Posttraumatic Stress DisorderNCT01595464
Mind-Body Skills Groups for the Treatment of War-Related Trauma in Adults in Gaza
A study testing Mind-Body Skills Groups in people with Posttraumatic Stress Disorder, run by The Center for Mind-Body Medicine at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Posttraumatic Stress Disorder
- What is being tested?
- Mind-Body Skills Groups
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 148 participants
- Where
- 1 siteIsrael
- Study dates
- Mar 2012to Oct 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 PTSD Checklist- Civilian version
Who cannot join
- former psychosocial or medical treatment for mental health conditions
- significant cognitive impairment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Controlled Study of Mind-Body Skills Groups for the Treatment of War-Related Trauma in Adults in Gaza
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.
- Conditions
- Posttraumatic Stress Disorder
- Being tested
- Mind-Body Skills Groups
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mind-Body Skills GroupsBehavioural
Teaching mind-body skills such as meditation, biofeedback, guided imagery, and meditation in a group setting
| Study group | Role | What they receive |
|---|---|---|
| Mind-Body Skills Groups | Experimental | Not described Receives: Behavioral: Mind-Body Skills Groups |
| Control Group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
PTSD Checklist-Civilian Version
Measured: Change from Baseline (Week 1) at 11 weeks
PTSD Checklist-Civilian Version
Measured: Change from Week 11 at 23 weeks
PTSD Checklist-Civilian Version
Measured: Change from Baseline (Week1) at 23 Weeks
Secondary outcomes (6)
Center for Epidemiological Studies Depression Scale (CES-D)
Measured: Change from Baseline (Week 1) at 11 weeks
Center for Epidemiological Studies Depression Scale (CES-D)
Measured: Change from Week 11 at 23 weeks
Center for Epidemiological Studies Depression Scale (CES-D)
Measured: Change from Baseline (Week1) at 23 Weeks
Posttraumatic Growth Inventory
Measured: Change from Baseline (Week 1) at 11 weeks
Posttraumatic Growth Inventory
Measured: Change from Week 11 at 23 weeks
Posttraumatic Growth Inventory
Measured: Change from Baseline (Week1) at 23 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2012 (estimated)
- Study startMar 2012
- Primary completionOct 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Posttraumatic Stress DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 148 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Center for Mind-Body Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- The Atlantic Philanthropies
- Responsible party
- Principal investigator, James S. Gordon, M.D., The Center for Mind-Body Medicine
- Investigators
- James S Gordon, MD, Principal investigator, The Center for Mind-Body Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01595464
- Sponsor's protocol ID
- GA-CMBM-001
- Status last verified
- Jan 2014
- First submitted
- 8 May 2012
- Last updated
- 29 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Study of Mind-Body Skills Groups for the Treatment of War-Related Trauma in Adults in Gaza
- ClinicalTrials.gov ID
- NCT01595464
- Acronym / sponsor ID
- GA-CMBM-001
- Conditions
- Posttraumatic Stress Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 148 participants (actual)
- Lead sponsor
- The Center for Mind-Body MedicineUniversity, hospital or other
- Collaborators
- The Atlantic Philanthropies
- Study start
- Mar 2012
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 10 May 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mind-Body Skills Groups | Experimental | Behavioral: Mind-Body Skills Groups |
| Control Group | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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 PTSD Checklist- Civilian version
Key exclusion criteria (2 listed)
- former psychosocial or medical treatment for mental health conditions
- significant cognitive impairment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mind-Body Skills GroupsTeaching mind-body skills such as meditation, biofeedback, guided imagery, and meditation in a group setting | Behavioural | Mind-Body Skills Groups |
Primary outcome
PTSD Checklist-Civilian Version
Time frame: Change from Baseline (Week 1) at 11 weeks
PTSD Checklist-Civilian Version
Time frame: Change from Week 11 at 23 weeks
PTSD Checklist-Civilian Version
Time frame: Change from Baseline (Week1) at 23 Weeks
6 secondary outcomes
Center for Epidemiological Studies Depression Scale (CES-D)
Time frame: Change from Baseline (Week 1) at 11 weeks
Center for Epidemiological Studies Depression Scale (CES-D)
Time frame: Change from Week 11 at 23 weeks
Center for Epidemiological Studies Depression Scale (CES-D)
Time frame: Change from Baseline (Week1) at 23 Weeks
Posttraumatic Growth Inventory
Time frame: Change from Baseline (Week 1) at 11 weeks
Posttraumatic Growth Inventory
Time frame: Change from Week 11 at 23 weeks
Posttraumatic Growth Inventory
Time frame: Change from Baseline (Week1) at 23 Weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2014.
- The Center for Mind-Body Medicine websiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James S Gordon, MD principal investigator
The Center for Mind-Body Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mind-Body Skills Groups in people with Posttraumatic Stress Disorder, run by The Center for Mind-Body Medicine at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PTSD Checklist-Civilian Version (time frame: Change from Baseline (Week 1) at 11 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2014.