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CompletedNCT02120937Updated May 18, 2016

Mindfulness in Mood Dysregulated Youth

An interventional study of MBCT-C Therapy in Bipolar Disorder, Mood Disorder and Emotional Disturbance, sponsored by University of Cincinnati. Completed at 1 site in United States. Open to participants aged 10 Years to 17 Years. Per ClinicalTrials.gov, last updated 2016-05-18.

Sponsored by University of Cincinnati · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
10
Allocation
Not applicable
Ages
10 Years to 17 Years
Sex
All
01

Study summary

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

Read the 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.

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Conditions studied

  • Bipolar Disorder
  • Mood Disorder
  • Emotional Disturbance

Keywords

  • amygdala
  • mindfulness
  • mood
  • emotion
  • bipolar disorder
  • parental bipolar disorder
  • adolescence
03

In context

Bipolar Disorder

1,601 studies on the registry are indexed under Bipolar Disorder; 254 are open to participants now.

This study's enrollment of 10 is below the median of 64 across 1,223 interventional studies indexed under Bipolar Disorder.

Browse Bipolar Disorder studies →

Lead sponsor

University of Cincinnati is the lead sponsor of 314 studies on the registry; 43 are open to participants now.

Of its 22 completed or terminated interventional studies of FDA-regulated products, 15 (68%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
10 Years to 17 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
10 participants (actual)

Study arms

  • 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

Interventions

  • BehavioralMBCT-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).

    Also known as: Mindfulness Based Cognitive Therapy-Children

06

What researchers measure

Primary outcomes

  1. Change in ERC

    Change from baseline to endpoint ( 12 weeks) in ratings on the Emotion Regulation Checklist

    Time frame: 12 weeks

  2. Change in CDRS-R

    Change from baseline to endpoint (12 weeks) on the ratings on the Children's Depression Rating Scale-Revised.

    Time frame: 12 weeks

  3. Change in YMRS

    Change from baseline to endpoint (12 weeks) in ratings on the Young Mania Rating Scale.

    Time frame: 12 weeks

Secondary outcomes

  1. Change in amygdala, insula, and prefrontal activation.

    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.

    Time frame: 12 weeks

07

Study locations

1 site
  • University of Cincinnati
    Cincinnati, Ohio 45219, United States
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 18, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02120937
Lead sponsor
University of Cincinnati
Responsible party
Melissa Delbello (MD, University of Cincinnati) — Principal investigator
First posted
Apr 23, 2014
Start date
Mar 2014
Primary completion
Mar 2016
Completion
Mar 2016
Last update
May 18, 2016

Study contacts

Melissa P DelBello, MD
principal investigator · University of Cincinnati
Sian Cotton, PhD
principal investigator · University of Cincinnati

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2015. You cannot join it, but the record below documents what was studied.

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