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

NCT ID: NCT02090595

Last Updated: 2016-05-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-07-31
• Study Completion Date: 2015-07-31

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.

Conditions

Anxiety; Bipolar Disorder

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

MBCT-C

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.

Group Type: EXPERIMENTAL

MBCT-C

Intervention Type: BEHAVIORAL

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

Education and Therapy

Group Type: OTHER

Waitlist Control

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

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.

Intervention Type: 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

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Cincinnati

OTHER

Sponsor Role: lead

Responsible Party

Melissa Delbello

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Melissa DelBello, MD

Role: PRINCIPAL_INVESTIGATOR

University of Cincinnati

Locations

University of Cincinnati

Cincinnati, Ohio, United States

Countries

United States

Other Identifiers

2013-3124

Identifier Type: -

Identifier Source: org_study_id