This study aims to examine the effectiveness, feasibility, and applicability of the adapted and translated CR from Mullen and colleagues (2017), named Mindset, for students with psychotic problems in the Netherlands.
ID
Source
Brief title
Condition
- Schizophrenia and other psychotic disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
A checklist derived from evaluation interviews with both trainers and
participants will be used as main outcome parameter of the training feasibility
and applicability. Training fidelity will be measured using written evaluation
from the trainers. The main study parameters of the effect measurements will be
school functioning, school satisfaction, strategy use, subjective cognitive
functioning, and early school leaving.
Secondary outcome
Secondary study parameters include objective cognitive functioning and quality
of life.
Background summary
Most severe mental illnesses have their onset between the age of 18 and 25 and
include having cognitive problems. At this age, many adolescents participate in
higher education. Students with severe mental illnesses are therefore at risk
of early school leaving. Leaving school without receiving a degree reduces the
chances of employment later on in life, leading to decreased social
participation of these students. It is known that reduced social participation
worsens the long-term prognosis of the disorder. A training that focuses on
school participation may therefore increase social inclusion and social
participation, making implementation of such a training important on a personal
and societal level. A group of researchers in the United States (US) have
developed a training that focuses on the remediation of cognitive abilities,
specifically focusing on educational participation (Mullen et al., 2017). This
type of cognitive remediation (CR) is not available in the Netherlands yet.
This study aims to adapt and translate the CR developed by the researchers in
the US (Rutgers University), and apply this training to students diagnosed with
psychotic spectrum disorder. The study will be in collaboration with four Dutch
Mental Health Care institutes (MHC; in Dutch: Geestelijke Gezondheidszorg,
GGz), namely GGz Drenthe, GGz Friesland, GGz Groningen (Lentis), and UCP
Groningen. The developers of the training, will be available for consultation
during the study.
Study objective
This study aims to examine the effectiveness, feasibility, and applicability of
the adapted and translated CR from Mullen and colleagues (2017), named Mindset,
for students with psychotic problems in the Netherlands.
Study design
The study will be a mixed methods single blind randomized controlled trial
focusing on evaluating the feasibility and applicability of the intervention,
and pilot testing the adapted and translated CR from Mullen and colleagues
(2017), named Mindset.
Intervention
This study will include 60 participants from four Dutch MHC institutes, namely
GGz Drenthe, GGz Friesland, GGz Groningen (Lentis), and UCP Groningen. Half of
the participants (N=30) will receive the training whereas the other half will
act as an active control group. The CR-group will receive the CR consisting of
thirteen individual-based meetings of one hour spread over thirteen weeks. The
control group will receive twelve weekly assignments per email of one hour,
plus a session zero for the assessment of their personal goals. The students
in the control group get the opportunity to receive the training one year
after the CR-group when desired.
Study burden and risks
We do not expect that the intervention causes any risk for the participants.
Participants in the CR-group will attend one introduction session (session
zero) and twelve training sessions of one hour. In addition, participants will
do twelve homework assignments of approximately fifteen minutes. Participants
in the control group will receive twelve assignments of one hour spread over
twelve weeks, plus a session zero for the assessment of their personal goals.
Three measurement points of 90 minutes (for overview see 6.3 *Study
procedures*) will be scheduled to fill in the questionnaires. In addition, an
evaluation interview will be scheduled, with a duration of approximately one
hour. The time participants invest in the study will therefore be sixteen hours
for the training (thirteen hours for the control group) and 5,5 hours for the
research measurements, making it 21.5 hours in total for the study per
participants in the CR group and 18,5 hours per participant in the control
group.
Zernikeplein 23
Groningen 9747 AS
NL
Zernikeplein 23
Groningen 9747 AS
NL
Listed location countries
Age
Inclusion criteria
Diagnosed with psychotic spectrum disorder, perceived cognitive disabilities which interfere with the ability to participate in regular education, aged above 18, in treatment at one of the participating Mental Health Care centers, participating in regular education namely MBO (intermediate vocational education), HBO (higher vocational education), and WO (university education), and at least one year participating in education after start of the training
Exclusion criteria
Participation in supported education or cognitive remediation program within the past year
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 | NL62069.042.17 |
OMON | NL-OMON26227 |