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

NCT05523544 | Completed

• 1 other identifier: BvRVUBdeeloz4
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief 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. Individuals with PDs have an increased risk of violence and a higher recidivism risk than offenders without PDs. 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. For forensic patients, ST was adjusted by adding specific modes. This adjustment showed promising results. 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. Some instruments that measure PF, for instance the SIPP-118 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 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 and having other psychological problems, 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.

Conditions

Personality Disorders

Keywords

personality disorders; forensic outpatient; schematherapy

Outcome Measures

Primary Outcomes (6)

• Change from baseline in schemas (EMS) on The Young Schema Questionnaire, at Week 26, Week 52, Week 78 and Week 104

  The Young Schema Questionnaire (YSQ-3; Young \& Brown, 2005) is a questionnaire (short form, version 3) that measures 18 EMS as described by Young et al. (2003) in their book about ST. The questionnaire consists of 90 items. Items are rated along a 6-point scale. Change is: (baseline - Week 26 score) (baseline - Week 52 score) (baseline - Week 78 score) (baseline - Week 104 score).

  baseline, 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.

  The Dutch Short Schema Mode Inventory (SMI; Lobbestael et al., 2010) measures 14 SM. These SM can be divided in healthy modes, parent modes, child modes and coping modes. The questionnaire consists of 118 items. The short scale was developed with reference to the long SMI (Young et al., 2007). Items are rated on a 6-point scale. Change is: (baseline - Week 26 score) (baseline - Week 52 score) (baseline - Week 78 score) (baseline - Week 104 score).

  baseline, 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.

  Schemamodes (SM) (vulnerable child, healthy adult en main coping mode) will also be assessed by an additionally very short (maximum 2 minutes) weekly rating to collect repeated measurements. These SM are assessed by a numeric rating scale from 1 to 6, similarly to the scoring on the SMI. The modes are accompanied by an image that represents the specific mode, to make the rating simple and quick. Change is: (baseline - up to Week 104 score).

  baseline, till the end of treatment (maximum Week 104 of treatment) 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.

  The SIPP-118 (Verheul et al., 2008) is a self-report instrument to measure the severity of personality pathology and was specifically developed for treatment outcome research. Items measure the core components of (mal-)adaptive personality functioning with 16 facets grouped into five higher order domains (Self-Control, Identity Integration, Relational Capacities, Responsibility, and Social Concordance). The instrument consists of 118 items. Items are rated on a 4-point scale. Respondents indicate the extent to which they agree with statements over a timeframe of the last three months. Change is: (baseline - Week 26 score) (baseline - Week 52 score) (baseline - Week 78 score) (baseline - Week 104 score).

  baseline, 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.

  The LPFS-BF 2.0 (Hutsebaut et al., 2016) is a self-report instrument to measure the levels of PF of criterion A of the AMPD. It is a 12-item instrument, and each item is intended to capture one of the features as indicated in the levels of PF scale. The LPFS-BF 2.0 covers the two domains Self and Other (Waugh et al., 2021). Items are rated on a 4-point scale. Change is: (baseline - Week 26 score) (baseline - Week 52 score) (baseline - Week 78 score) (baseline - Week 104 score).

  baseline, 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.

  The FARE (van Horn et al., 2016) is a RAI that was developed for adults aged 18 years and older, who are treated in a forensic outpatient clinics for their delinquent behavior. The FARE is used to determine the current risk of recidivism in delinquent behavior (general recidivism) and to monitor the progress of treatment based on the dynamic risk factors every 6 months. It consists of 6 static risk factors (unchangeable characteristics like age of first contact with police) and 11 dynamic risk factors (changeable through intervention like problematic (ex-)partner relationship). Each item is scored on a 5-point scale. After administering the FARE, a clinical estimation of the recidivism risk of a patient is made: very low, low, moderate, high or very high. The individual dynamic risk factors are incorporated into the patients' goals for treatment. Change is: (baseline - Week 26 score) (baseline - Week 52 score) (baseline - Week 78 score) (baseline - Week 104 score).

  baseline, Week 26, Week 52, Week 78 and Week 104

Secondary Outcomes (2)

• Change from baseline in quality of live on the World Health Organization Quality of live brief form, at Week 26, Week 52, Week 78 and Week 104.

  baseline, Week 26, Week 52, Week 78 and Week 104

• Change from baseline in symptomatic distress on the Brief Symptom Inventory, at Week 26, Week 52, Week 78 and Week 104.

  baseline, Week 26, Week 52, Week 78 and Week 104

Study Arms (1)

schematherapy

OTHER

all (8) participant wil recieve the same treatment, schematherpay which is treatment as usual for personality disorders in forensic psychiatric care. They will be asked however to fill in extra questionnaires to study the effect of the treatment.

Behavioral: schematherapy

Interventions

schematherapy BEHAVIORAL

psychotherapy

schematherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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").

Sponsors & Collaborators

• Vrije Universiteit Brussel: lead

Study Sites (1)

VUB

Brussels, Belgium

Location

MeSH Terms

Conditions

Personality Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Barbera van reijswoud, drs

  Vrije Universiteit Brussel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Model Details: 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.

Study Record Dates

• First Submitted: August 25, 2022
• First Posted: August 31, 2022
• Study Start: August 25, 2022
• Primary Completion: August 25, 2025
• Study Completion: August 25, 2025
• Last Updated: September 19, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)