Bipolar Disorder, NOSNCT02435225
Brain Connectivity and Mindfulness Training in Youth With Bipolar Disorder Not Otherwise Specified (NOS)
A study testing Mindfulness Based Stress Reduction for Teens Group in people with Bipolar Disorder, NOS, run by Stanford University at 1 site in United States.
Trial summary
The investigators propose to study 30 adolescents with bipolar disorder, not otherwise specified (BD NOS) and a family history of Bipolar I Disorder (BD) at baseline with rs-fMRI (functional magnetic resonance imaging) and functional connectivity (FC) analyses and compare data with previously acquired rs-fMRI and FC… Read more about this study
- Who is it for?
- Ages 13 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Bipolar Disorder, NOS
- What is being tested?
- Mindfulness Based Stress Reduction for Teens Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- May 2014to Sep 2017
- 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 13 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Ages 13-17
- Diagnosed with BD-NOS
- First or second degree relative diagnosed with bipolar I or II
Who cannot join
- Not English speaking
- For those who are to participate in the MRI scan, having any metal in the body or movement disorders will be an exclusionary factor
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University School of Medicine
Stanford, California, 94305
About this study
Official title: Brain Connectivity and Mindfulness Training in Youth With Bipolar Disorder NOS
The investigators propose to study 30 adolescents with bipolar disorder, not otherwise specified (BD NOS) and a family history of Bipolar I Disorder (BD) at baseline with rs-fMRI (functional magnetic resonance imaging) and functional connectivity (FC) analyses and compare data with previously acquired rs-fMRI and FC data from 20 age- and gender-matched healthy controls (HC). Subjects will then undergo a 12-week Mindfulness based stress reduction- teen (MBSR-T) intervention and be reassessed and rescanned. The intervention and scanning will take place in groups of 6-8 subjects/group/year over the 4 years. This proposal will be a natural progression of past research, while extending the investigators' expertise to include advanced FC analyses and mindfulness based interventions in youth with mood dysregulation. The investigators will also integrate trainees into the imaging and therapy components of this study, furthering our mission of mentoring the next generation of innovative researchers who will push the field forward.
- Conditions
- Bipolar Disorder, NOS
- Being tested
- Mindfulness Based Stress Reduction for Teens Group
- Medical subject headings
- Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness Based Stress Reduction for Teens GroupBehavioural
A 12-Week weekly group intervention to train adolescents in mindfulness practice
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness group | Experimental | Participation in a 12 week mindfulness therapy group. Receives: Behavioral: Mindfulness Based Stress Reduction for Teens Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dorsal Medial Network functional connectivity
(1) Use ICA to compare DMN in subjects with BD NOS to healthy controls (HC)
Measured: 12 weeks
Functional connectivity of sgACC with thalamus, VMPFC, and amygdala
(2) Investigate level of FC of the sgACC with thalamus, VMPFC, amygdala, and FC of pCing with amygdala/hippocampus, comparing subjects to HC.
Measured: 12 weeks
Secondary outcomes (1)
Degree of Mindfulness
Will use measures of self report to determine amount and quality of mindfulness practice and degree of daily mindfulness achieved
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 posted6 May 2015 (estimated)
- Study startMay 2014
- Primary completionJun 2014
- Study completionSep 2017
Why it stopped: Change in goals of PI
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bipolar Disorder, NOSStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- 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
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kiki D Chang, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02435225
- Sponsor's protocol ID
- MH10126001
- Status last verified
- Jul 2018
- First submitted
- 7 Aug 2013
- Last updated
- 19 Jul 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brain Connectivity and Mindfulness Training in Youth With Bipolar Disorder NOS
- ClinicalTrials.gov ID
- NCT02435225
- Acronym / sponsor ID
- MH10126001
- Conditions
- Bipolar Disorder, NOS
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Change in goals of PI
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- May 2014 (actual)
- Primary completion
- Jun 2014 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 6 May 2015 (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.
The investigators propose to study 30 adolescents with bipolar disorder, not otherwise specified (BD NOS) and a family history of Bipolar I Disorder (BD) at baseline with rs-fMRI (functional magnetic resonance imaging) and functional connectivity (FC) analyses and compare data with previously acquired rs-fMRI and FC data from 20 age- and gender-matched healthy controls (HC). Subjects will then undergo a 12-week Mindfulness based stress reduction- teen (MBSR-T) intervention and be reassessed and rescanned. The intervention and scanning will take place in groups of 6-8 subjects/group/year over the 4 years. This proposal will be a natural progression of past research, while extending the investigators' expertise to include advanced FC analyses and mindfulness based interventions in youth with mood dysregulation. The investigators will also integrate trainees into the imaging and therapy components of this study, furthering our mission of mentoring the next generation of innovative researchers who will push the field forward.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mindfulness group | Experimental | Behavioral: Mindfulness Based Stress Reduction for Teens GroupParticipation in a 12 week mindfulness therapy group. |
Who may qualify
- Ages
- 13 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Ages 13-17
- Diagnosed with BD-NOS
- First or second degree relative diagnosed with bipolar I or II
Key exclusion criteria (2 listed)
- Not English speaking
- For those who are to participate in the MRI scan, having any metal in the body or movement disorders will be an exclusionary factor
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 |
|---|---|---|
| Mindfulness Based Stress Reduction for Teens GroupA 12-Week weekly group intervention to train adolescents in mindfulness practice | Behavioural | Mindfulness group |
Primary outcome
Dorsal Medial Network functional connectivity
Time frame: 12 weeks
(1) Use ICA to compare DMN in subjects with BD NOS to healthy controls (HC)
Functional connectivity of sgACC with thalamus, VMPFC, and amygdala
Time frame: 12 weeks
(2) Investigate level of FC of the sgACC with thalamus, VMPFC, amygdala, and FC of pCing with amygdala/hippocampus, comparing subjects to HC.
1 secondary outcome
Degree of Mindfulness
Time frame: 12 weeks
Results and safety
The study was stopped early (reason given: Change in goals of PI). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2018.
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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.
Kiki D Chang, MD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness Based Stress Reduction for Teens Group in people with Bipolar Disorder, NOS, run by Stanford University 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 3 inclusion and 2 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: stopped early, as of the sponsor's last update on 19 Jul 2018. 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 was stopped early (reason given: Change in goals of PI). Results are not available in the source record.
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?
Dorsal Medial Network functional connectivity (time frame: 12 weeks). The study lists 2 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 19 Jul 2018; AzTrials last refreshed its copy on 6 Nov 2026.