Mindfulness Based Cognitive Therapy for Youth With Anxiety at Risk for Bipolar Disorder
- Conditions
- AnxietyBipolar Disorder
- Interventions
- Behavioral: MBCT-CBehavioral: Waitlist Control
- Registration Number
- NCT02090595
- Lead Sponsor
- University of Cincinnati
- Brief Summary
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 35
- 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
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description MBCT-C MBCT-C 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. Waitlist Control Waitlist Control Education and Therapy
- Primary Outcome Measures
Name Time Method The Pediatric Anxiety Rating Scale 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.
- Secondary Outcome Measures
Name Time Method Mood 12 weeks 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.
Behavioral 12 weeks The Child Behavior Checklist (CBCL) is a rating scale to examine a child's behavior.
Change in other Anxiety 12 weeks 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.
Quality of Life 12 weeks 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.
Trial Locations
- Locations (1)
University of Cincinnati
🇺🇸Cincinnati, Ohio, United States