Post Traumatic Stress DisorderNCT00521768
Effectiveness of Prolonged Exposure of PTSD in a Community Setting of PTSD Sufferers
A study testing Prolonged exposure in people with Post Traumatic Stress Disorder and Anxiety Disorder, run by HaEmek Medical Center, Israel at 1 site in Israel.
Trial summary
Introduction: Efforts to bridge the gap between research based treatment modalities advancements and clinical practice have received the highest priority in the research community. In the child psychiatry field there is an urging need to promote bridging this gap. Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Post Traumatic Stress Disorder, Anxiety Disorder
- What is being tested?
- Prolonged exposure
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 0 participants
- Where
- 1 siteIsrael
- Study dates
- Start not givento not given
- Phase
- Interventional
- 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 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Children age 6 to 18
- Language spoken: Hebrew
- DSM- IV R diagnosis: PTSD
- Anxiety disorder
Who cannot join
- Children presenting with psychotic symptoms,
- Children presenting with mental retardation
Trial locations and contacts
1 site in 1 country.
About this study
Introduction: Efforts to bridge the gap between research based treatment modalities advancements and clinical practice have received the highest priority in the research community. In the child psychiatry field there is an urging need to promote bridging this gap.
Parents and child health providers hesitate to refer children to child psychiatrist due to stigma but also due to lack of awareness of available and efficient treatment options. In the field of trauma treatment another reason for lack of treatment is lack of recognition of trauma related symptoms in children.
Read more
After the second Lebanon war scarce referrals to psychiatric clinics have been registered and access to treatment is low as indicated by 20 referrals in the past year to Emek Hospital.
We propose to explore the effectiveness of well-established adult treatment for PTSD, the Prolonged Exposure (PE), in community-based general pediatric clinics, serving an underprivileged diverse population.
Methods:
Twenty children age 6 to 18 attending general pediatric clinic and in Afula region will included.
children will be diagnosed using the Hebrew translation of the Childhood version of the Schedule for Affective Disorders and Schizophrenia (Apter et al., 1989 Children will receive the Children's Depression Inventory (CDI) and the. CPSS All subjects will be treated with a manualized 12-week Prolonged Exposure protocol Ratings will be made at baseline, 6weeks, and 12 weeks using CDI and CPSS
Hypothesis:
- PE adapted for pediatric population will be effective in treating single-event traumas in a community setting.
Read the detailed description
SPECIFIC AIMS The aim of the study is to examine the effectiveness of PE treatment of PTSD in community settings
BACKGROUND AND SIGNIFICANCE There is a great need to apply scientific achievements in behavioral science research to community-based clinical settings. Many recent advances in psychology with significant potential to improve clinical practice and intervention have not yet been utilized in clinical settings.
A recent report of the NIH National Advisory Mental Health Council Behavioral Science Workgroup has defined this approach, "Translational research", as follows: "Translational research in the behavioral and social sciences addresses how basic behavioral processes inform the diagnosis, prevention, treatment and delivery of services for mental illness, and conversely, how knowledge of mental illness increases our understanding of basic behavioral processes. " (NIH publication, 2001).
PTSD in children is a well established diagnosis.Recent studies have shown 30 % of children presenting with PTSD symptoms after the second Lebanon war Parents and child health providers hesitate to refer children to child psychiatrist due to stigma but also due to lack of awareness of available and efficient treatment options. In the field of trauma treatment another reason for lack of treatment is lack of recognition of trauma related symptoms in children.
After the second Lebanon war scarce referrals to psychiatric clinics have been registered and access to treatment is low as indicated by 20 referrals in the past year to Ha'Emek Medical Center child and adolescent psychiatric clinic.
Ha'Emek medical center is initiating a community base PTSD treatment program to children attending general pediatric clinics.
We propose to explore the effectiveness of well-established adult treatment for PTSD, the Prolonged Exposure (PE), in community-based general pediatric clinics, serving an underprivileged diverse population.
RESEARCH DESIGN AND METHODS Subjects: Twenty children age 6 to 18 referred to the community base PTSD treatment program offered by the Ha'Emek medical center in Afula will be include: All families referred to the PTSD treatment program will be offered to participate in the research protocol. We expect 50 families to be included in the treatment program. Only subject whose both parents will agree for inclusion in the research program will be included.
DSM- IV R diagnosis: PTSD Evaluation/Instruments Socio-Demographics Data: Child: Age, Sex, grade level and medical history. Parents: Age, marital status, ethnic background, country of birth, language spoken at home, education level, occupational status.
Trauma History: Type of trauma, distance from Katushe fall Kiddy SADS: a semi structural interview CDI: a self report questionnaire CPSS: a self report questionnaire
Procedures:
Parents will be informed of the goals of the study by their primary child health provider, and will be offered the opportunity to meet with the mental health worker prior to enrollment.. Parents will be told that their participation in the research is voluntary and anonymous and their refusal to participate will not affect the services they receive by the project.
Children who will be diagnosed as having PTSD will be offered 12 sessions treatment by PE.
CDI and CPSS will be scored at time 0, time 6 weeks and time 12 weeks
- Conditions
- Post Traumatic Stress Disorder, Anxiety Disorder
- Being tested
- Prolonged exposure
- Keywords
- Post traumatic stress disorder, Anxiety disorder, Comunity base intervention, Education, Behavioural treatment
- Medical subject headings
- Stress Disorders, Post-Traumatic, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prolonged exposureBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
CDI questionaire
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2007 (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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- HaEmek Medical Center, Israel
- Sponsor type
- University, hospital or other
- Investigators
- Ziva Bracha, MD, Principal investigator, HaEmek MC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00521768
- Sponsor's protocol ID
- CT20
- Status last verified
- Jul 2015
- First submitted
- 27 Aug 2007
- Last updated
- 7 Jul 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Prolonged Exposure of PTSD in a Community Setting of PTSD Sufferers
- ClinicalTrials.gov ID
- NCT00521768
- Acronym / sponsor ID
- CT20
- Conditions
- Post Traumatic Stress Disorder, Anxiety Disorder
- Keywords
- Post traumatic stress disorder, Anxiety disorder, Comunity base intervention, Education, Behavioural treatment
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- HaEmek Medical Center, IsraelUniversity, hospital or other
- First posted
- 28 Aug 2007 (estimated)
- 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.
Introduction: Efforts to bridge the gap between research based treatment modalities advancements and clinical practice have received the highest priority in the research community. In the child psychiatry field there is an urging need to promote bridging this gap.
Parents and child health providers hesitate to refer children to child psychiatrist due to stigma but also due to lack of awareness of available and efficient treatment options. In the field of trauma treatment another reason for lack of treatment is lack of recognition of trauma related symptoms in children.
After the second Lebanon war scarce referrals to psychiatric clinics have been registered and access to treatment is low as indicated by 20 referrals in the past year to Emek Hospital.
We propose to explore the effectiveness of well-established adult treatment for PTSD, the Prolonged Exposure (PE), in community-based general pediatric clinics, serving an underprivileged diverse population.
Methods:
Twenty children age 6 to 18 attending general pediatric clinic and in Afula region will included.
children will be diagnosed using the Hebrew translation of the Childhood version of the Schedule for Affective Disorders and Schizophrenia (Apter et al., 1989 Children will receive the Children's Depression Inventory (CDI) and the. CPSS All subjects will be treated with a manualized 12-week Prolonged Exposure protocol Ratings will be made at baseline, 6weeks, and 12 weeks using CDI and CPSS
Hypothesis:
- PE adapted for pediatric population will be effective in treating single-event traumas in a community setting.
Detailed description
SPECIFIC AIMS The aim of the study is to examine the effectiveness of PE treatment of PTSD in community settings
BACKGROUND AND SIGNIFICANCE There is a great need to apply scientific achievements in behavioral science research to community-based clinical settings. Many recent advances in psychology with significant potential to improve clinical practice and intervention have not yet been utilized in clinical settings.
A recent report of the NIH National Advisory Mental Health Council Behavioral Science Workgroup has defined this approach, "Translational research", as follows: "Translational research in the behavioral and social sciences addresses how basic behavioral processes inform the diagnosis, prevention, treatment and delivery of services for mental illness, and conversely, how knowledge of mental illness increases our understanding of basic behavioral processes. " (NIH publication, 2001).
PTSD in children is a well established diagnosis.Recent studies have shown 30 % of children presenting with PTSD symptoms after the second Lebanon war Parents and child health providers hesitate to refer children to child psychiatrist due to stigma but also due to lack of awareness of available and efficient treatment options. In the field of trauma treatment another reason for lack of treatment is lack of recognition of trauma related symptoms in children.
After the second Lebanon war scarce referrals to psychiatric clinics have been registered and access to treatment is low as indicated by 20 referrals in the past year to Ha'Emek Medical Center child and adolescent psychiatric clinic.
Ha'Emek medical center is initiating a community base PTSD treatment program to children attending general pediatric clinics.
We propose to explore the effectiveness of well-established adult treatment for PTSD, the Prolonged Exposure (PE), in community-based general pediatric clinics, serving an underprivileged diverse population.
RESEARCH DESIGN AND METHODS Subjects: Twenty children age 6 to 18 referred to the community base PTSD treatment program offered by the Ha'Emek medical center in Afula will be include: All families referred to the PTSD treatment program will be offered to participate in the research protocol. We expect 50 families to be included in the treatment program. Only subject whose both parents will agree for inclusion in the research program will be included.
DSM- IV R diagnosis: PTSD Evaluation/Instruments Socio-Demographics Data: Child: Age, Sex, grade level and medical history. Parents: Age, marital status, ethnic background, country of birth, language spoken at home, education level, occupational status.
Trauma History: Type of trauma, distance from Katushe fall Kiddy SADS: a semi structural interview CDI: a self report questionnaire CPSS: a self report questionnaire
Procedures:
Parents will be informed of the goals of the study by their primary child health provider, and will be offered the opportunity to meet with the mental health worker prior to enrollment.. Parents will be told that their participation in the research is voluntary and anonymous and their refusal to participate will not affect the services they receive by the project.
Children who will be diagnosed as having PTSD will be offered 12 sessions treatment by PE.
CDI and CPSS will be scored at time 0, time 6 weeks and time 12 weeks
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Children age 6 to 18
- Language spoken: Hebrew
- DSM- IV R diagnosis: PTSD
- Anxiety disorder
Key exclusion criteria (2 listed)
- Children presenting with psychotic symptoms,
- Children presenting with mental retardation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prolonged exposure | Behavioural | – |
Primary outcome
CDI questionaire
Time frame: 12 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2015.
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.
Ziva Bracha, MD principal investigator
HaEmek MC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prolonged exposure in people with Post Traumatic Stress Disorder and Anxiety Disorder, run by HaEmek Medical Center, Israel 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 4 inclusion and 2 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: withdrawn, as of the sponsor's last update on 7 Jul 2015. 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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CDI questionaire (time frame: 12 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 7 Jul 2015.