In preparation for a multicentre randomized controlled trial (RCT) we want to test the psychomotor assertiveness training in a feasibility study. The aim of this study is threefold: 1) We want to evaluate and improve intervention protocol also using…
ID
Source
Brief title
Condition
- Schizophrenia and other psychotic disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
We hypothesise that the assertiveness intervention is applicable and its
effects can be measured in a RCT using the chosen outcome measures, and that
the chosen set up will lead to a sufficient number of participants. We
constructed three goals to investigate this hypotheses. First of all we want to
evaluate and improve intervention protocols. Trainers, participants, and
involved psychiatric workers are asked for feedback and asked about wanted and
unwanted effect of the sessions. After the intervention participants fill in an
qualitative questionnaire about the subjective experience of the training. We
expect that 80% of the participants indicate on this questionnaire that the
intervention was *helpful* or *very helpful*. We also expect that the trainers
and involved psychiatric workers have a positive opinion on the interventions
protocol. Second, we want to explore parameters that are needed for the RCT.
The feasibility study will tell us more about the willingness of therapist to
refer clients to the intervention and the willingness of clients to
participate. The coordinating researcher will monitor intervention adherence,
drop-outs, and keep track of the time schedules and intervention procedures. We
expect to find 24 patients willing to participate and drop-out rate will not be
higher than 20%. Third, we want to explore suitable outcome measures to
estimate sample size and power calculation for the RCT. We will use a
theory-based selection of the instruments stated in Table 2. We expect that the
effect sizes of these instruments are small to moderate.
Secondary outcome
see primary study parameters
Background summary
Contrary to what is generally thought, people with psychotic disorder have an
increased risk of victimization, instead of being possible offenders. Research
shows several factors associated with victimization in patients with psychotic
disorder. These factors are partly due to the clinical syndrome. Impaired
social cognition, decreased insight and problems in aggression regulation may
lead to inadequate social behavior that increase the risk of victimization. In
turn victimization can increase self-stigma resulting in reduced self-esteem,
empowerment, and assertiveness. Making patients more vulnerable for people who
want to take advantage of them. In addition, the traumatic experience of the
victimization could induce strong physiological responses to external stimuli
resulting in aggression regulation problems. Consequently, once being a victim
chances for revictimization are high. Aim of this study is to prevent
(re)victimization using a new psychomotor assertiveness training with elements
of kickboxing that addresses the risk factors.
Study objective
In preparation for a multicentre randomized controlled trial (RCT) we want to
test the psychomotor assertiveness training in a feasibility study. The aim of
this study is threefold: 1) We want to evaluate and improve intervention
protocol also using participants experience. 2) We want to explore parameters
that are needed for the RCT. For example: the willingness of onsite therapist
to select patients and the willingness of patients to participate in an
intervention that includes kickboxing, and adherence rate. 3) We want to
explore suitable outcome measures and estimate sample size and power
calculation for the RC.
Study design
To test the effects of the intervention we want to perform a feasibility study
with a pretest-posttest quasi-experimental design without a control group.
Intervention
To address these specific risk factors we developed a psychomotor assertiveness
training with elements of kickboxing. The intervention consists of 20-sessions
of group training divided into five modules. There is one session per week with
a duration of 75 minutes. One group has eight participants and there are three
groups in total. All the sessions will be given by a psychomotor trainer and
an expert by experience in cooperation with a fighting sport expert and a
psychologist.
Study burden and risks
We don*t expect any adverse events to happen for this reason no risks are
associated with participation.
We expect that the psychomotor assertiveness training will increase social
participation and prevent (re)victimization of people with a psychotic
disorder.
Grote Kruisstraat 1/2
Groningen 9712 TS
NL
Grote Kruisstraat 1/2
Groningen 9712 TS
NL
Listed location countries
Age
Inclusion criteria
- A diagnosis in the psychotic spectrum;
- Being able to give informed consent;
- 18 years or older;
Exclusion criteria
- Florid psychosis (mean positive symptoms > 5 measured by PANSS);
- Substance dependence (not substance abuse)
- IQ < 70
- Co-morbid neurological disorder
- Co-morbid personality disorder cluster B
- pregnancy
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 | NL49520.042.14 |