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OpenTrials
Completed

NCT Number: NCT02852616

Trajectories of Psychopathology in Response to NET

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.

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Key information

Conditions

Posttraumatic Stress Disorder (PTSD) Mental Disorders Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma and Stressor Related Disorders

Age range

12 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Konstanz

Konstanz, Baden-Wurttemberg, 78457, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Narrative Exposure Therapy

Behavioral

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

Other names: NET

Primary outcomes

  1. 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

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

    Time frame: up to 1 year

    Emotional distress symptoms are measured with the Refugee Health Screener - 15 (RHS-15; Hollifield, et al., 2013)

Sponsors and collaborators

Lead sponsor

University of Konstanz

Other

Registry information

Official study title

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

Acronym: TOP-NET

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Aug 2, 2016
Registry last updated
Oct 1, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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