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

NCT06378463 | Recruiting

• 1 other identifier: PSY-2324-S-0362
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 3

Brief Summary

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

Keywords

Cognitive training; Cognitive functioning; Cognitive rehabilitation; Cognitive remediation; Functional recovery; Community recovery; Non-invasive brain stimulation; transcranial Electrical Stimulation; transcranial Direct Current Stimulation

Outcome Measures

Primary Outcomes (4)

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

  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.

  Baseline (16 weeks before start of treatment), pre-treatment, post-treatment (after 16-20 weeks of treatment) and 6-months post-treatment

• Goal Attainment Scale (GAS)

  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.

  Baseline (16 weeks before start of treatment), pre-treatment, post-treatment (after 16-20 weeks of treatment) and 6-months post-treatment

• Social Functioning Scale (SFS)

  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.

  Baseline (16 weeks before start of treatment), pre-treatment, post-treatment (after 16-20 weeks of treatment) and 6-months post-treatment

• Behapp application

  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.

  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)

Secondary Outcomes (13)

• 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

• 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

• 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

• 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

• 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

Study Arms (2)

active tDCS + CR

ACTIVE COMPARATOR

For active tDCS, the current will be 2 mA and will be administered for 20 min with a fade-in/out of 30 s. The anode will be positioned at Fp1 and the cathode at C3, following the 10-20 system.

Other: Cognitive remediation + active tDCS

sham tDCS + CR

SHAM COMPARATOR

For the sham tDCS, the fade-in will be identical as for the active tDCS. After 30 s the current will fade-out over 30 s. In addition to those above, a standard control pulse, with no therapeutic effect, will be frequently sent to monitor electric conductivity (\~ 0.02mA in duration of 3 s, send every 0.55 s). The anode will be positioned at Fp1 and the cathode at C3, following the 10-20 system.

Other: Cognitive remediation + sham tDCS

Interventions

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.

active tDCS + CR

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.

sham tDCS + CR

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of Groningen: lead
• Stichting Cosis: collaborator
• Lentis Psychiatric Institute: collaborator
• GGZ Friesland: collaborator

Study Sites (3)

Cosis

Assen, Drenthe, 9400 AE, Netherlands

RECRUITING

Lentis

Zuidlaren, Drenthe, 9470 AC, Netherlands

RECRUITING

GGZ Friesland

Leeuwarden, Provincie Friesland, 8932 PA, Netherlands

RECRUITING

MeSH Terms

Conditions

Mental Disorders

Interventions

Cognitive Remediation

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Lisette van der Meer, PhD

  Department of Clinical and Developmental Neuropsychology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lisette van der Meer, PhD

CONTACT

+31628259303; l.van.der.meer@rug.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: April 17, 2024
• First Posted: April 22, 2024
• Study Start: May 6, 2024
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: May 20, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

NL (3)