The aim of the present study is to optimize treatment selection by examining patient characteristics that predict (differential) treatment response across MBT and ST. These characteristics will be investigated and converted to actuarial formulas (…
ID
Source
Brief title
Condition
- Personality disorders and disturbances in behaviour
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome measure is change in the severity and frequency of the
DSM-5 BPD manifestations (BPDSI-IV, total score; Arntz et al., 2003;
Giesen-Bloo, Wachters, Schouten, & Arntz, 2010). This outcome measure is
frequently used in other studies of ST: Giesen-Bloo et al. (2006), Van Asselt
et al. (2008), Nadort et al. (2009), and Wetzelaer et al. (2014).
Secondary outcome
As accumulating evidence suggests that symptoms and level of functioning are
only loosely associated, attention will be paid to outcome in terms of both
symptom change and functioning, including relational, occupational, and
personal (wellbeing) functioning. Therefore, the secondary outcome measures
will include:
* DSM-5 diagnostic status, assessed by the Structured Clinical Interviews for
the Diagnostic and Statistical Manual of Mental Disorders-5 (DSM-5) Clinician
Version (SCID-5-CV) and Personality Disorders (SCID-5-PD)*.
* BPDSI-IV (Arntz et al., 2003; Giesen-Bloo et al., 2010) reliable change and
recovery (i.e., score below 15).
* Dimensional scores for each of the DSM-5 BPD-criteria as assessed with the
BPDSI-IV (Arntz et al., 2003; Giesen-Bloo et al., 2006).
* Psychopathology, personality characteristics, and behavioral proclivities,
assessed by the Minnesota Multiphasic Personality Inventory-2 Restructured Form
(MMPI-2-rf; Ben-Porath & Tellegen, 2008).
* General functioning, including work/study and societal participation,
assessed by the WHO Disability Assessment Schedule (WHODAS 2.0; Üstün,
Kostanjsek, Chatterji, & Rehm, 2010).
* General psychopathology as measured with the Brief Symptom Inventory (BSI;
Derogatis & Melisaratos, 1983).
* Quality of life, assessed using the EuroQol EQ-5D-5L (Rabin & Charro, 2001).
* Happiness, measured with a single question on general happiness (Veenhoven,
2008).
* Sleep, measured using the Insomnia Sleep Index (Bastien, Vallières, & Morin,
2001) and two items measuring nightmare frequency.
* Costs, including healthcare, patient and family costs and costs outside the
health care sector, will be measured using a retrospective cost interview
especially designed for BPD patients (Wetzelaer et al., 2014).
Both treatments include non-specific (attachment and alliance) and specific
(mentalization in MBT and schema modes in ST) mechanisms of change. Measures of
the mechanisms of change will include:
* Alliance, measured by the Working Alliance Inventory-Short Revised (WAI-S;
Horvarth & Greenberg, 1989; Vertommen & Vervaeke, 1990);
* Attachment, assessed by the Experiences in Close Relationships-Relationship
Structures questionnaire (ECR-RS; Fraley, Heffernan, Vicary, & Brumbaugh, 2011)
and the Adult Attachment Projective Picture System (AAP; George & West, 2001);
* Schema mode ratings, assessed by the Schema Mode Inventory (SMI; Young et
al., 2007);
* Mentalizing ratings, measured by the Movie for the Assessment of Social
Cognition (MASC; Dziobek et al., 2006), the Reflective Function Questionnaire
(RFQ; Fonagy & Ghinai, 2008), two subscales, Difficulty in Identifying Feelings
and Difficulty in Describing Feelings, of the Toronto Alexithymia Scale-20
(TAS-20; Bagby, Parker, & Taylor, 1994; Bagby, Taylor, & Parker, 1994; Kooiman,
Spinhoven, & Trijsburg, 2002), and one subscale, Perspective Taking, of the
Interpersonal Reactivity Index (Davis, 1980; De Corte et al., 2007).
Predictors of (differential) treatment response are selected based on the
literature and expert clinicians* appraisals of BPD patient characteristics
that predict (differential) treatment response across MBT and ST. In addition,
patients* monthly ratings of symptoms, schemas and level of mentalization of
the participants will be collected.
*As long as the Dutch versions of the SCID-5-CV and SCID-5-PD aren*t available,
we will make use of the SCID-I for Axis I disorders of the DSM-IV and SCID-II
for Axis II disorders (i.e., personality disorders) of the DSM-IV.
Background summary
Borderline personality disorder (BPD) is a complex and severe mental disorder,
characterized by a pervasive pattern of instability in emotion regulation,
self-image, interpersonal relationships, and impulse control (APA, 1994; Skodol
et al., 2002). The prevalence in general populations is estimated to be 1% to
3% (Trull, Jahng, Tomko, Wood, & Sher, 2010) and 10% to 25% among psychiatric
outpatient and inpatient individuals (Leichsenring, Leibing, Kruse, New, &
Leweke, 2011). BPD has traditionally been viewed as one of the most difficult
psychiatric disorders to treat. However, during recent years, a number of
promising treatments have been developed and evaluated. Among these are
Mentalization Based Treatment (MBT; Bateman & Fonagy, 2004) and Schema Therapy
(ST; Arntz & Van Genderen, 2009; Young et al., 2003).
Several studies have demonstrated the effectiveness and the efficacy of MBT
(e.g., Bateman & Fonagy, 2008; Bales et al., 2012) and ST (for a review, see
Jacob & Arntz, 2013). However, none of the studies investigated mechanisms of
change (i.e., mediators of treatment effects). This is remarkable, given that
information about mediational processes is very valuable for the development
and improvement of effective interventions (Cheong, MacKinnon, & Khoo, 2003).
In addition, research on moderators of treatment effectiveness is also
lacking. In clinical practice it is not sufficient to know what treatment works
in general; it is crucial to understand which treatment is optimal for the
present patient. The selection of the optimal treatment for a particular
patient (i.e., personalized medicine) is a daily task of the clinician and one
of the major challenges in health care research, but very scant evidence is
available to guide these decisions. This is problematic since BPD patients vary
greatly in treatment outcome. Understanding and predicting variation in
outcomes between BPD patients will yield great benefits for patients, including
prevention of overtreatment and potential harm of treatments (e.g.,
demoralization). To conclude, research on mediators and moderators of treatment
effects is needed.
Study objective
The aim of the present study is to optimize treatment selection by examining
patient characteristics that predict (differential) treatment response across
MBT and ST. These characteristics will be investigated and converted to
actuarial formulas (see DeRubeis et al., 2014). In addition, mechanisms of
change in MBT and ST will be investigated. Also therapeutic and organizational
characteristics that may influence the effectiveness of MBT and ST will be
investigated. Finally, the (cost-)effectiveness of MBT and ST among BPD
patients will be examined.
Study design
The study design is a multisite randomized controlled trial (RCT) in which
multiple mental health care centers will collaborate. Patients will be
recruited from the mental health care centers. All patients with BPD or
suspicion of BPD will be asked to participate in the screening process. In the
screening process, patients will be assessed for eligibility to participate in
this study based on the inclusion and exclusion criteria. Diagnostic criteria
will be assessed by means of the SCID, executed by trained SCID interviewers.
The other assessments will be conducted by the local research assistants.
Furthermore, a motivational/availability interview will be part of the
screening process. When a patient is eligible for participation, he or she will
be randomized to MBT or ST by the research staff, using computerized random
assignment. The first assessment will occur after inclusion and before
randomization. The subsequent six assessments will occur at 7.5, 13.5, 19.5,
25.5, 31 and 36 months after the start of the treatment.
Intervention
1. Mentalization-Based Treatment (MBT)
2. Schema Therapy (ST)
There are two different intervention conditions, MBT or ST, which participants
are randomly assigned to. Both treatments will consist of a combination of
individual sessions and group sessions with nine patients. MBT has a maximum
duration of 36 months. It starts with a pretreatment program of about six weeks
consisting of an introductory course to MBT (MBT-I) and individual sessions
with crisis planning as focus. The main treatment consists of a treatment phase
and a maintenance phase. The treatment phase consists of weekly group (75
minutes) and individual (45 minutes) psychotherapy with a maximum duration of
18 months. The maintenance phase consists of intermittent individual sessions
with a maximum of once a week and a maximum duration of 16.5 months.
ST has a maximum duration of 25.5 months and starts with a pretreatment
program of about six weeks consisting of several (approximately three)
individual sessions. The main treatment consists of a treatment phase and a
maintenance phase. The treatment phase has a maximum duration of 18 months and
consists of weekly group (90 minutes) and individual (45 minutes) psychotherapy
for a period of 12 months, continued by weekly group psychotherapy and biweekly
individual psychotherapy for a period of six months. The maintenance phase
consists of biweekly individual psychotherapy for a period of three months,
continued by three months of one individual session each month.
Study burden and risks
There are in total seven measurements over three years. A measurement takes
about three hours. The measurements are conducted by trained research
assistants. In addition, over a period of two years, the client completes every
month a short online questionnaire (max. 10 minutes) about the experienced
symptoms. The assessments will take a total of about 25 hours over three years.
The results of the assessments can be partly used for routine outcome
monitoring (ROM). ROM is required within institutions. The total time spent by
a client in this study, without time spending on the ROM, is about two hours
per measurement and in total about 18 hours over three years.
There are no direct risks involved for patients involved in this study.
Patients will receive an evidence-based treatment. In addition, patients will
receive a treatment they probably would receive even if they did not
participate in the study. Participating in interviews and filling out
questionnaires is often part of centers* regular practice and does not involve
specific risks. Participants are told that Schema Therapy involves processing
of adverse childhood experiences. Potential participants that don't want a
treatment partially focusing on their childhood can therefore decide not to
participate.
Finally, BPD is characterized by self-injury, suicidality, and crisis. For
emergencies, the emergency procedure of each mental health care institute will
be followed. An emergency hospitalization will take place in case this is
necessary. Any additional treatment, whether individual sessions or
hospitalization, will be monitored and included in the analyses. Patients will
only be withdrawn for the study at their request.
Nieuwe Achtergracht 129b
Amsterdam 1018WS
NL
Nieuwe Achtergracht 129b
Amsterdam 1018WS
NL
Listed location countries
Age
Inclusion criteria
1. Primary diagnosis of BPD
2. Age 18-65 years
3. Borderline Personality Disorder Severity Index, fourth edition (BPDSI-IV) score above 20
4. Dutch literacy
5. The willingness and ability to participate in (group) treatment for at least 24 months
Exclusion criteria
1. Psychotic disorder (except short reactive psychotic episodes, see BPD criterion 9 of the DSM-5)
2. Severe addiction requiring clinical detoxification (after which entering is possible)
3. Bipolar I disorder (except when in full remission)
4. IQ < 80
5. Travel time to the MBT or ST setting longer than 45 minutes (except when the participant lives in the same city)
6. No fixed home address
7. Have received ST or MBT in the previous year
8. Antisocial personality disorder with a history of physical interpersonal violence (in the last two years)
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 | NL61468.018.17 |