Cognitive Remediation and Transcranial Direct Current Stimulation in Severe Mental Illness (SMI)
NCT06378463, Not applicable, Active not recruiting, University of Groningen
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Cognitive Remediation and Transcranial Direct Current Stimulation in Severe Mental Illness (SMI) | ClinicalTrials.gov |
| NCT number | NCT06378463 | ClinicalTrials.gov |
| Status | Active not recruiting | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 126 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | University of Groningen | ClinicalTrials.gov |
| Conditions | Severe Mental Illness | ClinicalTrials.gov |
| Interventions | Cognitive remediation + active tDCS, Cognitive remediation + sham tDCS | ClinicalTrials.gov |
| First posted | 2024-04-22 | ClinicalTrials.gov |
| Last updated | 2026-06-26 | ClinicalTrials.gov |
Registered outcomes 17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Independent Living Skills Survey self- and observer-rated questionnaire (ILSS) | Baseline (16 weeks before start of treatment), pre-treatment, post-treatment (after 16-20 weeks of treatment) and 6-months post-treatment | The Independent Living Skills Survey (ILSS) is a questionnaire that measures the basic functional living skills of individuals with SMI. The ILSS will be completed by the participant and by the participant's case manager. | ClinicalTrials.gov |
| Primary | Goal Attainment Scale (GAS) | Baseline (16 weeks before start of treatment), pre-treatment, post-treatment (after 16-20 weeks of treatment) and 6-months post-treatment | This questionnaire is a measure to capture self-reported recovery goals in a structured way, which has also been used in rehabilitation practice. Based upon an interview, the participant defines up to three personal recovery goals that can be scored and weighted on importance and difficulty for which a scoring manual is available. | ClinicalTrials.gov |
| Secondary | Controlled Oral World Association Task (COWAT) | Baseline (16 weeks before start of treatment), pre-treatment, post-treatment (after 16-20 weeks of treatment) and 6-months post-treatment | The COWAT is a test for verbal fluency and speed of processing. Participants have to name as many words as possible within a time span of 60 seconds, beginning with a given letter. | ClinicalTrials.gov |
| Secondary | Trail Making Test (TMT) | Baseline (16 weeks before start of treatment), pre-treatment, post-treatment (after 16-20 weeks of treatment) and 6-months post-treatment | The Trail Making Test assesses visual search abilities, processing speed, and mental flexibility. Participants are provided with a sheet of paper, containing only digits or digits and letters, and are instructed to connect them in increasing order. | ClinicalTrials.gov |
| Secondary | Digit span (forward & backward) | Baseline (16 weeks before start of treatment), pre-treatment, post-treatment (after 16-20 weeks of treatment) and 6-months post-treatment | The Digit Span forward is a test for immediate auditory attention. The Digit Span backward is a test for working memory. The test leader reads sequences of digits out loud, gradually increasing the digit span. The participant is asked to repeat the digits in the same order (forward) or reverse order (backward). | ClinicalTrials.gov |
| Secondary | Wechsler Memory Scale - Visual Reproduction I and II | Baseline (16 weeks before start of treatment), pre-treatment, post-treatment (after 16-20 weeks of treatment) and 6-months post-treatment | The Visual Reproduction subtest of the Wechsler Memory Scale (WMS) assesses visual memory for abstract designs. During this task, participants are presented with a series of designs. Each design is displayed for 10 seconds, after which the participant is asked to reproduce it from memory. After 30 minutes, a recognition task of the same designs is administered. | ClinicalTrials.gov |
| Secondary | Stroop Color and Word Task (SCWT) | Baseline (16 weeks before start of treatment), pre-treatment, post-treatment (after 16-20 weeks of treatment) and 6-months post-treatment | The SCWT is used to test speed of processing, cognitive flexibility, and cognitive control. The participants first perform a basic task, which is reading names of colors. The performance on this task is compared with the performance on a task in which the ink color of incongruent color words has to be named. Hence, a habitual response needs to be suppressed in support of an unusual one. The increase in time taken to perform the latter task compared with the basic task is referred to as "the Stroop interference effect" and provides a general measure of executive functioning. | ClinicalTrials.gov |
| Secondary | 15 Word Test (15-WT) | Baseline (16 weeks before start of treatment), pre-treatment, post-treatment (after 16-20 weeks of treatment) and 6-months post-treatment | The 15-WT learning task is a test for verbal memory. The test leader reads 15 words out loud and participants are asked to recall as many words as possible. This procedure is repeated for four times. | ClinicalTrials.gov |
| Secondary | Behavioral Assessment of the Dysexecutive System (BADS) - Key Search task | Baseline (16 weeks before start of treatment), pre-treatment, post-treatment (after 16-20 weeks of treatment) and 6-months post-treatment | The Key search task is a subtest of the BADS, a test battery used to evaluate executive functions. In this task, participants are asked to plan a search route for an imaginary lost key within a field. | ClinicalTrials.gov |
| Secondary | Cognitive Failure Questionnaire (CFQ) | Baseline (16 weeks before start of treatment), pre-treatment, post-treatment (after 16-20 weeks of treatment) and 6-months post-treatment | The CFQ is a questionnaire to measure subjective cognitive functioning. The scale includes 25 questions that represent the cognitive subdomains attention and memory. | ClinicalTrials.gov |
| Secondary | Self-Evaluation of Negative Symptoms (SNS) | Baseline (16 weeks before start of treatment), pre-treatment, post-treatment (after 16-20 weeks of treatment) and 6-months post-treatment | The SNS questionnaire assesses negative symptoms from the perspective of the service user. | ClinicalTrials.gov |
| Secondary | DEX self/informant | Baseline (16 weeks before start of treatment), pre-treatment, post-treatment (after 16-20 weeks of treatment) and 6-months post-treatment | The DEX questionnaire is a 20-item measure used to evaluate subjective cognitive performance, focusing on problems related to planning and organization. There are two versions of the questionnaire: one to be completed by the participant and the other by their case manager. | ClinicalTrials.gov |
| Secondary | General Self-Efficacy Scale (GSES) | Baseline (16 weeks before start of treatment), pre-treatment, post-treatment (after 16-20 weeks of treatment) and 6-months post-treatment | The GSES is a measure used to assess self-efficacy, the degree to which the respondent perceives himself or herself as capable of attaining goals, overcoming challenges, and performing well on tasks. | ClinicalTrials.gov |
| Secondary | Nurses' Observation Scale of Cognitive Abilities (NOSCA) | Baseline (16 weeks before start of treatment), pre-treatment, post-treatment (after 16-20 weeks of treatment) and 6-months post-treatment | The NOSCA is a behavioral rating scale to examine cognitive abilities in service users. The scale comprises eight subscales, representing subdomains of cognition. The answers are based on observations of a participants' case manager. | ClinicalTrials.gov |
| Secondary | Social Functioning Scale (SFS) | Baseline (16 weeks before start of treatment), pre-treatment, post-treatment (after 16-20 weeks of treatment) and 6-months post-treatment | The SFS is a standard measure that was developed and validated for people with schizophrenia and includes the following subscales: social engagement or withdrawal, interpersonal functioning, current social activities, recreational activities, independence-competence, independence-performance, and employment. | ClinicalTrials.gov |
| Secondary | Behapp application | Throughout the entire study period, up to 16 months (including baseline (16 weeks before start of treatment), pre-treatment, post-treatment (after 16-20 weeks of treatment) and 6-months post-treatment) | Behapp is a smartphone app that was developed to objectively and passively measure sociability and social exploration. After installation, Behapp will continuously monitor measures of communication events (e.g., incoming and outgoing phone calls), app activity (e.g., social media or entertainment apps), and location via GPS. Data are encrypted before saving on the participants' device and deleted immediately after uploading to the secured data server. The content of calls, SMS messages, and apps will not be registered, collected, or saved by Behapp. | ClinicalTrials.gov |
| Secondary | In-depth interview | Post-treatment (after 16-20 weeks of treatment) | The in-depth interview aims to understand service users' metacognitive skills and subjective experiences. An adapted version of the Metacognition Assessment Scale (MAS-A) is used. Higher scores on each subscale (self-reflectivity, understanding the other's mind, decentration, and mastery) indicate a greater ability to form complex representations of oneself and others. The MAS-A is used to score the answers on the Indiana Psychiatric Illness Interview (IPII), a semi-structured interview designed to examine spontaneous metacognitive thoughts that lasts 30 to 60 minutes. We revised the IPII to emphasize cognitive experiences over illness experiences and to evaluate metacognitive ability. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 5
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Digit Span Test | Secondary outcome | ConductCognition |
| Stroop Color-Word Test | Secondary outcome | ConductCognition |
| Trail Making Test A | Secondary outcome | ConductCognition |
| Trail Making Test B | Secondary outcome | ConductCognition |
| Verbal Fluency | Secondary outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)