PTSDNCT01090518
Cortisol Augmentation of a Psychological Treatment in Warfighters With Post Traumatic Stress Disorder (PTSD)
A study testing Prolonged Exposure therapy and Hydrocortisone in people with PTSD, run by Bronx VA Medical Center at 1 site in United States.
Trial summary
This study seeks to examine the efficacy of hydrocortisone administration in the augmentation of the therapeutic effects of Prolonged Exposure (PE) therapy, an empirically tested treatment shown to be effective in the the treatment of posttraumatic stress disorder (PTSD). Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- PTSD
- What is being tested?
- Prolonged Exposure therapy and Hydrocortisone
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2010to Nov 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 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A primary diagnosis of chronic PTSD according to Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) diagnostic criteria, resulting from a deployment-related traumatic event, and a minimum PTSD severity of 50 (CAPS).
- The veteran must either be unmedicated or on a stable psychotropic regimen (i.e., 1 or more months on the same regimen).
Who cannot join
- Lifetime history of psychotic disorder, bipolar disorder, or obsessive compulsive disorder.
- Moderate or severe traumatic brain injury (TBI).
- A medical or mental health problem other than PTSD that requires immediate clinical attention.
- Substance abuse or dependence within the last 3 months.
- Suicidal risk (as determined by response of 5 or 6 on the suicidality items of the Montgomery Asberg Depression Rating Scale (MADRS)) and/or assessed suicide risk on the basis of clinical judgment.
- Persons on a psychotropic medication regimen that has not been consistent for one month.
Show all 9Show fewer
- Presence of diabetes mellitus or any current unstable medical illness or condition that represents a contraindication to taking glucocorticoids (this will be determined by history and/or abnormal laboratory findings at medical clearance).
- Unwillingness to discontinue other specialized psychotherapy for PTSD during the 10 weeks of study treatment and the 6 week follow-up. (Self-help (non-trauma focused) groups or supportive counseling can be continued but not initiated.)
- Pregnant women or those planning to become pregnant within the study period will not be enrolled. Female participants must agree to use an effective method of birth control (i.e., oral contraceptive, Norplant, diaphragm, condom, or spermicide, abstinence) during the course of the study to ensure they do not become pregnant during the course of the study.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
James J. Peters Veterans Affairs Medical Center
The Bronx, New York, 10468
Rachel Yehuda, PhD
About this study
This study seeks to examine the efficacy of hydrocortisone administration in the augmentation of the therapeutic effects of Prolonged Exposure (PE) therapy, an empirically tested treatment shown to be effective in the the treatment of posttraumatic stress disorder (PTSD). The augmentation builds on both the translation of neuroscience findings demonstrating the effects of glucocorticoids (GCs) on learning, and on empirical clinical findings from other investigators demonstrating beneficial effects of GCs in reducing traumatic memories in trauma-exposed persons.
- Conditions
- PTSD
- Being tested
- Prolonged Exposure therapy, Hydrocortisone
- 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
10 weekly sessions
HydrocortisoneDrug
30mg 20 minutes prior to each PE session including imaginal exposure (8 total)
Prolonged Exposure therapyBehavioural
10 weekly sessions
| Study group | Role | What they receive |
|---|---|---|
| Prolonged Exposure therapy with Hydrocortisone | Active comparator | Not described Receives: Behavioral: Prolonged Exposure therapy; Drug: Hydrocortisone |
| Prolonged Exposure therapy with placebo | Placebo comparator | Not described Receives: Behavioral: Prolonged Exposure therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
PTSD symptom severity as assessed by the Clinician Administered PTSD Scale (CAPS)
Measured: week 0
PTSD symptom severity as assessed by the Clinician Administered PTSD Scale (CAPS)
Measured: week 10
PTSD symptom severity as assessed by the Clinician Administered PTSD Scale (CAPS)
Measured: week 16
Secondary outcomes (9)
Cognitive performance (learning and retention in an episodic memory task, attention and working memory)
Measured: week 0
Cognitive performance (learning and retention in an episodic memory task, attention and working memory)
Measured: week 10
Cognitive performance (learning and retention in an episodic memory task, attention and working memory)
Measured: week 16
Other measures of clinical outcome, psychological state and functioning
Measured: week 0
Other measures of clinical outcome, psychological state and functioning
Measured: week 10
Other measures of clinical outcome, psychological state and functioning
Measured: week 16
Biological measures associated with PTSD severity
Measured: week 0
Biological measures associated with PTSD severity
Measured: week 10
Biological measures associated with PTSD severity
Measured: week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2010 (estimated)
- Study startFeb 2010
- Primary completionNov 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PTSDStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bronx VA Medical Center
- Sponsor type
- US federal agency
- Collaborators
- Lightfighter Trust
- Responsible party
- Principal investigator, Rachel Yehuda, Bronx VA Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01090518
- Sponsor's protocol ID
- LFT2009-02-1
- Status last verified
- Feb 2013
- First submitted
- 11 Mar 2010
- Last updated
- 5 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cortisol Augmentation of a Psychological Treatment in Warfighters With Post Traumatic Stress Disorder (PTSD)
- ClinicalTrials.gov ID
- NCT01090518
- Acronym / sponsor ID
- LFT2009-02-1
- Conditions
- PTSD
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Bronx VA Medical CenterUS federal agency
- Collaborators
- Lightfighter Trust
- Study start
- Feb 2010
- Primary completion
- Nov 2013 (estimated)
- First posted
- 22 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.
This study seeks to examine the efficacy of hydrocortisone administration in the augmentation of the therapeutic effects of Prolonged Exposure (PE) therapy, an empirically tested treatment shown to be effective in the the treatment of posttraumatic stress disorder (PTSD). The augmentation builds on both the translation of neuroscience findings demonstrating the effects of glucocorticoids (GCs) on learning, and on empirical clinical findings from other investigators demonstrating beneficial effects of GCs in reducing traumatic memories in trauma-exposed persons.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prolonged Exposure therapy with Hydrocortisone | Active comparator | Behavioral: Prolonged Exposure therapy, Drug: Hydrocortisone |
| Prolonged Exposure therapy with placebo | Placebo comparator | Behavioral: Prolonged Exposure therapy |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- A primary diagnosis of chronic PTSD according to Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) diagnostic criteria, resulting from a deployment-related traumatic event, and a minimum PTSD severity of 50 (CAPS).
- The veteran must either be unmedicated or on a stable psychotropic regimen (i.e., 1 or more months on the same regimen).
Key exclusion criteria (9 listed)
- Lifetime history of psychotic disorder, bipolar disorder, or obsessive compulsive disorder.
- Moderate or severe traumatic brain injury (TBI).
- A medical or mental health problem other than PTSD that requires immediate clinical attention.
- Substance abuse or dependence within the last 3 months.
- Suicidal risk (as determined by response of 5 or 6 on the suicidality items of the Montgomery Asberg Depression Rating Scale (MADRS)) and/or assessed suicide risk on the basis of clinical judgment.
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 therapy10 weekly sessions | Behavioural | Prolonged Exposure therapy with Hydrocortisone |
| Hydrocortisone30mg 20 minutes prior to each PE session including imaginal exposure (8 total) | Drug | Prolonged Exposure therapy with Hydrocortisone |
| Prolonged Exposure therapy10 weekly sessions | Behavioural | Prolonged Exposure therapy with placebo |
Primary outcome
PTSD symptom severity as assessed by the Clinician Administered PTSD Scale (CAPS)
Time frame: week 0
PTSD symptom severity as assessed by the Clinician Administered PTSD Scale (CAPS)
Time frame: week 10
PTSD symptom severity as assessed by the Clinician Administered PTSD Scale (CAPS)
Time frame: week 16
9 secondary outcomes
Cognitive performance (learning and retention in an episodic memory task, attention and working memory)
Time frame: week 0
Cognitive performance (learning and retention in an episodic memory task, attention and working memory)
Time frame: week 10
Cognitive performance (learning and retention in an episodic memory task, attention and working memory)
Time frame: week 16
Other measures of clinical outcome, psychological state and functioning
Time frame: week 0
Other measures of clinical outcome, psychological state and functioning
Time frame: week 10
Other measures of clinical outcome, psychological state and functioning
Time frame: week 16
Biological measures associated with PTSD severity
Time frame: week 0
Biological measures associated with PTSD severity
Time frame: week 10
Biological measures associated with PTSD severity
Time frame: week 16
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2013.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prolonged Exposure therapy and Hydrocortisone in people with PTSD, run by Bronx VA Medical Center 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 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: status not confirmed, as of the sponsor's last update on 5 Feb 2013. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rachel Yehuda, PhD (718-741-4000 ext. 6964, rachel.yehuda@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PTSD symptom severity as assessed by the Clinician Administered PTSD Scale (CAPS) (time frame: week 0). 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 5 Feb 2013.