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

Anxiety research study

What is the primary objective of this study?

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

Who is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Anxiety

Bipolar Disorder

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Behavioral:MBCT-CA 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.

Behavioral:Waitlist ControlWaitlist 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.

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

MBCT-CMindfulness-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.

Waitlist ControlEducation and Therapy

Study Status

Completed

Start Date: July 2013

Completed Date: July 2015

Phase: N/A

Type: Interventional

Design:

Primary Outcome: The Pediatric Anxiety Rating Scale

Secondary Outcome: Change in other Anxiety

Study sponsors, principal investigator, and references

Principal Investigator: Melissa DelBello, MD

Lead Sponsor: University of Cincinnati

Collaborator:

More information:https://clinicaltrials.gov/show/NCT02090595

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