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The Effects of Schema Therapy in Outpatient Forensic Mental Health Care: a Single Case Multiple-baseline Study. - Trial NCT05523544

Access comprehensive clinical trial information for NCT05523544 through Pure Global AI's free database. This phase not specified trial is sponsored by Vrije Universiteit Brussel and is currently Recruiting. The study focuses on Personality Disorders. Target enrollment is 8 participants.

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NCT05523544
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Trial Details
ClinicalTrials.gov โ€ข NCT05523544
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The Effects of Schema Therapy in Outpatient Forensic Mental Health Care: a Single Case Multiple-baseline Study.

Study Focus

Personality Disorders

schematherapy

Interventional

behavioral

Sponsor & Location

Vrije Universiteit Brussel

Brussels, Belgium

Timeline & Enrollment

N/A

Aug 25, 2022

Aug 25, 2027

8 participants

Primary Outcome

Change from baseline in schemas (EMS) on The Young Schema Questionnaire, at Week 26, Week 52, Week 78 and Week 104,Change from baseline in schema modes on The Dutch Short Schema Mode Inventory, at Week 26, Week 52, Week 78 and Week 104.,Change from baseline till the end of treatment with a maximum from 2 years (Week 104) of treatment, in the schemamodes vulnerable child, healthy adult and main coping mode on a numeric scale rating, measured once a week.,Change from baseline in personality problems on the Severity Indices of Personality Problems, at Week 26, Week 52, Week 78 and Week 104.,Change from baseline in personality problems on the Level of Personality functioning Scale-Brief Form 2.0, at Week 26, Week 52, Week 78 and Week 104.,Change from baseline in recidivism risk on the personality problems on the Forensic Ambulatory Risk Evaluation, at Week 26, Week 52, Week 78 and Week 104.

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).

ICD-10 Classifications

Specific personality disorders
Other specific personality disorders
Personality disorder, unspecified
Disorders of adult personality and behaviour
Other specified disorders of adult personality and behaviour

Data Source

ClinicalTrials.gov

NCT05523544

Non-Device Trial