Borderline Personality DisorderNCT02517723
Narrative Exposure Therapy in Women With Borderline Personality Disorder and Posttraumatic Stress Disorder
A study testing Narrative Exposure Therapy, Dialectical Behavior Therapy and Standard Inpatient Care in people with Borderline Personality Disorder and Stress Disorders, Post-Traumatic, run by Evangelisches Krankenhaus Bielefeld gGmbH at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Borderline Personality Disorder, Stress Disorders, Post-Traumatic
- What is being tested?
- Narrative Exposure Therapy, Dialectical Behavior Therapy and Standard Inpatient Care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 1 siteGermany
- Study dates
- Apr 2014to 31 Jan 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site
Clinic of Psychiatry, Evangelisches Krankenhaus Bielefeld
Bielefeld, 33617
About this study
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)
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).
- Being tested
- Narrative Exposure Therapy, Dialectical Behavior Therapy, Standard Inpatient Care, Waiting List
- Keywords
- Borderline Personality Disorder, comorbid Posttraumatic Stress Disorder, Narrative Exposure Therapy, Dialectical-Behavioral Therapy
- Medical subject headings
- Borderline Personality Disorder, Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Narrative Exposure TherapyBehavioural
Also called NET
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.
Dialectical Behavior TherapyBehavioural
Also called DBT
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.
Standard Inpatient CareBehavioural
Also called SIC
Unspecific group therapy that is identical in both groups (music therapy etc.)
Waiting ListOther
Treatment as usual in the community (no DBT, no exposure of trauma memories)
| Study group | Role | What they receive |
|---|---|---|
| SIC + NET | Experimental | Waiting List + Standard Inpatient Care + Narrative Exposure Therapy Receives: Behavioral: Narrative Exposure Therapy; Behavioral: Standard Inpatient Care; Other: Waiting List |
| SIC + DBT | Active comparator | Waiting List + Standard Inpatient Care + Dialectical Behavior Therapy Receives: Behavioral: Dialectical Behavior Therapy; Behavioral: Standard Inpatient Care; Other: Waiting List |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from first investigation in Posttraumatic Symptom Severity at 18 months (Clinician-Administered PTSD Scale; CAPS)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: first investigation (t1), after waiting list (3 months, t2), directly after therapy (6 months, t3), 1 year after therapy (18 months, t4)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2015 (estimated)
- Study startApr 2014
- Primary completion31 Jan 2020
- Study completion31 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Borderline Personality DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Evangelisches Krankenhaus Bielefeld gGmbH
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Dr. med. Martin Driessen, Evangelisches Krankenhaus Bielefeld gGmbH
- Investigators
- Carolin Steuwe, M.Sc., Study director, Clinic of Psychiatry, Evangelisches Krankenhaus BielefeldMartin Driessen, Prof. Dr. med., Principal investigator, Clinic of Psychiatry, Evangelisches Krankenhaus Bielefeld
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02517723
- Sponsor's protocol ID
- NET_BPS+PTBS
- Status last verified
- Oct 2021
- First submitted
- 6 Jan 2014
- Last updated
- 8 Oct 2021
- Results posted
- No
Publications
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.
PubMed 34899426Storebo 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.
PubMed 32368793Steuwe 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.
PubMed 27439618
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT02517723
- Acronym / sponsor ID
- NET_BPS+PTBS
- Keywords
- Borderline Personality Disorder, comorbid Posttraumatic Stress Disorder, Narrative Exposure Therapy, Dialectical-Behavioral Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Evangelisches Krankenhaus Bielefeld gGmbHUniversity, hospital or other
- Study start
- Apr 2014 (actual)
- Primary completion
- 31 Jan 2020 (actual)
- Study completion
- 31 Jan 2020 (actual)
- First posted
- 7 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SIC + NET | Experimental | Behavioral: Narrative Exposure Therapy, Behavioral: Standard Inpatient Care, Other: Waiting ListWaiting List + Standard Inpatient Care + Narrative Exposure Therapy |
| SIC + DBT | Active comparator | Behavioral: Dialectical Behavior Therapy, Behavioral: Standard Inpatient Care, Other: Waiting ListWaiting List + Standard Inpatient Care + Dialectical Behavior Therapy |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Narrative Exposure TherapyAlso: NETNarrative 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. | Behavioural | SIC + NET |
| Dialectical Behavior TherapyAlso: DBTDialectical 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. | Behavioural | SIC + DBT |
| Standard Inpatient CareAlso: SICUnspecific group therapy that is identical in both groups (music therapy etc.) | Behavioural | SIC + DBT, SIC + NET |
| Waiting ListTreatment as usual in the community (no DBT, no exposure of trauma memories) | Other | SIC + DBT, SIC + NET |
Primary outcome
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)
4 secondary outcomes
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)
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)
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)
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2021.
- Derived from this study: PubMed 34899426Steuwe 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.
- Derived from this study: PubMed 32368793Storebo 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.
- Derived from this study: PubMed 27439618Steuwe 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carolin Steuwe, M.Sc. study director
Clinic of Psychiatry, Evangelisches Krankenhaus Bielefeld
Martin Driessen, Prof. Dr. med. principal investigator
Clinic of Psychiatry, Evangelisches Krankenhaus Bielefeld
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Narrative Exposure Therapy, Dialectical Behavior Therapy and Standard Inpatient Care in people with Borderline Personality Disorder and Stress Disorders, Post-Traumatic, run by Evangelisches Krankenhaus Bielefeld gGmbH at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02517723, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2021.