The aim of the present study is to optimize treatment selection by examining patient characteristics that predict (differential) treatment response across DBT 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-5, 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-5 (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-5 (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)
and the Mental Health Quality of Life seven-dimensional Questionnaire
(MHQoL-7D; van Krugten et al., 2019).
- 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).
- A subgroup of patients (N=30) will receive two additional questionnaires,
including the Young Schema Questionnaire-3 short form (YSQ-3SF; Rijkeboer,
2012) and the PTSD Checklist for DSM-5 (PCL-5; Weathers et al., 2013), in order
to get more insight in the effect of timing of trauma treatment in ST by using
Imagery Rescripting (ImRs).
Both treatments include non-specific (e.g., alliance) and specific (e.g.,
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);
- ST: schema mode ratings, assessed by the Schema Mode Inventory (SMI; Young et
al., 2007);
- DBT: DBT skills use, assessed by the Dialectical Behavior Therapy-Ways of
Coping Checklist (DBT-WCCL; Neacsiu, Rizvi, Vitaliano, Lynch, & Linehan, 2010),
emotion regulation, assessed by the Difficulties in Emotion Regulation Scale
Short Form (DERS-SF; Kaufman et al., 2016) excluding the Awareness subscale,
based on recommendations of among others Hallion, Steinman, Tolin, and
Diefenbach (2018) and Bardeen, Fergus, and Orcutt (2012), and awareness,
assessed by the Difficulties in Emotion Regulation Scale 18 (DERS-18; Victor &
Klonsky, 2016).
Predictors of (differential) treatment response have been selected based on the
literature, suggestions of an expert by experience, and expert clinicians*
appraisals of BPD patient characteristics that predict (differential) treatment
response across DBT and ST. A subgroup of patients (N=30) will also receive the
Childhood Trauma Questionnaire-Short Form (CTQ-SF; Bernstein et al., 2003).
In addition, patients* three-monthly ratings of their symptoms and the proposed
mechanisms of change will be collected, including:
- BPS symptoms, assessed by a selection of items of the BPD Checklist
(Ultrashort BPD Checklist; Bloo, Arntz, & Schouten, 2018);
- Functioning, assessed by a modified version of the Outcome Rating Scale (ORS;
Miller, Duncan, Brown, Sparks, & Claud, 2003);
- Happiness, measured with a single question on general happiness (Veenhoven,
2008);
- Core beliefs, measured by using a semi-structured interview following the
procedure of among others Videler et al. (2017);
- VAS items measuring proposed mechanisms of change of Schema Therapy;
- A selection of schema modes, measured by the SMI, consisting of five
maladaptive schema modes central to BPD (i.e., vulnerable child, angry child,
impulsive child, detached protector, and punitive parent) and one functional
schema mode (i.e., healthy adult);
- DBT skills use, assessed by the DBT-WCCL (Neacsiu, Rizvi, Vitaliano, Lynch, &
Linehan, 2010).
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
Dialectical Behavior Therapy (DBT; Linehan, 1993a, 1993b) and Schema Therapy
(ST; Arntz & Van Genderen, 2009; Young et al., 2003).
Several studies have demonstrated the effectiveness and the efficacy of DBT
(for a review, see for example Kliem, Kröger, & Kosfelder, 2010; Panos,
Jackson, Hasan, & Panos, 2014) and ST (for a review, see Jacob & Arntz, 2013).
However, mechanisms of change (i.e., mediators of treatment effects) have
rarely been studied. 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
DBT and ST. These characteristics will be investigated and converted to
actuarial formulas (see DeRubeis et al., 2014). In addition, mechanisms of
change in DBT and ST will be investigated. Also therapeutic and organizational
characteristics that may influence the effectiveness of DBT and ST will be
investigated. Finally, the (cost-)effectiveness of DBT 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 DBT or ST by the research staff, using computerized covariate
adaptive randomization, taking into account gender, severity of BPD (BPDSI-5
score <= 24; BPDSI-5 score > 24), and treatment capacity. Patients recruited in
PsyQ Rotterdam that have been randomized to ST will be randomized again to
condition A, in which patients receive ImRs during months two, three, and four,
or condition B, in which patients receive ImRs after the first four months.
The first assessment will occur after inclusion and before randomization. The
subsequent six assessments will occur at 7, 13, 19, 25, 31 and 36 months after
the start of the treatment.
Intervention
1. Dialectical Behavior Therapy (DBT)
2. Schema Therapy (ST)
There are two different intervention conditions, DBT or ST, which participants
are randomly assigned to. Both treatments will consist of a combination of
individual sessions and group sessions with nine patients. DBT has a maximum
duration of 25 months. It starts with a pretreatment program of four weeks
consisting of several (approximately five) individual sessions. The main
treatment consists of a treatment phase and a maintenance phase. The treatment
phase consists of weekly individual psychotherapy sessions (50 minutes), weekly
skills training groups (150 minutes), and phone consultation, with a maximum
duration of 12 months. The maintenance phase has a maximum duration of 12
months and consists of an eHealth intervention, monthly individual
psychotherapy sessions, and three-monthly group sessions.
ST has a maximum duration of 25 months and starts with a pretreatment program
of four 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.
The treatments will be delivered face-to-face. If face-to-face treatment is not
possible due to restrictions of visits to mental health care centers taken by
the government during the COVID-19 pandemic, the treatment will be delivered
via videoconferencing.
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
three-month a short online questionnaire (max. 20 minutes) about the
experienced symptoms. A subgroup of patients (N=30) will receive an extended
version of the first three-monthly assessment. The assessments will take a
total of about 25-28 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 18-20 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, fifth edition (BPDSI-5)
score above 20
4. Dutch literacy
5. The willingness and ability to participate in (group) treatment for a
maximum of 24 months and to complete the assessments over a period of three
years
Exclusion criteria
1. Psychotic disorder in the past year (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 with at least one manic episode in the past year
4. IQ< 80
5. Travel time to the DBT 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 DBT 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
In other registers
| Register | ID |
|---|---|
| CCMO | NL66731.018.18 |