score - mean)/standard/deviation]. Then the composite score is created by summing z-scores.
Measured: Baseline (0 months), Post (through study completion, an average of 3 months)
Change in reactive cognitive control composite behavioral score
The reactive composite variable consists aggregates the reactive condition of 4 tasks (Stroop, Cued Task-Switching, AX-CPT, Sternberg WM). For each task, a z-score is computed for each participant from their behavioral performance score : [(participant score - mean)/standard/deviation]. Then the composite score is created by summing z-scores.
Measured: Baseline (0 months), Post (through study completion, an average of 3 months)
Change in proactive cognitive control composite brain imaging activation score
The proactive composite variable consists aggregates the proactive condition of 4 tasks (Stroop, Cued Task-Switching, AX-CPT, Sternberg WM). For each task, a z-score is computed for each participant from the brain activation score in the region of interest (ROI): [(participant score - mean)/standard/deviation]. Then the composite score is created by summing z-scores.
Measured: Baseline (0 months), Post (through study completion, an average of 3 months)
Change in reactive cognitive control composite brain imaging activation score
The reactive composite variable consists aggregates the reactive condition of 4 tasks (Stroop, Cued Task-Switching, AX-CPT, Sternberg WM). For each task, a z-score is computed for each participant from the brain activation score in the region of interest (ROI): [(participant score - mean)/standard/deviation]. Then the composite score is created by summing z-scores.
Measured: Baseline (0 months), Post (through study completion, an average of 3 months)
Secondary outcomes (4)
Psychological well-being
Score on the Satisfaction with Life self-report measure
Measured: Baseline (0 months), Post (through study completion, an average of 3 months)
Mindfulness
Score on the MAAS self-report measure
Measured: Baseline (0 months), Post (through study completion, an average of 3 months)
Anxiety
Score on the STAI self-report measure
Measured: Baseline (0 months), Post (through study completion, an average of 3 months)
Positive and Negative Mood
Score on the PANAS self-report measure
Measured: Baseline (0 months), Post (through study completion, an average of 3 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2018
- Study start3 Jul 2017
- Primary completion31 Mar 2020
- Study completion31 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive ChangeStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- discordant twin design
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03466164
- Sponsor's protocol ID
- 1R21AT009483
- Status last verified
- Jun 2020
- First submitted
- 30 Jan 2018
- Last updated
- 9 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neural Mechanisms of Mindfulness: a Discordant Twin Design
- ClinicalTrials.gov ID
- NCT03466164
- Acronym / sponsor ID
- 1R21AT009483
- Conditions
- Cognitive Change
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- 3 Jul 2017 (actual)
- Primary completion
- 31 Mar 2020 (actual)
- Study completion
- 31 Mar 2020 (actual)
- First posted
- 15 Mar 2018 (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.
This project focuses on understanding the cognitive and neural mechanisms by which mindfulness training (MT) results in positive behavioral change and enhanced psychological well-being. Participants will complete two sets of cognitive tasks during functional magnetic resonance imaging (fMRI) and either be assigned to an MT intervention between scan sets or after scan sets.
Detailed description
This project focuses on understanding the cognitive and neural mechanisms by which mindfulness training (MT) results in positive behavioral change and enhanced psychological well-being. Although MT is rapidly gaining in popularity as a life-style intervention, there are still critical gaps in our understanding of its primary mechanism of action. Current theoretical frameworks suggest that MT operates by improving attentional control, emotional regulation, and self-awareness capabilities, potentially by targeting neuroplastic brain mechanisms of executive control. This suggests an important role for cognitive neuroscience research, but current work is still in its infancy, and subject to a number of well-recognized methodological and conceptual limitations. The proposed project aims to systematically remedy these limitations of prior MT research, by leveraging the unique opportunities offered by the Human Connectome Project (HCP), and on-going NIH R01-funded research. A key feature of the project is the use of a randomized, longitudinal discordant twin design, in which monozygotic (MZ; identical) twin pairs will be recruited, with one co-twin randomly assigned to the MT condition (mindfulness-based stress reduction, or MBSR; the most-validated and standardized form of MT instruction) and the other serving as a (wait-list) control. Each co-twin will undergo extensive behavioral and MRI neuroimaging assessments in a pre/post fashion, before and after the MT (or no-contact control) intervention, to test for specific MT-related effects. The discordant twin design, though never previously employed in an MT context, is widely recognized as one of the strongest for causal inference, since it avoids many of the challenges and confounds associated with inadequately matched control groups, and enables twin-pair focused analyses, which greatly increase statistical power. The investigators will use this design to investigate theoretically-focused hypotheses that stem from a guiding framework regarding the neural mechanisms of cognitive control. Specifically, using a newly developed cognitive control task battery, the investigator will test the counter-intuitive hypothesis that MT produces an enhancement in the neural mechanism and circuits associated with reactive (rather than proactive) control. An additional subset of MZ twin participants will undergo retesting with the original HCP protocol, in order to provide a comprehensive assessment and comparison of MT effect sizes across multiple domains of cognitive and brain function. Success in this project will have high relevance for public health, by providing innovative experimental tools and a novel theoretical framework from which to empirically evaluate and better understand the potential impact of MT programs as lifestyle interventions for enhancing psychological well-being in healthy populations.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- discordant twin design
| Arm | Type | Receives |
|---|---|---|
| Behavioral: Mindfulness Based Stress Reduction Program | Experimental | Behavioral: Mindfulness Based Stress Reduction ProgramMindfulness-Based Stress Reduction MZ: identical (monozygotic; MZ) twins are tested in a pre-post manner, with only one twin randomly assigned to MT in between the two testing sessions |
| Control MZ | No intervention | –Control MZ twin will complete 2 testing sessions without intervention. |
Who may qualify
- Ages
- 22 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- monozygotic (MZ) or dizygotic (DZ) twins
- age range 22 to 45 years
- native English speaker
Key exclusion criteria (9 listed)
- current psychiatric diagnosis
- taking psychoactive medication
- medical disorder that affects cognitive or motor function
- present or past head injury with documented neurological sequelae, and/or causing loss of consciousness.
- Pregnancy
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 Based Stress Reduction ProgramAlso: MBSR8 week, 10-session course of mindfulness training | Behavioural | Behavioral: Mindfulness Based Stress Reduction Program |
Primary outcome
Change in proactive cognitive control composite behavioral score
Time frame: Baseline (0 months), Post (through study completion, an average of 3 months)
The proactive composite variable consists aggregates the proactive condition of 4 tasks (Stroop, Cued Task-Switching, AX-CPT, Sternberg WM). For each task, a z-score is computed for each participant from their behavioral performance score: [(participant score - mean)/standard/deviation]. Then the composite score is created by summing z-scores.
Change in reactive cognitive control composite behavioral score
Time frame: Baseline (0 months), Post (through study completion, an average of 3 months)
The reactive composite variable consists aggregates the reactive condition of 4 tasks (Stroop, Cued Task-Switching, AX-CPT, Sternberg WM). For each task, a z-score is computed for each participant from their behavioral performance score : [(participant score - mean)/standard/deviation]. Then the composite score is created by summing z-scores.
Change in proactive cognitive control composite brain imaging activation score
Time frame: Baseline (0 months), Post (through study completion, an average of 3 months)
The proactive composite variable consists aggregates the proactive condition of 4 tasks (Stroop, Cued Task-Switching, AX-CPT, Sternberg WM). For each task, a z-score is computed for each participant from the brain activation score in the region of interest (ROI): [(participant score - mean)/standard/deviation]. Then the composite score is created by summing z-scores.
Change in reactive cognitive control composite brain imaging activation score
Time frame: Baseline (0 months), Post (through study completion, an average of 3 months)
The reactive composite variable consists aggregates the reactive condition of 4 tasks (Stroop, Cued Task-Switching, AX-CPT, Sternberg WM). For each task, a z-score is computed for each participant from the brain activation score in the region of interest (ROI): [(participant score - mean)/standard/deviation]. Then the composite score is created by summing z-scores.
4 secondary outcomes
Psychological well-being
Time frame: Baseline (0 months), Post (through study completion, an average of 3 months)
Mindfulness
Time frame: Baseline (0 months), Post (through study completion, an average of 3 months)
Anxiety
Time frame: Baseline (0 months), Post (through study completion, an average of 3 months)
Positive and Negative Mood
Time frame: Baseline (0 months), Post (through study completion, an average of 3 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 9 Jun 2020.
- Individual participant dataSharing planned: Undecided
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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 Based Stress Reduction Program in people with Cognitive Change, run by Washington University School of Medicine 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 3 inclusion and 9 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 9 Jun 2020. 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?
Change in proactive cognitive control composite behavioral score (time frame: Baseline (0 months), Post (through study completion, an average of 3 months)). 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 9 Jun 2020.