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ID
Source
Brief title
Health condition
Personality disorder, substance use disorder
Sponsors and support
Intervention
Outcome measures
Primary outcome
Dysfunctional core belief strength (visual analog scale 0-100)
Secondary outcome
Craving for drugs (PACS, also adapted for different substances); global impairment (OQ-45); QGR-S (visual analog scale); SCID-5-PV; SMI; YSQ (35 items); PID-5-SF
Background summary
In this study, we will do further research of Schema Therapy (ST) and SafePath, a milieu-therapeutic form of ST, for double-diagnosed (substance abuse plus personality disorder) patients in a clinical setting at de Hoop. De Hoop has already implemented this therapeutic approach for several years under the supervision of D. Bernstein. All enrolled patients will receive the same treatment as not enrolled patients. This proposal represents an open trial in which we will test the already implemented treatment model on a clinical ward, involving a case series design (Kazdin, 2010) in which each patient forms its own individual control based on their own natural waiting list baseline.
Study objective
In terms of effectiveness, we hypothesized that for each patient during treatment:
1 Compared to a waiting list baseline, the intensive inpatient treatment with adapted ST interventions together with ST milieu therapy during 12 weeks results in larger improvements in core PD cognitions over time (interaction effects condition*time; primary outcome).
2 Compared to a waiting list baseline the treatment phase results in larger improvements in healthy schema modes (Healthy Adult and Happy Child) and larger decreases Schema Modes, especially ‘the Detached Protector’, ‘the Detached Self-soother’, ‘impulsive child’ and EMSs in the DR domain and ‘Insufficient Self-control’, over time (interaction effect condition*time on observed behavior problems; secondary outcomes).
3 Compared to a waiting list baseline, the treatment phase result in larger improvements in craving and general complaints. (interaction effect condition*time on observed behavior problems; secondary outcomes).
4 Compared to a waiting list baseline, the treatment phase, results in larger decreases in negatively valued cognitive and affective aspects of God representations and larger increases in supportively valued cognitive and affective aspects of God representations in patients with a Christian religious affiliation over time (interaction effect condition*time on observed behavior problems; secondary outcomes).
5 Visual inspection of slopes and effect sizes during different measurements time points, shows that increases in healthy schema modes (Healthy Adult and Happy Child) and supportive religious representations and decreases in problematic schema coping, especially avoidant coping, problematic Schema Modes, especially ‘the Detached Protector’, ‘the Detached Self-soother’, and EMSs, in the DR domain and ‘Insufficient Self-control’, and negative religious representations go together with decreases in reported PD-cognitions, PD pathology, general complaints, and craving (SUD pathology) within patients.
Study design
Weekly measurements start from inclusion (dysfunctional core belief strength; PACS; God cognition strength). For remaining variables, three measurement points (after inclusion, at start of treatment, and at end of treatment).
Intervention
A therapeutic approach, including a group Schema Therapy as well as SafePath (a milieu-form of ST) aimed at substance use disorder and personality disorder provided in a clinical setting during 12 weeks.
Inclusion criteria
Inclusion criteria are that patients have an indication for treatment in an inpatient setting for SUD (substance use disorder) at the 4life clinic at the Hoop ggz, following the Dutch guidelines (De Beer & Van de Glind, 2009). Patients have a diagnosis of DSM-5 SUD and have minimally five PD traits (this is seen as clinically significant for PD (Verheul, Bartak, & Widiger, 2007)), age 18-65 years, with an indication of at least a normal intelligence based on a completed primary and secondary education and clinical impression, and a willingness to participate in the study confirmed by a signed informed consent.
Exclusion criteria
Exclusion criteria are an severe autism spectrum disorder, schizophrenia or other psychotic disorders, and the presence of significant risk for suicide based on psychiatric evaluation. Other exclusion criteria are the current use of heroin, methadone or another heroin replacement, acute delirium symptoms, or have otherwise specific medical needs. These clients are refered to a more medical oriented inpatient detoxification.
Further, we exclude patients whose waiting list times are less than two weeks, because that allows insufficient time to gather three necessary baseline observations.
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
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Other (possibly less up-to-date) registrations in this register
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In other registers
Register | ID |
---|---|
NTR-new | NL8191 |
Other | ERCPN Maastricht : ERCPN- 201_05_11_2018 |