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Mindfulness in Mood Dysregulated Youth

Primary Purpose

Bipolar Disorder, Mood Disorder, Emotional Disturbance

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
MBCT-C Therapy
Sponsored by
University of Cincinnati
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bipolar Disorder focused on measuring amygdala, mindfulness, mood, emotion, bipolar disorder, parental bipolar disorder, adolescence

Eligibility Criteria

10 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Cincinnati

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

MBCT-C Therapy

Arm Description

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).

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.

Full Information

First Posted
April 18, 2014
Last Updated
May 17, 2016
Sponsor
University of Cincinnati
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1. Study Identification

Unique Protocol Identification Number
NCT02120937
Brief Title
Mindfulness in Mood Dysregulated Youth
Official Title
Neural Basis of Mindfulness in Mood Dysregulated Youth
Study Type
Interventional

2. Study Status

Record Verification Date
September 2015
Overall Recruitment Status
Completed
Study Start Date
March 2014 (undefined)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
March 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Cincinnati

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bipolar Disorder, Mood Disorder, Emotional Disturbance
Keywords
amygdala, mindfulness, mood, emotion, bipolar disorder, parental bipolar disorder, adolescence

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MBCT-C Therapy
Arm Type
Experimental
Arm Description
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).
Intervention Type
Behavioral
Intervention Name(s)
MBCT-C Therapy
Other Intervention Name(s)
Mindfulness Based Cognitive Therapy-Children
Intervention Description
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).
Primary Outcome Measure Information:
Title
Change in ERC
Description
Change from baseline to endpoint ( 12 weeks) in ratings on the Emotion Regulation Checklist
Time Frame
12 weeks
Title
Change in CDRS-R
Description
Change from baseline to endpoint (12 weeks) on the ratings on the Children's Depression Rating Scale-Revised.
Time Frame
12 weeks
Title
Change in YMRS
Description
Change from baseline to endpoint (12 weeks) in ratings on the Young Mania Rating Scale.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Change in amygdala, insula, and prefrontal activation.
Description
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.
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
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 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Melissa P DelBello, MD
Organizational Affiliation
University of Cincinnati
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sian Cotton, PhD
Organizational Affiliation
University of Cincinnati
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Cincinnati
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Mindfulness in Mood Dysregulated Youth

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