Post Traumatic Stress DisorderPTSDNCT03350438
Participation in Occupations and Perception of Quality of Life, Comparing Adults With and Without PTSD
An observational study of Post Traumatic Stress Disorder, run by Ziv Hospital at 1 site in Israel.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years, men only
- Conditions the study is for
- Post Traumatic Stress Disorder
- How many people
- 80 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Jan 2018to 30 Oct 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 60 years
- Men only
- Adult
Study population: men, age 18-60, Hebrew speaking, read and write in Hebrew, have been diagnosed with PTSD following a trauma that occurred over one year before the current study.
Who may be able to join
- Hebrew speaking, read and write in Hebrew, have been diagnosed with PTSD following a trauma that occurred over one year before the current study.
Who cannot join
- Other psychiatric disorders, cognitive or physical impairments.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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.
Read the 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.
- Conditions
- Post Traumatic Stress Disorder
- Keywords
- participation, quality of life, occupational therapy
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: two weeks
Secondary outcomes (3)
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.
Measured: 24-48 hours
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
Measured: 1 month
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.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2017
- Study start1 Jan 2018 (estimated)
- Primary completion30 Jul 2018 (estimated)
- Study completion30 Oct 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Traumatic Stress DisorderStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ziv Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Lidia Isakson, PHD, Principal investigator, Ziv Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03350438
- Sponsor's protocol ID
- 0023-17-ziv
- Acronym
- PTSD
- Status last verified
- Oct 2017
- First submitted
- 19 Nov 2017
- Last updated
- 2 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03350438
- Acronym / sponsor ID
- PTSD / 0023-17-ziv
- Conditions
- Post Traumatic Stress Disorder
- Keywords
- participation, quality of life, occupational therapy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Ziv HospitalOther government
- Study start
- 1 Jan 2018 (estimated)
- Primary completion
- 30 Jul 2018 (estimated)
- Study completion
- 30 Oct 2018 (estimated)
- First posted
- 22 Nov 2017 (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.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Male only
- Age groups
- Adult
- Study population
- men, age 18-60, Hebrew speaking, read and write in Hebrew, have been diagnosed with PTSD following a trauma that occurred over one year before the current study.
Key inclusion criteria (1 listed)
- Hebrew speaking, read and write in Hebrew, have been diagnosed with PTSD following a trauma that occurred over one year before the current study.
Key exclusion criteria (1 listed)
- Other psychiatric disorders, cognitive or physical impairments.
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
self reported quality of life
Time frame: two weeks
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.
3 secondary outcomes
Self Reported Dissociation
Time frame: 24-48 hours
self reported participation
Time frame: 1 month
self reported ptsd symptoms
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2017.
Related trials for Post Traumatic Stress Disorder
Recruiting
NightWare and Cardiovascular Health in Women With PTSD
Post Traumatic Stress Disorder, Cardiovascular Diseases
Not yet recruiting
A Transdiagnostic Sleep Health Intervention for Veterans With PTSD
Stress Disorders, Post-Traumatic, Sleep Initiation and Maintenance Disorders
Not yet recruitingPhase 3
Women Who Are Victims of Violence: Treatment of PTSD Through Reactivation of Traumatic Memories Using Propranolol
Post-Traumatic Stress Disorder, PTSD
RecruitingPhase 4
The Effects of Orexin Antagonism on Fear Extinction in PTSD
Insomnia, PTSD
Recruiting
Advancing Skills Through Consultation, Education, and Novel Technologies
PTSD - Post Traumatic Stress Disorder
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. This study is not recruiting at the moment.
Lidia Isakson, PHD principal investigator
Ziv Hospital
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 Ziv Hospital at 1 site in Israel.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 2 Dec 2017. 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 Israel. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact ariela rosenblum, BA (0508434154, ariela.r@ziv.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
self reported quality of life (time frame: two weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Dec 2017.