- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05840120
Studying the Clinical Research Experiences of Patients With PTSD
PTSD Clinical Trials Review: Examining Patient Experiences in PTSD Clinical Trials to Identify Influencing Factors
Clinical research participation percentages haven't always been fully representative of a given demographic.
The goal is to find out which aspects of a clinical study may make it more difficult for patients to take part or see it through.
The data will be evaluated through different demographic lenses and identify trends that could help improve the experience of future PTSD patients during clinical trials.
Study Overview
Status
Conditions
Study Type
Enrollment (Anticipated)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Must have a medical diagnosis of PTSD that has been confirmed by a physician.
- Aged ≥ 18 years old and ability to provide written informed consent obtained prior to participation in the study and any related procedures being performed.
- Willing and able to comply with scheduled visits, treatment schedule, laboratory tests and other requirements of the study.
Exclusion Criteria:
- Pregnant or lactating woman
- Patients with any significant history of non-compliance to medical regimens or with inability to grant a reliable informed consent.
- Known medical condition that, in the investigator's opinion, would increase the risk associated with study participation or study drug(s) administration or interfere with the interpretation of safety results
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Rate of patients who decide to enroll in a PTSD medical study.
Time Frame: 3 months
|
3 months
|
Number of PTSD patients who remain in clinical trial until completion.
Time Frame: 12 months
|
12 months
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Steenkamp MM, Litz BT, Hoge CW, Marmar CR. Psychotherapy for Military-Related PTSD: A Review of Randomized Clinical Trials. JAMA. 2015 Aug 4;314(5):489-500. doi: 10.1001/jama.2015.8370.
- Ronconi JM, Shiner B, Watts BV. Inclusion and exclusion criteria in randomized controlled trials of psychotherapy for PTSD. J Psychiatr Pract. 2014 Jan;20(1):25-37. doi: 10.1097/01.pra.0000442936.23457.5b.
- Sofuoglu M, Rosenheck R, Petrakis I. Pharmacological treatment of comorbid PTSD and substance use disorder: recent progress. Addict Behav. 2014 Feb;39(2):428-33. doi: 10.1016/j.addbeh.2013.08.014. Epub 2013 Aug 22.
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 80684805
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on PTSD
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University of PittsburghCompletedPTSD | Non PTSDUnited States
-
Imperial College Healthcare NHS TrustImperial College LondonRecruiting
-
VA Office of Research and DevelopmentUniversity of California, San DiegoRecruiting
-
University of Wisconsin, MadisonNational Institute of Mental Health (NIMH)Active, not recruiting
-
Oregon Health and Science UniversityEnrolling by invitation
-
VA Office of Research and DevelopmentCompleted
-
VA Office of Research and DevelopmentPortland VA Medical CenterActive, not recruiting
-
VA Office of Research and DevelopmentSan Diego Veterans Healthcare SystemCompleted
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Creighton UniversityCompleted
-
VA Eastern KansasTerminated