Mindfulness in Mood Dysregulated Youth

NCT02120937 | Completed

• 1 other identifier: 2014-0453
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Bipolar Disorder; Mood Disorder; Emotional Disturbance

Keywords

amygdala; mindfulness; mood; emotion; bipolar disorder; parental bipolar disorder; adolescence

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• Change in amygdala, insula, and prefrontal activation.

  12 weeks

Study Arms (1)

MBCT-C Therapy

EXPERIMENTAL

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

MBCT-C Therapy BEHAVIORAL

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

MBCT-C Therapy

Eligibility Criteria

• Age: 10 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• To be included in this study, subjects must meet the following criteria:
• Ages 10 -17 years; inclusive at the time of consent
• At least one biological parent with bipolar I disorder, confirmed with the SCID-P/L
• 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
• Fluent in English
• Provision of written informed consent/assent as previously described
• Agrees to participate in at least 75% of sessions.

You may not qualify if:

• Previously documented diagnosis of mental retardation or an IQ \<70
• Any lifetime DSM-V diagnosis of bipolar disorder, schizophrenia or other psychotic disorder
• Previous participation in a mindfulness-based treatment, including MBCT-C
• A substance use disorder (except nicotine or caffeine) within the past 3 months
• 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
• 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
• Psychotherapy initiated within 2 month prior to screening or plan to initiate psychotherapy during study participation
• Significant psychiatric symptoms that require hospitalization
• 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
• Female patients who are either pregnant or lactating; All girls will have a urine pregnancy test prior to MR scans
• Any contraindication to an MRI scan (e.g., metal clips, braces or claustrophobia)
• Neurological disorders (e.g. epilepsy) or severe head trauma resulting in loss of consciousness for \> 10 minutes or any unstable medical illness.

Sponsors & Collaborators

• University of Cincinnati: lead

Study Sites (1)

University of Cincinnati

Cincinnati, Ohio, 45219, United States

Location

MeSH Terms

Conditions

Bipolar Disorder; Mood Disorders; Affective Symptoms

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Melissa P DelBello, MD

  University of Cincinnati

  PRINCIPAL INVESTIGATOR

• Sian Cotton, PhD

  University of Cincinnati

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: April 18, 2014
• First Posted: April 23, 2014
• Study Start: March 1, 2014
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: May 18, 2016

Record last verified: 2015-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)