Trajectories of Psychopathology in Response to NET

NCT ID: NCT02852616

Last Updated: 2019-10-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

85 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-12-31

Study Completion Date

2018-08-31

Brief Summary

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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

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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.

Conditions

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Posttraumatic Stress Disorder (PTSD)

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Narrative Exposure Therapy

Participants with a PTSD diagnosis

Group Type ACTIVE_COMPARATOR

Narrative Exposure Therapy

Intervention Type BEHAVIORAL

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

no / standard treatment

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Narrative Exposure Therapy

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

Intervention Type BEHAVIORAL

Other Intervention Names

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NET

Eligibility Criteria

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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
Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Konstanz

OTHER

Sponsor Role lead

Responsible Party

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Prof. Dr. Thomas Elbert

Professor for Clinical Psychology and Behavioural Neuroscience

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Thomas Elbert, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

University of Konstanz

Locations

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University of Konstanz

Konstanz, Baden-Wurttemberg, Germany

Site Status

Countries

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Germany

References

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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.

Reference Type DERIVED
PMID: 32552778 (View on PubMed)

Other Identifiers

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ERC-2012-AdG 323977 NET-Course

Identifier Type: -

Identifier Source: org_study_id

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