Back to resultsMindfulness Based Cognitive Therapy for Youth With Anxiety at Risk for Bipolar Disorder (Mindfulness)
Primary Purpose
Anxiety, Bipolar Disorder
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
MBCT-C
Waitlist Control
Sponsored by
About this trial
This is an interventional treatment trial for Anxiety focused on measuring bipolar disorder, anxiety, mindfulness, high risk, cognitive behavioral
Eligibility Criteria
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
Sites / Locations
- University of Cincinnati
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
MBCT-C
Waitlist Control
Arm Description
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.
Education and Therapy
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
Behavioral
The Child Behavior Checklist (CBCL) is a rating scale to examine a child's behavior.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02090595
Brief Title
Mindfulness Based Cognitive Therapy for Youth With Anxiety at Risk for Bipolar Disorder
Acronym
Mindfulness
Official Title
Neurofunctional Effects of Mindfulness Based Cognitive Therapy for Youth With Symptoms of Anxiety and a Familial Risk for Developing Bipolar Disorder
Study Type
Interventional
2. Study Status
Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
July 2013 (undefined)
Primary Completion Date
July 2015 (Actual)
Study Completion Date
July 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Cincinnati
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety, Bipolar Disorder
Keywords
bipolar disorder, anxiety, mindfulness, high risk, cognitive behavioral
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
35 (Actual)
8. Arms, Groups, and Interventions
Arm Title
MBCT-C
Arm Type
Experimental
Arm Description
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.
Arm Title
Waitlist Control
Arm Type
Other
Arm Description
Education and Therapy
Intervention Type
Behavioral
Intervention Name(s)
MBCT-C
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Waitlist Control
Intervention Description
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 Outcome Measure Information:
Title
The Pediatric Anxiety Rating Scale
Description
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.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Change in other Anxiety
Description
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.
Time Frame
12 weeks
Title
Mood
Description
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.
Time Frame
12 weeks
Title
Behavioral
Description
The Child Behavior Checklist (CBCL) is a rating scale to examine a child's behavior.
Time Frame
12 weeks
Title
Quality of Life
Description
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.
Time Frame
12 weeks
Other Pre-specified Outcome Measures:
Title
Potential Mediators
Description
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.
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Melissa DelBello, MD
Organizational Affiliation
University of Cincinnati
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Cincinnati
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Mindfulness Based Cognitive Therapy for Youth With Anxiety at Risk for Bipolar Disorder
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