The primary objective of this study is to investigate the effectiveness of TE-ST in enhancing personality functioning as compared to long-term schema group therapy. Secondary objectives to the study are: to explore the effect on reducing general…
ID
Source
Brief title
Condition
- Personality disorders and disturbances in behaviour
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameter is the level of personality functioning as measured by
the Level of Personality Functioning Scale - Brief Form (LPFS-BF). It is tested
whether TE-ST is non-inferior to long term group schema therapy.
Secondary outcome
Secondary objectives to the study are: to explore the effect on decreasing the
severity of general psychiatric complaints (Brief Symptom Inventory),
personality disorder symptoms (PID-5-BF) of time-limited compared to long-term
group schema therapy; to understand the effect of increasing emotion regulation
ability (DERS), and improving functioning (WHODAS-2) and quality of life
(MHQOL) of time-limited compared to long-term group schema therapy; to
understand the effectiveness of therapy from the patient*s perspective using
patient derived goals in time-limited compared to long-term group schema
therapy; to estimate the cost-effectiveness (TIC-P/EQ-5D-5L) of time-limited
compared to long-term group schema therapy; to understand what factors are
predictive in therapy outcome (CTQ, YSQ, SMI, DES-T).
Background summary
Personality disorders are prevalent and can be successfully treated using
psychotherapy. However, while the burden for patients is high, access to
treatment is limited due to wait lists. There is a need to study the
effectiveness of brief interventions. Specifically, time-limited schema group
therapy has shown promising results. Therefore, this study seeks to investigate
whether time-limited experiential group schema therapy (TE-ST) is equally
effective to long-term group schema therapy.
Study objective
The primary objective of this study is to investigate the effectiveness of
TE-ST in enhancing personality functioning as compared to long-term schema
group therapy. Secondary objectives to the study are: to explore the effect on
reducing general psychiatric symptoms and decreasing the severity of
personality disorder symptoms of time-limited compared to long-term group
schema therapy; to understand the effect of increasing emotion regulation
ability, and improving functioning and quality of life of time-limited compared
to long-term group schema therapy; to understand the effectiveness of therapy
from the patient*s perspective using patient derived goals in time-limited
compared to long-term group schema therapy; to estimate the cost-effectiveness
of time-limited compared to long-term group schema therapy; to understand what
factors are predictive in therapy outcome.
Study design
The study is a multi-centre randomised controlled non-inferiority trial with
two arms comparing TE-ST to long-term group schema therapy.
Intervention
Within the experimental condition TE-ST is provided consisting of 18 90-minute
group sessions and two 60 minute follow up sessions. Experiential techniques
like imagery, imagery with rescripting, historical roleplay and chair
techniques will be included. In the control condition, experiential group
schema therapy is provided consisting of 36 90-minute group sessions and two
60-minute follow up sessions.
Study burden and risks
The present study consists of completing questionnaires, with no additional
risks involved. There is a burden for the participant in terms of time to
complete the questionnaires. We expect that both arms of the study will be
equally effective in reducing psychiatric distress. Therefore, we do not expect
any adverse effects of the experiential group schema therapy. However, there is
a risk that the time-limited treatment will be less effective in reducing
personality functioning than the longer treatment. Benefits may be an
improvement of functioning and a decline of psychiatric complaints.
Lijnbaan 4
's Gravenhage 2512VA
NL
Lijnbaan 4
's Gravenhage 2512VA
NL
Listed location countries
Age
Inclusion criteria
1. DSM-5 classification of a personality disorder preferably assessed with the
aid of the Structured Clinical Interview of DSM-5 Disorders (SCID-5-P, Arntz,
Kamphuis & Derks, 2017). The SCID-5-P is part of the standard admission
procedure for specialised care. A different standardised assessment may be
used.
2. Age at least 18 years,
3. Eligibility for group therapy based on;
a. symptoms of personality disorders are the reason for seeking help,
b. the patient is motivated to follow psychotherapy in a group, and
c. the clinical judgement of the group therapists.
The latter is based on the patient ability to attend group meetings, the
patient openness within a group and the patient reflective ability given the
input of other patients.
Exclusion criteria
1. Acute crisis (such as suicidality) for which a patient needs inpatient
treatment,
2. Acute psychotic episode or psychotic disorder, autism spectrum disorder or
alcohol or drugs-related disorders as primary diagnosis,
3. Limited knowledge of the Dutch language,
4. Severe auditory problems that interfere with participation in a group, or
severe stuttering,
5. Estimated IQ below 70.
Design
Recruitment
Medical products/devices used
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 | NL86131.078.24 |