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NCT01595477 Clinical Trial

Mind-Body Skills Groups for the Treatment of War-Related Trauma in Children in Gaza

Posttraumatic Stress Disorder Clinical Trial

Official title:
A Randomized Controlled Study of Mind-Body Skills Groups for the Treatment of War-Related Trauma in Children in Gaza

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01595477
Other study ID # GC-CMBM-001
Secondary ID
Status Completed
Phase N/A
First received May 8, 2012
Last updated January 27, 2014
Start date March 2012
Est. completion date August 2012

Study information
Verified date January 2014
Source The Center for Mind-Body Medicine
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

The objective of this study is to determine whether participation in a mind-body skills program by war-traumatized children in Gaza will result in improvement of posttraumatic stress symptoms, depression, and decreased hopelessness compared to a control group.

Recruitment information / eligibility
Status Completed
Enrollment 114
Est. completion date August 2012
Est. primary completion date August 2012
Accepts healthy volunteers No
Gender Both
Age group 8 Months to 13 Years
Eligibility Inclusion Criteria:

- having experienced a political violence or war-related criterion A stressor

- meeting the American Psychiatric Association (DSM-IV-TR) criteria for PTSD according to screening scores on the Child PTSD Symptom Scale

Exclusion Criteria:

- former psychosocial or medical treatment for mental health conditions

- significant cognitive impairment

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Behavioral:
• Mind-Body Skills Group
Teaching mind-body skills such as meditation, biofeedback, guided imagery, and meditation in a group setting

Locations
Country Name City State
Israel The Center for Mind-Body Medicine Gaza City Palestine

Sponsors (2)
Lead Sponsor Collaborator
The Center for Mind-Body Medicine The Atlantic Philanthropies

Country where clinical trial is conducted

Israel, 

Outcome
Type Measure Description Time frame Safety issue
Primary Child PTSD Symptom Scale Change from Baseline (Week 1) at 6 weeks No
Primary Child PTSD Symptom Scale Change from Week 6 at 18 weeks No
Primary Child PTSD Symptom Scale Change from Baseline (Week 1) at 18 weeks No
Secondary Children's Depression Inventory -2 Short Form Change from Baseline (Week 1) at 6 weeks No
Secondary Children's Depression Inventory -2 Short Form Change from Week 6 at 18 weeks No
Secondary Children's Depression Inventory -2 Short Form Change from Baseline (Week 1) at 18 weeks No
Secondary Hopelessness Scale for Children Change from Baseline (Week 1) at 6 weeks No
Secondary Hopelessness Scale for Children Change from Week 6 at 18 weeks No
Secondary Hopelessness Scale for Children Change from Baseline (Week 1) at 18 weeks No
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