Ignite Creation Date:
2024-05-05 @ 5:08 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00391430
Status:
TERMINATED
Last Update Posted:
2021-07-21
First Post:
2006-10-20
Brief Title:
Cognitive Behavioral Therapy Versus Sertraline in the Treatment of Post-Traumatic Stress Disorder
Sponsor:
NYU Langone Health
Organization:
NYU Langone Health
Study Overview
Official Title:
Cognitive Behavioral Therapy vs Sertraline in the Treatment of Post Traumatic Stress Disorder
Status:
TERMINATED
Status Verified Date:
2021-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Difficulty enrolling subjects
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will evaluate which parts of the brain are affected by treatment with behavioral therapy versus medication therapy in people with post-traumatic stress disorder
Detailed Description:
Post-traumatic stress disorder PTSD is an anxiety disorder that can develop after exposure to a traumatic event PTSD symptoms may include emotional numbness loss of interest in activities that were once enjoyable irritability and sleep problems Medication therapy behavioral therapy and a combination of both therapies are among the available treatment options for people with PTSD Cognitive behavioral therapy CBT a type of talking therapy that has been shown to be effective in treating PTSD teaches patients how to alter their thinking to in turn improve how they feel A selective serotonin reuptake inhibitor SSRI is a type of medication that has also been effective in treating PTSD Information about the comparative physiological effects of each of these treatments on people with PTSD is needed This study will evaluate which parts of the brain are affected by CBT treatment versus SSRI treatment in people with PTSD
Participants with and without PTSD will be enrolled in this 12-week open label study Following a screening visit to determine eligibility participants with PTSD will be offered a choice of either CBT or SSRI treatment Those participants who choose CBT will attend 16 therapy sessions The first phase of therapy will focus on the development of emotional and interpersonal regulation skills The second phase will use a modified form of prolonged exposure therapy which has been effective in reducing symptoms of PTSD Participants who elect to receive medication will take sertraline an SSRI that has been safe and effective in treating PTSD These participants will attend 12 treatment sessions Pre- and post-treatment fear response will be assessed in all participants using fMRI scans to measure brain responses and using saliva samples to test cortisol levels All participants will also self-administer saliva samples at various points during the 3 days prior to fMRI scanning Other outcomes will be assessed throughout the study using questionnaires
For information on a related study please follow this link
httpclinicaltrialsgovshowNCT00648375
Participants with and without PTSD will be enrolled in this 12-week open label study Following a screening visit to determine eligibility participants with PTSD will be offered a choice of either CBT or SSRI treatment Those participants who choose CBT will attend 16 therapy sessions The first phase of therapy will focus on the development of emotional and interpersonal regulation skills The second phase will use a modified form of prolonged exposure therapy which has been effective in reducing symptoms of PTSD Participants who elect to receive medication will take sertraline an SSRI that has been safe and effective in treating PTSD These participants will attend 12 treatment sessions Pre- and post-treatment fear response will be assessed in all participants using fMRI scans to measure brain responses and using saliva samples to test cortisol levels All participants will also self-administer saliva samples at various points during the 3 days prior to fMRI scanning Other outcomes will be assessed throughout the study using questionnaires
For information on a related study please follow this link
httpclinicaltrialsgovshowNCT00648375
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| DATR A3-NSC | US NIH GrantContract | None | httpsreporternihgovquickSearchP50MH058911 |
| P50MH058911 | NIH | None | None |