Mindfulness in Mood Dysregulated Youth

Bipolar Disorder Clinical Trial

Official title:

Neural Basis of Mindfulness in Mood Dysregulated Youth

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02120937
• Other study ID #: 2014-0453
• Status: Completed
• Phase: N/A
• First received: April 18, 2014
• Last updated: May 17, 2016
• Start date: March 2014
• Est. completion date: March 2016

Study information

• Verified date: September 2015
• Source: University of Cincinnati
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 10 Years to 17 Years

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Affective Symptoms
• Bipolar Disorder
• Disease
• Emotional Disturbance
• Mood Disorder
• Mood Disorders

Intervention

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).

Locations

Country	Name	City	State
United States	University of Cincinnati	Cincinnati	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
University of Cincinnati

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in ERC	Change from baseline to endpoint ( 12 weeks) in ratings on the Emotion Regulation Checklist	12 weeks	No
Primary	Change in CDRS-R	Change from baseline to endpoint (12 weeks) on the ratings on the Children's Depression Rating Scale-Revised.	12 weeks	No
Primary	Change in YMRS	Change from baseline to endpoint (12 weeks) in ratings on the Young Mania Rating Scale.	12 weeks	No
Secondary	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	No