Clinical trial NCT02517723: Narrative Exposure Therapy in Women With Borderline Personality Disorder and Posttraumatic Stress Disorder
Official title: A Randomized Controlled Clinical Trial (RCCT) to Test the Effectiveness of Narrative Exposure Therapy (NET) Versus Dialectical-Behavioral Therapy in Reducing Trauma Related Symptoms in Women Suffering From Borderline Personality Disorder (BPD) and Posttraumatic Stress Disorder (PTSD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Borderline Personality Disorder
Stress Disorders, Post-Traumatic
Keywords: Borderline Personality Disorder
comorbid Posttraumatic Stress Disorder
Narrative Exposure Therapy
Dialectical-Behavioral Therapy
Lead sponsor: Evangelisches Krankenhaus Bielefeld gGmbH
Sponsor class: OTHER
First posted: 2015-08-07
Enrollment: 67
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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).


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change from first investigation in Posttraumatic Symptom Severity at 18 months (Clinician-Administered PTSD Scale; CAPS)
timeFrame: first investigation (t1), after waiting list (3 months, t2), directly after therapy (3 months, t1), 1 year after therapy (15 months, t3)
Secondary outcomes:
measure: Change from first investigation in Borderline Symptome Severity at 18 months(Borderline Symptom Liste; BSL)
timeFrame: first investigation (t1), after waiting list (3 months, t2), directly after therapy (6 months, t3), 1 year after therapy (18 months, t4)
measure: Change from first investigation in Severity of Dissociative Symptoms at 18 months (Fragebogen zu Dissoziativen Symptome ;FDS)
timeFrame: first investigation (t1), after waiting list (3 months, t2), directly after therapy (6 months, t3), 1 year after therapy (18 months, t4)
measure: Change from first investigation in Severity of Depressive Symptoms at 18 months (Becks Depressions Inventar II, BDI-II)
timeFrame: first investigation (t1), after waiting list (3 months, t2), directly after therapy (6 months, t3), 1 year after therapy (18 months, t4)
measure: Change from first investigation in Quality of Life at 12 months (WHO-Qualitiy of Life; WHOQOL)
timeFrame: first investigation (t1), after waiting list (3 months, t2), directly after therapy (6 months, t3), 1 year after therapy (18 months, t4)
Other outcomes:
Locations:
city: Bielefeld
country: Germany
facility: Clinic of Psychiatry, Evangelisches Krankenhaus Bielefeld
Study officials:
affiliation: Clinic of Psychiatry, Evangelisches Krankenhaus Bielefeld
name: Carolin Steuwe, M.Sc.
role: STUDY_DIRECTOR
affiliation: Clinic of Psychiatry, Evangelisches Krankenhaus Bielefeld
name: Martin Driessen, Prof. Dr. med.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.