nctId: NCT06378463 id: PSY-2324-S-0362 briefTitle: Cognitive Remediation and Transcranial Direct Current Stimulation in Severe Mental Illness (SMI) acronym: HEADDSET+ overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2027-04 date: 2027-04 date: 2024-04-22 date: 2024-04-22 name: University of Groningen class: OTHER name: Stichting Cosis name: Lentis Psychiatric Institute name: GGZ Friesland 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. conditions: Severe Mental Illness studyType: INTERVENTIONAL phases: NA 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 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 count: 126 type: ESTIMATED name: Cognitive remediation + active tDCS name: Cognitive remediation + sham tDCS measure: Independent Living Skills Survey self- and observer-rated questionnaire (ILSS) measure: Goal Attainment Scale (GAS) measure: Controlled Oral World Association Task (COWAT) measure: Trail Making Test (TMT) measure: Digit span (forward & backward) measure: Wechsler Memory Scale - Visual Reproduction I and II measure: Stroop Color and Word Task (SCWT) measure: 15 Word Test (15-WT) measure: Behavioral Assessment of the Dysexecutive System (BADS) - Key Search task measure: Cognitive Failure Questionnaire (CFQ) measure: Self-Evaluation of Negative Symptoms (SNS) measure: DEX self/informant measure: General Self-Efficacy Scale (GSES) measure: Nurses' Observation Scale of Cognitive Abilities (NOSCA) sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Cosis city: Assen state: Drenthe zip: 9400 AE country: Netherlands name: Liesbeth Brand, MSc role: CONTACT phone: +31682079633 email: l.brand@cosis.nu lat: 52.99667 lon: 6.5625 facility: Lentis city: Zuidlaren state: Drenthe zip: 9470 AC country: Netherlands name: Lisette van der meer, PhD role: CONTACT phone: +31628259303 email: l.vandermeer@lentis.nl lat: 53.09417 lon: 6.68194 facility: GGZ Friesland city: Leeuwarden state: Friesland zip: 8932 PA country: Netherlands name: Sander De Vos, PhD role: CONTACT phone: +31 6 47368400 email: sander.de.vos@ggzfriesland.nl lat: 53.20139 lon: 5.80859 hasResults: False