Brief Summary

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

Trial Health

On Track

Trial Health Score

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

Enrollment

148

participants targeted

Target at 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

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Study Timeline

Key milestones and dates

7 months study duration

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

5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2012

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2012

Completed

Last Updated

January 29, 2014

Status Verified

January 1, 2014

Enrollment Period

7 months

First QC Date

May 8, 2012

Last Update Submit

January 27, 2014

Conditions

Posttraumatic Stress Disorder

Outcome Measures

Primary Outcomes (3)

PTSD Checklist-Civilian Version
Change from Baseline (Week 1) at 11 weeks
PTSD Checklist-Civilian Version
Change from Week 11 at 23 weeks
PTSD Checklist-Civilian Version
Change from Baseline (Week1) at 23 Weeks

Secondary Outcomes (6)

Center for Epidemiological Studies Depression Scale (CES-D)
Change from Baseline (Week 1) at 11 weeks
Center for Epidemiological Studies Depression Scale (CES-D)
Change from Week 11 at 23 weeks
Center for Epidemiological Studies Depression Scale (CES-D)
Change from Baseline (Week1) at 23 Weeks
Posttraumatic Growth Inventory
Change from Baseline (Week 1) at 11 weeks
Posttraumatic Growth Inventory
Change from Week 11 at 23 weeks
+1 more secondary outcomes

Study Arms (2)