Improving Cognition in Severe Mental Illness: Cognitive Remediation Training combined with transcranial Direct Current Stimulation, a feasibility study.

7% of service users suffering from severe mental illness needs long term
intensive treatment and support in a clinical setting or sheltered living (Van
Hoof et al., 2015). In this group of service users, the illness is often
chronic and characterized by an incomplete recovery (Trieman & Leff, 2002;
Uggerby et al., 2011). Service users often experience problems on multiple
domains, such as persistent complaints as a result of medication resistance
(Meltzer, 1997), physical health problems (McEvoy et al., 2005) and self-care
(Wiersma et al, 2000), psychosocial (Harvey et al., 2012), and cognitive
dysfunctioning (Palmer et al., 2009; Velligan et al, 1997). The recovery
process in this group of service users is therefore complex. A fundamental
challenge in the treatment of these service users is cognitive dysfunctioning.

The primary goal is of this feasibility study is to compare two often used
cognitive remediation programs, Circuits and Compensatory Cognitive Training,
on the feasibility for the described group of service users. The program
demonstrating the most optimal feasibility will be applied in a large
randomized controlled trial aimed at improving cognitive functioning in this
group of services users. Additionally, non-invasive brain stimulation with
transcranial Direct Current Stimulation (tDCS) may promote improvements of CRT.
To investigate whether the combination of CRT and tDCS is well tolerated by the
study population, both interventions will be applied simultaneously in one
session.

In this open label feasibility study, service users will be randomized over six
weeks of cognitive remediation training with either Circuits or Compensatory
Cognitive Training. Training sessions will be given twice weekly, for the
duration of 30 minutes. All participants will receive one session of tDCS in
combination with CRT. Before randomization and after the training period, an
observation-based assessment for cognitive abilities will be performed. The
participants receive a short assessment after the training period, concerning
feasibility of both CRT programs and CRT in combination with tDCS.

During six weeks, service users will receive two sessions of cognitive
remediation training per week, using either Circuits or Compensatory Cognitive
Training. One training session will be combined with brain stimulation using
transcranial Direct Current Stimulation.

Firstly, an observational assessment for cognitive abilities is performed by
the participant's casemanager, so that it does not require effort from the
participant. The casemanagers are also asked to fill in a questionnaire about a
participant's life skills. This will take 10 minutes. The participants is asked
to perform two tasks that will take 10 minutes. Next, participants will receive
twelve 30-minute CRT sessions (six weeks, twice weekly). CRT will be given
using either the computer-based program Circuits, or pen-and-pencil based
program Compensatory Cognitive Training. One training session will be combined
with brain stimulation using transcranial Direct Current Stimulation (tDCS).
During the tDCS procedure, participants are exposed to a very low electrical
current of 2 Ma. The use of tDCS to date has not resulted in significant
adverse effects, apart from mild headache or a mild tingling sensation
underneath the electrodes. The stimulation parameters are well within
international safety guidelines. Shortly after the training period,
participants' casemanager are asked to again complete the observational
assessment and participants are asked several questions about the feasibility
of the training programs and tDCS. This will take approximately 20 minutes.
As this study applies CRT over a short period, aimed at the
investigation of the feasibility of both CRT programs and the combination of
CRT with tDCS, the probability that cognitive performance will improve is
small. Therefore, participating in this study does not have direct benefits for
the service users. However, the results of this study will be used in the
development of a large randomized controlled trial that will have improvement
of cognition as its main study parameter.