Mindfulness Based Cognitive Therapy for Youth With Anxiety at Risk for Bipolar Disorder

Study Overview
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Brief Summary
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Children who have parents with bipolar disorder are at risk for developing anxiety disorders.

Detailed Description
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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.

Official Title
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Neurofunctional Effects of Mindfulness Based Cognitive Therapy for Youth With Symptoms of Anxiety and a Familial Risk for Developing Bipolar Disorder

Conditions
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Anxiety, Bipolar Disorder

Intervention / Treatment
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* Behavioral: MBCT-C
* Behavioral: Waitlist Control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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) 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

Ages Eligible for Study
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Minimum Age: 10 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MBCT-C<br>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. | Behavioral: MBCT-C<br>* 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.<br>|
| Other: Waitlist Control<br>Education and Therapy | Behavioral: Waitlist Control<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 12 weeks | 
| Behavioral | The Child Behavior Checklist (CBCL) is a rating scale to examine a child's behavior. | 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. | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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bipolar disorder, anxiety, mindfulness, high risk, cognitive behavioral