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Published in: Trials 1/2020

Open Access 01-12-2020 | Schizophrenia | Study protocol

Effects of Transcranial Direct Current Stimulation (tDCS) and Approach Bias Modification (ABM) training on food cravings in people taking antipsychotic medication

Authors: Luiza Grycuk, Gemma Gordon, Fiona Gaughran, Iain C. Campbell, Ulrike Schmidt

Published in: Trials | Issue 1/2020

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Abstract

Background

Antipsychotic drug-induced weight gain puts individuals with schizophrenia at increased cardiometabolic risk. As a potential intervention for this problem, we describe the theoretical background and a protocol for a feasibility randomised controlled trial (RCT) of approach bias modification (ABM) training combined with real versus sham (placebo) transcranial direct current stimulation (tDCS). The primary aim of this trial is to obtain information that will guide decision making and protocol development in relation to a future large-scale RCT of ABM and tDCS in this group of participants. Second, the study will assess the preliminary efficacy of ABM + tDCS in reducing food cravings in people who take antipsychotic medication.

Methods

Thirty adults with a DSM-V diagnosis of schizophrenia or schizoaffective disorder treated with anti-psychotic medication will be randomly allocated to receive five sessions that will combine ABM and real or sham tDCS, in a parallel group design. In this feasibility study, a broad range of outcome variables will be examined. Measures will include food craving, psychopathology (e.g. symptoms of schizophrenia and depression), neuropsychological processes (such as attentional bias and impulsiveness), and the tolerability and acceptability of tDCS. The feasibility of conducting a large-scale RCT of ABM + tDCS and appropriateness of tDCS as a treatment for antipsychotic drug-induced weight gain will be evaluated by assessment of recruitment and retention rates, acceptability of random allocation, blinding success (allocation concealment), completion of treatment sessions and research assessments (baseline, post-treatment and follow-up).

Discussion

The effect sizes generated and other findings from this trial will inform a future large-scale RCT with respect to decisions on primary outcome measures and other aspects of protocol development. In addition, results from this study will provide a preliminary indication of the efficacy of ABM + tDCS treatment for antipsychotic drug-induced weight gain.

Trial registration

ISRCTN Registry, ISRCTN13280178. Registered on 16 October 2018.
Appendix
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Literature
1.
Ballon JS, Pajvani U, Freyberg Z, Leibel RL, Lieberman JA. Molecular pathophysiology of metabolic effects of antipsychotic medications. Trends Endocrinol Metab. 2014;25(11):593–600.PubMedCrossRef
2.
Brown S, Inskip H, Barraclough B. Causes of the excess mortality of schizophrenia. Br J Psychiatry. 2000;177(3):212–7.PubMedCrossRef
3.
Allison DB, Mentore JL, Heo M, Chandler LP, Cappelleri JC, Infante MC, et al. Antipsychotic-induced weight gain: a comprehensive research synthesis. Am J Psychiatry. 1999;156(11):1686–96.PubMed
4.
Fountaine RJ, Taylor AE, Mancuso JP, Greenway FL, Byerley LO, Smith SR, et al. Increased food intake and energy expenditure following administration of olanzapine to healthy men. Obesity. 2010;18(8):1646–51.PubMedCrossRef
5.
Gothelf D, Falk B, Singer P, Kairi M, Phillip M, Zigel L, et al. Weight gain associated with increased food intake and low habitual activity levels in male adolescent schizophrenic inpatients treated with olanzapine. Am J Psychiatry. 2002;159(6):1055–7.PubMedCrossRef
6.
Dipasquale S, Pariante CM, Dazzan P, Aguglia E, McGuire P, Mondelli V. The dietary pattern of patients with schizophrenia: a systematic review. J Psychiatr Res. 2013;47(2):197–207.PubMedCrossRef
7.
Caemmerer J, Correll CU, Maayan L. Acute and maintenance effects of non-pharmacologic interventions for antipsychotic associated weight gain and metabolic abnormalities: a meta-analytic comparison of randomized controlled trials. Schizophr Res. 2012;140(1–3):159–68.PubMedCrossRef
8.
Henderson DC, Cagliero E, Gray C, Nasrallah RA, Hayden DL, Schoenfeld DA, et al. Clozapine, diabetes mellitus, weight gain, and lipid abnormalities: a five-year naturalistic study. Am J Psychiatry. 2000;157(6):975–81.PubMedCrossRef
9.
Firth J, Cotter J, Elliott R, French P, Yung A. A systematic review and meta-analysis of exercise interventions in schizophrenia patients. Psychol Med. 2015;45(7):1343–61.PubMedCrossRef
10.
Bonfioli E, Berti L, Goss C, Muraro F, Burti L. Health promotion lifestyle interventions for weight management in psychosis: a systematic review and meta-analysis of randomised controlled trials. BMC Psychiatry. 2012;12(1):78.PubMedPubMedCentralCrossRef
11.
Coccurello R, Moles A. Potential mechanisms of atypical antipsychotic-induced metabolic derangement: clues for understanding obesity and novel drug design. Pharmacol Ther. 2010;127(3):210–51.PubMedCrossRef
12.
Baptista T. Body weight gain induced by antipsychotic drugs: mechanisms and management. Acta Psychiatr Scand. 1999;100(1):3–16.PubMedCrossRef
13.
Miller DD, Ellingrod VL, Holman TL, Buckley PF, Arndt S. Clozapine-induced weight gain associated with the 5HT2C receptor− 759C/T polymorphism. Am J Med Genet B Neuropsychiatr Genet. 2005;133(1):97–100.CrossRef
14.
Malhotra AK, Correll CU, Chowdhury NI, Müller DJ, Gregersen PK, Lee AT, et al. Association between common variants near the melanocortin 4 receptor gene and severe antipsychotic drug–induced weight gain. Arch Gen Psychiatry. 2012;69(9):904–12.PubMedPubMedCentralCrossRef
15.
Blouin M, Tremblay A, Jalbert ME, Venables H, Bouchard RH, Roy MA, et al. Adiposity and eating behaviors in patients under second generation antipsychotics. Obesity (Silver Spring). 2008;16(8):1780–7.CrossRef
16.
Brömel T, Blum W, Ziegler A, Schulz E, Bender M, Fleischhaker C, et al. Serum leptin levels increase rapidly after initiation of clozapine therapy. Mol Psychiatry. 1998;3(1):76.PubMedCrossRef
17.
Theisen FM, Linden A, Konig IR, Martin M, Remschmidt H, Hebebrand J. Spectrum of binge eating symptomatology in patients treated with clozapine and olanzapine. J Neural Transm (Vienna). 2003;110(1):111–21.CrossRef
18.
Mathews J, Newcomer JW, Mathews JR, Fales CL, Pierce KJ, Akers BK, et al. Neural correlates of weight gain with olanzapine. Arch Gen Psychiatry. 2012;69(12):1226–37.PubMedCrossRef
19.
Stip E, Lungu OV, Anselmo K, Letourneau G, Mendrek A, Stip B, et al. Neural changes associated with appetite information processing in schizophrenic patients after 16 weeks of olanzapine treatment. Transl Psychiatry. 2012;2:e128.PubMedPubMedCentralCrossRef
20.
Brunoni AR, Moffa AH, Fregni F, Palm U, Padberg F, Blumberger DM, et al. Transcranial direct current stimulation for acute major depressive episodes: meta-analysis of individual patient data. Br J Psychiatry. 2016;208(6):522–31.PubMedPubMedCentralCrossRef
21.
Donde C, Neufeld NH, Geoffroy PA. The Impact of Transcranial Direct Current Stimulation (tDCS) on Bipolar Depression, Mania, and Euthymia: a Systematic Review of Preliminary Data. Psychiatr Q. 2018;89(4):855–67.PubMedCrossRef
22.
Kekic M, Boysen E, Campbell IC, Schmidt U. A systematic review of the clinical efficacy of transcranial direct current stimulation (tDCS) in psychiatric disorders. J Psychiatr Res. 2016;74:70–86.PubMedCrossRef
23.
Dalton B, Campbell IC, Schmidt U. Neuromodulation and neurofeedback treatments in eating disorders and obesity. Curr Opin Psychiatry. 2017;30(6):458–73.PubMedCrossRef
24.
25.
Van den Eynde F, Claudino AM, Mogg A, Horrell L, Stahl D, Ribeiro W, et al. Repetitive transcranial magnetic stimulation reduces cue-induced food craving in bulimic disorders. Biol Psychiatry. 2010;67(8):793–5.PubMedCrossRef
26.
Van den Eynde F, Guillaume S, Broadbent H, Campbell I, Schmidt U. Repetitive transcranial magnetic stimulation in anorexia nervosa: a pilot study. Eur Psychiatry. 2013;28(2):98–101.PubMedCrossRef
27.
Fregni F, Orsati F, Pedrosa W, Fecteau S, Tome FA, Nitsche MA, et al. Transcranial direct current stimulation of the prefrontal cortex modulates the desire for specific foods. Appetite. 2008;51(1):34–41.PubMedCrossRef
28.
Goldman RL, Borckardt JJ, Frohman HA, O’Neil PM, Madan A, Campbell LK, et al. Prefrontal cortex transcranial direct current stimulation (tDCS) temporarily reduces food cravings and increases the self-reported ability to resist food in adults with frequent food craving. Appetite. 2011;56(3):741–6.PubMedCrossRef
29.
Montenegro RA, Okano AH, Cunha FA, Gurgel JL, Fontes EB, Farinatti PT. Prefrontal cortex transcranial direct current stimulation associated with aerobic exercise change aspects of appetite sensation in overweight adults. Appetite. 2012;58(1):333–8.PubMedCrossRef
30.
Beard C, Sawyer AT, Hofmann SG. Efficacy of attention bias modification using threat and appetitive stimuli: A meta-analytic review. Behav Ther. 2012;43(4):724–40.PubMedPubMedCentralCrossRef
31.
Jones EB, Sharpe L. Cognitive bias modification: a review of meta-analyses. J Affect Disord. 2017;223:175–83.PubMedCrossRef
32.
Kakoschke N, Kemps E, Tiggemann M. Approach bias modification training and consumption: A review of the literature. Addict Behav. 2017;64:21–8.PubMedCrossRef
33.
Brockmeyer T, Hahn C, Reetz C, Schmidt U, Friederich HC. Approach bias and cue reactivity towards food in people with high versus low levels of food craving. Appetite. 2015;95:197–202.PubMedCrossRef
34.
Brockmeyer T, Friederich HC, Kuppers C, Chowdhury S, Harms L, Simmonds J, et al. Approach bias modification training in bulimia nervosa and binge-eating disorder: A pilot randomized controlled trial. Int J Eat Disord. 2019;52(5):520–9.PubMedCrossRef
35.
Nitsche MA, Cohen LG, Wassermann EM, Priori A, Lang N, Antal A, et al. Transcranial direct current stimulation: state of the art 2008. Brain Stimul. 2008;1(3):206–23.PubMedCrossRef
36.
Fritsch B, Reis J, Martinowich K, Schambra HM, Ji Y, Cohen LG, et al. Direct current stimulation promotes BDNF-dependent synaptic plasticity: potential implications for motor learning. Neuron. 2010;66(2):198–204.PubMedPubMedCentralCrossRef
37.
Stagg CJ, Nitsche MA. Physiological basis of transcranial direct current stimulation. Neuroscientist. 2011;17(1):37–53.PubMedCrossRef
38.
Heeren A, Baeken C, Vanderhasselt M-A, Philippot P, De Raedt R. Impact of anodal and cathodal transcranial direct current stimulation over the left dorsolateral prefrontal cortex during attention bias modification: an eye-tracking study. PLoS One. 2015;10(4):e0124182.PubMedPubMedCentralCrossRef
39.
Den Uyl TE, Gladwin TE, Rinck M, Lindenmeyer J, Wiers RW. A clinical trial with combined transcranial direct current stimulation and alcohol approach bias retraining. Addict Biol. 2017;22(6):1632–40.CrossRef
40.
Kekic M, McClelland J, Bartholdy S, Boysen E, Musiat P, Dalton B, et al. Single-Session Transcranial Direct Current Stimulation Temporarily Improves Symptoms, Mood, and Self-Regulatory Control in Bulimia Nervosa: A Randomised Controlled Trial. PLoS One. 2017;12(1):e0167606.PubMedPubMedCentralCrossRef
41.
Kekic M, McClelland J, Campbell I, Nestler S, Rubia K, David AS, et al. The effects of prefrontal cortex transcranial direct current stimulation (tDCS) on food craving and temporal discounting in women with frequent food cravings. Appetite. 2014;78:55–62.PubMedCrossRef
42.
Jansen JM, Daams JG, Koeter MW, Veltman DJ, van den Brink W, Goudriaan AE. Effects of non-invasive neurostimulation on craving: a meta-analysis. Neurosci Biobehav Rev. 2013;37(10 Pt 2):2472–80.PubMedCrossRef
43.
Lowe CJ, Hall PA, Staines WR. The effects of continuous theta burst stimulation to the left dorsolateral prefrontal cortex on executive function, food cravings, and snack food consumption. Psychosom Med. 2014;76(7):503–11.PubMedCrossRef
44.
Song S, Zilverstand A, Gui W, Li H-J, Zhou X. Effects of single-session versus multi-session non-invasive brain stimulation on craving and consumption in individuals with drug addiction, eating disorders or obesity: A meta-analysis. Brain Stimul. 2019;12:606–18.PubMedCrossRef
45.
46.
Lancaster GA, Dodd S, Williamson PR. Design and analysis of pilot studies: recommendations for good practice. J Eval Clin Pract. 2004;10(2):307–12.PubMedCrossRef
47.
Julious SA. Sample size of 12 per group rule of thumb for a pilot study. Pharm Stat. 2005;4(4):287–91.CrossRef
48.
49.
Brockmeyer T, Schmidt U, Friederich H-C. The ABBA study–approach bias modification in bulimia nervosa and binge eating disorder: study protocol for a randomised controlled trial. Trials. 2016;17(1):466.PubMedPubMedCentralCrossRef
50.
51.
Jasper HH. The 10-20 electrode system of the International Federation. Electroencephalogr Clin Neurophysiol. 1958;10:371–5.
52.
Brunoni AR, Nitsche MA, Bolognini N, Bikson M, Wagner T, Merabet L, et al. Clinical research with transcranial direct current stimulation (tDCS): challenges and future directions. Brain Stimul. 2012;5(3):175–95.PubMedCrossRef
53.
Poreisz C, Boros K, Antal A, Paulus W. Safety aspects of transcranial direct current stimulation concerning healthy subjects and patients. Brain Res Bull. 2007;72(4–6):208–14.PubMedCrossRef
54.
Brunoni AR, Amadera J, Berbel B, Volz MS, Rizzerio BG, Fregni F. A systematic review on reporting and assessment of adverse effects associated with transcranial direct current stimulation. Int J Neuropsychopharmacol. 2011;14(8):1133–45.PubMedCrossRef
55.
Chan A-W, Tetzlaff JM, Altman DG, Laupacis A, Gøtzsche PC, Krleža-Jerić K, et al. SPIRIT 2013 statement: defining standard protocol items for clinical trials. Ann Intern Med. 2013;158(3):200–7.PubMedPubMedCentralCrossRef
56.
Moher D, Schulz KF, Altman DG. The CONSORT statement: revised recommendations for improving the quality of reports of parallel group randomized trials. BMC Med Res Methodol. 2001;1(1):2.PubMedPubMedCentralCrossRef
57.
58.
Fairburn, Christopher G. Cognitive behavior therapy and eating disorders. Guilford Press; 2008.
59.
Meule A, Hermann T, Kübler A. A short version of the Food Cravings Questionnaire—Trait: the FCQ-T-reduced. Front Psychol. 2014;5:190.PubMedPubMedCentral
60.
De Houwer J, Crombez G, Baeyens F, Hermans D. On the generality of the affective Simon effect. Cogn Emot. 2001;15(2):189–206.CrossRef
61.
Lovibond PF, Lovibond SH. The structure of negative emotional states: Comparison of the Depression Anxiety Stress Scales (DASS) with the Beck Depression and Anxiety Inventories. Behav Res Ther. 1995;33(3):335–43.PubMedCrossRef
62.
Nasreddine ZS, Phillips NA, Bédirian V, Charbonneau S, Whitehead V, Collin I, et al. The Montreal Cognitive Assessment, MoCA: a brief screening tool for mild cognitive impairment. J Am Geriatr Soc. 2005;53(4):695–9.PubMedCrossRef
63.
Patton JH, Stanford MS, Barratt ES. Factor structure of the Barratt impulsiveness scale. J Clin Psychol. 1995;51(6):768–74.CrossRefPubMed
64.
Østergaard SD, Opler MG, Correll CU. Bridging the Measurement Gap Between Research and Clinical Care in Schizophrenia: Positive and Negative Syndrome Scale-6 (PANSS-6) and Other Assessments Based on the Simplified Negative and Positive Symptoms Interview (SNAPSI). Innov Clin Neurosci. 2017;14(11–12):68.PubMedPubMedCentral
65.
Østergaard SD, Lemming OM, Mors O, Correll CU, Bech P. PANSS-6: a brief rating scale for the measurement of severity in schizophrenia. Acta Psychiatr Scand. 2016;133(6):436–44.PubMedCrossRef
66.
Horvath JC, Forte JD, Carter O. Quantitative Review Finds No Evidence of Cognitive Effects in Healthy Populations From Single-session Transcranial Direct Current Stimulation (tDCS). Brain Stimul. 2015;8(3):535–50.PubMedCrossRef
67.
68.
Brunoni AR, Schestatsky P, Lotufo PA, Bensenor IM, Fregni F. Comparison of blinding effectiveness between sham tDCS and placebo sertraline in a 6-week major depression randomized clinical trial. Cli Neurophysiol. 2014;125(2):298–305.CrossRef
Metadata
Title
Effects of Transcranial Direct Current Stimulation (tDCS) and Approach Bias Modification (ABM) training on food cravings in people taking antipsychotic medication
Authors
Luiza Grycuk
Gemma Gordon
Fiona Gaughran
Iain C. Campbell
Ulrike Schmidt
Publication date
01-12-2020
Publisher
BioMed Central
Keyword
Schizophrenia
Published in
Trials / Issue 1/2020
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-020-4112-y

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