Studying the Clinical Research Experiences of Patients With PTSD
NCT ID: NCT05840120
Last Updated: 2023-05-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
500 participants
OBSERVATIONAL
2024-05-31
2026-05-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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CASE_CROSSOVER
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Power Life Sciences Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Michael B Gill
Role: STUDY_DIRECTOR
Power Life Sciences Inc.
Central Contacts
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References
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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.
Provided Documents
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Document Type: Informed Consent Form
Other Identifiers
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80684805
Identifier Type: -
Identifier Source: org_study_id
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