Clinical trial NCT00599742: Comorbidity Between Balance and Childhood Anxiety
Official title: Comorbidity Between Balance and Childhood Anxiety: Treatment of Anxiety by Training of Balance
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Anxiety
Keywords: Balance disorder
Vestibular disorder
Generalized anxiety disorder
Separation anxiety disorder
Children
Balance training
Lead sponsor: Lev-Hasharon Mental Healtlh Center
Sponsor class: OTHER_GOV
Collaborators: name: Tel Aviv University
name: Institute of Physical Education and Sports Sciences
name: University of Haifa
First posted: 2008-01-24
Enrollment: 64
Sex: ALL
Minimum age (years): 8
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

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.

Eligibility 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

Primary outcomes:
measure: Balance improvement and anxiety reduction
timeFrame: After 7 weeks of training
Secondary outcomes:
Other outcomes:
Locations:
city: Netanya
country: Israel
facility: Child and Adolescent Mental Health Clinic, Lev Hasharon MHC
city: Netanya
country: Israel
facility: Wingate Institute for Physical Education
Study officials:
affiliation: Lev HaSharon Mental Health Center
name: Michal Rappaport, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.