Mindfulness in Mood Dysregulated Youth

May 17, 2016 updated by: Melissa Delbello, University of Cincinnati

Neural Basis of Mindfulness in Mood Dysregulated Youth

Mindfulness group therapy can help children with mood irregularities and family history of bipolar disorder.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Mindfulness Based Cognitive Therapy (MBCT) is a manualized psychotherapeutic intervention that is a combination of mindfulness techniques and cognitive behavioral therapy. MBCT-C, which is mindfulness based cognitive based therapy for children, involves weekly group sessions, home practice, and the core curriculum of formal mindfulness practices (e.g. body scan, sitting, movement and walking meditations). Group sessions will involve guided meditation practices, instructor-led discussion of experiences and psychoeducation. By fopstering the ability to pay close attention to thoughts, emotions and body sensations, participants learn to make better choices to deal with stress, anxiety, depression, pain and other challenges. This can allow them to more effectively use the principles of cognitive behavioral therapy.

Twelve children aged 10-17 with mood dysregulation and a bipolar parent will be in the study for 12 weeks. There will be two groups receiving intervention: one group recruited from the community and one group recruited from a known high-risk cohort.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
10

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • University of Cincinnati

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

10 years to 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

To be included in this study, subjects must meet the following criteria:

  1. Ages 10 -17 years; inclusive at the time of consent
  2. At least one biological parent with bipolar I disorder, confirmed with the SCID-P/L
  3. CDRS-R score > 28 or YMRS score > 12 or ERC score > 36 at screening and baseline since clinically significant elevation on any of these scales suggests mood dysregulation
  4. Fluent in English
  5. Provision of written informed consent/assent as previously described
  6. Agrees to participate in at least 75% of sessions.

Exclusion Criteria:

  1. Previously documented diagnosis of mental retardation or an IQ <70
  2. Any lifetime DSM-V diagnosis of bipolar disorder, schizophrenia or other psychotic disorder
  3. Previous participation in a mindfulness-based treatment, including MBCT-C
  4. A substance use disorder (except nicotine or caffeine) within the past 3 months
  5. Judged clinically to be at risk from suicide as defined as having active suicidal ideation, intent or plan, or a serious suicide attempt within 30 days, or a baseline CDRS-R suicide score of >3
  6. Concurrent treatment with psychotropic medications that have been adjusted during the 30 days prior to screening or are anticipated during the course of study participation
  7. Psychotherapy initiated within 2 month prior to screening or plan to initiate psychotherapy during study participation
  8. Significant psychiatric symptoms that require hospitalization
  9. Mood symptoms resulting from acute medical illness or acute intoxication or withdrawal from drugs or alcohol as determined by medical evaluation or rapid symptom resolution
  10. Female patients who are either pregnant or lactating; All girls will have a urine pregnancy test prior to MR scans
  11. Any contraindication to an MRI scan (e.g., metal clips, braces or claustrophobia)
  12. Neurological disorders (e.g. epilepsy) or severe head trauma resulting in loss of consciousness for > 10 minutes or any unstable medical illness.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: MBCT-C Therapy
Mindfulness Based Cognitive Therapy for Children is a manualized psychotherapeutic intervention that combines mindfulness techniques with certain features of cognitive behavioral therapy. This particular protocol for youth includes weekly group sessions, regular home practice, and the core curriculum of formal mindfulness practices (e.g., body scan, sitting, movement, and walking meditations).
Behavioral: MBCT-C Therapy
Mindfulness Based Cognitive Therapy for Children is a manualized psychotherapeutic intervention that combines mindfulness techniques with certain features of cognitive behavioral therapy. This particular protocol for youth includes weekly group sessions, regular home practice, and the core curriculum of formal mindfulness practices (e.g., body scan, sitting, movement, and walking meditations).
Other Names:
  • Mindfulness Based Cognitive Therapy-Children

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in ERC
Time Frame: 12 weeks
Change from baseline to endpoint ( 12 weeks) in ratings on the Emotion Regulation Checklist
12 weeks
Change in CDRS-R
Time Frame: 12 weeks
Change from baseline to endpoint (12 weeks) on the ratings on the Children's Depression Rating Scale-Revised.
12 weeks
Change in YMRS
Time Frame: 12 weeks
Change from baseline to endpoint (12 weeks) in ratings on the Young Mania Rating Scale.
12 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in amygdala, insula, and prefrontal activation.
Time Frame: 12 weeks
We will examine baseline to endpoint changes in task related VLPFC, amygdala, and insula activation. We will examine associations among changes in activation in these brain regions and changes in mood regulation rating scale scores.Additionally, we will examine changes in seed-based resting state connectivity measures using amygdala and insula as the seeds and examining connectivity with VLPFC regions. Finally, we will use correlation to assess associations among changes in resting state connectivity of these regions and changes in mindfulness measures.
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Cincinnati

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Melissa P DelBello, MD, University of Cincinnati
  • Principal Investigator: Sian Cotton, PhD, University of Cincinnati

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 18, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 21, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 23, 2014

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 18, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 17, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2014-0453

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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