- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03350438
Participation in Occupations and Perception of Quality of Life, Comparing Adults With and Without PTSD (PTSD)
Participation in Everyday Occupations and Perception of Quality of Life-comparing Adults Eith PTSD With Typical Adults and Assessing the Relationship Between the Two Measures
Study Overview
Status
Conditions
Detailed 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.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: ariela rosenblum, BA
- Phone Number: 0508434154
- Email: ariela.r@ziv.health.gov.il
Study Locations
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Galilee
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Safed, Galilee, Israel, 13100
- Ziv Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
---|
PTSD Patients
patients ranging 18-60, diagnosed with PTSD following a trauma that occured over one year before the current study and do not have other health problems that may affect their everyday participation.
|
healthy adults
healthy adults, ranging 18-60, without any health problems that may affect their everyday participation.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
self reported quality of life
Time Frame: two weeks
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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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Self Reported Dissociation
Time Frame: 24-48 hours
|
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.
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24-48 hours
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self reported participation
Time Frame: 1 month
|
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
|
self reported ptsd symptoms
Time Frame: 1 month
|
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
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Lidia Isakson, PHD, Ziv Hospital
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0023-17-ziv
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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