Comorbidity Between Balance and Childhood Anxiety

• ClinicalTrials.gov Identifier: NCT00599742
• Recruitment Status: Unknown
• First Posted: January 24, 2008
• Last Update Posted: January 24, 2008
• Sponsor: Lev-Hasharon Mental Healtlh Center
• Collaborators: Tel Aviv University; Institute of Physical Education and Sports Sciences; University of Haifa
• Information provided by: Lev-Hasharon Mental Healtlh Center

Study Description

Brief Summary:

Previous studies report frequent comorbidity of anxiety and sensory-motor imbalance in adults (Sklare et al., 2001). Only a few studies tested the comorbidity in children. We confirmed that: a) children with primary diagnosis of poor balance demonstrate an elevated anxiety level (Brat et al., 2006, submitted) and, b) children with primary diagnosis of generalized anxiety disorder demonstrate poor balance performance (Erez et al., 2004). These studies demonstrate the presence of balance-anxiety comorbidity in children with primary disorder of either balance or anxiety. Our theoretical reasoning formalized under the "three stage theory of learning" points to the possibility that poor balance may either predispose or cause the emergence of anxiety disorder (Erez et al., 2004). Thus, in the present study we test two predictions: (a) high prevalence of comorbidity of anxiety and balance disorders in children with a primary diagnosis of generalized or separation anxiety disorder, and, (b) intensive balance training, but not training of flexibility and power, will reduce the level of anxiety in children with primary diagnosis of anxiety.

Condition or disease	Intervention/treatment	Phase
Anxiety	Behavioral: Balance training; Behavioral: Motor training	Not Applicable

Detailed Description:

Study sample: 64 children, 8 to 14 years old, with diagnosis of generalized or separation anxiety.

Training: 32 of these children will undergo balance training and the other 32 children will undergo motor training of power and flexibility. Training will last 7 weeks, twice per week, 1 hr each session.

Tests: Balance and anxiety tests will be applied before training period, immediately after the last training session and again 2 months after the last training session.

Tests will include standard balance performance tests and questionnaires of anxiety.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 64 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Official Title: Comorbidity Between Balance and Childhood Anxiety: Treatment of Anxiety by Training of Balance
• Study Start Date: December 2007
• Estimated Primary Completion Date: December 2010
• Estimated Study Completion Date: December 2010

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: A; Balance training group	Behavioral: Balance training; Physical exercise of balance. The training will last 7 weeks, twice per week, 1 hour per session.
Active Comparator: B; Motor Training	Behavioral: Motor training; Motor exercise of power and flexibility. The training will last 7 weeks, twice per week, 1 hour per session.

Outcome Measures

Primary Outcome Measures :

1. Balance improvement and anxiety reduction [ Time Frame: After 7 weeks of training ]

Eligibility Criteria

• Ages Eligible for Study: 8 Years to 14 Years (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• Ages 8-14
• Boy or girl
• Generalized or separation anxiety disorder
• Agreement to participate and written informed consent

Exclusion Criteria:

• Major affective disorders
• Severe developmental disorders
• Refusal to participate

Contacts and Locations

Locations

Israel

Child and Adolescent Mental Health Clinic, Lev Hasharon MHC; Recruiting

Netanya, Israel

Contact: Michal Rappaport, MD +972-9-833-4466 michalra@lev-hasharon.co.il

Principal Investigator: Michal Rappaport, MD

Wingate Institute for Physical Education; Recruiting

Netanya, Israel

Contact: Roni Lidor, PhD +972-9-863-9247 lidor@wincol.ac.il

Sub-Investigator: Roni Lidor, PhD

Sponsors and Collaborators

Lev-Hasharon Mental Healtlh Center

Tel Aviv University

Institute of Physical Education and Sports Sciences

University of Haifa

Investigators

• Principal Investigator: Michal Rappaport, MD; Lev HaSharon Mental Health Center

More Information

Additional Information:

website of location of study 

Publications:

Erez O, Gordon CR, Sever J, Sadeh A, Mintz M. Balance dysfunction in childhood anxiety: findings and theoretical approach. J Anxiety Disord. 2004;18(3):341-56. doi: 10.1016/S0887-6185(02)00291-8.

Sklare DA, Konrad HR, Maser JD, Jacob RG. Special issue on the interface of balance disorders and anxiety: an introduction and overview. J Anxiety Disord. 2001 Jan-Apr;15(1-2):1-7. doi: 10.1016/s0887-6185(00)00039-6. No abstract available.

• Responsible Party: Michal Rappaport MD, Lev Hasharon Mental Health Center, Child and Adolescent Mental Health Clinic,
• ClinicalTrials.gov Identifier: NCT00599742
• Other Study ID Numbers: LH22/2007.CTIL; 920070174
• First Posted: January 24, 2008
• Last Update Posted: January 24, 2008
• Last Verified: January 2008

Keywords provided by Lev-Hasharon Mental Healtlh Center:

Balance disorder; Vestibular disorder; Generalized anxiety disorder; Separation anxiety disorder; Children; Balance training

Additional relevant MeSH terms:

Anxiety Disorders; Mental Disorders