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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02517723
Other study ID # NET_BPS+PTBS
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 2014
Est. completion date January 31, 2020

Study information

Verified date October 2021
Source Evangelisches Krankenhaus Bielefeld gGmbH
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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).


Recruitment information / eligibility

Status Completed
Enrollment 67
Est. completion date January 31, 2020
Est. primary completion date January 31, 2020
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 65 Years
Eligibility 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

Study Design


Intervention

Behavioral:
Narrative Exposure Therapy
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 Therapy
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 Care
Unspecific group therapy that is identical in both groups (music therapy etc.)
Other:
Waiting List
Treatment as usual in the community (no DBT, no exposure of trauma memories)

Locations

Country Name City State
Germany Clinic of Psychiatry, Evangelisches Krankenhaus Bielefeld Bielefeld

Sponsors (1)

Lead Sponsor Collaborator
Evangelisches Krankenhaus Bielefeld gGmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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)
Secondary 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)
Secondary 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)
Secondary 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)
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