PTSDNCT00751855
Cortisol Augmentation of Prolonged Exposure Therapy
A study testing Prolonged Exposure therapy and Hydrocortisone in people with PTSD, run by VISN 3 Mental Illness Research, Education and Clinical 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 years and older
- 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
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2008to Feb 2011
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Veterans who experienced a criterion A trauma while deployed, and a current diagnosis of PTSD with a minimum of 6 months
- Capable of understanding, reading and writing English
Who cannot join
- Incapable and/or unwilling to provide written informed consent prior to participation
- Unwilling and/or unable to discontinue current psychotherapy
- Regular use of psychotropic medication including antidepressants, benzodiazepines, lithium, mood stabilizers, over-the-counter supplements (melatonin, kava-kava, ephedra)
- Regular use of oral or inhaled steroids
- Significant illness (e.g., type I or II diabetes requiring the use of insulin, HIV, AIDS, seizure disorder, anemia, Lyme disease, etc.)
- The veteran, the veteran's physician, or the study physician think that the veteran's clinical state necessitates the prompt initiation of pharmacotherapy or other treatment that would preclude involvement in the study
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- Morbid obesity (VMI > 40)
- Clinically significant laboratory abnormalities as determine during medical clearance procedures
- For women, a positive pregnancy test
- Heavy smoking (more than 2 packs a day)
- Substance and/or alcohol abuse and/or dependence within the previous 6 months
- Response of 3 or 4 on the suicidality items of the HDRS or an assessed serious suicide risk
- Current psychosocial problems that might interfere with treatment compliance
- A lifetime history of schizophrenia, schizoaffective disorder, bipolar disorder, obsessive compulsive disorder or PTSD due to a trauma not sustained in the combat theater
Trial locations and contacts
1 site in 1 country.
United States1 site
James J. Peters Veterans Affairs Medical Center
The Bronx, New York, 10468
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, placebo
- 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 45 minutes prior to each PE session including imaginal exposure (8 total)
placeboDrug
placebo
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Prolonged Exposure therapy with Hydrocortisone Receives: Behavioral: Prolonged Exposure therapy; Drug: Hydrocortisone |
| 2 | Placebo comparator | Prolonged Exposure therapy with placebo Receives: Behavioral: Prolonged Exposure therapy; Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in PTSD symptom severity as assessed by the Clinician Administered PTSD Scale (CAPS)
Measured: Baseline (Week 0), endpoint (week 11)
Secondary outcomes (3)
Cognitive performance (learning and retention in an episodic memory task, attention and working memory)
Measured: Baseline (Week 0), endpoint (week 11)
Other measures of clinical outcome, psychological state and functioning
Measured: Approximately 1 week prior to starting therapy (Week 0) and approximately 1 week after completing 10 weeks of therapy (week 11)
Biological measures associated with PTSD severity
Measured: Approximately 1 week prior to starting therapy (Week 0) and approximately 1 week after completing 10 weeks of therapy (week 11)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2008 (estimated)
- Study startJul 2008
- Primary completionFeb 2011
- Study completionFeb 2011
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
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- VISN 3 Mental Illness Research, Education and Clinical Center
- Sponsor type
- US federal agency
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00751855
- Sponsor's protocol ID
- YEH-08-044
- Status last verified
- Oct 2010
- First submitted
- 11 Sep 2008
- Last updated
- 27 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cortisol Augmentation of Prolonged Exposure Therapy
- ClinicalTrials.gov ID
- NCT00751855
- Acronym / sponsor ID
- YEH-08-044
- Conditions
- PTSD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- VISN 3 Mental Illness Research, Education and Clinical CenterUS federal agency
- Study start
- Jul 2008
- Primary completion
- Feb 2011 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 12 Sep 2008 (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 |
|---|---|---|
| 1 | Active comparator | Behavioral: Prolonged Exposure therapy, Drug: HydrocortisoneProlonged Exposure therapy with Hydrocortisone |
| 2 | Placebo comparator | Behavioral: Prolonged Exposure therapy, Drug: placeboProlonged Exposure therapy with placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Veterans who experienced a criterion A trauma while deployed, and a current diagnosis of PTSD with a minimum of 6 months
- Capable of understanding, reading and writing English
Key exclusion criteria (14 listed)
- Incapable and/or unwilling to provide written informed consent prior to participation
- Unwilling and/or unable to discontinue current psychotherapy
- Regular use of psychotropic medication including antidepressants, benzodiazepines, lithium, mood stabilizers, over-the-counter supplements (melatonin, kava-kava, ephedra)
- Regular use of oral or inhaled steroids
- Significant illness (e.g., type I or II diabetes requiring the use of insulin, HIV, AIDS, seizure disorder, anemia, Lyme disease, etc.)
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 | 1, 2 |
| Hydrocortisone30mg 45 minutes prior to each PE session including imaginal exposure (8 total) | Drug | 1 |
| placeboplacebo | Drug | 2 |
Primary outcome
Change in PTSD symptom severity as assessed by the Clinician Administered PTSD Scale (CAPS)
Time frame: Baseline (Week 0), endpoint (week 11)
3 secondary outcomes
Cognitive performance (learning and retention in an episodic memory task, attention and working memory)
Time frame: Baseline (Week 0), endpoint (week 11)
Other measures of clinical outcome, psychological state and functioning
Time frame: Approximately 1 week prior to starting therapy (Week 0) and approximately 1 week after completing 10 weeks of therapy (week 11)
Biological measures associated with PTSD severity
Time frame: Approximately 1 week prior to starting therapy (Week 0) and approximately 1 week after completing 10 weeks of therapy (week 11)
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 27 Jul 2012.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 VISN 3 Mental Illness Research, Education and Clinical 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 14 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 27 Jul 2012. 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?
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?
Change in PTSD symptom severity as assessed by the Clinician Administered PTSD Scale (CAPS) (time frame: Baseline (Week 0), endpoint (week 11)). 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 27 Jul 2012.