Clinical trial NCT06378463: Cognitive Remediation and Transcranial Direct Current Stimulation in Severe Mental Illness (SMI)
Official 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
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
Lead sponsor: University of Groningen
Sponsor class: OTHER
Collaborators: name: Stichting Cosis
name: Lentis Psychiatric Institute
name: GGZ Friesland
First posted: 2024-04-22
Enrollment: 126
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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).
Primary purpose: TREATMENT

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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Independent Living Skills Survey self- and observer-rated questionnaire (ILSS)
timeFrame: Baseline (16 weeks before start of treatment), pre-treatment, post-treatment (after 16-20 weeks of treatment) and 6-months post-treatment
measure: Goal Attainment Scale (GAS)
timeFrame: Baseline (16 weeks before start of treatment), pre-treatment, post-treatment (after 16-20 weeks of treatment) and 6-months post-treatment
measure: Social Functioning Scale (SFS)
timeFrame: Baseline (16 weeks before start of treatment), pre-treatment, post-treatment (after 16-20 weeks of treatment) and 6-months post-treatment
measure: Behapp application
timeFrame: 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:
measure: Controlled Oral World Association Task (COWAT)
timeFrame: Baseline (16 weeks before start of treatment), pre-treatment, post-treatment (after 16-20 weeks of treatment) and 6-months post-treatment
measure: Trail Making Test (TMT)
timeFrame: Baseline (16 weeks before start of treatment), pre-treatment, post-treatment (after 16-20 weeks of treatment) and 6-months post-treatment
measure: Digit span (forward & backward)
timeFrame: Baseline (16 weeks before start of treatment), pre-treatment, post-treatment (after 16-20 weeks of treatment) and 6-months post-treatment
measure: Wechsler Memory Scale - Visual Reproduction I and II
timeFrame: Baseline (16 weeks before start of treatment), pre-treatment, post-treatment (after 16-20 weeks of treatment) and 6-months post-treatment
measure: Stroop Color and Word Task (SCWT)
timeFrame: Baseline (16 weeks before start of treatment), pre-treatment, post-treatment (after 16-20 weeks of treatment) and 6-months post-treatment
measure: 15 Word Test (15-WT)
timeFrame: Baseline (16 weeks before start of treatment), pre-treatment, post-treatment (after 16-20 weeks of treatment) and 6-months post-treatment
measure: Behavioral Assessment of the Dysexecutive System (BADS) - Key Search task
timeFrame: Baseline (16 weeks before start of treatment), pre-treatment, post-treatment (after 16-20 weeks of treatment) and 6-months post-treatment
measure: Cognitive Failure Questionnaire (CFQ)
timeFrame: Baseline (16 weeks before start of treatment), pre-treatment, post-treatment (after 16-20 weeks of treatment) and 6-months post-treatment
measure: Self-Evaluation of Negative Symptoms (SNS)
timeFrame: Baseline (16 weeks before start of treatment), pre-treatment, post-treatment (after 16-20 weeks of treatment) and 6-months post-treatment
measure: DEX self/informant
timeFrame: Baseline (16 weeks before start of treatment), pre-treatment, post-treatment (after 16-20 weeks of treatment) and 6-months post-treatment
measure: General Self-Efficacy Scale (GSES)
timeFrame: Baseline (16 weeks before start of treatment), pre-treatment, post-treatment (after 16-20 weeks of treatment) and 6-months post-treatment
measure: Nurses' Observation Scale of Cognitive Abilities (NOSCA)
timeFrame: Baseline (16 weeks before start of treatment), pre-treatment, post-treatment (after 16-20 weeks of treatment) and 6-months post-treatment
measure: In-depth interview
timeFrame: Post-treatment (after 16-20 weeks of treatment)
Other outcomes:
Locations:
city: Assen
country: Netherlands
facility: Cosis
state: Drenthe
city: Zuidlaren
country: Netherlands
facility: Lentis
state: Drenthe
city: Leeuwarden
country: Netherlands
facility: GGZ Friesland
state: Friesland
Study officials:
affiliation: Department of Clinical and Developmental Neuropsychology
name: Lisette van der Meer, PhD
role: PRINCIPAL_INVESTIGATOR
References: