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

Primary Purpose

Posttraumatic Stress Disorder

Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Mind-Body Skills Group
Sponsored by
The Center for Mind-Body Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Posttraumatic Stress Disorder

Eligibility Criteria

8 Months - 13 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The Center for Mind-Body Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Mind-Body Skills Groups

Control Group

Arm Description

Outcomes

Primary Outcome Measures

Child PTSD Symptom Scale
Child PTSD Symptom Scale
Child PTSD Symptom Scale

Secondary Outcome Measures

Children's Depression Inventory -2 Short Form
Children's Depression Inventory -2 Short Form
Children's Depression Inventory -2 Short Form
Hopelessness Scale for Children
Hopelessness Scale for Children
Hopelessness Scale for Children

Full Information

First Posted
May 8, 2012
Last Updated
January 27, 2014
Sponsor
The Center for Mind-Body Medicine
Collaborators
The Atlantic Philanthropies
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1. Study Identification

Unique Protocol Identification Number
NCT01595477
Brief Title
Mind-Body Skills Groups for the Treatment of War-Related Trauma in Children in Gaza
Official Title
A Randomized Controlled Study of Mind-Body Skills Groups for the Treatment of War-Related Trauma in Children in Gaza
Study Type
Interventional

2. Study Status

Record Verification Date
January 2014
Overall Recruitment Status
Completed
Study Start Date
March 2012 (undefined)
Primary Completion Date
August 2012 (Actual)
Study Completion Date
August 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Center for Mind-Body Medicine
Collaborators
The Atlantic Philanthropies

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Posttraumatic Stress Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
114 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mind-Body Skills Groups
Arm Type
Experimental
Arm Title
Control Group
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
Mind-Body Skills Group
Intervention Description
Teaching mind-body skills such as meditation, biofeedback, guided imagery, and meditation in a group setting
Primary Outcome Measure Information:
Title
Child PTSD Symptom Scale
Time Frame
Change from Baseline (Week 1) at 6 weeks
Title
Child PTSD Symptom Scale
Time Frame
Change from Week 6 at 18 weeks
Title
Child PTSD Symptom Scale
Time Frame
Change from Baseline (Week 1) at 18 weeks
Secondary Outcome Measure Information:
Title
Children's Depression Inventory -2 Short Form
Time Frame
Change from Baseline (Week 1) at 6 weeks
Title
Children's Depression Inventory -2 Short Form
Time Frame
Change from Week 6 at 18 weeks
Title
Children's Depression Inventory -2 Short Form
Time Frame
Change from Baseline (Week 1) at 18 weeks
Title
Hopelessness Scale for Children
Time Frame
Change from Baseline (Week 1) at 6 weeks
Title
Hopelessness Scale for Children
Time Frame
Change from Week 6 at 18 weeks
Title
Hopelessness Scale for Children
Time Frame
Change from Baseline (Week 1) at 18 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Months
Maximum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James S Gordon, MD
Organizational Affiliation
The Center for Mind-Body Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Center for Mind-Body Medicine
City
Gaza City
State/Province
Palestine
Country
Israel

12. IPD Sharing Statement

Links:
URL
http://www.cmbm.org
Description
The Center for Mind-Body Medicine website

Learn more about this trial

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

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