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Improving outcome through improving cognition in Severe Mental Illness: Cognitive Remediation Training combined with transcranial Direct Current Stimulation, a randomized, sham-controlled, multi-center trial.

Improving outcome through improving cognition in Severe Mental Illness: Cognitive Remediation Training combined with transcranial Direct Current Stimulation, a randomized, sham-controlled, multi-center trial. - Improving outcome through improving cognition in Severe Mental Illness

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON56558
Enrollment
126
Registered
2024-02-06
Start date
2024-05-06
Completion date
Unknown
Last updated
2024-12-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

serious mental illnesses

Interventions

CIRCuiTS. Computerized Interactive Remediation of Cognition and Thinking Skills (CIRCuiTS) is a computer training composed of tasks that improve cognitive skills in the domains of attention, memory,
2) evaluate their goals, strengths and difficulties at pre-planned times
3) learn to make a plan of action by choosing cognitive strategies prior to a task and evaluating how useful they were afterwards. Furthermore, tasks are programmed to take place in a virtual villa

Sponsors

Lentis (Groningen)
Lead Sponsor

Eligibility

Age
18 Years to 64 Years

Inclusion criteria

Inclusion criteria: Service users can be included if they meet the criteria for SMI (Delespaul et al., 2013): - A psychiatric disorder that requires care/treatment (no remission of positive, negative and cognitive symptoms); - Severe disabilities in social and/or societal functioning (no functional remission); - Disabilities are the result of a psychiatric disorder - Disabilities are structural (at least several years); - Coordinated professional care is necessary to realize a treatment plan. Each participant in the study should sign informed consent, and only those who are fully capable of making their own decision regarding participation in the study will be included. Additional criteria for inclusion are an age of between 18 and 65 years and sufficient written and oral mastery of the Dutch language.

Exclusion criteria

Exclusion criteria: Service users will be excluded from tDCS if they have: • Metal implants inside the skull or eye; • Severe scalp skin lesions; • A history of previous seizures. • Alcohol or drug abuse;

Design outcomes

Primary

MeasureTime frame
Daily functioning, measured by: (a) Goal Attainment Scale (Turner-Stokes et al., 2009; evaluation of attainment of individual goals); (b) the Independent Living Skills Survey (Wallace et al., 2000; daily functioning questionnaire & observation list) (c) Behapp application (www.behapp.com; Eskes et al., 2016a, b; app to measure social behaviour in an objective and passive manner)

Secondary

MeasureTime frame
Cognitive functioning measured with (a) a neuropsychological test battery (Stroop test (Stroop, 1935), 15-Word Test (Saan & Deelman, 1986), Verbal Fluency (Schmand et al., 2008), Digit Span Forward and Backward (Wechsler, 1944), Trail Making Test (Reitan, 1956), BADS Key Search Taak (Wilson et al., 1997), Wechsler Memory Scale IV Visual Reproduction (Wechsler, 2009) (b) Cognitive Failures Questionnaire (subjective cognitive functioning, Broadbent et al., 1982); (c) Nurses' Observation Scale of Cognitive Abilities (perceived cognitive functioning, Persoon et al., 2012). (d) DEX questionnaire (Wilson et al., 1997; meet metacognitief functioneren) Overige secundaire onderzoeksvariabelen (e) Self Evaluation of Negative Symptoms (Dollfus, Mach & Morello, 2016; measures negative symptoms experienced by the participant) (f) General Self-Efficacy Scale (Chen, Gully, & Eden, 2001; measures self-efficacy) (g) Service user expectation (measures expectations of the participant prior to the start of the trial) (h) In-depth interview to measure subjective metacognitive functioning

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)