The present study focusses especially on the value of cognitive skill training within a program of work integration by means of IPS. Research shows that these interventions indeed lead to enhanced cognitive skills (Wykes et al. 2011). According to…
ID
Source
Brief title
Condition
- Psychiatric disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary goals of this research is to investigate the effects of an
cognitive remediation therapy (Circuits), combined with Individual Placement
and Support (IPS) on participation in regular employment or education in people
with early psychosis. In addition, the effects of the combined training are
evaluated specifically looking at work functioning and the effects on memory,
attention and executive functioning.
As primary outcome measure for participation, *the number of hours worked in
regular jobs or education*, was used.
Secondary outcome
As secundary outcome measures different participation questionnaires were taken
and also some cognitive tests.
- Social Participation questionnaire
- Number of days to regular job or education
- Amount of salary earned in regular work
- Amount of absence in regular work or education program
- Work situation: type of job, satisfaction with work, discomfort
experienced because of psychological symptoms
- Hindering factors by searching and maintaining a regular job/education
- Implications of the job experienced by the patient
- BACS cognitive battery (Brief Assessment of Cognition in Schizophrenia)
- Memory
- Attention
- Executive function
- Trailmaking test
- Executive functioning
- CFQ questionnaire (Cognitive Failure Questionnaire)
- Subjective cognitive functioning
- Psymate (computerized experience sampling)
- Mood
- Activities
- NEL questionnaire (Nederlandse Empowerment Lijst)
- Empowerment
- ISMI questionnaire (Internalized Stigma of Mental Ilness)
- Self-stigma
- SES questionnaire (Rosenberg Self-Esteem Scale)
- Self-Esteem
- PANSS questionnaire (Postive And Negative Symptom Scale)
- Positive and Negative symptoms of psychosis
Background summary
When a person experiences a period of psychosis, a condition is meant in which
someone lost the connection with everyday reality. A psychosis is a disturbance
of the activity of certain brain areas. As a result, people experience
different phenomena such as: delusions, hallucinations, disturbances in
reasoning and thought and strange or disordered behaviour. The term, *early
psychosis* refers to the first couple of years (usually three) after the start
of the first psychosis.
A recent international meta-analysis of Van Os (2009) shows that approximately
8% of the adult general population has had previous psychotic experiences and
that 4% reported psychotic symptoms with suffering and need for help. Another
meta-analysis of McGrath (2004), studying the incidence of psychotic disorders,
computed a median of 15 new cases of psychosis per 100.000 people each year. In
the north of the Netherlands a incidence of 11 new cases per 100.000 (age
15-44) was found in the 80s (Giel, 1980). And recently another study in the
north of Holland reported 22 new cases per 100.00 (Boonstra, 2008). In the
Hague the incidence of non-affective psychosis was 35 per 100.00 (Veling,
2006). Approximately 3000 young adults experience their first psychosis each
year in the Netherlands (Handboek Vroege Psychose, 2013).
Usually a psychosis arises in adolescence or early adulthood (McGorry, 2011).
This period is crucial for the development of identity, independency, entering
into relationships and correct decision making in education and work. The
psychosis tends to disrupt the natural course of development of these important
processes, thus damaging the personal and social development of these young
people. This damage is not always repairable. The longer the psychosis remains
and the longer the development stays disrupted, the more social relationships
are lost and the more difficult it is to get started again. But there are more
reasons that emphasize the need for quick and intensive treatment.
There are indications that recovery after a period of psychosis, in particular
in the short term, is harder after a longer period between onset and treatment
(Marshall, 2005). The duration of untreated psychosis is related to a smaller
chance of full recovery, slower recovery of social and community functioning
and a higher risk of relapse. In addition, quick recognition and treatment are
associated with full recovery and better progress.
Research shows that young people with psychotic experiences have a lower
quality of life experience than their healthy peers. This effect remains
visible on different areas of life such as, work, education, living, social
contacts and leasure time (Trimbos, 2012; van Wel & van Weethel, 2012; Lester
et al. 2012). Early guidance in education and work in combination with
supporting and strengthening the occupational competence seem important
opportunities for improvement, according to the literature.
Also within the subject of employment and previous education, youngsters
experiencing early psychosis seem to fall short (Hendriksen et al. 2013).
Finding a job or resuming education or professional training seems to be a
difficult task in which support is needed. Individual Placement and Support
(IPS) is an evidence based method that is developed to support and assist in
the (future) wishes with respect to work and education among people with early
psychosis. De effectiveness of IPS on employment has been acknowledged in many
trails (Crowther et al. 2001; van Busschbach et al. 2011; Knapp et al. 2013).
Especially in people with early psychosis beneficial results were found (Drake
et al. 2013; Dudley et al. 2013).
People experiencing early psychosis often feel hindered by decreased
concentration and less ability to organize their daily life independently.
Practical tasks such as planning and organising take more effort, time and
energy. Young patients report to attach great importance to training in this
area (Hendriksen et al. 2013). According to recent findings, cognitive skill
training needs to include learning- and problem solving strategies for the
training to have an effect on daily life (Wykes & Spaulding, 2011).
Study objective
The present study focusses especially on the value of cognitive skill training
within a program of work integration by means of IPS. Research shows that these
interventions indeed lead to enhanced cognitive skills (Wykes et al. 2011).
According to recent findings, cognitive skill training needs to include
learning- and problem solving strategies for the training to have an effect on
daily life (Wykes & Spaulding, 2011). In the multidisciplinary guideline for
schizophrenia the practical value of cognitive remediation therapy as *stand
alone* intervention is doubted. There is a risk that the learned skills do not
generalize to daily life. But there is hope for the inclusion of CRT in a labor
reintegration program. If well supported, the enhanced cognitive skills such
as, planning, organising, memory and social cognition can be directly put to
use (McGurk et al. 2007). This way, people are more equipped to sustain their
work or education.
The primary goal of this study is to investigate the effects of a cognitive
remediation training (Circuits), offered in combination with Individual
Placement and Support, on participation in regular employment or education in
people suffering from early psychosis. Secondly, we look at the effects of the
combination of CRT and IPS, on functioning in regular employment and we
investigate the effects on memory, attention and executive functioning.
Study design
A Randomised controlled trial with two arms is performed, in which the program
Circuits, as CRT, combined with IPS, is compared to IPS in combination with a
placebo intervention. The placebo intervention consists out of computer
activities that have no known effects on cognitive abilities. The participants
are divided at random in one of the two conditions by an independent
statistician. The participants are, however, assigned by their own locations.
The IPS trainer and CRT trainer are two different persons. Therefore, the
effect remains pure. A baseline measurement is done at T0 and three times
after, at 6 months and 18 months follow up. Independent research assistants
collect patient information blindly.
According to the power analysis, 200 participants are needed, 100 participants
in each condition, to achieve the needed effect size.
Intervention
This intervention consists out of a combination of IPS and Circuits (CRT).
CIRCuiTS (Computerised Interactive Remediation of Cognition-Training for
Schizophrenia) is a computer program for cognitive remediation developed by
Wykes and this research Team (Institute of of Psychiatry, Kings College,
Londen). The program consists out of different exercises to train cognitive
skills such as, memory, attention, cognitive flexibility and metacognitive
skills. The exercises vary in the degree of abstraction. Tasks can be adjusted
automatically to the abilities of the participants and also it is possible to
compose an individual program. A usual program consists out of 40 sessions of
15-60 minutes, at least three times a week with additional homework. The
original program is written in English and for this research especially, it was
translated in Dutch.
IPS supports patients with severe psychotic disorders in getting and keeping
paid work. The method originates in America, where it was developed in *90 by
Becker and Drake (1993). In comparison with the usual employment integration,
IPS distinguishes itself by directly searching for paid jobs instead of
starting with training first. And also IPS-workers are integrated within the
mental health care team. The wish of the client to find work is considered a
main point and is directive for the employment counselling. The placebo
intervention consists out of a selection of different computer games of which
no effect on cognitive functioning is te be expected. The frequency and
duration of the therapist guidance is equal to the experimental condition. The
therapist offers weakly 60 to 90 minutes of guidance, distributed over two
sessions.
Study burden and risks
This intervention does not focus on the treatment of complaints. The exercises
in the intervention are focused on the possible increase of cognitive abilities
and supporting and finding a paid job or education. The taken measures don*t
have any risks. Also we don*t expect the intervention to have any negative
outcomes or risks. The participants invest 3 times 1,5 * 2 hours of their time
doing measurements. After which they participate in the intervention for 15
following weeks.
Da Costakade 45
Utrecht 3521 VS
NL
Da Costakade 45
Utrecht 3521 VS
NL
Listed location countries
Age
Inclusion criteria
Inclusion criteria:
- Age > 18 years
- Have had their first psychosis in the past 5 years and are currently under care of an early psychosis team or (F)ACT Team (Flexible-Assertive Community Treatment).
- All identified subtypes of psychosis are included except psychosis by acquired (and detectable) brain injury and psychosis after substance use
- Interest for guidance in finding or keeping a regular job or education
- Interest in improving cognitive skills and interest in following a cognitive training program
- Demonstrable cognitive deficits at baseline
- Willingness to informed consent.
Exclusion criteria
Exclusion criteria:
- Psychosis by acquired brain injury
- Psychosis after substance use
- Inadequate knowledge of the Dutch language (estimation made by team members and baseline measurement)
- Intellectual disability (IQ < 70)
- Patients that already participate in other studies that cannot be combined with the present study
- Unwillingness to informed consent
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
Register | ID |
---|---|
CCMO | NL50176.029.14 |
OMON | NL-OMON27685 |