Narrative Exposure Therapy in Women With Borderline Personality Disorder and Posttraumatic Stress Disorder
Primary Purpose
Borderline Personality Disorder, Stress Disorders, Post-Traumatic
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Narrative Exposure Therapy
Dialectical Behavior Therapy
Standard Inpatient Care
Waiting List
Sponsored by
About this trial
This is an interventional treatment trial for Borderline Personality Disorder focused on measuring Borderline Personality Disorder, comorbid Posttraumatic Stress Disorder, Narrative Exposure Therapy, Dialectical-Behavioral Therapy
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
Sites / Locations
- Clinic of Psychiatry, Evangelisches Krankenhaus Bielefeld
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
SIC + NET
SIC + DBT
Arm Description
Waiting List + Standard Inpatient Care + Narrative Exposure Therapy
Waiting List + Standard Inpatient Care + Dialectical Behavior Therapy
Outcomes
Primary Outcome Measures
Change from first investigation in Posttraumatic Symptom Severity at 18 months (Clinician-Administered PTSD Scale; CAPS)
Secondary Outcome Measures
Change from first investigation in Borderline Symptome Severity at 18 months(Borderline Symptom Liste; BSL)
Change from first investigation in Severity of Dissociative Symptoms at 18 months (Fragebogen zu Dissoziativen Symptome ;FDS)
Change from first investigation in Severity of Depressive Symptoms at 18 months (Becks Depressions Inventar II, BDI-II)
Change from first investigation in Quality of Life at 12 months (WHO-Qualitiy of Life; WHOQOL)
Full Information
NCT ID
NCT02517723
First Posted
January 6, 2014
Last Updated
October 7, 2021
Sponsor
Evangelisches Krankenhaus Bielefeld gGmbH
1. Study Identification
Unique Protocol Identification Number
NCT02517723
Brief Title
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
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
April 2014 (Actual)
Primary Completion Date
January 31, 2020 (Actual)
Study Completion Date
January 31, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Evangelisches Krankenhaus Bielefeld gGmbH
4. Oversight
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Borderline Personality Disorder, Stress Disorders, Post-Traumatic
Keywords
Borderline Personality Disorder, comorbid Posttraumatic Stress Disorder, Narrative Exposure Therapy, Dialectical-Behavioral Therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
67 (Actual)
8. Arms, Groups, and Interventions
Arm Title
SIC + NET
Arm Type
Experimental
Arm Description
Waiting List + Standard Inpatient Care + Narrative Exposure Therapy
Arm Title
SIC + DBT
Arm Type
Active Comparator
Arm Description
Waiting List + Standard Inpatient Care + Dialectical Behavior Therapy
Intervention Type
Behavioral
Intervention Name(s)
Narrative Exposure Therapy
Other Intervention Name(s)
NET
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Dialectical Behavior Therapy
Other Intervention Name(s)
DBT
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Standard Inpatient Care
Other Intervention Name(s)
SIC
Intervention Description
Unspecific group therapy that is identical in both groups (music therapy etc.)
Intervention Type
Other
Intervention Name(s)
Waiting List
Intervention Description
Treatment as usual in the community (no DBT, no exposure of trauma memories)
Primary Outcome Measure Information:
Title
Change from first investigation in Posttraumatic Symptom Severity at 18 months (Clinician-Administered PTSD Scale; CAPS)
Time Frame
first investigation (t1), after waiting list (3 months, t2), directly after therapy (3 months, t1), 1 year after therapy (15 months, t3)
Secondary Outcome Measure Information:
Title
Change from first investigation in Borderline Symptome Severity at 18 months(Borderline Symptom Liste; BSL)
Time Frame
first investigation (t1), after waiting list (3 months, t2), directly after therapy (6 months, t3), 1 year after therapy (18 months, t4)
Title
Change from first investigation in Severity of Dissociative Symptoms at 18 months (Fragebogen zu Dissoziativen Symptome ;FDS)
Time Frame
first investigation (t1), after waiting list (3 months, t2), directly after therapy (6 months, t3), 1 year after therapy (18 months, t4)
Title
Change from first investigation in Severity of Depressive Symptoms at 18 months (Becks Depressions Inventar II, BDI-II)
Time Frame
first investigation (t1), after waiting list (3 months, t2), directly after therapy (6 months, t3), 1 year after therapy (18 months, t4)
Title
Change from first investigation in Quality of Life at 12 months (WHO-Qualitiy of Life; WHOQOL)
Time Frame
first investigation (t1), after waiting list (3 months, t2), directly after therapy (6 months, t3), 1 year after therapy (18 months, t4)
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carolin Steuwe, M.Sc.
Organizational Affiliation
Clinic of Psychiatry, Evangelisches Krankenhaus Bielefeld
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Martin Driessen, Prof. Dr. med.
Organizational Affiliation
Clinic of Psychiatry, Evangelisches Krankenhaus Bielefeld
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinic of Psychiatry, Evangelisches Krankenhaus Bielefeld
City
Bielefeld
ZIP/Postal Code
33617
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
34899426
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.
Results Reference
derived
PubMed Identifier
32368793
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.
Results Reference
derived
PubMed Identifier
27439618
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.
Results Reference
derived
Learn more about this trial
Narrative Exposure Therapy in Women With Borderline Personality Disorder and Posttraumatic Stress Disorder
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