The Effects of Schema Therapy in Outpatient Forensic Mental Health Care: a Single Case Multiple-baseline Study. (STOFSCED)

  • STATUS
    Recruiting
  • End date
    Aug 25, 2027
  • participants needed
    8
  • sponsor
    Vrije Universiteit Brussel
Updated on 7 October 2022

Summary

Forensic psychiatry aims at reducing recidivism risk by treating mental or psychiatric problems. In forensic psychiatry approximately between 42 and 84% of the patients have PDs (Logan, 2020; de Ruiter, 2009). Individuals with PDs have an increased risk of violence and a higher recidivism risk than offenders without PDs (Yu et al., 2012). Consequently, in outpatient forensic mental health settings, PDs are both assessed and treated.

Treatment of PDs with ST was demonstrated to be effective in regular mental health care (Bamelis et al., 2014). For forensic patients, ST was adjusted by adding specific modes. This adjustment showed promising results (Bernstein et al., 2012, 2021). However, this study was limited to closed forensic psychiatric hospitals where patients were admitted mandatorily.

In recent years, there has been a development in the field of personality and PDs with more attention for personality functioning (PF) as the core of personality pathology. This is described in Criterion A of the Alternative Model for Personality Disorders (AMPD) in the DSM-5 section III (APA, 2013; Emerging Measures and Models). Some instruments that measure PF, for instance the SIPP-118 (Verheul et.al., 2008) are applicable to measure the change in PF as an effect of treatment. In forensic outpatient mental health, as far as we know, no specific instrument has been identified as a routine outcome monitoring during PD treatment.

This study will examine the outcome of ST for PDs in forensic outpatient mental health. To our knowledge this has not been studied before. We will examine three primary outcomes. A first outcome is measured in terms of changes towards more adaptive schemas and modes. A second outcome is defined in terms of reducing recidivism risk. Thirdly, we will investigate whether the concept of severity of PF as described in Criterion A of the AMPD in the DSM-5 (APA, 2013) is useful to monitor the effect of ST treatment for these patients.

Because having a PD is known to correlate with experiencing a lesser quality of life (Soeteman et al., 2008) and having other psychological problems (Andrea & Verheul, 2017), these concepts are secondary outcome variables for the effect of treatment. Since the number of patients admitted for ST is limited, ST a long-term treatment is and patients must be willing to participate in a study, a Single Case Experimental Design (SCED) with a limited number of patients (N=8) seems to be the most applicable design (Kazdin, 1982).

Description

Personality disorders (PDs) are relatively common. In a systematic review Andrea & Verheul (2017) found that about 13% of the general population have a PD and that this percentage increases to almost 50% in psychiatric patients. Having a PD has a major impact on a patient, their environment and society. It is often accompanied by having other mental disorders such as an addiction or mood or anxiety disorders (Andrea & Verheul, 2017). It lowers quality of life (Soeteman et al., 2008), lowers life expectancy, and involves more costs due to frequent use of health care (Care Standard Personality Disorders, GGZ Standards, 2017).

In forensic psychiatry approximately between 42 and 84% of the patients have one or more PD (Logan, 2020; de Ruiter, 2009). Individuals with a PD have an increased risk of violence. Moreover, offenders with a PD have a higher recidivism risk than offenders without a PD (Yu et al., 2012). Forensic psychiatry aims to reduce recidivism risk by treating mental or psychiatric problems (Basic Care Program Expertise Center Forensic Psychiatry (EFP), 2019). Consequently, in outpatient forensic mental health settings, PDs are both assessed and treated. A frequently offered treatment for PDs is schematherapy (ST).

Treatment of PDs with Sschematherapy (ST) was demonstrated to be effective in regular mental health care (Bamelis et al., 2014). The presence of PD symptoms decreased, depression and anxiety decreased and quality of life improved. ST is a form of psychotherapy developed by Young (2003) that focuses on early maladaptive schemas (EMS) and schema modes (SM). EMS are defined as self-destructive core themes that pertain one's view of the self, others and the world. SM are cognitive, emotional or behavioral states of a person at a certain moment, SM can be adaptive or maladaptive. In ST the goal is to decrease the impact of EMS to replace maladaptive SM with more adaptive, healthy, SM. For forensic patients, ST was adjusted by adding specific SM. This adjustment showed promising results in forensic hospitals in terms of decreases in PD symptoms in a study of Bernstein et al. (2012, 2021). However, the study was limited to closed forensic psychiatric hospitals where patients were admitted mandatorily.

In recent years, there has been a development in the field of personality and PD with more attention for personality functioning (PF) as the core of personality pathology. This is described in Criterion A of the Alternative Model for Personality Disorders (AMPD) in the DSM-5 section III (APA, 2013; Emerging Measures and Models). This dimensional view fits better with clinical practice in which PF is considered a continuum from maladaptive to adaptive PF (Widiger et al., 2005) and where treatment of patients attempts to improve their PF (Verheul et al., 2008). Several instruments have been developed to measure this PF, including self-report questionnaires such as the Severity Indices of Personality Problems (SIPP-118; Verheul et.al, 2008), the Level of Personality functioning Scale-Brief Form 2.0 (LPFS-BF 2.0; Hutsebaut et al., 2016), and the General Assessment of Personality Disorder (GAPD; Livesly, 2006). A study comparing the content of eight instruments for measuring PF with each other (Waugh et al., 2021) found that raters demonstrated agreement when using the instruments and that the instruments were mostly similar in coverage of the underlying PF construct. Based on the conclusions of Waugh et al. (2021), ease of use, and availability in Dutch, we will use the LPFS-BF 2.0 and SIPP-118 for the current study. The LPFS-BF 2.0 is very short (12 items) and therefore easy and quick to administer. The LPFS-BF 2.0 was demonstrated as treatment outcome measure in a detention setting (Bach & Hutsebaut, 2018). The SIPP (in the study of Waugh, without further explanation, the short form (SF) version of the SIPP was used), is a good choice for investigating PD and severity of PF in terms of content captured (Waugh et al., 2021). The SIPP-118 is also applicable to measure the change in PF as an effect of treatment (Verheul et.al., 2008).

In forensic outpatient mental health, as far as we know, no specific instrument has been identified to be useful for measuring routine outcome monitoring (ROM) during PD treatment. Questionnaires assessing PF, such as the SIPP-118 or the LPFS-BF 2.0 might be suitable for this, as they can capture changes in PF during therapy. In forensic psychiatry effect of therapy is usually assessed by evaluating the recidivism risk, or likelihood of delinquency, by using a risk assessment instrument (RAI). In a RAI, a distinction is made between static and dynamic factors. The difference is explained in the forensic Basic Care Program (EFP, 2019): Static factors are mostly life course events that are unchangeable and cannot (anymore) be influenced by treatment, for example the number of convictions or a family history with crime. Dynamic factors are factors that can be influenced and for which research has shown there is a relationship with (criminal) behavior, for example alcoholism or impulsive behavior. Reducing dynamic factors with treatment is used mainly as a manner in forensics psychiatry to prevent crimes.

When considering the dynamic factors of the Forensic Ambulatory Risk Evaluation (FARE; Van Horn et al., 2016) and the facets of the SIPP-118, there appears to be overlap between several components (besides unique variance being captured). For example, both instruments contain the topics "self-reflection" (in the FARE presented in dysfunctional resolution skills), "emotion regulation" (in the FARE presented in poor impulse control) and "aggression regulation" (in the FARE presented in poor impulse control). Also "relational functions" (a domain in the SIPP-118) has a similarity with the item "problematic (ex-) partner relationships" in the FARE. The LPFS-BF 2.0 also shows overlap with concepts used in the FARE. It is therefore possible that these PF instruments could be of significance in monitoring treatment in forensic outpatient mental health, and a measure of PF might be even more sensitive to changes by treatment in case of PDs as this is the 'core' of personality pathology.

The current study will examine the outcome of ST for PDs in forensic outpatient mental health. To our knowledge this has not been studied before. We will examine three primary outcomes. A first outcome whether ST is an effective treatment is measured in terms of changes towards more adaptive EMS and SM (the classic outcome variables for ST). A second outcome is defined in terms of reducing recidivism risk (the classic outcome variable for forensic psychiatry). Thirdly, we will investigate whether the concept of severity of PF as described in Criterion A of the AMPD in the DSM-5 (APA, 2013) is useful to monitor the effect of ST treatment for these patients.

Because having a PD is known to correlate with experiencing a lesser quality of life (Soeteman et al., 2008) and having other psychological problems (Andrea & Verheul, 2017), both concepts (quality of life and the presence of psychological complaints) are secondary outcome variables for the effect of treatment.

Hypotheses
  1. Treatment of PD with ST in forensic outpatient mental health shows a positive change in EMS and SM as measured by a self-evaluation of the SM vulnerable child (VC), the main coping mode (MCM) and healthy adult (HA), and by the YSQ-3 (Young & Brown, 2005) and the SMI (Lobbestael et al., 2010) questionnaires. (Primary outcome variable.)
  2. Treatment of PD with ST in forensic outpatient mental health shows a positive change in recidivism risk as measured with the RAI FARE (van Horn et al., 2016) (clinical judgement). (Primary outcome variable.)
  3. Treatment of PD with ST in outpatient forensic mental health shows a positive change in PD as described in the AMPD and as measured with the self-report questionnaires SIPP-118 (Verheul et.al., 2008) and LPFS-BF 2.0 (Hutsebaut et al., 2016). (Primary outcome variables.)
  4. Treatment of PD with ST in outpatient forensic mental health shows a positive change for quality of life as measured with the World Health Organization Quality of Life Brief Form (WHOQoL-BREF; the WHOQoL group, 1996). (Secondary outcome variable.)
  5. Treatment of PD with ST in outpatient forensic mental health shows a positive change for psychological complaints as measured with the Brief Symptom Inventory (BSI; Derogatis, 1975; translated by de Beurs, 2008). (Secondary outcome variable).

In this study a non-concurrent multiple baseline Single Case Experimental Design (SCED) (Kazdin, 1982) will be done. A SCED is specific for small sample sizes. No control group is needed with this design. Each participant starts at its own date, in this way we create a within-subject design.

For PDs, ST is standard care at The Rooyse Wissel outpatient treatment centers (tRWot). ST is administered in one session each week by certified therapists. Last years at tRWot, waiting time between intake and start of the therapy was (unfortunately) common practice due to capacity problems in certified therapists. This waiting time will be used as the baseline phase in our study. There will be no extra waiting time for patients who participate in our study. During the waiting period no other form of psychotherapy will be administered which is also standard procedure. Other forms of treatment (for instance pharmacotherapy) will be registered. In the waiting period we will start with gathering data. After start of the ST, with a maximum of 2 years, during the treatment phase, data will be gathered. We aim at starting the study in 2022.

A minimum of 8 patients is targeted, as was used in a similar study with this design that also examined schematherapy (Videler, 2018). Since this is a SCED no sample size calculation is needed.

Information is extracted from the electronic patient file (EPD) and participants are also asked to fill in questionnaires.

Missing values will be noted by reviewing the completed questionnaires and will be checked with the participants as much as possible. Due to the limited number of intended participants, this is a realistic thing to do. If any values are missing, this will be mentioned when describing the results.

Besides the visual inspection that is typical for a SCED, a mixed-effects model with time as a continuous variable will be used to assess differences within each participant and among treatment phases on the primary and secondary outcomes of forensic care. The outcomes will be assessed longitudinally using fixed effects of time, the therapy x time interaction, and other baseline covariates. The random model part will be selected using the Bayesian information criterion (BIC) from either an 'unstructured', an Autoregressive (AR1) or an Autoregressive Moving Average (ARMA11) within-subject covariance structure. The model results will be presented as P values and 95% confidence intervals. Normal quantile plots of residuals, standardized residuals, and random effects will be used for model diagnostics. If the underlying assumptions underlying the mixed-effects model analysis are violated, we will conduct the analysis using a generalized estimation equation.

The effect of time on therapy will be assessed using Cohen's d. These effect sizes will be calculated as the change between the last intervention value and the baseline value to measure the strength of the treatment effect. Analyses will be done with SPSS.

The research data that are traceable (patient number of tRWot and date of birth) and the assigned subject number, are stored at the VUB in a secured Word file that is only accessible by B. van Reijswoud.

For the remaining data, this subject number is always used for identification. These data are put directly into SPSS under the subject number. The questionnaires that are completed on paper by the participants are also stored at the VUB (only) with the subject number.

Details
Condition Personality Disorders
Treatment schematherapy
Clinical Study IdentifierNCT05523544
SponsorVrije Universiteit Brussel
Last Modified on7 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

patients with a PD who have been diagnosed with the SCID-5-PD
patients who will receive ST for their PD
and are willing to sign informed consent to participate in the study

Exclusion Criteria

patients with an IQ lower than 80
patients with actual psychosis
patients with actual bipolar problems
patients having a severe addiction
sex offenders
patients who can be involuntary admitted in psychiatric hospital when they do not cooperate in treatment ("TBS met voorwaarden")
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