Stress DisordersNCT00374738
Effects of an Alternative Treatment for Military Sexual Trauma on PTSD Symptoms, Neurosteroids and Brain Function
A study testing Guided Imagery for Trauma (GIFT) in people with Stress Disorders, run by Samueli Institute for Information Biology at 1 site in United States.
Trial summary
Our specific aims are: 1. To examine the efficacy of GIFT in improving MST-related clinical outcomes in women veterans 2. To examine the effects of GIFT on fronto-limbic brain function and 3. To examine the effects of GIFT on levels of neuroactive steroid associated with PTSD. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Stress Disorders
- What is being tested?
- Guided Imagery for Trauma (GIFT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2006to Sep 2008
- 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 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18-65
- Status as a woman veteran
- Receives care at the Durham VAMC
- History of MST
- DSM-IV diagnosis of PTSD, confirmed by CAPS interview
- Able to participate in a research interview in English
- Regular telephone access
Who cannot join
- Current diagnosis of organic or psychotic mental disorder
- Suicidality or parasuicidality
- Ongoing family violence
- Alcohol or drug dependence within previous 3 months
- Enrolled in cognitive-behavioral/exposure-based therapy during study period.
- Supportive therapy and psychiatric medications (if stabilized at least 3 months prior to enrollment) are acceptable.
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- An uncontrolled medical condition
- Foreign metallic objects or implanted devices in the body incompatible with MRI
- Positive pregnancy test as determined by serum ß-HCG level
- Claustrophobia
- CNS neoplasms or neurological conditions such as Parkinson's Disease, Huntington's Chorea, demyelinating diseases, seizures, hydrocephalus, etc.
Trial locations and contacts
1 site in 1 country.
United States1 site
Women Veterans' Comprehensive Health Center (WVCHC) @ Durham Veterans Affairs Medical Center (DVAMC)
Durham, North Carolina, 27705
About this study
Our specific aims are:
- To examine the efficacy of GIFT in improving MST-related clinical outcomes in women veterans
- To examine the effects of GIFT on fronto-limbic brain function and
- To examine the effects of GIFT on levels of neuroactive steroid associated with PTSD.
Read the detailed description
Guided imagery is a complementary and alternative treatment (CAM) modality. This directed meditation technique uses healing imagery to promote recovery in a variety of illnesses, including cancer, heart disease and, more recently, posttraumatic stress disorder (PTSD). PTSD is a severe and disabling anxiety disorder. It is among the most common mental disorders, affecting 10% of women in the United States during their lifetime. Sexual assault is the most common cause of PTSD. Similarly, military sexual trauma (MST) is disturbingly common among women in the armed forces. At least 20% of women veterans using VA services report a history of sexual assault. Unfortunately, high rates of MST-related PTSD are anticipated among women currently deployed to Iraq and Afghanistan.
To address this issue, we will evaluate a guided imagery intervention for women veterans who have MST-related PTSD. We will evaluate the efficacy of Guided Imagery for Trauma (GIFT) in decreasing PTSD symptoms. Using brain-imaging techniques, this research will examine the effects of GIFT on brain function in the areas associated with PTSD. We will also examine the effects of GIFT on neurosteroids, which are candidate modulators of PTSD symptoms, and may also represent novel targets for therapeutic intervention.
- Conditions
- Stress Disorders
- Being tested
- Guided Imagery for Trauma (GIFT)
- Keywords
- Guided Imagery for Trauma (GIFT), Posttraumatic Stress Disorder (PTSD), Military Sexual Trauma (MST), Military Sexual Trauma - related PTSD
- Medical subject headings
- Stress Disorders, Traumatic, Stress Disorders, Post-Traumatic, Military Sexual Trauma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Guided Imagery for Trauma (GIFT)Behavioural
Guided Imagery for Trauma (GIFT) - music and voice narration over a 12-week intervention. The control intervention included a relaxing music audio (the same music used in the guided imagery audio but without the narrative voiceover), PDA to log audio use, orientation and weekly phone consults, but did not have access to the patient advocate or to the guided imagery instructions provided on the GIFT audio.
| Study group | Role | What they receive |
|---|---|---|
| GIFT Intervention | Experimental | Guided Imagery for Trauma (GIFT) Receives: Behavioral: Guided Imagery for Trauma (GIFT) |
| Music Control | No intervention | Relaxing Music Audio control; same music used in guided imagery, with no narrative voice. |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2006 (estimated)
- Study startNov 2006
- Primary completionSep 2008
- Study completionSep 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress DisordersStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samueli Institute for Information Biology
- Sponsor type
- University, hospital or other
- Collaborators
- Duke University, Durham VA Medical Center
- Responsible party
- Sponsor
- Investigators
- Jennifer L. Strauss, PhD, Principal investigator, Duke University Medical Center & Durham VA Medical CenterChristine Marx, MD, MA, Principal investigator, Duke University Medical Center & Durham VA Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00374738
- Sponsor's protocol ID
- NC181BO-1 (IRB #01012)
- Other IDs
- DUHS Protocol No. 5023-05-10R2
- Status last verified
- May 2016
- First submitted
- 7 Sep 2006
- Last updated
- 12 May 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: Study terminated/inactive.
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of an Alternative Treatment for Military Sexual Trauma on PTSD Symptoms, Neurosteroids and Brain Function
- ClinicalTrials.gov ID
- NCT00374738
- Acronym / sponsor ID
- NC181BO-1 (IRB #01012)
- Conditions
- Stress Disorders
- Keywords
- Guided Imagery for Trauma (GIFT), Posttraumatic Stress Disorder (PTSD), Military Sexual Trauma (MST), Military Sexual Trauma - related PTSD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Samueli Institute for Information BiologyUniversity, hospital or other
- Collaborators
- Duke University, Durham VA Medical Center
- Study start
- Nov 2006
- Primary completion
- Sep 2008 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 11 Sep 2006 (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.
Our specific aims are:
- To examine the efficacy of GIFT in improving MST-related clinical outcomes in women veterans
- To examine the effects of GIFT on fronto-limbic brain function and
- To examine the effects of GIFT on levels of neuroactive steroid associated with PTSD.
Detailed description
Guided imagery is a complementary and alternative treatment (CAM) modality. This directed meditation technique uses healing imagery to promote recovery in a variety of illnesses, including cancer, heart disease and, more recently, posttraumatic stress disorder (PTSD). PTSD is a severe and disabling anxiety disorder. It is among the most common mental disorders, affecting 10% of women in the United States during their lifetime. Sexual assault is the most common cause of PTSD. Similarly, military sexual trauma (MST) is disturbingly common among women in the armed forces. At least 20% of women veterans using VA services report a history of sexual assault. Unfortunately, high rates of MST-related PTSD are anticipated among women currently deployed to Iraq and Afghanistan.
To address this issue, we will evaluate a guided imagery intervention for women veterans who have MST-related PTSD. We will evaluate the efficacy of Guided Imagery for Trauma (GIFT) in decreasing PTSD symptoms. Using brain-imaging techniques, this research will examine the effects of GIFT on brain function in the areas associated with PTSD. We will also examine the effects of GIFT on neurosteroids, which are candidate modulators of PTSD symptoms, and may also represent novel targets for therapeutic intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GIFT Intervention | Experimental | Behavioral: Guided Imagery for Trauma (GIFT)Guided Imagery for Trauma (GIFT) |
| Music Control | No intervention | –Relaxing Music Audio control; same music used in guided imagery, with no narrative voice. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Aged 18-65
- Status as a woman veteran
- Receives care at the Durham VAMC
- History of MST
- DSM-IV diagnosis of PTSD, confirmed by CAPS interview
Key exclusion criteria (11 listed)
- Current diagnosis of organic or psychotic mental disorder
- Suicidality or parasuicidality
- Ongoing family violence
- Alcohol or drug dependence within previous 3 months
- Enrolled in cognitive-behavioral/exposure-based therapy during study period.
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 |
|---|---|---|
| Guided Imagery for Trauma (GIFT)Guided Imagery for Trauma (GIFT) - music and voice narration over a 12-week intervention. The control intervention included a relaxing music audio (the same music used in the guided imagery audio but without the narrative voiceover), PDA to log audio use, orientation and weekly phone consults, but did not have access to the patient advocate or to the guided imagery instructions provided on the GIFT audio. | Behavioural | GIFT Intervention |
Primary outcome
Not reported in the source record.
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 12 May 2016.
- Individual participant dataSharing planned: No. Study terminated/inactive.
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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.
Jennifer L. Strauss, PhD principal investigator
Duke University Medical Center & Durham VA Medical Center
Christine Marx, MD, MA principal investigator
Duke University Medical Center & Durham VA Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Guided Imagery for Trauma (GIFT) in people with Stress Disorders, run by Samueli Institute for Information Biology 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 7 inclusion and 11 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 12 May 2016. 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.
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 12 May 2016.