Studying the Clinical Research Experiences of Patients With PTSD
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
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Study Design
Outcome Measures
Primary Outcome Measures
- Rate of patients who decide to enroll in a PTSD medical study. [3 months]
- Number of PTSD patients who remain in clinical trial until completion. [12 months]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Must have a medical diagnosis of PTSD that has been confirmed by a physician.
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Aged ≥ 18 years old and ability to provide written informed consent obtained prior to participation in the study and any related procedures being performed.
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Willing and able to comply with scheduled visits, treatment schedule, laboratory tests and other requirements of the study.
Exclusion Criteria:
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Pregnant or lactating woman
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Patients with any significant history of non-compliance to medical regimens or with inability to grant a reliable informed consent.
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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
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Power Life Sciences Inc.
Investigators
- Study Director: Michael B Gill, Power Life Sciences Inc.
Study Documents (Full-Text)
More Information
Publications
- 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.
- 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.
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