Exploring Clinical Study Experiences of People With Post Traumatic Stress Disorder

NCT06146049 | Not Yet Recruiting

• 1 other identifier: 65314844
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

Post Traumatic Stress Disorder

Keywords

Post Traumatic Stress Disorder

Outcome Measures

Primary Outcomes (2)

• 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

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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.

You may qualify if:

• Diagnosis of post traumatic stress disorder
• No prior treatment for post traumatic stress disorder
• Willing and able to provide informed consent.

You may not qualify if:

• Enrolled in another research study
• Psychiatric or behavioral illness
• Inability to provide written informed consent

Sponsors & Collaborators

• Power Life Sciences Inc.: lead

Study Sites (1)

Power Life Sciences

San Francisco, California, 94107, United States

Location

Related Publications (3)

• 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.

  PMID: 32319346 BACKGROUND

• 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.

  PMID: 36571476 BACKGROUND

• 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.

  PMID: 33574791 BACKGROUND

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Officials

• Michael B Gill

  Power Life Sciences Inc.

  STUDY DIRECTOR

Central Study Contacts

Michael B Gill

CONTACT

4159004227; bask@withpower.com

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2023
• First Posted: November 24, 2023
• Study Start: December 1, 2024
• Primary Completion: December 1, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: November 24, 2023

Record last verified: 2023-11

Locations

US (1)