Posttraumatic Stress DisordersNCT02757339
Evaluating the Neurobiological Basis of Traumatic Dissociation in Women With Histories of Abuse and Neglect
An observational study of Posttraumatic Stress Disorders and Dissociative Identity Disorder, run by Mclean Hospital at 1 site in United States.
Trial summary
This study aims to evaluate the neurobiological basis of traumatic dissociation in a cross-diagnostic sample of women who have histories of childhood abuse and neglect. Read more about this study
- Who is it for?
- Ages 18 to 89 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Posttraumatic Stress Disorders, Dissociative Identity Disorder
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2015to Jun 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 89 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study will enroll up to 90 female patients with either DID or PTSD ages 18-89. We will also recruit up to 60 control subjects matched for demographics (age, race, gender).
Who may be able to join
- Female
- Clinical diagnosis of PTSD or DID and history of childhood abuse, or healthy controls
- Age between 18 and 89
- Legal and mental competency of the patient
Who cannot join
- Male
- Under 18 or over 89
- Legal or mental incompetence
- Delirium secondary to medical illness
- PTSD or DID due to general medical or neurological illness
- History of neurological conditions that may cause significant psychiatric symptomatology (e.g., dementia)
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- Any contraindication to MR scans, including claustrophobia, pregnancy, metal implants, etc.
- Current alcohol or substance dependence or abuse (within the last month)
- A history of schizophrenia or other psychotic disorder
- History of head injury or loss of consciousness for longer than 5 min (including concussion)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Evaluating the Neurobiological Basis of Traumatic Dissociation in a Cross-Diagnostic Sample of Women With Histories of Childhood Abuse and Neglect
This study aims to evaluate the neurobiological basis of traumatic dissociation in a cross-diagnostic sample of women who have histories of childhood abuse and neglect.
Read the detailed description
Dissociative symptoms commonly are associated with exposure to traumatic stress. Preliminary evidence from functional magnetic resonance imaging-based analysis (fMRI) of neural activation during dissociative symptom provocation in patients with PTSD or DID has implicated certain key structures involved in the generation of dissociative symptoms. Given the presumed region-to-region neural interplay implicit within this model, the investigators believe the use of intrinsic functional connectivity MRI (fcMRI) represents a valuable next line of investigation into the neurobiology of traumatic dissociation. The investigators also believe that a genetic approach holds promise as another converging line of inquiry into our understanding of traumatic dissociation.
To evaluate the neurobiological basis of traumatic dissociation, this study will recruit patients with PTSD or DID, and recruit matched controls to identify neurobiological correlates of traumatic dissociation.The study will compare the phenomenology of traumatic dissociation in patients with different PTSD subtypes and DID using standardized measures to look at the neurological and genetic correlates.
This study will also include a follow up visit that includes neuroimaging and genetic assessments.
- Keywords
- neurobiology, PTSD, DID
- Medical subject headings
- Stress Disorders, Post-Traumatic, Dissociative Identity Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Women with History of Childhood Abuse | The study will enroll up to 140 female patients with either DID or PTSD ages 18-89 | |
| Healthy Control Group | We will recruit up to 60 control subjects matched for demographics (age, race, gender). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline correlates of traumatic dissociation in Functional Magnetic Resonance Imaging at 36 to 56 weeks
Study participation will involve a baseline 60 minute cognitive assessment and a 60 minute Magnetic Resonance Imaging (MRI) at the 3 Tesla magnet in the McLean Hospital Imaging Center focusing on attention, emotion regulation, and symptoms of depersonalization. The first time point is baseline.The second time point will be 36-56 weeks after the baseline 60 minute Magnetic Resonance Imaging (MRI) scan at the 3 Tesla magnet in the McLean Hospital Imaging Center.
Measured: Baseline and 36 to 56 weeks after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2016 (estimated)
- Study startJun 2015
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Posttraumatic 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mclean Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Milissa Kaufman, Mclean Hospital
- Investigators
- Milissa L Kaufman, M.D./Ph.D, Principal investigator, Mclean Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02757339
- Sponsor's protocol ID
- 2014P001429
- Status last verified
- Jun 2026
- First submitted
- 17 Mar 2016
- Last updated
- 25 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Neurobiological Basis of Traumatic Dissociation in a Cross-Diagnostic Sample of Women With Histories of Childhood Abuse and Neglect
- ClinicalTrials.gov ID
- NCT02757339
- Acronym / sponsor ID
- 2014P001429
- Keywords
- neurobiology, PTSD, DID
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Mclean HospitalUniversity, hospital or other
- Study start
- Jun 2015 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 2 May 2016 (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.
This study aims to evaluate the neurobiological basis of traumatic dissociation in a cross-diagnostic sample of women who have histories of childhood abuse and neglect.
Detailed description
Dissociative symptoms commonly are associated with exposure to traumatic stress. Preliminary evidence from functional magnetic resonance imaging-based analysis (fMRI) of neural activation during dissociative symptom provocation in patients with PTSD or DID has implicated certain key structures involved in the generation of dissociative symptoms. Given the presumed region-to-region neural interplay implicit within this model, the investigators believe the use of intrinsic functional connectivity MRI (fcMRI) represents a valuable next line of investigation into the neurobiology of traumatic dissociation. The investigators also believe that a genetic approach holds promise as another converging line of inquiry into our understanding of traumatic dissociation.
To evaluate the neurobiological basis of traumatic dissociation, this study will recruit patients with PTSD or DID, and recruit matched controls to identify neurobiological correlates of traumatic dissociation.The study will compare the phenomenology of traumatic dissociation in patients with different PTSD subtypes and DID using standardized measures to look at the neurological and genetic correlates.
This study will also include a follow up visit that includes neuroimaging and genetic assessments.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Women with History of Childhood Abuse | – | –The study will enroll up to 140 female patients with either DID or PTSD ages 18-89 |
| Healthy Control Group | – | –We will recruit up to 60 control subjects matched for demographics (age, race, gender). |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study will enroll up to 90 female patients with either DID or PTSD ages 18-89. We will also recruit up to 60 control subjects matched for demographics (age, race, gender).
Key inclusion criteria (4 listed)
- Female
- Clinical diagnosis of PTSD or DID and history of childhood abuse, or healthy controls
- Age between 18 and 89
- Legal and mental competency of the patient
Key exclusion criteria (10 listed)
- Male
- Under 18 or over 89
- Legal or mental incompetence
- Delirium secondary to medical illness
- PTSD or DID due to general medical or neurological illness
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change from Baseline correlates of traumatic dissociation in Functional Magnetic Resonance Imaging at 36 to 56 weeks
Time frame: Baseline and 36 to 56 weeks after baseline
Study participation will involve a baseline 60 minute cognitive assessment and a 60 minute Magnetic Resonance Imaging (MRI) at the 3 Tesla magnet in the McLean Hospital Imaging Center focusing on attention, emotion regulation, and symptoms of depersonalization. The first time point is baseline.The second time point will be 36-56 weeks after the baseline 60 minute Magnetic Resonance Imaging (MRI) scan at the 3 Tesla magnet in the McLean Hospital Imaging Center.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2026.
- Individual participant dataSharing planned: Undecided
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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.
Milissa L Kaufman, M.D./Ph.D principal investigator
Mclean Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Posttraumatic Stress Disorders and Dissociative Identity Disorder, run by Mclean Hospital 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 4 inclusion and 10 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: enrolling by invitation, as of the sponsor's last update on 25 Jun 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
Change from Baseline correlates of traumatic dissociation in Functional Magnetic Resonance Imaging at 36 to 56 weeks (time frame: Baseline and 36 to 56 weeks after baseline). 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 25 Jun 2026.