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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03350438
Other study ID # 0023-17-ziv
Secondary ID
Status Not yet recruiting
Phase N/A
First received November 19, 2017
Last updated November 30, 2017
Start date January 1, 2018
Est. completion date October 30, 2018

Study information

Verified date October 2017
Source Ziv Hospital
Contact ariela rosenblum, BA
Phone 0508434154
Email ariela.r@ziv.health.gov.il
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This study assesses the relationship between participation and quality of life the way adults with and without Post Traumatic Stress Disorder (PTSD) experience it in everyday life. Both groups will fill out Questionnaires and the answers will be compared. In addition different aspects of dissociation will be taken in to consideration.


Description:

Post Traumatic Stress Disorder has been known to severely impair participation in everyday activities such as work, recreation and social participation. In turn, these impairments can diminish quality of life. However, the relationship between PTSD, functioning and quality of life remains incompletely understood.

Since achieving full participation in daily activities is the main goal of occupational therapy, and since quality of life is a primary treatment success measure, it is important to fully understand the relationship between PTSD, participation and quality of life.

Various studies show that dissociation affects different body functions that manage and monitor mental functioning. Since quality of life is a subjective measure that relies on one's ability to mentally represent himself and others it is important to tack into consideration the way that dissociation affects the relationships described above.

The research contains 4 Questionnaires that will be filed out by the participants and the data from the Questionnaires will be analyzed and compared.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 80
Est. completion date October 30, 2018
Est. primary completion date July 30, 2018
Accepts healthy volunteers
Gender Male
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria:

- Hebrew speaking, read and write in Hebrew, have been diagnosed with PTSD following a trauma that occurred over one year before the current study.

Exclusion Criteria:

- Other psychiatric disorders, cognitive or physical impairments.

Study Design


Locations

Country Name City State
Israel Ziv Hospital Safed Galilee

Sponsors (1)

Lead Sponsor Collaborator
Ziv Hospital

Country where clinical trial is conducted

Israel, 

Outcome

Type Measure Description Time frame Safety issue
Primary self reported quality of life self reported quality of life, 26 items scored 1-5 (1=not at all/very bad 5=very much/very good) regarding how a person feels about his quality of life, health and other aspects of life in the past two weeks. two weeks
Secondary Self Reported Dissociation Self Reported Dissociative Experiences, 10 items scored 1-5 (1=not at all true 5=always true) regarding different experiences and reactions during the traumatic event and after. 24-48 hours
Secondary self reported participation 88 different activities that are rated 0-1 in comparison to before the trauma. 0= if the person is not currently participating 0.5= if the person is participating less then before the trauma 1= if the person is participating the same as before the trauma 1 month
Secondary self reported ptsd symptoms self reported ptsd symptoms, 17 items scored 0-3, regarding different reactions, feelings and experiences according to what the patient has experienced in the past month. 1 month
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