Treatment of Posttraumatic Stress Disorder by Trained Lay... | NCT00550056

Studies
Treatment of Posttraumatic Stress Disorder by Trained Lay Counsellors in an African Refugee Settlement

NCT00550056

Sponsor

University of Konstanz

Status

Completed

Last Update Posted

Oct 26, 2007Estimated

Enrollment

277Actual

Phase

Phase 3

Conditions

Posttraumatic Stress Disorder

Interventions

Narrative Exposure Therapy
Trauma Counselling

Countries

Uganda

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

Oct 2007

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

Jan 2003

Primary Completion Date

Not provided

Completion Date

Apr 2004Actual

First Submitted Date

Oct 25, 2007

First Submission Date that Met QC Criteria

Oct 25, 2007

First Posted Date

Oct 26, 2007Estimated

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

Oct 25, 2007

Last Update Posted Date

Oct 26, 2007Estimated

Name	Class
German Research Foundation	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

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

The study is a pragmatic trial to study the efficacy of two active methods of psychotherapy for the treatment of posttraumatic stress disorder in a refugee camp in Africa. Treatment was administered by lay counsellors.

Detailed Description

Traumatic stress due to conflict and war causes major mental health problems in many resource-poor countries, especially those coping with displaced populations. There is a lack of intervention research in these populations.

Te purpose of this study was to examine whether trained lay counsellors can carry out effective treatment of PTSD in a refugee settlement.

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

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

277Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	NET	Behavioral: Narrative Exposure Therapy
2	Experimental	TC	Behavioral: Trauma Counselling
3	No Intervention	Monitoring Group

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Narrative Exposure Therapy	Behavioral	Six session of Narrative Exposure Therapy	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Posttraumatic Stress Symptoms measured with the Posttraumatic Diagnostic Scale		9 months

Secondary Outcomes

Measure	Description	Time Frame
Expert diagnosis of PTSD established with CIDI interview		9 months
Physical health symptoms assessed with a checklist		9 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Diagnosis of posttraumatic stress disorder

Exclusion Criteria:

Drug abuse
Psychosis
Mental retardation

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Thomas Elbert, PhD	University of Konstanz	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Nakivale Refugee Camp		Mbarara	Mbarara		Uganda

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