Post-Traumatic Stress DisorderPhase 2NCT00183300
Relationship Between the Biological and Psychological Correlates of PTSD
A Phase 2 study testing Prolonged Exposure Therapy in people with Post-Traumatic Stress Disorder, run by University of Pennsylvania at 1 site in United States.
Trial summary
This study will determine the effectiveness of immediate treatment with prolonged exposure therapy (PE) versus delaying treatment with PE in altering neuroendocrine-related symptoms of post-traumatic stress disorder in women. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Post-Traumatic Stress Disorder
- What is being tested?
- Prolonged Exposure Therapy
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2001to Jul 2007
- Phase
- Phase 2
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chronic post-traumatic stress disorder
- Minimum of 3 months passed since traumatic event happened
- Agree to use an effective form of contraception throughout the study
Who cannot join
- History of schizophrenia, bipolar disorder, or cognitive dysfunction due to a general medical condition
- History of alcohol or other drug abuse or dependence within 3 months of study enrollment
- Mental retardation or other pervasive developmental disorder
- Unwillingness or inability to discontinue current psychotherapy treatment (stable psychiatric medication therapy taken during the study is not criteria for exclusion)
- Significant risk of violence or history of serious violent behavior within one year of study enrollment
- Medically unstable condition
Show all 9Show fewer
- Continuing intimate relationship with the perpetrator when the trauma involves assault
- At risk for suicide risk
- Currently pregnant
Trial locations and contacts
1 site in 1 country.
United States1 site
Center for the Treatment and Study of Anxiety, University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: Effectiveness of Prolonged Exposure Therapy on Reducing Neuroendocrine-Related Symptoms of Post-Traumatic Stress Disorder in Women
This study will determine the effectiveness of immediate treatment with prolonged exposure therapy (PE) versus delaying treatment with PE in altering neuroendocrine-related symptoms of post-traumatic stress disorder in women.
Read the detailed description
Post-Traumatic Stress Disorder (PTSD) is a psychiatric disorder that can occur following exposure to a traumatic incident in which grave physical harm occurred or was threatened. PTSD is marked by clear biological changes as well as psychological symptoms. Many people with PTSD repeatedly relive the trauma in the form of flashback episodes, memories, nightmares, or frightening thoughts. Chronic PTSD can also affect the neuroendocrine system by altering functionality of some chemicals in the brain, including cortisol and catecholamines (e.g., norepinephrine). This study will determine the effectiveness of immediate treatment with prolonged exposure therapy (PE) versus delaying treatment with PE in altering neuroendocrine-related symptoms of post-traumatic stress disorder in women.
This single-blind study will randomly assign two thirds of participants to PE therapy immediately following a traumatic event and one third to a waitlist condition (WL), in which they will receive no treatment until a later date. Participants assigned to receive PE will do so once weekly for 10 weeks. Participants assigned to the WL condition will receive no treatment for 10 weeks, and then will begin PE therapy once weekly for an additional 10 weeks. Study visits will occur at baseline, Week 10, and 6 months post-treatment for those in both conditions, with additional visits 10 weeks and 6 months post-PE therapy for those in the WL condition. Psychological measurements to be assessed at these visits will include PTSD symptoms, anxiety, depression, and PTSD-related cognitions. Physical assessments will include urine and saliva tests, as well as a dexamethasone-suppression test. Participants in the PE condition will also provide saliva samples at points throughout the study to monitor changes in cortisol and catecholamines.
- Conditions
- Post-Traumatic Stress Disorder
- Being tested
- Prolonged Exposure Therapy
- Keywords
- Post-traumatic stress disorder, PTSD, Prolonged Exposure, Cognitive-Behavior Therapy
- 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.
Prolonged Exposure TherapyBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
PTSD severity; measured by the PSS-I immediately after 10 weeks of treatment and at 6-month follow-up
Salivary cortisol; measured immediately after 10 weeks of treatment
Urinary cortisol and catecholamines; measured immediately after 10 weeks of treatment and at 6-month follow-up
Secondary outcomes (4)
Depression; measured by the BDI immediately after 10 weeks of treatment and at 6-month follow-up
State-anxiety; measured by the STAI-S immediately after 10 weeks of treatment and at 6-month follow-up.
Trauma-related cognitions; measured by the PTCI immediately after 10 weeks of treatment and at 6-month follow-up
Salivary cortisol; measured at 6-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study startSep 2001
- Study completionJul 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-Traumatic Stress DisorderStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Enrolment
- 120 participants
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Edna B. Foa, Ph.D., Principal investigator, University of PennsylvaniaRachel Yehuda, Ph.D., Principal investigator, Mt. Sinai School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00183300
- Sponsor's protocol ID
- R01MH062003
- Other IDs
- R01MH062003, DATR AD-TS
- Status last verified
- Dec 2007
- First submitted
- 12 Sep 2005
- Last updated
- 6 Oct 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Prolonged Exposure Therapy on Reducing Neuroendocrine-Related Symptoms of Post-Traumatic Stress Disorder in Women
- ClinicalTrials.gov ID
- NCT00183300
- Acronym / sponsor ID
- R01MH062003
- Conditions
- Post-Traumatic Stress Disorder
- Keywords
- Post-traumatic stress disorder, PTSD, Prolonged Exposure, Cognitive-Behavior Therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Sep 2001
- Study completion
- Jul 2007 (actual)
- First posted
- 16 Sep 2005 (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 will determine the effectiveness of immediate treatment with prolonged exposure therapy (PE) versus delaying treatment with PE in altering neuroendocrine-related symptoms of post-traumatic stress disorder in women.
Detailed description
Post-Traumatic Stress Disorder (PTSD) is a psychiatric disorder that can occur following exposure to a traumatic incident in which grave physical harm occurred or was threatened. PTSD is marked by clear biological changes as well as psychological symptoms. Many people with PTSD repeatedly relive the trauma in the form of flashback episodes, memories, nightmares, or frightening thoughts. Chronic PTSD can also affect the neuroendocrine system by altering functionality of some chemicals in the brain, including cortisol and catecholamines (e.g., norepinephrine). This study will determine the effectiveness of immediate treatment with prolonged exposure therapy (PE) versus delaying treatment with PE in altering neuroendocrine-related symptoms of post-traumatic stress disorder in women.
This single-blind study will randomly assign two thirds of participants to PE therapy immediately following a traumatic event and one third to a waitlist condition (WL), in which they will receive no treatment until a later date. Participants assigned to receive PE will do so once weekly for 10 weeks. Participants assigned to the WL condition will receive no treatment for 10 weeks, and then will begin PE therapy once weekly for an additional 10 weeks. Study visits will occur at baseline, Week 10, and 6 months post-treatment for those in both conditions, with additional visits 10 weeks and 6 months post-PE therapy for those in the WL condition. Psychological measurements to be assessed at these visits will include PTSD symptoms, anxiety, depression, and PTSD-related cognitions. Physical assessments will include urine and saliva tests, as well as a dexamethasone-suppression test. Participants in the PE condition will also provide saliva samples at points throughout the study to monitor changes in cortisol and catecholamines.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Chronic post-traumatic stress disorder
- Minimum of 3 months passed since traumatic event happened
- Agree to use an effective form of contraception throughout the study
Key exclusion criteria (9 listed)
- History of schizophrenia, bipolar disorder, or cognitive dysfunction due to a general medical condition
- History of alcohol or other drug abuse or dependence within 3 months of study enrollment
- Mental retardation or other pervasive developmental disorder
- Unwillingness or inability to discontinue current psychotherapy treatment (stable psychiatric medication therapy taken during the study is not criteria for exclusion)
- Significant risk of violence or history of serious violent behavior within one year of study enrollment
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 |
|---|---|---|
| Prolonged Exposure Therapy | Behavioural | – |
Primary outcome
PTSD severity; measured by the PSS-I immediately after 10 weeks of treatment and at 6-month follow-up
Salivary cortisol; measured immediately after 10 weeks of treatment
Urinary cortisol and catecholamines; measured immediately after 10 weeks of treatment and at 6-month follow-up
4 secondary outcomes
Depression; measured by the BDI immediately after 10 weeks of treatment and at 6-month follow-up
State-anxiety; measured by the STAI-S immediately after 10 weeks of treatment and at 6-month follow-up.
Trauma-related cognitions; measured by the PTCI immediately after 10 weeks of treatment and at 6-month follow-up
Salivary cortisol; measured at 6-month follow-up
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 6 Oct 2015.
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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.
Edna B. Foa, Ph.D. principal investigator
University of Pennsylvania
Rachel Yehuda, Ph.D. principal investigator
Mt. Sinai School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Prolonged Exposure Therapy in people with Post-Traumatic Stress Disorder, run by University of Pennsylvania 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 3 inclusion and 9 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 6 Oct 2015. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 severity; measured by the PSS-I immediately after 10 weeks of treatment and at 6-month follow-up. 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 6 Oct 2015.