Trajectories of Psychopathology in Response to NET

Not Applicable

Completed

• Conditions: Posttraumatic Stress Disorder (PTSD)
• Interventions: Behavioral: Narrative Exposure Therapy

• Registration Number: NCT02852616
• Lead Sponsor: University of Konstanz

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.

Study Timeline

• Study Start: 2015-12
• Study First Submitted: 2016-06-01
• Study First Submitted QC: 2016-08-01
• Study First Posted: 2016-08-02
• Primary Completion: 2018-08
• Study Completion: 2018-08
• Status Verified: 2018-10
• Last Update Submitted: 2019-09-29
• Last Update Posted: 2019-10-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 85

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Narrative Exposure Therapy	Narrative Exposure Therapy	Participants with a PTSD diagnosis

Primary Outcome Measures

Name	Time	Method
Change in the progression of PTSD symptoms (PCL-5)	baseline, 3 and 6 months follow-up	PTSD symptoms are measured with the PTSD Checklist - 5 (PCL-5; Weathers, Litz, et al., 2013)

Secondary Outcome Measures

Name	Time	Method
Change in the progression of emotional distress symptoms (RHS-15)	up to 1 year	Emotional distress symptoms are measured with the Refugee Health Screener - 15 (RHS-15; Hollifield, et al., 2013)

Trial Locations

Locations (1)

University of Konstanz; 🇩🇪 Konstanz, Baden-Württemberg, Germany