Post Traumatic Stress DisorderNCT06146049
Exploring Clinical Study Experiences of People With Post Traumatic Stress Disorder
An observational study of Post Traumatic Stress Disorder, run by Power Life Sciences Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post Traumatic Stress Disorder
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2024to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Post traumatic stress disorder patients who are actively considering enrolling in a clinical trial for the said condition, but have not yet completed enrollment and randomization phases.
Who may be able to join
- Diagnosis of post traumatic stress disorder
- No prior treatment for post traumatic stress disorder
- Willing and able to provide informed consent.
Who cannot join
- Enrolled in another research study
- Psychiatric or behavioral illness
- Inability to provide written informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Power Life Sciences
San Francisco, California, 94107
Michael B Gill, 415-900-4227, https://www.withpower.com/contact-us@withpower.com
About this study
Official title: Examination of Participation Trends and Engagement Patterns of Participants in Post Traumatic Stress Disorder Clinical Trials
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.
- Conditions
- Post Traumatic Stress Disorder
- Keywords
- Post Traumatic Stress Disorder
- Medical subject headings
- Stress Disorders, Post-Traumatic
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of patients who decide to enroll in a post traumatic stress disorder clinical research.
Measured: 3 months
Number of post traumatic stress disorder study participants who remain in clinical study until completion.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2023
- Study startDec 2024 (estimated)
- Primary completionDec 2025 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Post Traumatic Stress DisorderStudies of the same condition, open and under way.
- More trials run by Power Life Sciences Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Power Life Sciences Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael B Gill, Study director, Power Life Sciences Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06146049
- Sponsor's protocol ID
- 65314844
- Status last verified
- Nov 2023
- First submitted
- 17 Nov 2023
- Last updated
- 24 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 32319346Lai 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.
PubMed 36571476Cenkner 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.
PubMed 33574791
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examination of Participation Trends and Engagement Patterns of Participants in Post Traumatic Stress Disorder Clinical Trials
- ClinicalTrials.gov ID
- NCT06146049
- Acronym / sponsor ID
- 65314844
- Conditions
- Post Traumatic Stress Disorder
- Keywords
- Post Traumatic Stress Disorder
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Power Life Sciences Inc.Industry (pharma, biotech, devices)
- Study start
- Dec 2024 (estimated)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 24 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Post traumatic stress disorder patients who are actively considering enrolling in a clinical trial for the said condition, but have not yet completed enrollment and randomization phases.
Key inclusion criteria (3 listed)
- Diagnosis of post traumatic stress disorder
- No prior treatment for post traumatic stress disorder
- Willing and able to provide informed consent.
Key exclusion criteria (3 listed)
- Enrolled in another research study
- Psychiatric or behavioral illness
- Inability to provide written informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Rate of patients who decide to enroll in a post traumatic stress disorder clinical research.
Time frame: 3 months
Number of post traumatic stress disorder study participants who remain in clinical study until completion.
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2023.
- Background: PubMed 32319346Casarin 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.
- Background: PubMed 36571476Lai 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.
- Background: PubMed 33574791Cenkner 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Michael B Gill study director
Power Life Sciences Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Post Traumatic Stress Disorder, run by Power Life Sciences Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 24 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michael B Gill (4159004227, bask@withpower.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of patients who decide to enroll in a post traumatic stress disorder clinical research. (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06146049, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2023.