Women's Post Traumatic Stress Disorder (PTSD) Research Study
Study Details
Study Description
Brief Summary
The purpose of this study is to examine the relationship between trauma and startle. The investigators are also looking at the effect of menstrual phase on this relationship.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
|
Detailed Description
The investigators are trying to understand if there is a relationship between the experience of traumatic events such as those experienced by people with post traumatic stress disorder and reactivity to startling noises or mild threats. So, the investigators are looking at startle reflex, heart rate, and stress hormone responses to short noises and small shocks in people exposed to trauma and who either do or do not have PTSD. Additionally, the investigators will be looking at how the menstrual cycle impacts these processes. The investigators know that women have twice the risk for developing PTSD and some research suggests that stress hormones change during the menstrual cycle and may have an effect on risk.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| PTSD group Individuals in this group meet criteria for PTSD as defined by DSM-IV |
|
| trauma control group individuals in this group do not meet criteria for any Axis I diagnosis as defined by DSM-IV |
Outcome Measures
Primary Outcome Measures
- Prepulse Inhibition [This measure was assessed twice for each participant, once in the midluteal phase of the menstrual cycle and once in the early follicular phase of the menstrual cycle, up to approximately 20 days apart.]
To calculate prepulse inhibition (PPI), first an O-EMG response score (O-EMG-R) for each trial was calculated. O-EMGR was measured in microvolts and each value was subjected to a square root transformation. For each participant, the mean O-EMG-R scores were calculated for both startle alone and prepulse + startle trials across the entire session. PPI is a ratio and was calculated by the formula below: PPI=(mean OEMG-R score on prepulse+startle trials-mean OEMG-R on Startle alone trials)/mean OEMG-R on startle alone trials. A negative value on this PPI ratio is indicative of greater prepulse inhibition. Means and SEs below reflect estimated means and SEs for the PTSD group and trauma control group from the ANOVA conducted with menstrual phase and the PTSD group X menstrual phase interaction included in the model.
Eligibility Criteria
Criteria
Inclusion Criteria:
- Women, ages 18-55 years old who have a regular menstrual cycle and who can come in to participate in the afternoon
Exclusion Criteria:
- Long-term medications, oral or steroid contraceptives, irregular menstrual cycle
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA | Boston | Massachusetts | United States | 02130 |
Sponsors and Collaborators
- VA Office of Research and Development
- VA Boston Healthcare System
- Boston VA Research Institute, Inc.
- Boston University
Investigators
- Principal Investigator: Suzanne Pineles, VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CDA-2-042-07F
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | PTSD Group | Trauma Control Group |
|---|---|---|
| Arm/Group Description | Individuals in this group meet criteria for PTSD as defined by DSM-IV | individuals in this group do not meet criteria for any Axis I diagnosis as defined by DSM-IV |
| Period Title: Overall Study | ||
| STARTED | 25 | 25 |
| Completed Study | 25 | 25 |
| COMPLETED | 22 | 25 |
| NOT COMPLETED | 3 | 0 |
Baseline Characteristics
| Arm/Group Title | PTSD Group | Trauma Control Group | Total |
|---|---|---|---|
| Arm/Group Description | Individuals in this group meet criteria for PTSD as defined by DSM-IV | individuals in this group do not meet criteria for any Axis I diagnosis as defined by DSM-IV | Total of all reporting groups |
| Overall Participants | 22 | 25 | 47 |
| Age (Count of Participants) | |||
| <=18 years |
0
0%
|
0
0%
|
0
0%
|
| Between 18 and 65 years |
22
100%
|
25
100%
|
47
100%
|
| >=65 years |
0
0%
|
0
0%
|
0
0%
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
22
100%
|
25
100%
|
47
100%
|
| Male |
0
0%
|
0
0%
|
0
0%
|
| Ethnicity (NIH/OMB) (Count of Participants) | |||
| Hispanic or Latino |
2
9.1%
|
0
0%
|
2
4.3%
|
| Not Hispanic or Latino |
20
90.9%
|
25
100%
|
45
95.7%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
| Race (NIH/OMB) (Count of Participants) | |||
| American Indian or Alaska Native |
1
4.5%
|
0
0%
|
1
2.1%
|
| Asian |
4
18.2%
|
1
4%
|
5
10.6%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
| Black or African American |
9
40.9%
|
11
44%
|
20
42.6%
|
| White |
5
22.7%
|
10
40%
|
15
31.9%
|
| More than one race |
1
4.5%
|
3
12%
|
4
8.5%
|
| Unknown or Not Reported |
2
9.1%
|
0
0%
|
2
4.3%
|
| Region of Enrollment (Count of Participants) | |||
| United States |
22
100%
|
25
100%
|
47
100%
|
| smokers (Count of Participants) | |||
| Count of Participants [Participants] |
5
22.7%
|
5
20%
|
10
21.3%
|
Outcome Measures
| Title | Prepulse Inhibition |
|---|---|
| Description | To calculate prepulse inhibition (PPI), first an O-EMG response score (O-EMG-R) for each trial was calculated. O-EMGR was measured in microvolts and each value was subjected to a square root transformation. For each participant, the mean O-EMG-R scores were calculated for both startle alone and prepulse + startle trials across the entire session. PPI is a ratio and was calculated by the formula below: PPI=(mean OEMG-R score on prepulse+startle trials-mean OEMG-R on Startle alone trials)/mean OEMG-R on startle alone trials. A negative value on this PPI ratio is indicative of greater prepulse inhibition. Means and SEs below reflect estimated means and SEs for the PTSD group and trauma control group from the ANOVA conducted with menstrual phase and the PTSD group X menstrual phase interaction included in the model. |
| Time Frame | This measure was assessed twice for each participant, once in the midluteal phase of the menstrual cycle and once in the early follicular phase of the menstrual cycle, up to approximately 20 days apart. |
Outcome Measure Data
| Analysis Population Description |
|---|
| all participants with valid psychophys data analyzed |
| Arm/Group Title | PTSD Group | Trauma Control Group |
|---|---|---|
| Arm/Group Description | Individuals in this group meet criteria for PTSD as defined by DSM-IV | individuals in this group do not meet criteria for any Axis I diagnosis as defined by DSM-IV |
| Measure Participants | 22 | 25 |
| Mean (Standard Error) [proportion of change in OEMGR response] |
-.19
(.04)
|
-.31
(.04)
|
Adverse Events
| Time Frame | ||||
|---|---|---|---|---|
| Adverse Event Reporting Description | ||||
| Arm/Group Title | PTSD Group | Trauma Control Group | ||
| Arm/Group Description | Individuals in this group meet criteria for PTSD as defined by DSM-IV | individuals in this group do not meet criteria for any Axis I diagnosis as defined by DSM-IV | ||
All Cause Mortality |
||||
| PTSD Group | Trauma Control Group | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | ||
Serious Adverse Events |
||||
| PTSD Group | Trauma Control Group | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/22 (0%) | 0/25 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
| PTSD Group | Trauma Control Group | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/22 (0%) | 0/25 (0%) | ||
Limitations/Caveats
More Information
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Suzanne Pineles |
|---|---|
| Organization | VA ORD |
| Phone | 857-364-5906 |
| suzanne.pineles@va.gov |
- CDA-2-042-07F