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van CCT (UK)

van CCT (UK)

Mindset. A cognitive rehabillitation training for young adults with psychotic spectrum disorder in an educational setting: A pilot study

- candidate number27834
- NTR NumberNTR6764
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR7-sep-2017
- Secondary IDsNL62069.042.17 CCMO (ABR-form METc)
- Public TitleMindset. A cognitive rehabillitation training for young adults with psychotic spectrum disorder in an educational setting: A pilot study
- Scientific TitleMindset. A cognitive remediation training for young adults with psychotic spectrum disorders to support their participation in education: A pilot study
- ACRONYMMindset
- hypothesisWe hypothesize that students having psychotic problems that followed the training show increased participation in education, increased school performance, less early school leaving, and improved cognitive functioning which are mediated by increased strategy use.
- Healt Condition(s) or Problem(s) studiedPsychosis, Psychotic disorders, Schizophrenia
- Inclusion criteriaDiagnosed 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 criteriaParticipation in supported education or cognitive remediation program within the past year.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingSingle
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-sep-2017
- planned closingdate1-sep-2019
- Target number of participants60
- InterventionsIntervention group receives a twelve weekly sessions of one hour.
The control group receives twelve weekly assignments via e-mail with a duration of approximately one hour.
Both groups get a one hour introduction session before the start of the study.
- Primary outcomeA 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 outcomeSecondary study parameters include objective cognitive functioning and quality of life.
- TimepointsMeasurements will be done at baseline (T0), post-treatment (5 months; T1), and follow-up after one year (12 months; T2).
- Trial web site
- statusopen: patient inclusion
- Sponsor/Initiator Hanze Hogeschool Groningen
- Funding
(Source(s) of Monetary or Material Support)
Hanzehogeschool Groningen, Stichting Agis Zorginnovatiefonds
- Publications
- Brief summaryMany students with a psychotic disorder have cognitive problems, which interfere with their school functioning. This study will test the applicability, feasibility, and effectiveness of a Cognitive Remediation training, named Mindset, in 60 students (aged 18 and older) with a psychotic spectrum disorder from regular education, namely MBO (intermediate vocational education), HBO (higher vocational education), and WO (university education). The training will be given at three participating Mental Health Care institutions. Half of the participants (N=30; 10 students per institution) 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.
- Main changes (audit trail)
- RECORD7-sep-2017 - 4-nov-2017

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