The main objectives of the present study are to examine the feasibility, efficacy and safety of intensive PE treatment within DBT for patients who have PTSD and a comorbid BPD.
ID
Source
Brief title
Condition
- Anxiety disorders and symptoms
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
- PTSD symptoms measured by the Posttraumatic Stress Symptom Scale, Self Report
- Safety measured by adverse events like suicidal attempts, non-suicidal
self-injury (NSSI), and crisis service use.
- For treatment compliance issues, cancelled treatment appointments will be
recorded throughout the DBT and PE programs, as is dropout of treatment.
- PTSD symptom severity is measured with a clinician rated instrument: the
Clinician-Administered PTSD Scale (CAPS-1)
- Subjective ratings of improvement will be assessed with the Global Severity
index (GSI)
Secondary outcome
- Severity of Borderline Personality Disorder will be assessed with the
Borderline Personality Disorder Severity Index (BPDSI)
- Depression will be measured with the Beck Depression Inventory-II (BDI-II)
- Dissociation will be measured with the Dissociative Experiences Scale -
revised version (DES-II)
- Posttraumatic cognitions will be measured by the Dutch version of the
Posttraumatic Cognitions Inventory (PTCI)
Background summary
After experiencing a traumatic event, people are at risk for developing a
posttraumatic stress disorder (PTSD). Patients suffering from PTSD, classified
in the DSM-IV as an anxiety disorder, typically re-experience the traumatic
event again and again in flashbacks and nightmares. These re-experiences are
highly fearful to patients. Therefore, they avoid thoughts about the traumatic
event, and situations that may trigger such memories. In addition, they are
continuously alert for possible threats, leading to severe sleeping and
concentration problems. A high comorbidity is shown between PTSD and borderline
personality disorder (BPD). Though effective treatments for PTSD like Prolonged
Exposure (PE) are available, patients with BPD are typically excluded from
clinical trials based on the belief that BPD patients are unable to tolerate
trauma-focused treatment, and may even get worse. However, recent studies
examining modified PE treatments, delivered as stand alone treatment or in
combination with Dialectical Behavior Therapy (DBT), have shown promising
results among BPD patients. We developed a short, intensive PE treatment for
PTSD patients with severe comorbidity like BPD. Preventing dropout, a major
problem in the BPD population, could be an important advantage of this short
treatment program. The present study aims to examine the feasibility, efficacy
and safety of PE in an intensive format for PTSD patients with a comorbid BPD.
Study objective
The main objectives of the present study are to examine the feasibility,
efficacy and safety of intensive PE treatment within DBT for patients who have
PTSD and a comorbid BPD.
Study design
The study has a multiple baseline design whereby patients are randomly
allocated to three different baseline length variations.
Intervention
Patients will receive DBT that is augmented by PE in an intensive format once
the patient achieves sufficient control over (non-)suicidal self-injurious
behaviour.
Study burden and risks
The burden and risks of the current study are limited. The intensive PE therapy
is expected to be an effective and safe form of treatment.
Tarweweg 2
Nijmegen 6543 AM
NL
Tarweweg 2
Nijmegen 6543 AM
NL
Listed location countries
Age
Inclusion criteria
General inclusion criteria of the study:
- Age between 18 and 65 years
- Current DSM-IV diagnosis of PTSD established with a structured diagnostic interview (CAPS-1), and a severity score of CAPS > 50.
- Current DSM-IV diagnosis of BPD established with a standardized, semi structured, diagnostic interview (SCID-II),
- Recent and/or imminent suicidal behavior or serious non-suicidal self-injury;Inclusion criteria to start Prolonged exposure
- Not at imminent risk of suicide
- No recent suicide attempts or serious non-suicidal self-injury
- PTSD is the highest priority target for the patient
Exclusion criteria
- Psychosis or delusion disorders (current or in the past)
- Bipolar disorder
- Substance abuse or dependence, or alcohol abuse or dependence
- Mental retardation.
- Insufficient ability to speak and write Dutch
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL45770.091.13 |