protocolSection identificationModule nctId: NCT06378463, orgStudyIdInfo id: PSY-2324-S-0362, briefTitle: Cognitive Remediation and Transcranial Direct Current Stimulation in Severe Mental Illness (SMI), acronym: HEADDSET+, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2027-04, completionDateStruct date: 2027-04, studyFirstPostDateStruct date: 2024-04-22, lastUpdatePostDateStruct date: 2024-04-22, sponsorCollaboratorsModule leadSponsor name: University of Groningen, class: OTHER, collaborators name: Stichting Cosis, collaborators name: Lentis Psychiatric Institute, collaborators name: GGZ Friesland, descriptionModule briefSummary: Seven per cent of patients suffering from severe mental illness (SMI) need long-term intensive treatment and support in a clinical setting or sheltered living. These service users often experience problems on multiple domains, such as persistent complaints as a result of medication resistance, physical health problems and self-care, psychosocial and cognitive dysfunctioning. Cognitive remediation (CR) training is a type of training aimed at improving thinking abilities (cognitive functioning) and daily functioning. However, we don't yet know if CR training can also help people with SMI who need supported housing due to their severe cognitive and daily living problems. In this project, we are investigating whether we can improve daily functioning in this group by using a form of CR training that focuses on learning new cognitive skills and how to use these new skills in everyday life. Additionally, we are exploring whether combining CR training with mild brain stimulation (transcranial Direct Current Stimulation) can enhance the effects of CR training., conditionsModule conditions: Severe Mental Illness, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: This is a pragmatic triple-blinded, randomized, sham-controlled trial, following a non-concurrent multiple baseline design, with the participants serving as their own control. Participants will be randomized over two groups: CIRCuiTS +sham tDCS (group 1), or CIRCuiTS + active tDCS (group 2). The trial will start with a first measurement (T0), followed by a waiting period of 16 weeks and a second measurement (T1). The waiting period serves as the control condition (service users are their own control). Next, the participants will be allocated to 16-20 weeks of either CIRCuiTS + sham tDCS or CIRCuiTS + active tDCS. This period of 16-20 weeks is not fixed as it depends upon how fast participants go through the program. This is followed by a third measurement after treatment (T2). There will be a fourth measurement six months after the end of the intervention (T3)., primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, maskingDescription: Participants will be randomly assigned to CR + sham tDCS (group 1) or CR + active tDCS (group 2) with a 1:1 allocation as per a computer-generated randomization plan using permuted blocks of random sizes. The block sizes will not be disclosed to ensure concealment. As such, both the researcher as the participant can stay blind to the tDCS treatment condition. Also, the assessors who will do neuropsychological tests are blind to the condition the participant is in and are blind to the type and aim of the treatment. After finishing measurement T2, the participants can indicate if they suspect to have experienced either the real or the sham tDCS treatment. The patients will be informed about the type of treatment they have received when all participants completed measurement T3., whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 126, type: ESTIMATED, armsInterventionsModule interventions name: Cognitive remediation + active tDCS, interventions name: Cognitive remediation + sham tDCS, outcomesModule primaryOutcomes measure: Independent Living Skills Survey self- and observer-rated questionnaire (ILSS), primaryOutcomes measure: Goal Attainment Scale (GAS), secondaryOutcomes measure: Controlled Oral World Association Task (COWAT), secondaryOutcomes measure: Trail Making Test (TMT), secondaryOutcomes measure: Digit span (forward & backward), secondaryOutcomes measure: Wechsler Memory Scale - Visual Reproduction I and II, secondaryOutcomes measure: Stroop Color and Word Task (SCWT), secondaryOutcomes measure: 15 Word Test (15-WT), secondaryOutcomes measure: Behavioral Assessment of the Dysexecutive System (BADS) - Key Search task, secondaryOutcomes measure: Cognitive Failure Questionnaire (CFQ), secondaryOutcomes measure: Self-Evaluation of Negative Symptoms (SNS), secondaryOutcomes measure: DEX self/informant, secondaryOutcomes measure: General Self-Efficacy Scale (GSES), secondaryOutcomes measure: Nurses' Observation Scale of Cognitive Abilities (NOSCA), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Cosis, city: Assen, state: Drenthe, zip: 9400 AE, country: Netherlands, contacts name: Liesbeth Brand, MSc, role: CONTACT, phone: +31682079633, email: l.brand@cosis.nu, geoPoint lat: 52.99667, lon: 6.5625, locations facility: Lentis, city: Zuidlaren, state: Drenthe, zip: 9470 AC, country: Netherlands, contacts name: Lisette van der meer, PhD, role: CONTACT, phone: +31628259303, email: l.vandermeer@lentis.nl, geoPoint lat: 53.09417, lon: 6.68194, locations facility: GGZ Friesland, city: Leeuwarden, state: Friesland, zip: 8932 PA, country: Netherlands, contacts name: Sander De Vos, PhD, role: CONTACT, phone: +31 6 47368400, email: sander.de.vos@ggzfriesland.nl, geoPoint lat: 53.20139, lon: 5.80859, hasResults: False