The primary aim of this study is to examine whether TAU plus MBT-P has a more positive effect on social functioning than TAU only.Secondly it will be examined whether this potential therapeutic effect is driven by an increase in social cognitive…
ID
Source
Brief title
Condition
- Schizophrenia and other psychotic disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Social functioning, the primary outcome measure, is measured with the Social
Functioning Scale
Secondary outcome
-Social Cogntition (Mediator Variable): The TAT (Thematic Apperception Test),
scored with the SCOR System (Social Cognition and Object Relations System), is
used to assess the patients* mentalizing capacity. It assesses a patient*s
emotional differentiation, the affect tone of his/her relationships, reflective
functioning, capacity for reality testing, emotional investment in
relationships and understanding of social causality. The hinting task is used
to asses the quality of patients' Theory of Mind.
- Social stress reactivity: Using an Experience Sampling Monitoring (ESM)
device called the PsyMate, we will measure changes in mood during stressful
social interaction. There will be four consecutive assessments: one assessment
before treatment, one assessment during treatment, one assessment directly
after treatment and one assessment six months after treatment. Each assessment
will last for five days. During these assessments, patients record daily social
interactions and the degree of social tension in those situations. Questions
pertaining to social stress include: *I would rather be alone'and 'I like the
present company'. Mood is measured with items such as: 'I feel gloomy'
(negative affect) and 'I feel enthousiastic' (positive affect).
- Quality of Life: Using the MANSA, the Manchester Short Assessment of quality
of life changes in overall life quality of patients are measured
- Positive, Negative, Anxious and Depressive Symptoms: anxious and depressive
symptoms are assessed by independent bachelor psychology graduates that are
blind to treatment allocation and measured with several items of the PANSS
(Item G2 and G4; Positive and Negative Syndrome Scale7). The PANSS, is a
30-item, 7-point Likert scale rating instrument developed for the assessment of
phenomena associated with schizophrenia. Symptoms over the past week are rated.
A Dutch version is used.
- Substance abuse: Patients are asked to report the instances of substance
(ab)use on the PsyMate during the PsyMate ESM measurement sessions.
- Awareness of having a mental disorder: measured using item G12 from the
PANSS.
- Personality organization (Moderator variable): Assessment of structural
personality pathology is done using the theory driven profile approach to the
DSFM (Dutch short Form of the MMPI).Three levels of Personality Organization
(PO) are distinguished: Neurotic PO (identity integration), Borderline PO
(identity diffusion) and Psychotic PO (identity diffusion combined with
impaired reality testing).
- Childhood Trauma (Moderator variable): The Childhood Experience of Care and
Abuse (CECA) interview is used to measure childhood and adolescent neglect and
abuse. The CECA is a semi-structured interview that aims to assess details and
the time-sequence of traumatic childhood experiences. It assesses lack of care
(neglect, antipathy), physical abuse, sexual abuse and psychological abuse,
known risk factors for psychosis.
- Somatization: somatization is measured using items pertaining to somatization
in the DSFM (Dutch short Form of the MMPI).
- Adherence to treatment is rated with the Medical Adherence Scale.
Background summary
Mentalization-Based Treatment (MBT) was initially developed by Peter Fonagy to
treat borderline personality disorders (BPD). In a set of studies, Peter Fonagy
and Anthony Bateman have shown that the effectiveness of MBT surpasses that of
standard psychiatric care regarding the treatment of Borderline Personality
Disorder. Although MBT was initially developed for the treatment of BPD , it
has since branched out as a treatment for a multitude of psychological
disorders. Most of these disorders, like BPD, are rooted in problematic
personalities, past attachment difficulties and current *mentalization*
impediments.
Mentalization - or social cognition - is the capacity to infer and understand
one*s own and others* mental states. It is believed that this capacity is
underdeveloped in patients with nonaffective psychotic disorders (NAPD). We
therefore hold that MBT might be especially effective regarding these patients.
Mentalization Based Treatment for Psychosis (MBT-P) is developed to target this
impediment in social cognitive capacity. It is a psychodynamic treatment rooted
in attachment and cognitive theory developed for the treatment of NAPD. MBT-P
aims to strengthen patients* social cognitive capacity in order to reduce
emotional reactivity in stressful social situations and improve social
functioning. It is expected that this can lead to a higher quality of life and
disease awareness and a reduction in substance abuse and depressive and anxious
symptoms.
Study objective
The primary aim of this study is to examine whether TAU plus MBT-P has a more
positive effect on social functioning than TAU only.
Secondly it will be examined whether this potential therapeutic effect is
driven by an increase in social cognitive capacity and a decrease in social
stress reactivity. Secondary outcome measures are: quality of life, disease
awareness, substance abuse and depressive and anxious symptoms.
Study design
The study is a partly open, partly single blind randomized controlled trial, in
which TAU plus MBT-P is compared to control condition (TAU only). Patients, the
clinicians and the local researcher (Jonas Weijers) know in which treatment
condition the patients are. However, the researchers (the research assistent
and psychology students) that perform the measurements after randomization do
not know to which condition the patients are allocated.
Intervention
Mentalization Based Treatment for Psychotic Disorders (MBT-P):
MBT-P is a type of MBT that has been specifically designed for patients with
non-affective psychotic disorders (NAPD), such as schizophrenia,
schizophreniform or schizoaffective disorder (295.x), delusional disorder
(297.1), brief psychotic disorder (298.8) or psychotic disorder not otherwise
specified (298.9). MBT-P is a long-term, psychological treatment consisting of
both group and individual sessions. It aims to increase the capacity of social
cognition, i.e. the capacity to understand mental states of both oneself and
others, in order to help individuals adapt to complex social interactions and
regulate distressing affect. It helps patients develop a more coherent and
reflective life narrative and interpersonal attunement. An adapted version of
the treatment protocol, as developed by Bateman and Fonagy for patients with
personality disorders (MBT-PD), is used for the treatment of NAPD. MBT-P is
limited to the first tree steps in the MBT-PD protocol: 1) learning to become
(self)conscious, 2) being reflective and 3) focusing on social interaction.
MBT-P is less intensive than MBT-PD in order to regulate arousal level.
Adjustments were made by adapting the treatment to the patients: this was done
by changing the dosage and by offering both group and individual sessions in
order to maximize compliance. Treatment goals were set realistically. Instead
of curing NAPD, the treatment focuses on improving quality of life a reduction
of social tension.
Study burden and risks
There are no known health risks to participation in this study. Although group
therapy can have adverse effects on patients, for example caused by exlusion.
Filling out questionnaires and participating in interviews does require a
certain level of energy and concentration. The study requires a substantial
time investment. Participating in the study itself will take a total of 22
hours in 2 years. Treatment in both conditions will last for 18 months. Some
activities will have to be interrupted in order to respond to the PsyMate.
Sometimes this will warrant an explanation to others nearby. Most people
however get used to this relatively quickly. Most of the measurements (about 16
hours in a total of 22 hours) will be measurements in daily life, which we
assess to be an acceptable burden. Participation is voluntary and everyone can
stop participation at any given moment without providing a reason. The MBT
condition contains 60 hours of grouptherapy sessions (60 sessions of 60
minutes) and 15 hours of individual therapy sessions (30 sessions of 30
minutes) spread over 18 months.
Universiteitssingel 40
Maastricht 6229 ER
NL
Universiteitssingel 40
Maastricht 6229 ER
NL
Listed location countries
Age
Inclusion criteria
* At least six months of prior treatment, which should include relevant psycho-education regarding nonaffective psychotic disorders (schizophrenia, schizophreniform or schizoaffective disorder (295.x), delusional disorder (297.1), brief psychotic disorder (298.8) or psychotic disorder not otherwise specified (298.9))
* Less than ten years of prior treatment for a nonaffective psychotic disorder.
* Age 18-55
* Informed consent
Exclusion criteria
* Intellectual disabilities and/or illiteracy (having attended Dutch MLK or ZMLK education).
* A lack of mastery of the Dutch language.
* Severe addiction to such an extent that inpatient detoxification is necessary. After detoxification the patient is still eligible for participation in the study.
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 | NL47236.068.13 |