Clinical trial NCT02090595: Mindfulness Based Cognitive Therapy for Youth With Anxiety at Risk for Bipolar Disorder
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
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety
Bipolar Disorder
Keywords: bipolar disorder
anxiety
mindfulness
high risk
cognitive behavioral
Lead sponsor: University of Cincinnati
Sponsor class: OTHER
First posted: 2014-03-18
Enrollment: 35
Sex: ALL
Minimum age (years): 10
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: The Pediatric Anxiety Rating Scale
timeFrame: 12 weeks
Secondary outcomes:
measure: Change in other Anxiety
timeFrame: 12 weeks
measure: Mood
timeFrame: 12 weeks
measure: Behavioral
timeFrame: 12 weeks
measure: Quality of Life
timeFrame: 12 weeks
Other outcomes:
measure: Potential Mediators
timeFrame: 12 weeks
Locations:
city: Cincinnati
country: United States
facility: University of Cincinnati
state: Ohio
Study officials:
affiliation: University of Cincinnati
name: Melissa DelBello, MD
role: PRINCIPAL_INVESTIGATOR
References: