NCT02517723

Brief Summary

Narrative Exposure Therapy (NET) is an evidence-based trauma-focussed treatment, suitable for survivors of prolonged and repeated exposure to traumatic stress and childhood adversity. Patients with Borderline Personality Disorder (BPD) often suffer from a comorbid Posttraumatic Stress Disorder (PTSD) caused by multiple traumatic events. Therapeutic aims are the reduction of PTSD-Symptoms in these patients via activation of associative neural networks related to traumatic experiences and habituation of fear and the placement of traumatic experiences in a reconstructed, detailed and consistent autobiography. This practice enables the processing of and coping with painful memories and the construction of clear contingencies of dangerous and safe conditions, generally leading to significant emotional recovery. The investigators assume that using NET the reduction of PTSD symptom severity is greater compared to treatment by Dialectical-Behavioral Therapy (DBT).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
67

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 6, 2014

Completed
3 months until next milestone

Study Start

First participant enrolled

April 1, 2014

Completed
1.4 years until next milestone

First Posted

Study publicly available on registry

August 7, 2015

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2020

Completed
Last Updated

October 8, 2021

Status Verified

October 1, 2021

Enrollment Period

5.8 years

First QC Date

January 6, 2014

Last Update Submit

October 7, 2021

Conditions

Keywords

Borderline Personality Disordercomorbid Posttraumatic Stress DisorderNarrative Exposure TherapyDialectical-Behavioral Therapy

Outcome Measures

Primary Outcomes (1)

  • Change from first investigation in Posttraumatic Symptom Severity at 18 months (Clinician-Administered PTSD Scale; CAPS)

    first investigation (t1), after waiting list (3 months, t2), directly after therapy (3 months, t1), 1 year after therapy (15 months, t3)

Secondary Outcomes (4)

  • Change from first investigation in Borderline Symptome Severity at 18 months(Borderline Symptom Liste; BSL)

    first investigation (t1), after waiting list (3 months, t2), directly after therapy (6 months, t3), 1 year after therapy (18 months, t4)

  • Change from first investigation in Severity of Dissociative Symptoms at 18 months (Fragebogen zu Dissoziativen Symptome ;FDS)

    first investigation (t1), after waiting list (3 months, t2), directly after therapy (6 months, t3), 1 year after therapy (18 months, t4)

  • Change from first investigation in Severity of Depressive Symptoms at 18 months (Becks Depressions Inventar II, BDI-II)

    first investigation (t1), after waiting list (3 months, t2), directly after therapy (6 months, t3), 1 year after therapy (18 months, t4)

  • Change from first investigation in Quality of Life at 12 months (WHO-Qualitiy of Life; WHOQOL)

    first investigation (t1), after waiting list (3 months, t2), directly after therapy (6 months, t3), 1 year after therapy (18 months, t4)

Study Arms (2)

SIC + NET

EXPERIMENTAL

Waiting List + Standard Inpatient Care + Narrative Exposure Therapy

Behavioral: Narrative Exposure TherapyBehavioral: Standard Inpatient CareOther: Waiting List

SIC + DBT

ACTIVE COMPARATOR

Waiting List + Standard Inpatient Care + Dialectical Behavior Therapy

Behavioral: Dialectical Behavior TherapyBehavioral: Standard Inpatient CareOther: Waiting List

Interventions

Narrative Exposure Therapy (NET) is based on Testimony Therapy in combination with cognitive behavioural exposure techniques and elements of client-centered counselling. The clients can restore their autobiographic memories about their traumatic experiences. In this way fragmentary memories are transformed into a coherent narrative structure. This practice enables the processing of painful emotions and the construction of clear contingencies of dangerous and safe conditions, generally leading to significant emotional recovery. Therapeutic aims are the reduction of PTSD-Symptomload via activation of fear-network and habituation of fear and the placement of traumatic experiences in a reconstructed, detailed and consistent autobiography. NET will be applied in eight sessions (90-120min/session) in a standardized, manualized manner.

Also known as: NET
SIC + NET

Dialectical behavior therapy is a cognitive behavioral treatment program developed by Marsha Linehan to treat suicidal clients meeting criteria for BPD. It directly targets suicidal behavior, behaviors that interfere with treatment delivery, and other dangerous, severe, or destabilizing behaviors. Via standard DBT patients improve behavioral capabilities, motivation for skillful behavior, generalization of gains to the natural environment, structuring the treatment environment so that it reinforces functional rather than dysfunctional behaviors. It also targets the therapist capabilities and motivation to treat patients effectively. Patients get weekly individual psychotherapy (1 h/wk), group skills training (3.75 h/wk), a weekly therapist consultation team meetings.

Also known as: DBT
SIC + DBT

Unspecific group therapy that is identical in both groups (music therapy etc.)

Also known as: SIC
SIC + DBTSIC + NET

Treatment as usual in the community (no DBT, no exposure of trauma memories)

SIC + DBTSIC + NET

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age ≥ 18 years
  • DSM-IV-TR diagnoses of BPD and PTSD
  • legal competence
  • none or stable medication
  • illegal drug abstinence for at least the last 6 months
  • capacity to consent and contract

You may not qualify if:

  • other severe mental disorders (e.g., bipolar disorder, acute psychosis)
  • simultaneous consumption of drugs
  • simultaneous participation in other treatment-studies
  • pregnancy or breastfeeding
  • lack of capability to negotiate a no-suicide agreement
  • suicide attempt or attempts during the 8 weeks prior to start of treatment
  • perpetrator-contact
  • Body Mass Index (BMI) \< 16

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinic of Psychiatry, Evangelisches Krankenhaus Bielefeld

Bielefeld, 33617, Germany

Location

Related Publications (3)

  • Steuwe C, Berg M, Beblo T, Driessen M. Narrative Exposure Therapy in Patients With Posttraumatic Stress Disorder and Borderline Personality Disorder in a Naturalistic Residential Setting: A Randomized Controlled Trial. Front Psychiatry. 2021 Nov 26;12:765348. doi: 10.3389/fpsyt.2021.765348. eCollection 2021.

  • Storebo OJ, Stoffers-Winterling JM, Vollm BA, Kongerslev MT, Mattivi JT, Jorgensen MS, Faltinsen E, Todorovac A, Sales CP, Callesen HE, Lieb K, Simonsen E. Psychological therapies for people with borderline personality disorder. Cochrane Database Syst Rev. 2020 May 4;5(5):CD012955. doi: 10.1002/14651858.CD012955.pub2.

  • Steuwe C, Rullkotter N, Ertl V, Berg M, Neuner F, Beblo T, Driessen M. Effectiveness and feasibility of Narrative Exposure Therapy (NET) in patients with borderline personality disorder and posttraumatic stress disorder - a pilot study. BMC Psychiatry. 2016 Jul 20;16:254. doi: 10.1186/s12888-016-0969-4.

MeSH Terms

Conditions

Borderline Personality DisorderStress Disorders, Post-Traumatic

Interventions

Dialectical Behavior TherapyWaiting Lists

Condition Hierarchy (Ancestors)

Personality DisordersMental DisordersStress Disorders, TraumaticTrauma and Stressor Related Disorders

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and ActivitiesAppointments and SchedulesOrganization and AdministrationHealth Services Administration

Study Officials

  • Carolin Steuwe, M.Sc.

    Clinic of Psychiatry, Evangelisches Krankenhaus Bielefeld

    STUDY DIRECTOR
  • Martin Driessen, Prof. Dr. med.

    Clinic of Psychiatry, Evangelisches Krankenhaus Bielefeld

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Martin Driessen, Prof. Dr. med.

Study Record Dates

First Submitted

January 6, 2014

First Posted

August 7, 2015

Study Start

April 1, 2014

Primary Completion

January 31, 2020

Study Completion

January 31, 2020

Last Updated

October 8, 2021

Record last verified: 2021-10

Locations