Trajectories of Psychopathology in Response to NET

NCT02852616 | Completed DMC

• 1 other identifier: ERC-2012-AdG 323977 NET-Course
• Study Type: interventional
• Target: 85
• Locations: 1 country
• Sites: 1

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.

Conditions

Posttraumatic Stress Disorder (PTSD)

Keywords

Course; Posttraumatic Stress Disorder; Narrative Exposure Therapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Change in the progression of emotional distress symptoms (RHS-15)

  up to 1 year

Study Arms (2)

Narrative Exposure Therapy

ACTIVE COMPARATOR

Participants with a PTSD diagnosis

Behavioral: Narrative Exposure Therapy

no / standard treatment

NO INTERVENTION

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

Interventions

Narrative Exposure Therapy BEHAVIORAL

8 - 15 sessions: 1 lifeline session, 5 - 12 sessions narrative exposure, 1-2 sessions of future-oriented counselling

Also known as: NET

Narrative Exposure Therapy

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Konstanz: lead

Study Sites (1)

University of Konstanz

Konstanz, Baden-Wurttemberg, 78457, Germany

Location

Related Publications (1)

• 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.

  PMID: 32552778 DERIVED

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Officials

• Thomas Elbert, Prof. Dr.

  University of Konstanz

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor for Clinical Psychology and Behavioural Neuroscience

Study Record Dates

• First Submitted: June 1, 2016
• First Posted: August 2, 2016
• Study Start: December 1, 2015
• Primary Completion: August 1, 2018
• Study Completion: August 1, 2018
• Last Updated: October 1, 2019

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)