NCT03350438

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 19, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 22, 2017

Completed
1 month until next milestone

Study Start

First participant enrolled

January 1, 2018

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2018

Completed
Last Updated

December 2, 2017

Status Verified

October 1, 2017

Enrollment Period

7 months

First QC Date

November 19, 2017

Last Update Submit

November 30, 2017

Conditions

Post Traumatic Stress Disorder

Keywords

participationquality of lifeoccupational therapy

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Self Reported Dissociation

    24-48 hours

  • self reported participation

    1 month

  • self reported ptsd symptoms

    1 month

Study Arms (2)

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.

Eligibility Criteria

Age18 Years - 60 Years
Sexmale
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

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

You may not qualify if:

  • Other psychiatric disorders, cognitive or physical impairments.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ziv Hospital

Safed, Galilee, 13100, Israel

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Study Officials

  • Lidia Isakson, PHD

    Ziv Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

ariela rosenblum, BA

CONTACT

0508434154ariela.r@ziv.health.gov.il

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 19, 2017

First Posted

November 22, 2017

Study Start

January 1, 2018

Primary Completion

July 30, 2018

Study Completion

October 30, 2018

Last Updated

December 2, 2017

Record last verified: 2017-10

Locations

IL(1)