AnxietyMindfulnessNCT02090595
Mindfulness Based Cognitive Therapy for Youth With Anxiety at Risk for Bipolar Disorder
A study testing MBCT-C in people with Anxiety and Bipolar Disorder, run by University of Cincinnati at 1 site in United States.
Trial summary
Children who have parents with bipolar disorder are at risk for developing anxiety disorders. Read more about this study
- Who is it for?
- Ages 10 to 17 years
- Conditions the study is for
- Anxiety, Bipolar Disorder
- What is being tested?
- MBCT-C
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2013to Jul 2015
- 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
- 10-17 years old
- At least one parent with bipolar disorder
- Meets clinical criteria for a specific anxiety disorder
- PARS -5 item scale score > 10 at screening and baseline of initial study phase
- Fluent in English;
- Provision of written informed consent/assent
- Agrees to participate in 75% of sessions
Who cannot join
- CANNOT Have any of the Following:
- Documented diagnosis of mental retardation or IQ <70
- Previous participation in mindfulness-based treatment
- Substance use disorder within last 3 months
- Judged clinically to be suicide risk
- Concurrent treatment with psychotropic medication (certain exceptions apply, ask for details)
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- Psychotherapy initiated within 2 months prior to screening or plan to initiate psychotherapy during study participation
- Any lifetime diagnosis of bipolar disorder, cyclothymia, schizophrenia, or other psychotic disorder
- Any symptom that requires admission to an inpatient psychiatric unit
- Anxiety symptoms resulting from acute medical illness or acute intoxication or withdrawal from drugs or alcohol
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Neurofunctional Effects of Mindfulness Based Cognitive Therapy for Youth With Symptoms of Anxiety and a Familial Risk for Developing Bipolar Disorder
Children who have parents with bipolar disorder are at risk for developing anxiety disorders.
Read the detailed description
Children who have parents with bipolar disorder are at risk for developing anxiety disorders. Typical treatments for anxiety in children are SSRI antidepressants. However, these medications may accelerate the onset of mania or hypomania in children with a family history of bipolar disorder or cause suicidal thinking in children. Studies trying alternative treatments to anxiety and possible bipolar disorder in children are needed, to establish other methods for treating childhood mental health. These studies can also help with early intervention and possible future prevention strategies for bipolar disorder. This study involves treating anxious children with Mindfulness Based Cognitive Therapy. They will have 12 weeks of mindfulness therapy in a group with other children where they will be led by a trained group leader, how to pay attention to anxiety cues and react differently.
- Conditions
- Anxiety, Bipolar Disorder
- Being tested
- MBCT-C, Waitlist Control
- Keywords
- bipolar disorder, anxiety, mindfulness, high risk, cognitive behavioral
- Medical subject headings
- Anxiety Disorders, Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MBCT-CBehavioural
A 12 week group therapy program for children with anxiety disorders. This involves teaching the children the pay attention to anxiety related cues with openness and non-judgment. Group leaders begin each session with: sitting meditation, review of the previous session and home practices, teaching a new mindfulness exercise, reading a group poem or story, distributing handouts, etc. There will be a new theme each week.
Waitlist ControlBehavioural
Waitlist Control (WC) will be the comparison condition. Some of the children in the study will initially participate in a 12 week WC prior to their participation in the MBCT-C. At each visit during the waitlist control period, participants and their families will receive materials about mood and anxiety disorders in youth, bipolar disorders, familial risk for bipolar disorder and treatment strategies for anxiety and depression in youth.
| Study group | Role | What they receive |
|---|---|---|
| MBCT-C | Experimental | Mindfulness-Based Cognitive Therapy for Anxious Children (MBCT-C) is a 12-week manualized group therapy program for children with anxiety disorders. The program involves teaching children to pay attention to anxiety-related thoughts, emotions, and physical sensations with openness and non-judgment. Receives: Behavioral: MBCT-C |
| Waitlist Control | Other | Education and Therapy Receives: Behavioral: Waitlist Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Pediatric Anxiety Rating Scale
Change from baseline to endpoint in the Pediatric Anxiety Rating Scale (PARS) score. The PARS is a rating scale (a form that a clinician fills out) to determine the severity of anxiety in children.
Measured: 12 weeks
Secondary outcomes (4)
Change in other Anxiety
The STAI-C is a rating scale that will determine the severity of state and trait related anxiety symptoms over time. State anxiety will be assessed at each visit. Trait anxiety will be assessed at Screening.Baseline and Week 12.
Measured: 12 weeks
Mood
The Children's Depression Rating Scale-Revised (CDRS) will measure symptoms of depression and the Young Mania Rating Scale (YMRS) will measure symptoms of mania.
Measured: 12 weeks
Behavioral
The Child Behavior Checklist (CBCL) is a rating scale to examine a child's behavior.
Measured: 12 weeks
Quality of Life
The Children's Global Assessment Score (CGAS) and the Children Health Questionnaire (CHQ) are rating scales that will determine a child's quality of life.
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 posted18 Mar 2014 (estimated)
- Study startJul 2013
- Primary completionJul 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies of the same condition, open and under way.
- More trials run by University of CincinnatiThe 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 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 DelBello, MD, Principal investigator, University of Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02090595
- Sponsor's protocol ID
- 2013-3124
- Acronym
- Mindfulness
- Status last verified
- May 2015
- First submitted
- 13 Mar 2014
- Last updated
- 18 May 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
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
- Neurofunctional Effects of Mindfulness Based Cognitive Therapy for Youth With Symptoms of Anxiety and a Familial Risk for Developing Bipolar Disorder
- ClinicalTrials.gov ID
- NCT02090595
- Acronym / sponsor ID
- Mindfulness / 2013-3124
- Conditions
- Anxiety, Bipolar Disorder
- Keywords
- bipolar disorder, anxiety, mindfulness, high risk, cognitive behavioral
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- University of CincinnatiUniversity, hospital or other
- Study start
- Jul 2013
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 18 Mar 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.
Children who have parents with bipolar disorder are at risk for developing anxiety disorders.
Detailed description
Children who have parents with bipolar disorder are at risk for developing anxiety disorders. Typical treatments for anxiety in children are SSRI antidepressants. However, these medications may accelerate the onset of mania or hypomania in children with a family history of bipolar disorder or cause suicidal thinking in children. Studies trying alternative treatments to anxiety and possible bipolar disorder in children are needed, to establish other methods for treating childhood mental health. These studies can also help with early intervention and possible future prevention strategies for bipolar disorder. This study involves treating anxious children with Mindfulness Based Cognitive Therapy. They will have 12 weeks of mindfulness therapy in a group with other children where they will be led by a trained group leader, how to pay attention to anxiety cues and react differently.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MBCT-C | Experimental | Behavioral: MBCT-CMindfulness-Based Cognitive Therapy for Anxious Children (MBCT-C) is a 12-week manualized group therapy program for children with anxiety disorders. The program involves teaching children to pay attention to anxiety-related thoughts, emotions, and physical sensations with openness and non-judgment. |
| Waitlist Control | Other | Behavioral: Waitlist ControlEducation and Therapy |
Who may qualify
- Ages
- 10 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 10-17 years old
- At least one parent with bipolar disorder
- Meets clinical criteria for a specific anxiety disorder
- PARS -5 item scale score > 10 at screening and baseline of initial study phase
- Fluent in English;
Key exclusion criteria (10 listed)
- Documented diagnosis of mental retardation or IQ <70
- Previous participation in mindfulness-based treatment
- Substance use disorder within last 3 months
- Judged clinically to be suicide risk
- Concurrent treatment with psychotropic medication (certain exceptions apply, ask for details)
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-CA 12 week group therapy program for children with anxiety disorders. This involves teaching the children the pay attention to anxiety related cues with openness and non-judgment. Group leaders begin each session with: sitting meditation, review of the previous session and home practices, teaching a new mindfulness exercise, reading a group poem or story, distributing handouts, etc. There will be a new theme each week. | Behavioural | MBCT-C |
| Waitlist ControlWaitlist Control (WC) will be the comparison condition. Some of the children in the study will initially participate in a 12 week WC prior to their participation in the MBCT-C. At each visit during the waitlist control period, participants and their families will receive materials about mood and anxiety disorders in youth, bipolar disorders, familial risk for bipolar disorder and treatment strategies for anxiety and depression in youth. | Behavioural | Waitlist Control |
Primary outcome
The Pediatric Anxiety Rating Scale
Time frame: 12 weeks
Change from baseline to endpoint in the Pediatric Anxiety Rating Scale (PARS) score. The PARS is a rating scale (a form that a clinician fills out) to determine the severity of anxiety in children.
4 secondary outcomes
Change in other Anxiety
Time frame: 12 weeks
Mood
Time frame: 12 weeks
Behavioral
Time frame: 12 weeks
Quality of Life
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: Undecided
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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 DelBello, MD 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 in people with Anxiety and Bipolar 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 10 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?
The Pediatric Anxiety Rating Scale (time frame: 12 weeks). 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.