Back to resultsA Randomized Clinical Trial of Hydrocortisone Augmentation of Prolonged Exposure
Primary Purpose
Post Traumatic Stress Disorder
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Hydrocortisone augmented Prolonged Exposure Therapy
Prolonged exposure therapy with placebo administration
Sponsored by
About this trial
This is an interventional treatment trial for Post Traumatic Stress Disorder focused on measuring PTSD
Eligibility Criteria
Inclusion Criteria:
- Age 18 to 89
- Capable of understanding, reading, and writing in English
- OIF/OEF veteran with criterion-A trauma while deployed
- Minimum PTSD severity of 60 (CAPS)
- Unmedicated or on a stable psychotropic regimen (i.e., 1 or more months on the same regimen)
Exclusion Criteria:
- Lifetime history of psychotropic 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
- 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 11 weeks of study treatment and the 3 month 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
Sites / Locations
- James J. Peters Veterans Affairs Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Prolonged Exposure therapy with Hydrocortisone
Prolonged Exposure therapy with placebo
Arm Description
Outcomes
Primary Outcome Measures
Clinician Administered PTSD Scale (CAPS)
Assessment of the severity of PTSD symptoms and of diagnosis of PTSD.
Clinician Administered PTSD Scale (CAPS)
Assessment of the severity of PTSD symptoms and of diagnosis of PTSD.
Clinician Administered PTSD Scale (CAPS)
Assessment of the severity of PTSD symptoms and of diagnosis of PTSD.
Secondary Outcome Measures
Biological measures associated with PTSD
Measures of neuroendocrinology, genotyping, gene expression, and methylation at glucocorticoid receptor.
Biological measures associated with PTSD
Measures of neuroendocrinology, genotyping, gene expression, and methylation at glucocorticoid receptor.
Biological measures associated with PTSD
Measures of neuroendocrinology, genotyping, gene expression, and methylation at glucocorticoid receptor.
MATRICS Consensus Cognitive Battery (MCCB)
Measure of cognitive ability in the following domains: processing speed, attention, working memory (verbal and non-verbal), verbal learning, visual learning, reasoning and problem solving, and social cognition.
MATRICS Consensus Cognitive Battery (MCCB)
Measure of cognitive ability in the following domains: processing speed, attention, working memory (verbal and non-verbal), verbal learning, visual learning, reasoning and problem solving, and social cognition.
MATRICS Consensus Cognitive Battery (MCCB)
Measure of cognitive ability in the following domains: processing speed, attention, working memory (verbal and non-verbal), verbal learning, visual learning, reasoning and problem solving, and social cognition.
Other measures of clinical, psychological, and functional outcome
Measures of symptom severity, trauma-related cognitions, and resiliency.
Other measures of clinical, psychological, and functional outcome
Measures of symptom severity, trauma-related cognitions, and resiliency.
Other measures of clinical, psychological, and functional outcome
Measures of symptom severity, trauma-related cognitions, and resiliency.
Full Information
NCT ID
NCT01525680
First Posted
February 1, 2012
Last Updated
November 27, 2013
Sponsor
Bronx VA Medical Center
Collaborators
United States Department of Defense
1. Study Identification
Unique Protocol Identification Number
NCT01525680
Brief Title
A Randomized Clinical Trial of Hydrocortisone Augmentation of Prolonged Exposure
Official Title
Improving PTSD Outcomes in OIF/OEF Returnees: A Randomized Clinical Trial of Hydrocortisone Augmentation of Prolonged Exposure Therapy"
Study Type
Interventional
2. Study Status
Record Verification Date
November 2013
Overall Recruitment Status
Unknown status
Study Start Date
April 2011 (undefined)
Primary Completion Date
September 2015 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bronx VA Medical Center
Collaborators
United States Department of Defense
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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). 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Traumatic Stress Disorder
Keywords
PTSD
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Prolonged Exposure therapy with Hydrocortisone
Arm Type
Active Comparator
Arm Title
Prolonged Exposure therapy with placebo
Arm Type
Placebo Comparator
Intervention Type
Other
Intervention Name(s)
Hydrocortisone augmented Prolonged Exposure Therapy
Intervention Description
11 sessions of PE. 20 minutes prior to final eight sessions, 30 mg hydrocortisone is administered.
Intervention Type
Other
Intervention Name(s)
Prolonged exposure therapy with placebo administration
Intervention Description
11 sessions of PE. 20 minutes prior to final eight sessions, placebo is administered.
Primary Outcome Measure Information:
Title
Clinician Administered PTSD Scale (CAPS)
Description
Assessment of the severity of PTSD symptoms and of diagnosis of PTSD.
Time Frame
week 0
Title
Clinician Administered PTSD Scale (CAPS)
Description
Assessment of the severity of PTSD symptoms and of diagnosis of PTSD.
Time Frame
week 12
Title
Clinician Administered PTSD Scale (CAPS)
Description
Assessment of the severity of PTSD symptoms and of diagnosis of PTSD.
Time Frame
week 23
Secondary Outcome Measure Information:
Title
Biological measures associated with PTSD
Description
Measures of neuroendocrinology, genotyping, gene expression, and methylation at glucocorticoid receptor.
Time Frame
week 0
Title
Biological measures associated with PTSD
Description
Measures of neuroendocrinology, genotyping, gene expression, and methylation at glucocorticoid receptor.
Time Frame
week 12
Title
Biological measures associated with PTSD
Description
Measures of neuroendocrinology, genotyping, gene expression, and methylation at glucocorticoid receptor.
Time Frame
week 23
Title
MATRICS Consensus Cognitive Battery (MCCB)
Description
Measure of cognitive ability in the following domains: processing speed, attention, working memory (verbal and non-verbal), verbal learning, visual learning, reasoning and problem solving, and social cognition.
Time Frame
week 0
Title
MATRICS Consensus Cognitive Battery (MCCB)
Description
Measure of cognitive ability in the following domains: processing speed, attention, working memory (verbal and non-verbal), verbal learning, visual learning, reasoning and problem solving, and social cognition.
Time Frame
week 12
Title
MATRICS Consensus Cognitive Battery (MCCB)
Description
Measure of cognitive ability in the following domains: processing speed, attention, working memory (verbal and non-verbal), verbal learning, visual learning, reasoning and problem solving, and social cognition.
Time Frame
week 23
Title
Other measures of clinical, psychological, and functional outcome
Description
Measures of symptom severity, trauma-related cognitions, and resiliency.
Time Frame
week 0
Title
Other measures of clinical, psychological, and functional outcome
Description
Measures of symptom severity, trauma-related cognitions, and resiliency.
Time Frame
week 12
Title
Other measures of clinical, psychological, and functional outcome
Description
Measures of symptom severity, trauma-related cognitions, and resiliency.
Time Frame
week 23
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Age 18 to 89
Capable of understanding, reading, and writing in English
OIF/OEF veteran with criterion-A trauma while deployed
Minimum PTSD severity of 60 (CAPS)
Unmedicated or on a stable psychotropic regimen (i.e., 1 or more months on the same regimen)
Exclusion Criteria:
Lifetime history of psychotropic 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
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 11 weeks of study treatment and the 3 month 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rachel Yehuda, PhD
Phone
718-741-4000
Ext
6964
Email
rachel.yehuda@va.gov
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rachel Yehuda, PhD
Organizational Affiliation
James J Peters VAMC/Mount Sinai School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
James J. Peters Veterans Affairs Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10468
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rachel Yehuda, PhD
Email
rachel.yehuda@va.gov
12. IPD Sharing Statement
Learn more about this trial
A Randomized Clinical Trial of Hydrocortisone Augmentation of Prolonged Exposure
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