The aim of this study is to explore GST + CRA in outpatients with PD and SUD. In addition, we will explore the relationship between childhood trauma, severity of SUD and PD and treatment response. The expectation is that GST, delivered alongside CRA…
ID
Source
Brief title
Condition
- Other condition
- Personality disorders and disturbances in behaviour
Synonym
Health condition
stoornis in middelengebruik
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Main study parameter/endpoint
The feasibility of GST will be explored and expressed qualitatively in terms
of:
1. Descriptions of the nature of obstacles and facilitators experienced by
participants, as assessed at one-week post-intervention follow-up in a
semi-structured interview based on the Patients Perceptions of Corrective
Experiences in Individual Therapy interview protocol (PPCEIT).
2. Participating therapists' experiences regarding the treatment program,
suggestions for improvement and recommendations for further implementation, as
assessed during a focus group interview after the data collection in
participating clients has been completed. If a participating therapist decides
to stop participating in the study early, he/she will be contacted for an
individual interview regarding his/her experiences with GST.
The feasibility of GST will be explored and expressed quantitatively in terms
of:
1. The average number (and SD + range) of ST and GST sessions missed.
2. The number of participants who dropout from treatment (absence of 30% or
more of the GST sessions (nine or more of total GST sessions missed) is
considered a treatment dropout. It is then assumed that a patient has missed
too many and that this negatively affects the effect of therapy.
3. Protocol adherence: after each GST session, participating therapists are
required to write down the extent to which they adhered to the treatment manual
and, if not, how they deviated and the reason. The data from this will be used
as talking points for the focus group interview
Secondary outcome
Changes in quantitative outcomes of weekly repeated measures (from baseline
(T0), over the course of treatment (T1-T4)), with regard to the potential
clinical efficacy of GST:
-Average substance use (in grams (drugs) or units (alcohol)) in the past week,
assessed with the MATE, section 1.
-Average craving in the past week, assessed with the MATE-Q1.
Changes in quantitative outcomes of periodic repeated measures (from baseline
(T0), over the course of treatment (T1-T4) and follow up (T5)), with regard to
the potential clinical efficacy of GST:
-Severity and treatment needs of addiction, assessed with the MATE-1.
-Quality of life, assessed with the WHOQoL-BREF . -
Severity indices in personality problems, assessed with the SIPP-SF
-The 16 core beliefs (early maladaptive schemas), assessed with the YSQ-S3.
-Schema modes, assessed with the SMI.
Other parameters in this study will be assessed in:
The severity and type of childhood trauma experienced, assessed with the CTQ
(baseline only).
Background summary
Substance use disorders (SUD) and personality disorders (PD) often co-occur.
Among patients in addiction care, the prevalence of a comorbid PD is 34% to 73%
(Verheul, 2001). The lifetime prevalence of comorbid disorders in alcohol use
is about five times higher among patients with a PD than in the general
population, while the risk of developing a comorbid disorder in drug use is
even 12 times increased (Trull et al., 2010). In a study by Walter et al.
(2015), a comorbid PD was seen in 46% of patients with SUD with antisocial
personality disorder (16%) and borderline personality disorder (BPD) (13%)
being the most common, followed by cluster C (particularly avoidant) and
cluster A (particularly paranoid) PD (Rounsaville et al., 1998). For example,
Kienast et al. (2014) found that about 78% of adults with BPD develop a
dependence on substances at some point in their lives. Most research has been
done on BPD and addiction.
The treatment prognosis of comorbid SUD and PD is unfavorable. SUD are more
severe, and relapses are more frequent. In addition, this group experiences
more psychiatric symptoms and impulsive and risky behaviors. There are more
interpersonal problems, negative feelings and lower quality of life. These
patients are also, on average, less adherent to treatment (Hasin et al., 2011;
Newton-Howes & Foulds, 2017). Kienast et al. (2014) also found that patients
were more likely to terminate their treatment prematurely and had shorter
abstinence periods, and therefore advocated for an integrated approach to the
combination of SUD and BPD. The Dutch Guideline on diagnostics and treatment of
PD also recommends integrated treatment of SUD and PD because treatment of only
one of the two disorders gives limited results (Bosch & Verheul, 2007; Fridell
& Hesse, 2006; Zanarini et al. 2004b). However, there has been limited research
on integrated treatment of SUD and PD.
Several explanations have been suggested for this high degree of comorbidity.
One is its relationship to Adverse Childhood Experiences (ACEs). Among other
things, Dijkhuizen (2013) wrote that common etiological factors such as genetic
or neurobiological vulnerability (impulsivity, emotion regulation) and early
childhood traumatic experiences can explain both PD and SUD development.
Edwards et al. (2003) also cite the relationship between ACEs and the
likelihood of mental health problems later in life as an explanation for high
levels of comorbidity. A meta-analysis by Porter et al. (2019) also confirmed
that exposure to ACEs is associated with BPD. Findings from a meta-analysis by
Pilkington et al. (2020) support the theory that early childhood neglect and
traumatization is associated with Early Maladaptive Schemas (EMS) in adulthood.
EMS are described by Young (2003) as deeply ingrained patterns of thoughts,
feelings and behavior that develop during childhood and may persist into
adulthood. In particular, the association between history of emotional abuse in
childhood and EMS have the most empirical support. In addition, Borgert et al.
(2022) found that ACEs are more likely to develop SUD. Thus, the relationship
between ACEs in both personality problems and addiction is a possible
explanation for the high co-morbidity. It is therefore important to investigate
effective treatment for this co-morbidity that takes trauma history into
account.
Schematherapy (ST) offers an interesting opportunity for treating patients with
SUD and co-morbid PD, because it explicitly addresses ACEs. ST was developed by
Jeffrey Young in 1980's as a pioneering integration of cognitive behavior
therapy with gestalt, object relations, and psychoanalytic approaches (Young,
1990). It is based on the concept of EMS, and it is hypothesized that these
schemas arise from unmet needs (physical and emotional neglect) or traumatic
experiences (sexual, physical and emotional abuse) in early life. These early
maladaptive schemas in turn make people vulnerable for developing mental
illness (Masley et al., 2012). Processing childhood memories through
experiential techniques is a central focus of schema therapy (Hoffart, Lunding
& Hoffart, 2016). This focus on early life experiences distinguishes schema
therapy from traditional cognitive approaches (Simard et al., 2011).
Dual Focus Schematherapy (DFST) approach was developed specifically for
patients with SUD and PD by Ball (1998)., The fundamental assumption underlying
DFST is that failed attempts to satisfy important basic needs can lead to the
development of maladaptive schemas and harmful coping strategies such as
addictive behaviors. Therefore, patients and therapists focus on identifying
and inhibiting schemas, followed by detecting the underlying basic needs and
satisfying them appropriately. DFST interprets substance use as a dysfunctional
coping strategy to deal with "difficult" moods or conflicts.
A few studies on integrated treatment of SUD and PD have focused on Ball's
(1998) and Ball & Young's (2000) DFST approach. However, several studies found
varying results (Ball, 2007, Ball et al., 2011). Criticism by Lee & Arntz
(2013) of the 2011 study conducted by Ball et al. was that it was difficult to
draw reliable conclusions, in part because of a high dropout rate and because
the treatment was not implemented as intended. For example, schemamodi were not
used, which is however used and recommended in published studies on the
treatment of a PS with ST (Farrel et al., 2009; Giesen-Bloo et al., 2006;
Nadort et al., 2009). Schema modes can be viewed as intense states of mind that
arise when one or more schemas are activated. Working with schema modes in
therapy provides common language and concrete clues to change because they are
often easily identifiable (Farrell et al., 2015).
Building on the research of Ball (1998, 2000, 2007), incorporating the
criticisms of Lee and Arntz (2013), a multiple baseline study of ST in 20
patients with an alcohol use disorder and BPD was recently conducted (Boog,
2022). Three months after the termination of ST, 68% of patients showed
remission of BPD and a significant decrease in drinking days. This suggests
that ST may be effective in treating patients with these comorbidities.
Research on groupwise ST (GST) in patients with a PD without diagnosed SUD
shows positive results on PD recovery and improvement in general functioning,
psychopathological symptoms and quality of life (Dickhaut et al. 2014; Farrell
et al. 2009). However, to date, no research has been conducted regarding GST in
patients with SUD and PD. Arntz et al (2022) showed that the combination of
individual ST and GST is the most effective ST format in BPD, compared to TAU
(the best available treatment at the study site at the time (TFP, MBT, CCT,
STEPPS, DBT, CBT or CAT)) and GST without individual ST. Given the high
prevalence of PD in patients with SUD, the poor treatment prognosis of this
comorbidity, and preliminary findings suggesting that GST may be an effective
treatment for this target population, there is clear clinical relevance to
further exploratory research on treatment through individual ST and GST
(hereafter GST), in patients with SUD and comorbid PD.
There is little research on patients' perspectives regarding ST and, to the
authors' knowledge, none at all on GST in patients with SUD and PD. Such
information is important because it provides insight into how therapy is
experienced by patients, and the limiting and facilitating factors they
encountered. Qualitative research by De Klerk et al. (2016) on both patient and
therapist perspectives on individual ST in personality problems showed that the
involved therapeutic relationship, the transparent and clear theoretical model,
and specific ST techniques were deemed important and helpful by patients.
Several patients felt that 50 sessions were not enough, however. Moreover, they
felt they were no
Study objective
The aim of this study is to explore GST + CRA in outpatients with PD and SUD.
In addition, we will explore the relationship between childhood trauma,
severity of SUD and PD and treatment response.
The expectation is that GST, delivered alongside CRA has clinical potential,
and is associated with significant reductions in SUD and improvement of
personality functioning and an increase in quality of life from baseline to
follow-up.
We also explore participants' and therapists' experiences with GST (in addition
to CRA) and identify what factors they have found to be facilitating or
limiting.
Study design
This pilot study uses a single group, repeated measures A (baseline)-B
(intervention) follow-up design. This combines both repeated measures on a
group level (within subjects, T0-T5, from baseline to three-month follow-up) as
well as a Single Case Experimental Design (SCED; within subjects, weekly
assessments during the A-B part of the study). A mixed method approach to data
collection is used whereby qualitative data is collected in a targeted
selection of participants within one week of finishing the B* phase using a
semi-structured interview and a focus group with therapists at the end of the
data collection phase of the study. Data collection will start in March 2024 at
three outpatient addiction care facilities of IrisZorg in Nijmegen, Arnhem and
Doetinchem/Zevenaar and will be completed by the end of 2025. The data
collection is spread over different phases and moments of measurement (see
Figure 1):
T0 (start baseline).
Phase A (baseline, duration 3-10 weeks): CRA + 3 pre-sessions case
conceptualization
T1 start of intervention
Phase B (junior phase (weeks 1-10 intervention phase)): GST + CRA
T2 (between phase B and B')
'Phase B' (phase medior (week 10-20 intervention phase): GST + CRA
T3 (between phase B' and B'')
Phase B'' (phase senior (week 20-30 intervention phase): GST + CRA
T4 end of intervention
T5: follow-up 3 months after end of GST: CRA (or disenrollment)
Clients will be assigned to a baseline period of at least three to a maximum of
10 weeks based on the moment of enrollment versus the length of the waiting
list.
Intervention
Prior to the group sessions, during the baseline phase, participants will have
three weekly pre-sessions with one of the group therapists to develop a global
case conceptualization, creating a model of the primary modes with the
participant and outlining goals for the group. Boog and colleagues (2022) did
not find any effect on personality functioning or substance use during this
phase of case conceptualization.
GST will be offered phase oriented. A total of 30 weekly sessions is provided,
mainly based on Farrel and Shaw (2012, 2014) and Tjoa and Muste (2021). The
outline comes from Tjoa and Muste's (2021) treatment manual developed for
people with cluster C personality disorder. For this study, we have added
elements that specifically address addiction using schematherapeutic
techniques. For an overview of these interventions see Appendix 1-3 or see the
manual, Appendix 4.
Group Schematherapy:
The initial 10 GST sessions constitute the 1st (junior) phase, followed by 10
sessions for the 2nd (medior) phase and subsequently 10 sessions for the 3rd
(senior) phase. The junior phase primarily focuses on awareness and healing.
Subsequently, in the following phases, there is a gradual shift towards
independent recognition of active modes in different situations (medior phase)
and managing them (senior phase). All phases will encompass a blend of
cognitive, experiential, and behavioral interventions. Initially, emphasis will
be on comprehension (cognition), followed by experiential processing in the
middle phase, and finally, in the last phase, emphasis will be on managing
different modes (behavioral change) (Tjoa & Muste, 2021).
The ultimate goal of ST is to establish a connection with *the vulnerable
child* within and thereby strengthen *the healthy adult*. Throughout all
phases, extra attention will be given to modes in which clients use substances,
dedicating one session in each intervention phase to this, using techniques
such as chair work involving addiction.
It is a semi-open group with an opportunity to enroll after an intervention
phase is finished (after 10 sessions). Individual evaluation with the group
therapists is planned after each intervention phase, in the presence of the
regular addiction treatment provider (to align with individual addiction
treatment), and significant others. The evaluation focuses on the predetermined
goals and sharpening or adjusting them aimed at the next phase. In addition to
GST, participants will receive 10 individual ST sessions with one of the group
therapists. In the 1st phase, these sessions occur every two weeks, in the 2nd
phase, every three weeks, and in the 3rd phase, every five weeks. These
sessions will delve deeper into the group sessions, incorporating extra
experiential exercises or engaging in trauma work, for example.
Given the complexity of this target group a relatively high treatment dropout
rate is expected. Absence of 30% or more of the GST sessions (nine or more of
total GST sessions missed) is considered a treatment dropout. It is then
assumed that a patient has missed too many and that this negatively affects the
effect of therapy.
Co-intervention CRA:
The Community Reinforcement Approach (CRA) is a behavioral therapy methodology
employed in addiction treatment (Meyers & Smith, 1995). It focuses on modifying
the existing lifestyle by integrating alternative, reinforcing elements, such
as engaging in enjoyable and social activities, thereby fostering a healthier
and more rewarding lifestyle that supersedes a lifestyle characterized by
excessive substance use. Emphasis is placed on collaboration among the patient,
therapist, and significant others of the patient to eliminate positive
reinforcement for substance use and enhance positive reinforcement for
alternative behaviors.
The fundamental procedures of CRA for treating addiction disorders include:
-Utilizing a quality-of-life questionnaire to formulate personalized treatment
goals and monitor progress,
-Functional analysis of substance use,
-Training in communication skills,
-Training in problem-solving skills,
-Training in social networks,
-Sobriety sampling (working toward periods of shorter or longer abstinence to
experience and evaluate the effects of abstinence),
-Learning to refuse substances,
-Counseling on social and recreational activities,
-Relapse prevention,
-Medication, and
-Relationship counseling (Roozen, Meyers & Smith, 2022).
The CRA therapist and patient collaboratively determine which modules to employ
based on the patient's goals and the required frequency of counseling. In
outpatient settings, the intensity typically involves one session per week,
with the duration determined by progress in achieving the goals. In addition to
these weekly sessions, medication-assisted treatment, group treatment CRA and
systemic therapy may be used. Within IrisZorg, an e-health platform is used to
aid treatment further.
Study burden and risks
The burden of participating in this study consists of completing
questionnaires. Participants will be rewarded/compensated for this by being
able to receive vouchers for completed questionnaires. No risks are expected
from participating in this study.
Meester B.M. Teldersstraat 7
Arnhem 6842 CT
NL
Meester B.M. Teldersstraat 7
Arnhem 6842 CT
NL
Listed location countries
Age
Inclusion criteria
Participating patients, based on patients* record information:
- Diagnosed with one or more substance use disorders according to DSM-5
criteria.
- Active Substance Use Disorder treatment, at least during groupschematherapy
- Personality Disorder according to DSM-5 criteria (or working hypotheses)
- Age between 18 and 70 years
- At least partial control over substance use; that is, participants can attend
sessions sober.
- Written informed consent.
Exclusion criteria
based on information from the patients* record there is no evidence of:
- Inadequate proficiency in the Dutch language.
- Severe, untreated ADHD symptoms due to overlapping features with a
personality disorder.
- Psychotic disorder (except for brief reactive psychoses consistent with the
Personality Disorder).
- Neurocognitive functional impairments.
- Bipolar disorder.
- Significant substance use without a desire to achieve abstinence.
- IQ lower than 80
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 | NL86152.091.24 |