Skip to main content
main-content

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Trials 1/2018

Effect of action-based cognitive remediation on cognition and neural activity in bipolar disorder: study protocol for a randomized controlled trial

Zeitschrift:
Trials > Ausgabe 1/2018
Autoren:
Caroline V. Ott, Maj Vinberg, Christopher R. Bowie, Ellen Margrethe Christensen, Gitte M. Knudsen, Lars V. Kessing, Kamilla W. Miskowiak
Wichtige Hinweise

Electronic supplementary material

The online version of this article (https://​doi.​org/​10.​1186/​s13063-018-2860-8) contains supplementary material, which is available to authorized users.
The original version of this article was revised: a comment in the Peripheral and neural biomarkers and genotype section was incorrectly phrased during editing. “4 weeks of treatment (four active ABCR sessions twice a week or control group sessions twice a week)” should have actually been described as “4 weeks of treatment (4 active, twice a week, ABCR sessions or 2 weekly control group sessions).”
A correction to this article is available online at https://​doi.​org/​10.​1186/​s13063-019-3289-4.

Abstract

Background

Cognitive impairment is present in bipolar disorder (BD) during the acute and remitted phases and hampers functional recovery. However, there is currently no clinically available treatment with direct and lasting effects on cognitive impairment in BD. We will examine the effect of a novel form of cognitive remediation, action-based cognitive remediation (ABCR), on cognitive impairment in patients with BD, and explore the neural substrates of potential treatment efficacy on cognition.

Methods/design

The trial has a randomized, controlled, parallel-group design. In total, 58 patients with BD in full or partial remission aged 18–55 years with objective cognitive impairment will be recruited. Participants are randomized to 10 weeks of ABCR or a control group. Assessments encompassing neuropsychological testing and mood ratings, and questionnaires on subjective cognitive complaints, psychosocial functioning, and quality of life are carried out at baseline, after 2 weeks of treatment, after the end of treatment, and at a six-month-follow-up after treatment completion. Functional magnetic resonance imaging scans are performed at baseline and 2 weeks into treatment. The primary outcome is a cognitive composite score spanning verbal memory, attention, and executive function. Two complete data sets for 52 patients will provide a power of 80% to detect a clinically relevant between-group difference on the primary outcome. Behavioral data will be analyzed using mixed models in SPSS while MRI data will be analyzed with the FMRIB Expert Analysis Tool (FEAT). Early treatment-related changes in neural activity from baseline to week 2 will be investigated for the dorsal prefrontal cortex and hippocampus as the regions of interest and with an exploratory whole-brain analysis.

Discussion

The results will provide insight into whether ABCR has beneficial effects on cognition and functioning in remitted patients with BD. The results will also provide insight into early changes in neural activity associated with improvement of cognition, which can aid future treatment development.

Trial registration

Clinicaltrials.​gov, NCT03295305. Registered on 26 September 2017.
Zusatzmaterial
Additional file 1: SPIRIT 2013 Checklist: Recommended items to address in a clinical trial protocol and related documents. (DOC 122 kb)
13063_2018_2860_MOESM1_ESM.doc
Literatur
Über diesen Artikel

Weitere Artikel der Ausgabe 1/2018

Trials 1/2018 Zur Ausgabe