Clinical trial NCT02852616: Trajectories of Psychopathology in Response to NET
Official title: Progression and Remittance of Traumatic Stress-related Symptoms During and After Narrative Exposure Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Posttraumatic Stress Disorder (PTSD)
Keywords: Course
Posttraumatic Stress Disorder
Narrative Exposure Therapy
Lead sponsor: University of Konstanz
Sponsor class: OTHER
First posted: 2016-08-02
Enrollment: 85
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in the progression of PTSD symptoms (PCL-5)
timeFrame: baseline, 3 and 6 months follow-up
Secondary outcomes:
measure: Change in the progression of emotional distress symptoms (RHS-15)
timeFrame: up to 1 year
Other outcomes:
Locations:
city: Konstanz
country: Germany
facility: University of Konstanz
state: Baden-Württemberg
Study officials:
affiliation: University of Konstanz
name: Thomas Elbert, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
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.