TOP-NET: Trajectories of Psychopathology in Response to NET

Sponsor

University of Konstanz (Other)

Overall Status

Completed

CT.gov ID

NCT02852616

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

2.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Posttraumatic Stress Disorder (PTSD)	Behavioral: Narrative Exposure Therapy	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

85 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Dec 1, 2015

Actual Primary Completion Date :

Aug 1, 2018

Actual Study Completion Date :

Aug 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Narrative Exposure Therapy Participants with a PTSD diagnosis	Behavioral: Narrative Exposure Therapy 8 - 15 sessions: 1 lifeline session, 5 - 12 sessions narrative exposure, 1-2 sessions of future-oriented counselling Other Names: NET
No Intervention: no / standard treatment Participants with a PTSD diagnosis / other mental health problems / no mental health problems

Arm

Intervention/Treatment

Active Comparator: Narrative Exposure Therapy

Participants with a PTSD diagnosis

Behavioral: Narrative Exposure Therapy

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

Other Names:

NET

No Intervention: no / standard treatment

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

Outcome Measures

Primary Outcome Measures

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

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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

12 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Konstanz	Konstanz	Baden-Württemberg	Germany	78457

Sponsors and Collaborators

University of Konstanz

Investigators

Principal Investigator: Thomas Elbert, Prof. Dr., University of Konstanz

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Prof. Dr. Thomas Elbert, Professor for Clinical Psychology and Behavioural Neuroscience, University of Konstanz

ClinicalTrials.gov Identifier:

NCT02852616

Other Study ID Numbers:

ERC-2012-AdG 323977 NET-Course

First Posted:

Aug 2, 2016

Last Update Posted:

Oct 1, 2019

Last Verified:

Oct 1, 2018

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Keywords provided by Prof. Dr. Thomas Elbert, Professor for Clinical Psychology and Behavioural Neuroscience, University of Konstanz

Course

Posttraumatic Stress Disorder

Narrative Exposure Therapy

Additional relevant MeSH terms:

Stress Disorders, Traumatic

Stress Disorders, Post-Traumatic

Study Results

No Results Posted as of Oct 1, 2019