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Completed

NCT Number: NCT01595477

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

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.

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Key information

Conditions

Posttraumatic Stress Disorder Mental Disorders Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma and Stressor Related Disorders

Age range

8 month–13 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Center for Mind-Body Medicine

Gaza City, Palestine, Israel

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mind-Body Skills Group

Behavioral

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

Primary outcomes

  1. Child PTSD Symptom Scale

    Time frame: Change from Baseline (Week 1) at 6 weeks

  2. Child PTSD Symptom Scale

    Time frame: Change from Week 6 at 18 weeks

  3. Child PTSD Symptom Scale

    Time frame: Change from Baseline (Week 1) at 18 weeks

Secondary outcomes

  1. Children's Depression Inventory -2 Short Form

    Time frame: Change from Baseline (Week 1) at 6 weeks

  2. Children's Depression Inventory -2 Short Form

    Time frame: Change from Week 6 at 18 weeks

  3. Children's Depression Inventory -2 Short Form

    Time frame: Change from Baseline (Week 1) at 18 weeks

  4. Hopelessness Scale for Children

    Time frame: Change from Baseline (Week 1) at 6 weeks

  5. Hopelessness Scale for Children

    Time frame: Change from Week 6 at 18 weeks

  6. Hopelessness Scale for Children

    Time frame: Change from Baseline (Week 1) at 18 weeks

Sponsors and collaborators

Lead sponsor

The Center for Mind-Body Medicine

Other

Collaborators

  • The Atlantic Philanthropies

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
May 10, 2012
Registry last updated
Jan 29, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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