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Clinical Trials/NCT02852616
NCT02852616
Completed
Not Applicable

Progression and Remittance of Traumatic Stress-related Symptoms During and After Narrative Exposure Therapy

University of Konstanz1 site in 1 country85 target enrollmentDecember 2015

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Posttraumatic Stress Disorder (PTSD)
Sponsor
University of Konstanz
Enrollment
85
Locations
1
Primary Endpoint
Change in the progression of PTSD symptoms (PCL-5)
Status
Completed
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
December 2015
End Date
August 2018
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
University of Konstanz
Responsible Party
Principal Investigator
Principal Investigator

Prof. Dr. Thomas Elbert

Professor for Clinical Psychology and Behavioural Neuroscience

University of Konstanz

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

Outcomes

Primary Outcomes

Change in the progression of PTSD symptoms (PCL-5)

Time Frame: baseline, 3 and 6 months follow-up

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

Secondary Outcomes

  • Change in the progression of emotional distress symptoms (RHS-15)(up to 1 year)

Study Sites (1)

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