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Completed

NCT Number: NCT02090595

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

Children who have parents with bipolar disorder are at risk for developing anxiety disorders.

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Key information

Age range

10 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Cincinnati

Cincinnati, Ohio, 45219, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MBCT-C

Behavioral

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 Control

Behavioral

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Change in other Anxiety

    Time frame: 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.

  2. Mood

    Time frame: 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.

  3. Behavioral

    Time frame: 12 weeks

    The Child Behavior Checklist (CBCL) is a rating scale to examine a child's behavior.

  4. Quality of Life

    Time frame: 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.

Other outcomes

  1. Potential Mediators

    Time frame: 12 weeks

    Exploration of whether or not measures of mindfulness, emotional deregulation and attention will serve as potential mediators. The hypothesis that increased mindfulness, emotional regulation, and attention will mediate treatment-related improvements in anxiety, mood and behavior and QOL will be evaluated using structural equation models.

Sponsors and collaborators

Lead sponsor

University of Cincinnati

Other

Registry information

Official study title

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

Acronym: Mindfulness

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Mar 18, 2014
Registry last updated
May 18, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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