Immunological Changes Through Narrative Treatment of Post... | NCT01206790

Studies
Immunological Changes Through Narrative Treatment of Post-Traumatic Stress Disorder (PTSD) in Torture Victims

NCT01206790

Sponsor

University of Konstanz

Status

Completed

Last Update Posted

Feb 22, 2012Estimated

Enrollment

47Actual

Phase

Not Applicable

Conditions

PTSD

Interventions

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2009

Primary Completion Date

May 2011Actual

Completion Date

Jan 2012Actual

First Submitted Date

Sep 21, 2010

First Submission Date that Met QC Criteria

Sep 21, 2010

First Posted Date

Sep 22, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 21, 2012

Last Update Posted Date

Feb 22, 2012Estimated

Name	Class
German Research Foundation	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Posttraumatic stress disorder (PTSD) is associated with poor health, high health care utilization, and an increased risk for a variety of somatic, inflammatory and autoimmune diseases. Research, including our own findings, indicates immunological alterations in PTSD patients. The aim of this study is to investigate whether alterations in the immune system of PTSD patients are reversible through a trauma-specific short-term therapy (Narrative Exposure Therapy).

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

47Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Narrative Exposure Therapy (NET)	Experimental		Behavioral: NET
Waitinglist Control Group	No Intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
NET	Behavioral	Narrative Exposure Therapy for traumatized survivors of organized violence	Narrative Exposure Therapy (NET)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
PTSD diagnosis and severity score according to the Clinicians Administered PTSD Scale (CAPS)		4 month after completion of treatment

Secondary Outcomes

Measure	Description	Time Frame
changes in immunological parameters		4 months after completion of treatment

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

PTSD diagnosis
experiences of organized violence/torture

Exclusion Criteria:

psychotic disorder
chronic inflammatory diseases

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

16 Years

Maximum Age

60 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Iris-Tatjana Kolassa, Prof. Dr.	University of Ulm	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Konstanz, Department of Psychology		Konstanz		78467	Germany

Condition Browse Module

MeSH Terms

ID	Term
D013313	Stress Disorders, Post-Traumatic

Ancestor Terms

ID	Term
D040921	Stress Disorders, Traumatic
D000068099	Trauma and Stressor Related Disorders
D001523	Mental Disorders

Browse Leaves

Not provided

Browse Branches

Not provided