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Improving Cognition in Severe Mental Illness by Combining Cognitive Remediation and Transcranial Direct Current Stimulation: Study Protocol for a Pragmatic Randomized Sham-Controlled Multi-Center Trial (HEADDSET+)

Published online by Cambridge University Press:  26 August 2025

N. C. Buist ,
A. Poppe ,
B. Ćurčić-Blake ,
G. H. M. Pijnenborg  and
L. van der Meer
N. C. Buist*
Affiliation:
Clinical and Developmental Neuropsychology, University of Groningen, Groningen Department of Rehabilitation, Lentis Psychiatric Institute, Zuidlaren
A. Poppe
Affiliation:
Clinical and Developmental Neuropsychology, University of Groningen, Groningen Department of Rehabilitation, Lentis Psychiatric Institute, Zuidlaren
B. Ćurčić-Blake
Affiliation:
Department of BSCS Neuroscience, University Medical Center Groningen, Groningen
G. H. M. Pijnenborg
Affiliation:
Clinical and Developmental Neuropsychology, University of Groningen, Groningen Department of Psychotic Disorders, GGZ Drenthe, Assen, Netherlands
L. van der Meer
Affiliation:
Clinical and Developmental Neuropsychology, University of Groningen, Groningen Department of Rehabilitation, Lentis Psychiatric Institute, Zuidlaren
*
*Corresponding author.

Abstract

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Introduction

Individuals with severe mental illness (SMI) frequently experience challenges in daily life, often attributable to cognitive impairments. Cognitive rehabilitation interventions can be implemented to enhance thinking abilities and improve functional outcomes. Transcranial direct current stimulation (tDCS) is a non-invasive brain stimulation technique that may promote neural plasticity and therefore, may enhance learning.

Objectives

This trial aims to determine whether individuals with SMI who need supported housing can improve cognitive and daily functioning after following cognitive remediation (CR). Next, this trial evaluates whether CR combined with tDCS will enhance the effect of CR alone. Lastly, this trial will investigate the subjective experience of the CR intervention. We expect that participants will improve in goal attainment and cognitive and daily functioning.

Methods

In this pragmatic, triple-blinded, randomized, sham-controlled multi-center trial, we will compare the experimental group (CR + active tDCS) with the control group (CR + sham tDCS). 126 participants with SMI will receive 16-20 weeks of twice-weekly CR (32-40 sessions of 30-45 minutes) combined with active (N = 63) or sham tDCS (N = 63), separated over five cohorts. We will recruit participants aged between 18 and 65 with SMI residing in supported living facilities. Functional, cognitive, and clinical outcome assessments will be performed at baseline, post-16-week waiting period, post-treatment, and 6-month post-treatment. Additionally, post-treatment participants will be asked to engage in an in-depth interview to evaluate their meta-cognitive skills and subjective experience of the treatment.

Results

Preliminary results from the post-treatment effects, along with insights from in-depth interviews conducted in the first cohort (N = 15) as well as post-16-week waiting period effects for goal attainment (including the second cohort, N ≈ 40) will be presented.

Conclusions

This randomized controlled trial will investigate the efficacy of CR and tDCS in enhancing recovery in people with SMI. If the intervention proves to be effective, it has the potential to be implemented into standard care for service users requiring long-term support.

Disclosure of Interest

None Declared

Information

Type
Abstract
Information
European Psychiatry , Volume 68 , Special Issue S1: Abstracts of the 33rd European Congress of Psychiatry , April 2025 , pp. S1071
Creative Commons
Creative Common License - CCCreative Common License - BY
This is an Open Access article, distributed under the terms of the Creative Commons Attribution licence (https://creativecommons.org/licenses/by/4.0/), which permits unrestricted re-use, distribution, and reproduction in any medium, provided the original work is properly cited.
Copyright
© The Author(s), 2025. Published by Cambridge University Press on behalf of European Psychiatric Association
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