Preventive Cognitive Therapy with Neurocognitive Remediation Therapy for partially remitted depressed patients

Neurocognitive remediation therapy (NCRT) is a transdiagnostic intervention
that is widely applied to reduce cognitive dysfunction in various disorders,
such as acquired brain injury, stroke, schizophrenia, multiple sclerosis, and
attention-deficit/hyperactivity disorder. Cognitive deficits are likewise
present in many depressed patients, as well as in partially remitted patients.
These cognitive deficits are linked to worse psychiatric and functional
outcomes (i.e. relapse, chronicity), and reduced quality of life. Current
evidence-based interventions for partially remitted depressed patients include
(continuation of) psychotherapy and pharmacology. In the case of remitted or
recovered patients, relapse prevention interventions are found to be effective,
however, do not protect all patients against relapse. Therefore, adding an
online NCRT (oNCRT) to psychotherapy may reduce depressive symptoms further and
improve quality of life. The present study may provide a new effective
neuropsychological intervention to reduce the huge burden of depression in
terms of improvement of symptoms, cognitive functioning, and quality of life as
assessed by patient reported outcome measures.

To investigate the added effectiveness of Preventive Cognitive Therapy (PCT)
with oNCRT as compared to PCT on depressive symptomatology over a one-year
period in 115 partially remitted depressed patients. We hypothesize that oNCRT
is able to augment the effects of regular Preventive Cognitive Therapy (PCT) in
partially remitted depressed patients. Primary objective is the course of
depressive symptoms over a one-year period. Secondary objectives are
neuropsychological function, affect, time to relapse, disability,
health-related quality of life and health care costs.

This is a national pragmatic randomized controlled multicentre study (1:1).
Prior to the RCT, a small non-randomized pilot study will be conducted with PCT
and oNCRT only.

All patients will receive weekly sessions of PCT during 8-weeks. PCT consists
of 8 weekly sessions of 60 minutes each, provided by trained and licensed
health care and clinical psychologists. The PCT will be offered online through
one of the trial sites. The oNCRT is targeted at the following deficits
relevant to depression: Attention, verbal working memory, shifting, and
planning. It consists of 3 weekly online sessions of 45-50 minutes each during
the 8 weeks. The oNCRT will be delivered at home, online, at the persons* home
computer.

This dual approach including the oNCRT to improve cognitive functioning
combined with PCT to further reduce residual depressive symptomatology, improve
cognitive functioning and daily functioning, and prevent recurrence, will
provide the patients with more tools to stay well longer. The oNCRT is added to
PCT in order to improve cognitive functioning. A potential benefit of
participating in this study might be the superiority of the intervention
compared to treatment as usual with respect to the health outcome. There will
be some burden of participating in this study, which includes a structured
psychiatric interview (+/- 60min) and neuropsychological assessment at baseline
(+/- 60min) and two times during study participation, and questionnaires at
baseline and monthly up to one year after baseline (+/- 20min). There are no
risks associated with PCT or oNCRT.