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

Anxiety Clinical Trial

— Mindfulness  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02090595
• Other study ID #: 2013-3124
• Status: Completed
• Phase: N/A
• First received: March 13, 2014
• Last updated: May 17, 2016
• Start date: July 2013
• Est. completion date: July 2015

Study information

• Verified date: May 2015
• Source: University of Cincinnati
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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 information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 10 Years to 17 Years

Eligibility

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 Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Bipolar Disorder

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	University of Cincinnati	Cincinnati	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
University of Cincinnati

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	No
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	Behavioral	The Child Behavior Checklist (CBCL) is a rating scale to examine a child's behavior.	12 weeks	No
Secondary	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	No