The goal of this clinical trial is to investigate if generalist treatment (GIT-PD) is non-inferior in improving level op personality functioning compared to specialist treatment (MBT/ST) in patients with severe personality disorders. The main questions it aims to answer are: 1. Is generalist treatment (GIT-PD) non-inferior in improving level of personality functioning compared to specialist treatment (MBT/ST) in patients suffering from severe personality disorders (PD)? 2. What patient characteristics predict which patients will benefit more from specialist or generalist treatment? Participants will be randomized to either specialist or generalist treatment. Interventions included in specialist treatment are Mentalization-Based Treatment (MBT) and Schema Therapy (ST). Generalist treatment will be offererd following the principles of the Guideline-Informed Treatment for Personality Disorders (GIT-PD), a principle-driven treatment framework based upon common factors and allowing personalized treatment according to patients' needs. All participating institutions offer GIT-PD and MBT and/or ST. Before, during and after following this treatment participants will complete measurements at 8 distinct time points. Participants will be asked to: * complete a range of instruments at baseline to enable the construction of a personalized advantage index to predict treatment response based on patient characteristics * complete questionnaires at all 7 post-randomization time points * undergo a semi-structured interview at 3 time points * follow treatment for personality disorders (either GIT-PD or MBT/ST)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
358
Schema therapy (ST) is an evidence-based, fully manualized, specialist form of psychotherapy for personality disorders (Bamelis et al., 2014; Sempértegui et al., 2013; Arntz et al., 2022). Eligible programs must adhere to the minimum standards described in the evidence-based literature. ST is an integrative treatment method, originally rooted in cognitive theory, but with additional influences from Gestalt, psychodynamic, and experiential methods. Schema therapy programs may differ in intensity and duration, even at the same site, but must include a minimum of either 40 sessions and/or a duration of 12 to 24 months. In addition, in order to be eligible, a schema therapy program must be of higher intensity or longer duration than the generalist treatment (GIT-PD) offered at the same site.
Mentalization-based treatment (MBT) is an evidence-based, fully manualized, specialist form of psychotherapy for personality disorders (Bateman \& Fonagy, 2008; Bateman \& Fonagy, 2009; Laurenssen et al., 2018; Juul et al., 2023). MBT is rooted in psychodynamic and attachment theory and aims to alter personality pathology by improving mentalizing and enhancing epistemic trust. Eligible programs must adhere to the minimum standards described in the evidence-based literature. MBT programs may differ in intensity and duration, even at the same site, but must include a minimum of either 40 sessions or a duration of 12 to 24 months. In additon, in order to be eligible, an MBT program must be of higher intensity or longer duration than the generalist treatment (GIT-PD) offered at the same site.
GIT-PD is a non-theoretical and non-methodological approach, based upon principles derived from common factors across evidence-based treatments for PD. GIT-PD has a flexible approach, enabling tailoring treatment to clinical needs of different types of patients. The treatment duration (start-end) is 12- 18 months. The treatment consists of three distinct phases. First, an assessment phase. Second, a modular treatment phase that offers either group or individual interventions. Third, a follow-up phase with limited treatment and focus on relapse prevention. In order to be eligible, GIT-PD should be less intensive than specialist psychotherapies offered in the control arm at the same location (i.e. MBT or ST). GIT-PD will not include evidence-based psychotherapy for personality disorders as described in previous RCTs.
GGZ de Viersprong
Halsteren, North Brabant, Netherlands
RECRUITINGGGZ Oost-Brabant
Helmond, North Brabant, Netherlands
RECRUITINGArkin NPI
Amsterdam, North Holland, Netherlands
RECRUITINGDimence Group
Almelo, Overijssel, Netherlands
RECRUITINGAltrecht
Zeist, Utrecht, Netherlands
NOT_YET_RECRUITINGLevel of Personality Functioning Scale - Brief Form 2.0 (LPFS-BF 2.0)
The LPFS-BF 2.0 is a self-report questionnaire consisting of 12 items (Weekers et al., 2018). Each item reflects a basic underlying impairment related to the 12 features of personality functioning according to Criterium A of the AMPD such as identity, self-direction, intimacy and relational functioning. The LPFS-BF 2.0 offers a severity index for personality pathology making it suitable for measuring treatment effects. Each item is scored on a scale from 1 (=very false or often false) to 4 (=very true or often true). Therefore, participants achieve a total score between 12 and 48 representing the severity of impairment in personality functioning. Data collection is done digitally via Castor or with pen and paper, based on participants preference. Pen and paper results are copied into Castor by hand by research assistants. Raw data is digitalized and stored on a local drive.
Time frame: From enrollment to the follow-up assessment 30 months after the start of treatment.
Semi-structured Interview for Personality Functioning (STiP-5.1)
The STiP-5.1 is a semi-structured clinical interview that provides a multi-item assessment of the severity of personality impairments according to the Level of Personal Functioning Scale (LPFS) of the AMPD included in Section III of DSM-5 (APA, 2013). The interviewer should rate the severity of each facet on a scale ranging between 'little to no impairment' (0) to 'extreme impairment' (4). It takes 45 minutes on average to administer the interview. A total score between 0 and 48 is given to indicate the participants global level of personality functioning . We administer the STiP-5.1 at 3 distinct time points. At the start and end of treatment and after 1 year follow up. All interviews are done by blinded research assistants, and the scores are directly logged in Castor. Interviews will be done either face to face or via video call.
Time frame: From enrollment to the follow-up assessment 30 months after the start of treatment.
Severity Indices of Personality Problems - Short Form (SIPP-SF)
The SIPP-SF is a dimensional self-report questionnaire measuring the severity of personality pathology by assessing the core components of adaptive personality functioning. The SIPP-SF is designed in line with the concept of personality disorders as defined in the AMPD. Participants rate the 60 items on a 4-point scale ranging from fully disagree (1) to fully agree (4). Data collection is done digitally via Castor or with pen and paper, based on participants preference. Pen and paper results are copied into Castor by hand by research assistants. Raw data is digitalized and stored on a local drive.
Time frame: From enrollment to the follow-up assessment 30 months after the start of treatment.
Brief Symptom Inventory (BSI)
The BSI is a self-report questionnaire investigating symptom severity, consisting of 53 items which can be answered using a scale ranging from 1 (not at all) to 5 (extremely). The total score represents the number of symptoms that participants experienced during the past week. A global severity index and sub scores on all 9 domains are calculated by summing the values on all items and dividing by the number of items/domains. Data collection is done digitally via Castor or with pen and paper, based on participants preference. Pen and paper results are copied into Castor by hand by research assistants. Raw data is digitalized and stored on a local drive.
Time frame: From enrollment to the follow-up assessment 30 months after the start of treatment.
Columbia Suicide Severity Rating Scale Screen Version (C-SSRS)
Suicidality is assessed using the C-SSRS. This self-report questionnaire covers 6 items and has been recommended by ICHOM as a standard outcome measurement in personality disorder research, due to its adequate psychometric properties (Prevolnik Rupel et al., 2021). The 6 items are answered with either 'yes' or 'no'. The total number of positive answers indicates suicide risk. Data collection is done digitally via Castor or with pen and paper, based on participants preference. Pen and paper results are copied into Castor by hand by research assistants. Raw data is digitalized and stored on a local drive.
Time frame: From enrollment to the follow-up assessment 30 months after the start of treatment.
SCID-5-PQ
The SCID-5-PQ (First et al., 2016) is a self-report measure assessing different criteria for DSM-5 personality disorders according to Section II. Participants are presented with 106 items describing whom they are as a person providing them with a dichotomous 'yes' or 'no' answer scheme. Data collection is done digitally via Castor or with pen and paper, based on participants preference. Pen and paper results are copied into Castor by hand by research assistants. Raw data is digitalized and stored on a local drive.
Time frame: From enrollment to the follow-up assessment 30 months after the start of treatment.
WHO Disability Assessment Schedule (WHODAS 2.0)
Social and professional functioning will be measured using the WHODAS 2.0 self-report questionnaire, which includes 12 items. This questionnaire has been recommended by ICHOM for its good reliability, adequate validity and high sensitivity to change (Prevolnik Rupel et al., 2021). Participants answer 12 questions across 6 domains on their daily functioning during the last 30 days. Answers across the 6 domains are weighted and summed to create a total score of disability ranging from 0 to 100. Data collection is done digitally via Castor or with pen and paper, based on participants preference. Pen and paper results are copied into Castor by hand by research assistants. Raw data is digitalized and stored on a local drive.
Time frame: From enrollment to the follow-up assessment 30 months after the start of treatment.
EQ-5D-5L
The EQ-5D-5L is a self-report questionnaire that covers 5 items measuring quality of life across 5 domains. Answer options consist of 5 levels ranging from 'no problems' to 'extreme problems'. The level indicates the health state for that domain and can be combined into a 5-digit number indicating the overall quality of life of the participant on that day. Data collection is done digitally via Castor or with pen and paper, based on participants preference. Pen and paper results are copied into Castor by hand by research assistants. Raw data is digitalized and stored on a local drive.
Time frame: From enrollment to the follow-up assessment 30 months after the start of treatment.
Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF)
The Q-LES-Q-SF is a self-report questionnaire consisting of 16 items.. Participants rate their satisfaction with different aspects of quality of life on a 5-point scale from "not at all or never" (1) to 'frequently or all the time" (5). The possible scores range from 14 to 70 with higher scores indicating greater satisfaction with life (Stevanovic, 2011). Data collection is done digitally via Castor or with pen and paper, based on participants preference. Pen and paper results are copied into Castor by hand by research assistants. Raw data is digitalized and stored on a local drive.
Time frame: From enrollment to the follow-up assessment 30 months after the start of treatment.
Treatment Inventory of Costs in Patients with psychiatric disorders (TIC-P for Adults)
The TIC-P for Adults will be used to assess healthcare consumption and productivity loss during the last 3 months. Through 57 items the costs of different types of care are determined, e.g. for medication use, sessions with therapists, doctor's appointments and more indirect costs like loss of productivity and informal care by the participants network. The first section comprises 8 general questions. The second section includes 22 items regarding healthcare consumption. The last part consists of12 items on informal care and productivity loss. Some items feature multiple follow up questions resulting in the total number of 57 items. Data collection is done digitally via Castor or with pen and paper, based on participants preference. Pen and paper results are copied into Castor by hand by research assistants. Raw data is digitalized and stored on a local drive.
Time frame: From enrollment to the follow-up assessment 30 months after the start of treatment.
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