The main goal is to investigate whether COMET can be used as an intervention to reduce paranoia in patients with psychotic disorder and paranoid thoughts. An aim is also to see if the treatmenteffect is stable after eight weeks.
ID
Source
Brief title
Condition
- Schizophrenia and other psychotic disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main outcome measure is the degree of paranoia. This will be measured using
a self-screening list, the Green Paranoid Thoughts Scale. This is a
symptom-specific tool for measuring paranoid thoughts. Self-esteem is measured
using the Rosenberg Self-esteem scale. Eight weeks after the last training,
both questionnaires will be taken again. In addition, the Positive And Negative
Syndrome Scale (PANSS) will be used. This is a semi-strucured interview to
measure the positive and negative symptoms and other psychopathology in
psychotic patients.
Secondary outcome
Eight weeks after completion the training participants, both of the
experimental and the control group, will be asked to fill in the questionnaires
again and the PANSS will be taken to investigate whether the effects of the
long-term training remain.
In addition, the degree of drop-out will be viewed.
Background summary
In this study, patients with psychotic disorder and paranoia are asked to
participate in a self-esteem training, the COMET. The expectation is that
enhancing the self-esteem by COMET reduces paranoid thoughts. The results are
measured using an RCT, where an experimental group is offered the COMET and a
control group 'treatment as usual'. The groups will be compared to each other
with self-report questionnaires and an semi-structured interview before and
after the training.
Study objective
The main goal is to investigate whether COMET can be used as an intervention to
reduce paranoia in patients with psychotic disorder and paranoid thoughts. An
aim is also to see if the treatmenteffect is stable after eight weeks.
Study design
After informed consent, participants will be randomly assigned to an
experimental condition in which they receive the COMET training or a control
condition in which they are offered a training called "Grip op je leven", the
treatment of usual.
Intervention
One group (experimental group) is offered the COMET, this is a self-esteem
training, developed by Kees Korrelboom (2011), and for which scientific
evidence has been found in other patient groups. Another group is offered
'treatment as usual'. This condition consists of a training group, called "Grip
op je leven ". Patients in this group receive a number of modules aimed at
improving regulation of emotions and coping skills. This training group will be
offered at the same time as COMET. The duration of the training is ten week,
for both groups.
Study burden and risks
The risks are expected to be very minimal or absent. The COMET has been
investigated before and proved to be effective and safe, even in patients with
a psychotic disorder. There are no studies known in which patients have been
psychologically harmed as a result of this training. The treatment as usual
group is offered a treatment which had been developed for patients with
psychotic vulnerability and previously offered to this group of patients. If
during the investigation psychological (and possibly psychotic) symptoms from
patients increase or worsen, appropriate (medical) intervention will be
applied. Participants are free at all times to withdraw from the study without
having any negative consequences for their treatment.
Willem Dreeslaan 2
Utrecht 3515GB
NL
Willem Dreeslaan 2
Utrecht 3515GB
NL
Listed location countries
Age
Inclusion criteria
Men and women, age of 18 and older, diagnosed with any psychotic disorder with paranoia and who are hospitalized. Patients are capable of reporting low self-esteem and their paranoid thoughts. All patients are mentally competent.
Exclusion criteria
Younger than 18 and older than 70
insufficient capacity of speaking and understanding Dutch language
Not capable of training in a group
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 | NL63893.078.17 |