Bipolar DisorderNCT02120937
Mindfulness in Mood Dysregulated Youth
A study testing MBCT-C Therapy in people with Bipolar Disorder and Mood Disorder, run by University of Cincinnati at 1 site in United States.
Trial summary
Mindfulness group therapy can help children with mood irregularities and family history of bipolar disorder. Read more about this study
- Who is it for?
- Ages 10 to 17 years
- Conditions the study is for
- Bipolar Disorder, Mood Disorder, Emotional Disturbance
- What is being tested?
- MBCT-C Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2014to Mar 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Neural Basis of Mindfulness in Mood Dysregulated Youth
Mindfulness group therapy can help children with mood irregularities and family history of bipolar disorder.
Read the 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.
- Conditions
- Bipolar Disorder, Mood Disorder, Emotional Disturbance
- Being tested
- MBCT-C Therapy
- Keywords
- amygdala, mindfulness, mood, emotion, bipolar disorder, parental bipolar disorder, adolescence
- Medical subject headings
- Bipolar Disorder, Mood Disorders, Affective Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MBCT-C TherapyBehavioural
Also called Mindfulness Based Cognitive Therapy-Children
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).
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Behavioral: MBCT-C Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in ERC
Change from baseline to endpoint ( 12 weeks) in ratings on the Emotion Regulation Checklist
Measured: 12 weeks
Change in CDRS-R
Change from baseline to endpoint (12 weeks) on the ratings on the Children's Depression Rating Scale-Revised.
Measured: 12 weeks
Change in YMRS
Change from baseline to endpoint (12 weeks) in ratings on the Young Mania Rating Scale.
Measured: 12 weeks
Secondary outcomes (1)
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.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2014 (estimated)
- Study startMar 2014
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bipolar DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Cincinnati
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Melissa Delbello, University of Cincinnati
- Investigators
- Melissa P DelBello, MD, Principal investigator, University of CincinnatiSian Cotton, PhD, Principal investigator, University of Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02120937
- Sponsor's protocol ID
- 2014-0453
- Status last verified
- Sep 2015
- First submitted
- 18 Apr 2014
- Last updated
- 18 May 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neural Basis of Mindfulness in Mood Dysregulated Youth
- ClinicalTrials.gov ID
- NCT02120937
- Acronym / sponsor ID
- 2014-0453
- Conditions
- Bipolar Disorder, Mood Disorder, Emotional Disturbance
- Keywords
- amygdala, mindfulness, mood, emotion, bipolar disorder, parental bipolar disorder, adolescence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of CincinnatiUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 23 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MBCT-C Therapy | Experimental | Behavioral: MBCT-C TherapyMindfulness 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). |
Who may qualify
- Ages
- 10 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MBCT-C TherapyAlso: Mindfulness Based Cognitive Therapy-ChildrenMindfulness 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). | Behavioural | MBCT-C Therapy |
Primary outcome
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.
1 secondary outcome
Change in amygdala, insula, and prefrontal activation.
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Melissa P DelBello, MD principal investigator
University of Cincinnati
Sian Cotton, PhD principal investigator
University of Cincinnati
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MBCT-C Therapy in people with Bipolar Disorder and Mood Disorder, run by University of Cincinnati at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in ERC (time frame: 12 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2016.