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

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University of Cincinnati

Status

Completed

Conditions

Bipolar Disorder
Anxiety

Treatments

Behavioral: MBCT-C
Behavioral: Waitlist Control

Study type

Interventional

Funder types

Other

Identifiers

NCT02090595
2013-3124

Details and patient eligibility

About

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

Full 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.

Enrollment

35 patients

Sex

All

Ages

10 to 17 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

35 participants in 2 patient groups

MBCT-C
Experimental group
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.
Treatment:
Behavioral: MBCT-C
Waitlist Control
Other group
Description:
Education and Therapy
Treatment:
Behavioral: Waitlist Control

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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