No registrations found.
Source
Brief title
Health condition
Cluster C Personality Disorders
Sponsors and support
Intervention
No registrations found.
Outcome measures
Primary outcome
Assessment of DSM-IV Personality Disorders questionnaire (ADP-IV)
Structural Clinical Interview for DSM-5 personality disorders (SCID-5-P), Structured Clinical Interview for DSM-5 Personality Questionnaire (SCID-5-PV)
Secondary outcome
Avoidant personality disorder severity index (AVPDSI), Dependent personality disorder se-verity index (DEPDSI), Compulsive personality disorder severity index (OCPDSI).
Inventory of Personality Organisation Short Form (IPO-16-NL)
Brief Symptom Inventory (BSI)
EQ-5D
Happiness Questionnaire
TiC-P
Background summary
Rationale: Cluster C personality disorders (PDs) are highly prevalent in clinical practice and are related to unfavorable outcome and chronicity of all common mental health disorders (e.g. depression and anxiety disorders). Although several forms of individual psychotherapy are commonly offered in clinical practice for this population, due to scarcity of well-designed studies evidence for differential efficacy, setting and format is lacking. Also, very little is known on working mechanisms of these psychotherapies. Finding evidence on the differential (cost)effectiveness for this group of patients and the working mechanisms of change is important to improve the quality of care for this vulnerable group of patients.
Objective: In this study we will compare the differential (cost)- effectiveness of three individual psychotherapies: short-term psychodynamic supportive psychotherapy (SPSP), affect phobia therapy (APT) and schema therapy (ST). Although these psychotherapies are commonly used in clinical practice, evidence for the cluster C PDs is restricted to one RCT for ST (Bamelis et al., 2014) and one for APT (Svartberg et al., 2004). Next we will investigate predictive factors, non-specific and therapy specific mediators.
Study design: A mono-center randomized clinical trial with three parallel groups 1) SPSP 2) APT 3) ST. Randomization on patient level will be pre-stratified according to type of personality disorders.
Study population: 205 patients with cluster C personality disorder(s) or other specified personality disorder with mainly cluster C traits, aged 18-65 years, seeking treatment at NPI, a Dutch mental health care institute specialized in personality disorders.
Intervention: SPSP, APT and ST (50 sessions per condition) are offered twice a week in sessions of 50 minutes for the first four to five months. After that, session frequency decreases to once a week. All conditions have a maximum duration of one year.
Main study parameters/endpoints: Personality change (ADP-IV and SCID-5-P) will be the main outcome measure. Secondary outcome measures are psychiatric symptoms, quality of life and costs from a societal perspective. Assessments will take place at baseline and at 1, 3, 6, 9, 12, 18, 24 and 36 months after the start of the treatment.
Study objective
Primary hypothesis: We expect a difference in (cost)effectiveness between SPSP, APT and ST in reducing personality pathology and psychiatric complaints.
Study design
Assessments will take place at baseline and at 1, 3, 6, 9, 12, 18, 24 and 36 months after the start of the treatment.
Intervention
1); SPSP; 2) APT; 3) ST. All conditions will provide 50 sessions, the first 32 sessions twice a week (4-5 months), the other 18 sessions weekly (4-5 months).
Inclusion criteria
- Primary diagnoses: DSM-5 diagnosis cluster C PD or Otherwise specified PD with predominantly cluster C traits, operationalized as a minimum of 5 cluster C traits
- Age 18-65 years
- A written informed consent
- Dutch literacy
- The willingness and ability to participate in an individual treatment of 50 sessions in one year.
Exclusion criteria
- (Subthreshold) cluster A or B PD
- Having received SPSP, APT or ST in the previous year
- Immediate intensive treatment or hospitalization is needed, e.g. acute suicidality
- Severe psychiatric disorder requiring priority in treatment (autism spectrum disorder, psychotic symptoms/disorder, bipolar disorder)
- Substance use disorder
- IQ <80
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
NTR-new | NL8545 |
Other | METC VUMC : METC2020.068 |