Comorbidity Between Balance and Childhood Anxiety

NCT ID: NCT00599742

Last Updated: 2008-01-24

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-12-31
• Study Completion Date: 2010-12-31

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.

Conditions

Anxiety

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

A

Balance training group

Group Type: ACTIVE_COMPARATOR

Balance training

Intervention Type: BEHAVIORAL

Physical exercise of balance. The training will last 7 weeks, twice per week, 1 hour per session.

B

Motor Training

Group Type: ACTIVE_COMPARATOR

Motor training

Intervention Type: BEHAVIORAL

Motor exercise of power and flexibility. The training will last 7 weeks, twice per week, 1 hour per session.

Interventions

Balance training

Physical exercise of balance. The training will last 7 weeks, twice per week, 1 hour per session.

Intervention Type: BEHAVIORAL

Motor training

Motor exercise of power and flexibility. The training will last 7 weeks, twice per week, 1 hour per session.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 14 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tel Aviv University

OTHER

Sponsor Role: collaborator

Institute of Physical Education and Sports Sciences

OTHER

Sponsor Role: collaborator

University of Haifa

OTHER

Sponsor Role: collaborator

Lev-Hasharon Mental Healtlh Center

OTHER_GOV

Sponsor Role: lead

Responsible Party

Lev Hasharon Mental Health Center, Child and Adolescent Mental Health Clinic,

Principal Investigators

Michal Rappaport, MD

Role: PRINCIPAL_INVESTIGATOR

Lev HaSharon Mental Health Center

Locations

Child and Adolescent Mental Health Clinic, Lev Hasharon MHC

Netanya, , Israel

Site Status: RECRUITING

Wingate Institute for Physical Education

Netanya, , Israel

Site Status: RECRUITING

Countries

Israel

Facility Contacts

Michal Rappaport, MD

Role: primary

michalra@lev-hasharon.co.il

+972-9-833-4466

Roni Lidor, PhD

Role: primary

lidor@wincol.ac.il

+972-9-863-9247

References

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.

Reference Type: BACKGROUND

PMID: 15125981 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 11388353 (View on PubMed)

Related Links

http://www.lev-hasharon.co.il

website of location of study

Other Identifiers

920070174

Identifier Type: -

Identifier Source: secondary_id

LH22/2007.CTIL

Identifier Type: -

Identifier Source: org_study_id