Trajectories of Psychopathology in Response to NET

Posttraumatic Stress Disorder (PTSD) Clinical Trial

— TOP-NET  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02852616
• Other study ID #: ERC-2012-AdG 323977 NET-Course
• Status: Completed
• Phase: N/A
• Start date: December 2015
• Est. completion date: August 2018

Study information

• Verified date: October 2018
• Source: University of Konstanz
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 85
• Est. completion date: August 2018
• Est. primary completion date: August 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Posttraumatic Stress Disorder (PTSD)
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Behavioral:
• Narrative Exposure Therapy
8 - 15 sessions: 1 lifeline session, 5 - 12 sessions narrative exposure, 1-2 sessions of future-oriented counselling

Locations

Country	Name	City	State
Germany	University of Konstanz	Konstanz	Baden-Württemberg

Sponsors (1)

Lead Sponsor	Collaborator
University of Konstanz

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	baseline, 3 and 6 months follow-up
Secondary	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)	up to 1 year