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NCT Number: NCT06378463

Cognitive Remediation and Transcranial Direct Current Stimulation in Severe Mental Illness (SMI)

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.

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Key information

Conditions

Severe Mental Illness Mental Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cosis, Assen, Drenthe, Netherlands

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About this study

A fundamental challenge for many people with severe mental illness (SMI) is dealing with the impact of cognitive impairments in daily life functioning. A possible treatment approach is cognitive remediation training (CR), a training developed to target cognitive deficits with the ultimate aim to improve daily functioning. Participants engage in cognitive exercises, learn more about their own cognition and the use of (cognitive) strategies to compensate for deficits. However, in people with SMI, abnormal synaptic plasticity is observed. This might hinder newly learned cognitive skills to sustain and limit the benefits from CR. For this reason, people with SMI may benefit from the combination of CR with a method that may promote neural plasticity: transcranial direct current stimulation (tDCS).

In a pragmatic, triple-blinded, randomized, sham-controlled, multi-center trial with a multiple baseline design, we will investigate the effectiveness of combining CR and tDCS in helping participants reach personal goals, minimizing problems in daily functioning and improving cognitive functioning. 126 service users with SMI will receive 16-20 weeks of twice-weekly CR combined with active (N=63) or sham tDCS (N=63). We will perform functional, cognitive, and clinical outcome assessments at baseline, after a 16-week waiting period, post-treatment and 6-months post-treatment and compare the effects within-participants (waiting period vs. treatment period) and between-participants (CR+active tDCS vs. CR+sham tDCS). Further, an optional in-depth interview will be conducted post-intervention (T2) to investigate subjective experiences of CR and its perceived effect on metacognition, daily functioning, helpful components, and areas for improvement.

This multi-center trial will evaluate whether CR on its own and whether CR in combination with tDCS can be a clinically relevant addition to further enhance recovery through enhancing service users' goal attainment, daily functioning and cognitive performance. In case results of this trial confirm our hypotheses, it may be recommended to include the combined information in the guidelines for SMI care and to implement the method in standardized care.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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;
  • Adults between the age of 18 and 65;
  • Sufficient written and oral mastery of the Dutch language.

Exclusion criteria

  • Having previously received CIRCuiTS;
  • Metal implants inside the skull or eye;
  • Severe scalp skin lesions;
  • A history of previous seizures;
  • Alcohol or drug abuse.

Treatment and study plan

Cognitive remediation + active tDCS

Other

The cognitive remediation program "Computerised Interactive Remediation of Cognition - a Training for Schizophrenia" (CIRCuiTS) improves cognitive and metacognitive skills and strategies and is specifically aimed at the generalization of newly learnt skills to daily life. This method also offers the possibility to personalize the training program based on individual goals and cognitive functioning of the service user.

Transcranial Direct Current Stimulation is used to promote neural plasticity, which applies a small electrical current over the cortex. This can alter the excitability of neurons, such that it increases or decreases spontaneous network activity. When applied to fronto-parietal neural networks simultaneously with their engagement in cognitive tasks of CIRCuiTS, it is expected that plasticity of these networks will be modulated, resulting in improvements in cognitive functioning.

In this condition, participants will receive active brain stimulation.

Cognitive remediation + sham tDCS

Other

The cognitive remediation program "Computerised Interactive Remediation of Cognition - a Training for Schizophrenia" (CIRCuiTS) improves cognitive and metacognitive skills and strategies and is specifically aimed at the generalization of newly learnt skills to daily life. This method also offers the possibility to personalize the training program based on individual goals and cognitive functioning of the service user.

Transcranial Direct Current Stimulation is used to promote neural plasticity, which applies a small electrical current over the cortex. This can alter the excitability of neurons, such that it increases or decreases spontaneous network activity. When applied to fronto-parietal neural networks simultaneously with their engagement in cognitive tasks of CIRCuiTS, it is expected that plasticity of these networks will be modulated, resulting in improvements in cognitive functioning.

In this condition, participants will receive sham brain stimulation.

Primary outcomes

  1. Independent Living Skills Survey self- and observer-rated questionnaire (ILSS)

    Time frame: 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.

  2. Goal Attainment Scale (GAS)

    Time frame: 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.

Secondary outcomes

  1. Controlled Oral World Association Task (COWAT)

    Time frame: 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.

  2. Trail Making Test (TMT)

    Time frame: 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.

  3. Digit span (forward & backward)

    Time frame: 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).

  4. Wechsler Memory Scale - Visual Reproduction I and II

    Time frame: 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.

  5. Stroop Color and Word Task (SCWT)

    Time frame: 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.

  6. 15 Word Test (15-WT)

    Time frame: 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.

  7. Behavioral Assessment of the Dysexecutive System (BADS) - Key Search task

    Time frame: 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.

  8. Cognitive Failure Questionnaire (CFQ)

    Time frame: 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.

  9. Self-Evaluation of Negative Symptoms (SNS)

    Time frame: 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.

  10. DEX self/informant

    Time frame: 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.

  11. General Self-Efficacy Scale (GSES)

    Time frame: 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.

  12. Nurses' Observation Scale of Cognitive Abilities (NOSCA)

    Time frame: 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.

  13. Social Functioning Scale (SFS)

    Time frame: 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.

  14. Behapp application

    Time frame: 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.

  15. In-depth interview

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Groningen

Other

Collaborators

  • GGZ Friesland
  • Lentis Psychiatric Institute
  • Stichting Cosis

Registry information

Official study title

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

Acronym: HEADDSET+

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Apr 22, 2024
Registry last updated
Jun 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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