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

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.

Study Overview

• Status: Completed
• Conditions: Anxiety; Bipolar Disorder
• Intervention / Treatment: Behavioral: MBCT-C; Behavioral: Waitlist Control

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 Type: Interventional
• Enrollment (Actual): 35
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cincinnati, Ohio, United States, 45219
      • University of Cincinnati

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 17 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: MBCT-C; 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.
Other: Waitlist Control; Education and Therapy	Behavioral: Waitlist Control; 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.

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Potential Mediators	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.	12 weeks

Collaborators and Investigators

• Sponsor: University of Cincinnati

Study record dates

Study Major Dates

• Study Start: July 1, 2013
• Primary Completion (Actual): July 1, 2015
• Study Completion (Actual): July 1, 2015

Study Registration Dates

• First Submitted: March 13, 2014
• First Submitted That Met QC Criteria: March 14, 2014
• First Posted (Estimate): March 18, 2014

Study Record Updates

• Last Update Posted (Estimate): May 18, 2016
• Last Update Submitted That Met QC Criteria: May 17, 2016
• Last Verified: May 1, 2015

More Information

Terms related to this study

• Keywords: bipolar disorder; anxiety; mindfulness; high risk; cognitive behavioral
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Bipolar and Related Disorders; Disease; Anxiety Disorders; Bipolar Disorder
• Other Study ID Numbers: 2013-3124

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED