NCT01595477

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
114

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2012

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 8, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 10, 2012

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
Last Updated

January 29, 2014

Status Verified

January 1, 2014

Enrollment Period

5 months

First QC Date

May 8, 2012

Last Update Submit

January 27, 2014

Conditions

Posttraumatic Stress Disorder

Outcome Measures

Primary Outcomes (3)

  • Child PTSD Symptom Scale

    Change from Baseline (Week 1) at 6 weeks

  • Child PTSD Symptom Scale

    Change from Week 6 at 18 weeks

  • Child PTSD Symptom Scale

    Change from Baseline (Week 1) at 18 weeks

Secondary Outcomes (6)

  • Children's Depression Inventory -2 Short Form

    Change from Baseline (Week 1) at 6 weeks

  • Children's Depression Inventory -2 Short Form

    Change from Week 6 at 18 weeks

  • Children's Depression Inventory -2 Short Form

    Change from Baseline (Week 1) at 18 weeks

  • Hopelessness Scale for Children

    Change from Baseline (Week 1) at 6 weeks

  • Hopelessness Scale for Children

    Change from Week 6 at 18 weeks

  • +1 more secondary outcomes

Study Arms (2)

Mind-Body Skills Groups

EXPERIMENTAL
Behavioral: Mind-Body Skills Group

Control Group

NO INTERVENTION

Interventions

Mind-Body Skills GroupBEHAVIORAL

Teaching mind-body skills such as meditation, biofeedback, guided imagery, and meditation in a group setting

Mind-Body Skills Groups

Eligibility Criteria

Age8 Months - 13 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • former psychosocial or medical treatment for mental health conditions
  • significant cognitive impairment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Center for Mind-Body Medicine

Gaza City, Palestine, Israel

Location

Related Links

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Study Officials

  • James S Gordon, MD

    The Center for Mind-Body Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Founder and Director

Study Record Dates

First Submitted

May 8, 2012

First Posted

May 10, 2012

Study Start

March 1, 2012

Primary Completion

August 1, 2012

Study Completion

August 1, 2012

Last Updated

January 29, 2014

Record last verified: 2014-01

Locations

IL(1)