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Trajectories of Psychopathology in Response to NET (TOP-NET)

Primary Purpose

Posttraumatic Stress Disorder (PTSD)

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Narrative Exposure Therapy
Sponsored by
University of Konstanz
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Posttraumatic Stress Disorder (PTSD) focused on measuring Course, Posttraumatic Stress Disorder, Narrative Exposure Therapy

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • For treatment group: PTSD diagnosis (DSM-IV or V)
  • For non-treatment group: none

Exclusion Criteria:

  • Acute psychosis
  • Cerebro-organic disease
  • Acute drug or alcohol intoxication
  • Already receiving another psychotherapy
  • Anti-epileptic drugs at baseline

Sites / Locations

  • University of Konstanz

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Narrative Exposure Therapy

no / standard treatment

Arm Description

Participants with a PTSD diagnosis

Participants with a PTSD diagnosis / other mental health problems / no mental health problems

Outcomes

Primary Outcome Measures

Change in the progression of PTSD symptoms (PCL-5)
PTSD symptoms are measured with the PTSD Checklist - 5 (PCL-5; Weathers, Litz, et al., 2013)

Secondary Outcome Measures

Change in the progression of emotional distress symptoms (RHS-15)
Emotional distress symptoms are measured with the Refugee Health Screener - 15 (RHS-15; Hollifield, et al., 2013)

Full Information

First Posted
June 1, 2016
Last Updated
September 29, 2019
Sponsor
University of Konstanz
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1. Study Identification

Unique Protocol Identification Number
NCT02852616
Brief Title
Trajectories of Psychopathology in Response to NET
Acronym
TOP-NET
Official Title
Progression and Remittance of Traumatic Stress-related Symptoms During and After Narrative Exposure Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
December 2015 (Actual)
Primary Completion Date
August 2018 (Actual)
Study Completion Date
August 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Konstanz

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Narrative Exposure Therapy (NET) has been proven to be effective in the treatment of Posttraumatic Stress Disorder (PTSD) and trauma-related depression in more than a dozen controlled clinical trials. Symptom reduction was greatest during long-term follow-ups after the completion of the therapy. In the current study, we will investigate the progression of PTSD symptoms and emotional stress before, during and after therapy. After a semi-structured interview all participants will be asked to report in monthly telephone interviews their core symptoms. Structured interviews after 6 and 12 months are used to validate the outcome. A convenience sample of individuals with a PTSD will be offered participation in the study.
Detailed Description
Participants will be recruited through the Center of Excellence for Psychotraumatology, University of Konstanz, with focus on refugees. All of them (approx. 100) will receive a structured interview and a detailed diagnosis. The interview includes questions about sociodemography, traumatic events, PTSD and depression symptomatology. Individuals with a PTSD diagnosis (up to 30) will be offered a Narrative Exposure Therapy (NET). Irrespective of treatment and diagnosis, respondents are asked to participate in monthly telephone interviews assessing trauma-related and emotional distress and changes in life. Interviews assessing PTSD, depression symptoms and emotional distress will be conducted 6 and 12 months after the initial interview. In addition, participants receiving NET will rate their PTSD symptoms and functionality prior to each therapy session.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Posttraumatic Stress Disorder (PTSD)
Keywords
Course, Posttraumatic Stress Disorder, Narrative Exposure Therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
85 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Narrative Exposure Therapy
Arm Type
Active Comparator
Arm Description
Participants with a PTSD diagnosis
Arm Title
no / standard treatment
Arm Type
No Intervention
Arm Description
Participants with a PTSD diagnosis / other mental health problems / no mental health problems
Intervention Type
Behavioral
Intervention Name(s)
Narrative Exposure Therapy
Other Intervention Name(s)
NET
Intervention Description
8 - 15 sessions: 1 lifeline session, 5 - 12 sessions narrative exposure, 1-2 sessions of future-oriented counselling
Primary Outcome Measure Information:
Title
Change in the progression of PTSD symptoms (PCL-5)
Description
PTSD symptoms are measured with the PTSD Checklist - 5 (PCL-5; Weathers, Litz, et al., 2013)
Time Frame
baseline, 3 and 6 months follow-up
Secondary Outcome Measure Information:
Title
Change in the progression of emotional distress symptoms (RHS-15)
Description
Emotional distress symptoms are measured with the Refugee Health Screener - 15 (RHS-15; Hollifield, et al., 2013)
Time Frame
up to 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: For treatment group: PTSD diagnosis (DSM-IV or V) For non-treatment group: none Exclusion Criteria: Acute psychosis Cerebro-organic disease Acute drug or alcohol intoxication Already receiving another psychotherapy Anti-epileptic drugs at baseline
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Elbert, Prof. Dr.
Organizational Affiliation
University of Konstanz
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Konstanz
City
Konstanz
State/Province
Baden-Württemberg
ZIP/Postal Code
78457
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32552778
Citation
Kaltenbach E, Hermenau K, Schauer M, Dohrmann K, Elbert T, Schalinski I. Trajectories of posttraumatic stress symptoms during and after Narrative Exposure Therapy (NET) in refugees. BMC Psychiatry. 2020 Jun 17;20(1):312. doi: 10.1186/s12888-020-02720-y.
Results Reference
derived

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Trajectories of Psychopathology in Response to NET

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