Neural Basis of Mindfulness in Mood Dysregulated Youth
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Bipolar Disorder
- Sponsor
- University of Cincinnati
- Enrollment
- 10
- Locations
- 1
- Primary Endpoint
- Change in ERC
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief Summary
Mindfulness group therapy can help children with mood irregularities and family history of bipolar disorder.
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.
Investigators
Melissa Delbello
MD
University of Cincinnati
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Change in ERC
Time Frame: 12 weeks
Change from baseline to endpoint ( 12 weeks) in ratings on the Emotion Regulation Checklist
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.
Change in YMRS
Time Frame: 12 weeks
Change from baseline to endpoint (12 weeks) in ratings on the Young Mania Rating Scale.
Secondary Outcomes
- Change in amygdala, insula, and prefrontal activation.(12 weeks)