Clinical trial NCT02120937: Mindfulness in Mood Dysregulated Youth
Official title: Neural Basis of Mindfulness in Mood Dysregulated Youth
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bipolar Disorder
Mood Disorder
Emotional Disturbance
Keywords: amygdala
mindfulness
mood
emotion
bipolar disorder
parental bipolar disorder
adolescence
Lead sponsor: University of Cincinnati
Sponsor class: OTHER
First posted: 2014-04-23
Enrollment: 10
Sex: ALL
Minimum age (years): 10
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in ERC
timeFrame: 12 weeks
measure: Change in CDRS-R
timeFrame: 12 weeks
measure: Change in YMRS
timeFrame: 12 weeks
Secondary outcomes:
measure: Change in amygdala, insula, and prefrontal activation.
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: University of Cincinnati
state: Ohio
Study officials:
affiliation: University of Cincinnati
name: Melissa P DelBello, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Cincinnati
name: Sian Cotton, PhD
role: PRINCIPAL_INVESTIGATOR
References: