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

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Netherlands
Cosis
RECRUITING
Assen
GGZ Friesland
RECRUITING
Leeuwarden
Lentis
RECRUITING
Zuidlaren
Contact Information
Primary
Lisette van der Meer, PhD
l.van.der.meer@rug.nl
+31628259303
Time Frame
Start Date: 2024-05-06
Estimated Completion Date: 2027-04
Participants
Target number of participants: 126
Treatments
Active_comparator: active tDCS + CR
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.
Sham_comparator: sham tDCS + CR
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.
Related Therapeutic Areas
Sponsors
Collaborators: Stichting Cosis, Lentis Psychiatric Institute, GGZ Friesland
Leads: University of Groningen

This content was sourced from clinicaltrials.gov