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…
ID
Source
Brief title
Condition
- Personality disorders and disturbances in behaviour
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Personality change (ADP-IV) will be the main outcome measure.
Secondary outcome
Secondary outcome measures are psychiatric symptoms, quality of life and costs
from a societal perspective. Assessments will take place at baseline (after
signing the Informed Consent), at the start of the treatment and at 1, 3, 6, 9,
12, 18, 24 and 36 months after the start of the treatment.
Background summary
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.
Study 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.
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.
Study burden and risks
Patients will be invited to a clinical interview prior to start of treatment,
12 and 24 months after start of treatment. Other measurements can be done
either online or on paper-and-pencil. Although the burden includes a
time-investment of the patient (by filling in questionnaires), no risks are
associated with participation in the study. Participators in all conditions
will receive specialized treatment for personality disorders, their treatment
and measurements will be well monitored and checked on adherence and additional
treatment is provided if necessary.
Domselaerstraat 128
Amsterdam 1093MB
NL
Domselaerstraat 128
Amsterdam 1093MB
NL
Listed location countries
Age
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)
- Severe substance use disorder
- IQ <80
Design
Recruitment
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 |
---|---|
CCMO | NL72823.029.20 |