Stress Disorders, Post TraumaticNCT01093053
Mind-Body Skills Groups for the Treatment of War Zone Stress in Military and Veteran Populations
A study testing Mind-Body Skills Groups and Standard Treatment in people with Stress Disorders, Post Traumatic and Brain Injuries, run by The Center for Mind-Body Medicine at 1 site in United States.
Trial summary
The purpose of this study is to determine whether participation in mind-body skills groups by veterans who have experienced a stressful war-related situation and have symptoms of posttraumatic stress disorder (PTSD), will improve symptoms of PTSD, depression and anxiety, reduce anger, improve quality of life, quality… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stress Disorders, Post Traumatic, Brain Injuries, Depressive Disorder
- What is being tested?
- Mind-Body Skills Groups and Standard Treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2010to Sep 2013
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- having experienced a deployment-related criterion A stressor and reporting post deployment stress symptoms which include: clinically diagnosed posttraumatic stress disorder (PTSD), or subthreshold PTSD symptoms
- comorbid conditions may also include mild traumatic brain injury, or clinically significant levels of depression or anxiety.
Who cannot join
- current uncontrolled psychotic or bipolar disorder
- significant cognitive impairment
- moderate or severe TBI
- substance dependence
- suicidal or homicidal ideation
Trial locations and contacts
1 site in 1 country.
United States1 site
Southeast Louisiana Veterans Healthcare System
New Orleans, Louisiana, 70112
About this study
Official title: A Randomized Controlled Study of Mind-Body Skills Groups for Treatment of War Zone Stress in Military and Veteran Populations
The purpose of this study is to determine whether participation in mind-body skills groups by veterans who have experienced a stressful war-related situation and have symptoms of posttraumatic stress disorder (PTSD), will improve symptoms of PTSD, depression and anxiety, reduce anger, improve quality of life, quality of sleep and result in posttraumatic growth (a positive change that people can experience when they have been in a traumatic situation).
Read the detailed description
The study will be a randomized controlled study where participants will be randomly selected to either participate in the mind-body skills program and to answer questionnaires before and after the program and again 6 months later or, if they are not randomized to the mind-body skills group program, they will answer the questionnaires during the same time periods without participating in the program. Both groups will also continue their medical treatment as usual. The mind-body skills group intervention consists of groups of 8-10 participants. Two formats will be offered. (1) A 2 hour group session once a week for 10 weeks or (2) Weekend groups which will be run on alternating Saturdays, with a 2 hour session in the morning and another 2 hour session in the afternoon. The groups will be run for a total of 5 Saturday sessions. Additional "reunion" groups will be held at 1 month, 3 months, and 6 months in order to reinforce skills and to provide continuing social support.
- Conditions
- Stress Disorders, Post Traumatic, Brain Injuries, Depressive Disorder, Anxiety Disorders, Anger
- Being tested
- Mind-Body Skills Groups, Standard Treatment
- Keywords
- Mind-Body Therapies
- Medical subject headings
- Combat Disorders, Brain Injuries, Depressive Disorder, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mind-Body Skills GroupsBehavioural
The mind-body skills group program teaches participants how to do meditation, guided imagery, breathing techniques, and biofeedback. These mind-body techniques are taught and practiced in small groups of 8 to 10 people and also contain an element of social support.
Standard TreatmentOther
May include individual or group psychotherapy consisting of cognitive behavioral therapy or present-centered (i.e. unrelated to mindfulness) psychotherapy as well as medication management. Medications for depression, anxiety, and sleep disorders are the most commonly used in standard treatment.
| Study group | Role | What they receive |
|---|---|---|
| Mind-Body Skills Groups | Experimental | Not described Receives: Behavioral: Mind-Body Skills Groups |
| Standard Treatment | Active comparator | Not described Receives: Other: Standard Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
PTSD checklist - military version
The PTSD checklist contains 17 items corresponding to the DSM-IV criteria for PTSD. Past month symptom severity is indicated using a 5 point scale.
Measured: Baseline; 12 weeks; 20 weeks
Secondary outcomes (7)
State-Trait Anger Expression Inventory-2
This is a 57 item consisting of a 4 point scale that measures the intensity of anger as an emotional state at a particular time (State Anger) and how often angry feelings are experienced over time as a personality trait (Trait Anger). There are 4 additional subscales which measure the outward expression of anger (Anger Expression-Out), holding or suppressing angry feelings (Anger Expression-In); controlling angry feelings by preventing the outward expression of anger (Anger Control-Out); and controlling anger feeling by calming down (Anger Control-In)
Measured: Baseline;12 weeks; 20 weeks
The Pittsburgh Sleep Quality Index
This 9 item questionnaire using a 4 point scale measures seven areas of sleep: subjective sleep quality, sleep latency, sleep duration, habitual seep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction.
Measured: Baseline;12 weeks; 20 weeks
The Patient Health Questionnaire-9
The Patient Health Questionnaire-9 is a 9 item self-report measure and is a widely used screening tool for depression.
Measured: Baseline;12 weeks; 20 weeks
State-Trait Anxiety Inventory
The State anxiety subscale will be used. It has 20 questions and uses a 4 point scale.
Measured: Baseline; 12 weeks; 20 weeks
The Posttraumatic Growth Inventory
The Posttraumatic Growth Inventory measures positive change that people can experience when they have been in a traumatic situation. It is a 21 item self report scale that includes five subscales: relating to others, new possibilities, personal strength, spiritual challenge, and appreciation of life.
Measured: Baseline;12 weeks; 20 weeks
The Medical Outcomes Study Short Form SF-36
The SF-36 has 36 questions and measures functional status in eight dimensions: physical functioning, social functioning, role functioning-physical, role functioning-emotional, vitality, mental health, bodily pain, and general health perception.
Measured: Baseline; 12 weeks; 20 weeks
The Inventory of Functional Impairment
The Inventory of Functional Impairment is an 87-item self-report measure designed to assess multiple dimensions of functional impairment experienced by active duty service members and veterans.
Measured: Baseline;12 weeks; 20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2010 (estimated)
- Study startSep 2010
- Primary completionSep 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress Disorders, Post TraumaticStudies 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
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Center for Mind-Body Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- U.S. Army Medical Research and Development Command, Southeast Louisiana Veterans Health Care System
- 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
- NCT01093053
- Sponsor's protocol ID
- 08144040
- Status last verified
- Jan 2014
- First submitted
- 24 Mar 2010
- 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 Treatment of War Zone Stress in Military and Veteran Populations
- ClinicalTrials.gov ID
- NCT01093053
- Acronym / sponsor ID
- 08144040
- Conditions
- Stress Disorders, Post Traumatic, Brain Injuries, Depressive Disorder, Anxiety Disorders, Anger
- Keywords
- Mind-Body Therapies
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- The Center for Mind-Body MedicineUniversity, hospital or other
- Collaborators
- U.S. Army Medical Research and Development Command, Southeast Louisiana Veterans Health Care System
- Study start
- Sep 2010
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 25 Mar 2010 (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 purpose of this study is to determine whether participation in mind-body skills groups by veterans who have experienced a stressful war-related situation and have symptoms of posttraumatic stress disorder (PTSD), will improve symptoms of PTSD, depression and anxiety, reduce anger, improve quality of life, quality of sleep and result in posttraumatic growth (a positive change that people can experience when they have been in a traumatic situation).
Detailed description
The study will be a randomized controlled study where participants will be randomly selected to either participate in the mind-body skills program and to answer questionnaires before and after the program and again 6 months later or, if they are not randomized to the mind-body skills group program, they will answer the questionnaires during the same time periods without participating in the program. Both groups will also continue their medical treatment as usual. The mind-body skills group intervention consists of groups of 8-10 participants. Two formats will be offered. (1) A 2 hour group session once a week for 10 weeks or (2) Weekend groups which will be run on alternating Saturdays, with a 2 hour session in the morning and another 2 hour session in the afternoon. The groups will be run for a total of 5 Saturday sessions. Additional "reunion" groups will be held at 1 month, 3 months, and 6 months in order to reinforce skills and to provide continuing social support.
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 |
| Standard Treatment | Active comparator | Other: Standard Treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- having experienced a deployment-related criterion A stressor and reporting post deployment stress symptoms which include: clinically diagnosed posttraumatic stress disorder (PTSD), or subthreshold PTSD symptoms
- comorbid conditions may also include mild traumatic brain injury, or clinically significant levels of depression or anxiety.
Key exclusion criteria (5 listed)
- current uncontrolled psychotic or bipolar disorder
- significant cognitive impairment
- moderate or severe TBI
- substance dependence
- suicidal or homicidal ideation
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 GroupsThe mind-body skills group program teaches participants how to do meditation, guided imagery, breathing techniques, and biofeedback. These mind-body techniques are taught and practiced in small groups of 8 to 10 people and also contain an element of social support. | Behavioural | Mind-Body Skills Groups |
| Standard TreatmentMay include individual or group psychotherapy consisting of cognitive behavioral therapy or present-centered (i.e. unrelated to mindfulness) psychotherapy as well as medication management. Medications for depression, anxiety, and sleep disorders are the most commonly used in standard treatment. | Other | Standard Treatment |
Primary outcome
PTSD checklist - military version
Time frame: Baseline; 12 weeks; 20 weeks
The PTSD checklist contains 17 items corresponding to the DSM-IV criteria for PTSD. Past month symptom severity is indicated using a 5 point scale.
7 secondary outcomes
State-Trait Anger Expression Inventory-2
Time frame: Baseline;12 weeks; 20 weeks
The Pittsburgh Sleep Quality Index
Time frame: Baseline;12 weeks; 20 weeks
The Patient Health Questionnaire-9
Time frame: Baseline;12 weeks; 20 weeks
State-Trait Anxiety Inventory
Time frame: Baseline; 12 weeks; 20 weeks
The Posttraumatic Growth Inventory
Time frame: Baseline;12 weeks; 20 weeks
The Medical Outcomes Study Short Form SF-36
Time frame: Baseline; 12 weeks; 20 weeks
The Inventory of Functional Impairment
Time frame: Baseline;12 weeks; 20 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.
Related trials for Stress Disorders, Post Traumatic
Recruiting
NightWare and Cardiovascular Health in Women With PTSD
Post Traumatic Stress Disorder, Cardiovascular Diseases
Not yet recruiting
A Transdiagnostic Sleep Health Intervention for Veterans With PTSD
Stress Disorders, Post-Traumatic, Sleep Initiation and Maintenance Disorders
Not yet recruitingPhase 3
Women Who Are Victims of Violence: Treatment of PTSD Through Reactivation of Traumatic Memories Using Propranolol
Post-Traumatic Stress Disorder, PTSD
RecruitingPhase 4
The Effects of Orexin Antagonism on Fear Extinction in PTSD
Insomnia, PTSD
Recruiting
Advancing Skills Through Consultation, Education, and Novel Technologies
PTSD - Post Traumatic Stress Disorder
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 and Standard Treatment in people with Stress Disorders, Post Traumatic and Brain Injuries, run by The Center for Mind-Body Medicine at 1 site in United States.
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 5 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 United States. 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 - military version (time frame: Baseline; 12 weeks; 20 weeks). 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.