Mindfulness in Mood Dysregulated Youth

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: Completed
• Conditions: Bipolar Disorder; Mood Disorder; Emotional Disturbance
• Intervention / Treatment: Behavioral: MBCT-C Therapy

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: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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

Outcome Measure	Measure Description	Time Frame
Change in ERC	Change from baseline to endpoint ( 12 weeks) in ratings on the Emotion Regulation Checklist	12 weeks
Change in CDRS-R	Change from baseline to endpoint (12 weeks) on the ratings on the Children's Depression Rating Scale-Revised.	12 weeks
Change in YMRS	Change from baseline to endpoint (12 weeks) in ratings on the Young Mania Rating Scale.	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	12 weeks

Collaborators and Investigators

• Sponsor: University of Cincinnati
• Investigators: Principal Investigator: Melissa P DelBello, MD, University of Cincinnati; Principal Investigator: Sian Cotton, PhD, University of Cincinnati

Study record dates

Study Major Dates

• Study Start: March 1, 2014
• Primary Completion (Actual): March 1, 2016
• Study Completion (Actual): March 1, 2016

Study Registration Dates

• First Submitted: April 18, 2014
• First Submitted That Met QC Criteria: April 21, 2014
• First Posted (Estimate): April 23, 2014

Study Record Updates

• Last Update Posted (Estimate): May 18, 2016
• Last Update Submitted That Met QC Criteria: May 17, 2016
• Last Verified: September 1, 2015

More Information

Terms related to this study

• Keywords: bipolar disorder; mindfulness; emotion; amygdala; adolescence; mood; parental bipolar disorder
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Pathologic Processes; Bipolar and Related Disorders; Disease; Bipolar Disorder; Mood Disorders; Affective Symptoms
• Other Study ID Numbers: 2014-0453

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO