Exploring Clinical Study Experiences of People With Post Traumatic Stress Disorder
Sponsor
Power Life Sciences Inc. (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT06146049
Collaborator
(none)
500
1
24
20.8
Study Details
Study Description
Brief Summary
Participation in post traumatic stress disorder observational study serves as a crucial contribution to advancing medical knowledge and refining the care provided to individuals facing similar health challenges.
The primary objective centers on a meticulous examination of trial completion rates and voluntary withdrawals within this distinct patient population.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
|
Study Design
Study Type:
Observational
Anticipated Enrollment
:
500 participants
Observational Model:
Case-Crossover
Time Perspective:
Prospective
Official Title:
Examination of Participation Trends and Engagement Patterns of Participants in Post Traumatic Stress Disorder Clinical Trials
Anticipated Study Start Date
:
Dec 1, 2024
Anticipated Primary Completion Date
:
Dec 1, 2025
Anticipated Study Completion Date
:
Dec 1, 2026
Outcome Measures
Primary Outcome Measures
- Rate of patients who decide to enroll in a post traumatic stress disorder clinical research. [3 months]
- Number of post traumatic stress disorder study participants who remain in clinical study until completion. [12 months]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Diagnosis of post traumatic stress disorder
-
No prior treatment for post traumatic stress disorder
-
Willing and able to provide informed consent.
Exclusion Criteria:
-
Enrolled in another research study
-
Psychiatric or behavioral illness
-
Inability to provide written informed consent
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Power Life Sciences | San Francisco | California | United States | 94107 |
Sponsors and Collaborators
- Power Life Sciences Inc.
Investigators
- Study Director: Michael B Gill, Power Life Sciences Inc.
Study Documents (Full-Text)
More Information
Publications
- Casarin J, Ielmini M, Cromi A, Lagana AS, Poloni N, Callegari C, Ghezzi F. Post-traumatic stress following total hysterectomy for benign disease: an observational prospective study. J Psychosom Obstet Gynaecol. 2022 Mar;43(1):11-17. doi: 10.1080/0167482X.2020.1752174. Epub 2020 Apr 22.
- Cenkner DP, Asnaani A, DiChiara C, Harb GC, Lynch KG, Greene J, Scott JC. Neurocognitive Predictors of Treatment Outcomes in Cognitive Processing Therapy for Post-traumatic Stress Disorder: Study Protocol. Front Psychol. 2021 Jan 26;12:625669. doi: 10.3389/fpsyg.2021.625669. eCollection 2021.
- Lai X, Chen J, Li H, Zhou L, Huang Q, Liao Y, Krewski D, Wen SW, Zhang L, Xie RH. The incidence of post-traumatic stress disorder following traumatic childbirth: A systematic review and meta-analysis. Int J Gynaecol Obstet. 2023 Jul;162(1):211-221. doi: 10.1002/ijgo.14643. Epub 2023 Jan 19.
Responsible Party:
Power Life Sciences Inc.
ClinicalTrials.gov Identifier:
NCT06146049
Other Study ID Numbers:
- 65314844
First Posted:
Nov 24, 2023
Last Update Posted:
Nov 24, 2023
Last Verified:
Nov 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Power Life Sciences Inc.
Additional relevant MeSH terms: