Specialized post-inpatient psychotherapy for sustained recovery in anorexia nervosa via videoconference - study protocol of the randomized controlled SUSTAIN trial.
Aftercare
Anorexia nervosa
Eating disorder
Inpatient
Psychotherapy
RCT
Recovery
Relapse
Treatment
Videoconference
Journal
Journal of eating disorders
ISSN: 2050-2974
Titre abrégé: J Eat Disord
Pays: England
ID NLM: 101610672
Informations de publication
Date de publication:
19 May 2021
19 May 2021
Historique:
received:
22
02
2021
accepted:
04
05
2021
entrez:
20
5
2021
pubmed:
21
5
2021
medline:
21
5
2021
Statut:
epublish
Résumé
A major barrier to long-term recovery from anorexia nervosa (AN) are early and frequent relapses after inpatient treatment. There is an urgent need for enhanced continuity of specialized care involving effective aftercare interventions and relapse prevention strategies in order to improve the long-term outcome for patients with AN. SUSTAIN is a multi-center, prospective, randomized-controlled trial investigating the efficacy of a novel post-inpatient aftercare intervention for patients with AN as compared to optimized treatment-as-usual (TAU-O). The SUSTAIN aftercare intervention is based on the cognitive-interpersonal maintenance model of AN and specifically tailored to achieve sustained recovery in AN following inpatient treatment. The SUSTAIN aftercare intervention comprises 20 treatment sessions over eight months and will be predominantly delivered via videoconference to overcome discontinuity of care. TAU-O refers to routine outpatient psychotherapy as generally offered in the German health care system. A total number of 190 patients receiving inpatient or day-hospital treatment for AN will be randomized and assessed over a 14-month period following randomization including a 6 months follow-up. Minimum Body Mass Index (BMI) is 15 kg/m The results of the present trial will provide evidence if the novel aftercare intervention fosters sustained recovery in patients affected by severe courses of AN. The SUSTAIN trial was prospectively registered on November 18, 2020, under the registration number DRKS00023372 at the German Clinical Trials Register ( https://www.drks.de/drks_web/ ) which is an acknowledged primary register of the World Health Organization ( http://apps.who.int/trialsearch/ ). Protocol version: 1.2.
Sections du résumé
BACKGROUND
BACKGROUND
A major barrier to long-term recovery from anorexia nervosa (AN) are early and frequent relapses after inpatient treatment. There is an urgent need for enhanced continuity of specialized care involving effective aftercare interventions and relapse prevention strategies in order to improve the long-term outcome for patients with AN.
METHODS
METHODS
SUSTAIN is a multi-center, prospective, randomized-controlled trial investigating the efficacy of a novel post-inpatient aftercare intervention for patients with AN as compared to optimized treatment-as-usual (TAU-O). The SUSTAIN aftercare intervention is based on the cognitive-interpersonal maintenance model of AN and specifically tailored to achieve sustained recovery in AN following inpatient treatment. The SUSTAIN aftercare intervention comprises 20 treatment sessions over eight months and will be predominantly delivered via videoconference to overcome discontinuity of care. TAU-O refers to routine outpatient psychotherapy as generally offered in the German health care system. A total number of 190 patients receiving inpatient or day-hospital treatment for AN will be randomized and assessed over a 14-month period following randomization including a 6 months follow-up. Minimum Body Mass Index (BMI) is 15 kg/m
DISCUSSION
CONCLUSIONS
The results of the present trial will provide evidence if the novel aftercare intervention fosters sustained recovery in patients affected by severe courses of AN.
TRIAL REGISTRATION
BACKGROUND
The SUSTAIN trial was prospectively registered on November 18, 2020, under the registration number DRKS00023372 at the German Clinical Trials Register ( https://www.drks.de/drks_web/ ) which is an acknowledged primary register of the World Health Organization ( http://apps.who.int/trialsearch/ ). Protocol version: 1.2.
Identifiants
pubmed: 34011399
doi: 10.1186/s40337-021-00416-6
pii: 10.1186/s40337-021-00416-6
pmc: PMC8132489
doi:
Types de publication
Journal Article
Langues
eng
Pagination
61Subventions
Organisme : Bundesministerium für Bildung und Forschung
ID : 01KG2009
Références
Zipfel S, Giel KE, Bulik CM, Hay P, Schmidt U. Anorexia nervosa: aetiology, assessment, and treatment. Lancet Psychiatry. 2015;2(12):1099–111. https://doi.org/10.1016/S2215-0366(15)00356-9 .
doi: 10.1016/S2215-0366(15)00356-9
pubmed: 26514083
van Hoeken D, Hoek HW. Review of the burden of eating disorders: mortality, disability, costs, quality of life, and family burden. Curr Opin Psychiatry. 2020;33(6):521–7. https://doi.org/10.1097/YCO.0000000000000641 .
doi: 10.1097/YCO.0000000000000641
pubmed: 32796186
pmcid: 7575017
Cruz AM, Goncalves-Pinho M, Santos JV, Coutinho F, Brandao I, Freitas A. Eating disorders-related hospitalizations in Portugal: a nationwide study from 2000 to 2014. Int J Eat Disord. 2018;51(10):1201–6. https://doi.org/10.1002/eat.22955 .
doi: 10.1002/eat.22955
pubmed: 30265756
Stoving RK, Larsen PV, Winkler LA, Bilenberg N, Roder ME, Steinhausen HC. Time trends in treatment modes of anorexia nervosa in a nationwide cohort with free and equal access to treatment. Int J Eat Disord. 2020;53(12):1952–9. https://doi.org/10.1002/eat.23378 .
doi: 10.1002/eat.23378
pubmed: 32893903
pmcid: 7754480
Zeeck A, Herpertz-Dahlmann B, Friederich HC, Brockmeyer T, Resmark G, Hagenah U, et al. Psychotherapeutic treatment for anorexia nervosa: a systematic review and network meta-analysis. Front Psychiatry. 2018;9:158. https://doi.org/10.3389/fpsyt.2018.00158 .
doi: 10.3389/fpsyt.2018.00158
pubmed: 29765338
pmcid: 5939188
Friedman K, Ramirez AL, Murray SB, Anderson LK, Cusack A, Boutelle KN, et al. A narrative review of outcome studies for residential and partial hospital-based treatment of eating disorders. Eur Eat Disord Rev. 2016;24(4):263–76. https://doi.org/10.1002/erv.2449 .
doi: 10.1002/erv.2449
pubmed: 27062687
Schlegl S, Quadflieg N, Lowe B, Cuntz U, Voderholzer U. Specialized inpatient treatment of adult anorexia nervosa: effectiveness and clinical significance of changes. BMC Psychiatry. 2014;14(1):258. https://doi.org/10.1186/s12888-014-0258-z .
doi: 10.1186/s12888-014-0258-z
pubmed: 25193513
pmcid: 4172844
Fichter MM, Quadflieg N, Crosby RD, Koch S. Long-term outcome of anorexia nervosa: results from a large clinical longitudinal study. Int J Eat Disord. 2017;50(9):1018–30. https://doi.org/10.1002/eat.22736 .
doi: 10.1002/eat.22736
pubmed: 28644530
Khalsa SS, Portnoff LC, McCurdy-McKinnon D, Feusner JD. What happens after treatment? A systematic review of relapse, remission, and recovery in anorexia nervosa. J Eat Disord. 2017;5(1):20. https://doi.org/10.1186/s40337-017-0145-3 .
doi: 10.1186/s40337-017-0145-3
pubmed: 28630708
pmcid: 5470198
Berends T, Boonstra N, van Elburg A. Relapse in anorexia nervosa: a systematic review and meta-analysis. Curr Opin Psychiatry. 2018;31(6):445–55. https://doi.org/10.1097/YCO.0000000000000453 .
doi: 10.1097/YCO.0000000000000453
pubmed: 30113325
Bardone-Cone AM, Hunt RA, Watson HJ. An overview of conceptualizations of eating disorder recovery, recent findings, and future directions. Curr Psychiatry Rep. 2018;20(9):79. https://doi.org/10.1007/s11920-018-0932-9 .
doi: 10.1007/s11920-018-0932-9
pubmed: 30094740
de Vos JA, LaMarre A, Radstaak M, Bijkerk CA, Bohlmeijer ET, Westerhof GJ. Identifying fundamental criteria for eating disorder recovery: a systematic review and qualitative meta-analysis. J Eat Disord. 2017;5(1):34. https://doi.org/10.1186/s40337-017-0164-0 .
doi: 10.1186/s40337-017-0164-0
pubmed: 29118983
pmcid: 5664841
Treasure J, Oyeleye O, Bonin EM, Zipfel S, Fernandez-Aranda F. Optimising care pathways for adult anorexia nervosa. What is the evidence to guide the provision of high-quality, cost-effective services? Eur Eat Disord Rev. 2021;29(3):306–15.
Resmark G, Herpertz S, Herpertz-Dahlmann B, Zeeck A. Treatment of anorexia nervosa-new evidence-based guidelines. J Clin Med. 2019;8(2):153.
National Institute for Health and Care Excellence (NICE). Eating disorders: recognition and treatment 2017 [Available from: https://www.nice.org.uk/guidance/ng69/chapter/Recommendations#treating-anorexia-nervosa .
Russell GF, Szmukler GI, Dare C, Eisler I. An evaluation of family therapy in anorexia nervosa and bulimia nervosa. Arch Gen Psychiatry. 1987;44(12):1047–56. https://doi.org/10.1001/archpsyc.1987.01800240021004 .
doi: 10.1001/archpsyc.1987.01800240021004
pubmed: 3318754
Pike KM, Walsh BT, Vitousek K, Wilson GT, Bauer J. Cognitive behavior therapy in the posthospitalization treatment of anorexia nervosa. Am J Psychiatry. 2003;160(11):2046–9. https://doi.org/10.1176/appi.ajp.160.11.2046 .
doi: 10.1176/appi.ajp.160.11.2046
pubmed: 14594754
Fichter MM, Quadflieg N, Nisslmuller K, Lindner S, Osen B, Huber T, et al. Does internet-based prevention reduce the risk of relapse for anorexia nervosa? Behav Res Ther. 2012;50(3):180–90. https://doi.org/10.1016/j.brat.2011.12.003 .
doi: 10.1016/j.brat.2011.12.003
pubmed: 22317754
Carter JC, McFarlane TL, Bewell C, Olmsted MP, Woodside DB, Kaplan AS, et al. Maintenance treatment for anorexia nervosa: a comparison of cognitive behavior therapy and treatment as usual. Int J Eat Disord. 2009;42(3):202–7. https://doi.org/10.1002/eat.20591 .
doi: 10.1002/eat.20591
pubmed: 18949764
Kaye WH, Nagata T, Weltzin TE, Hsu LK, Sokol MS, McConaha C, et al. Double-blind placebo-controlled administration of fluoxetine in restricting- and restricting-purging-type anorexia nervosa. Biol Psychiatry. 2001;49(7):644–52. https://doi.org/10.1016/S0006-3223(00)01013-1 .
doi: 10.1016/S0006-3223(00)01013-1
pubmed: 11297722
Walsh BT, Kaplan AS, Attia E, Olmsted M, Parides M, Carter JC, et al. Fluoxetine after weight restoration in anorexia nervosa: a randomized controlled trial. JAMA. 2006;295(22):2605–12. https://doi.org/10.1001/jama.295.22.2605 .
doi: 10.1001/jama.295.22.2605
pubmed: 16772623
Parling T, Cernvall M, Ramklint M, Holmgren S, Ghaderi A. A randomised trial of acceptance and commitment therapy for anorexia nervosa after daycare treatment, including five-year follow-up. BMC Psychiatry. 2016;16(1):272. https://doi.org/10.1186/s12888-016-0975-6 .
doi: 10.1186/s12888-016-0975-6
pubmed: 27473046
pmcid: 4966749
Neumayr C, Voderholzer U, Tregarthen J, Schlegl S. Improving aftercare with technology for anorexia nervosa after intensive inpatient treatment: a pilot randomized controlled trial with a therapist-guided smartphone app. Int J Eat Disord. 2019;52(10):1191–201. https://doi.org/10.1002/eat.23152 .
doi: 10.1002/eat.23152
pubmed: 31429974
Cardi V, Ambwani S, Robinson E, Albano G, MacDonald P, Aya V, et al. Transition Care in Anorexia Nervosa through Guidance Online from peer and Carer expertise (TRIANGLE): study protocol for a randomised controlled trial. Eur Eat Disord Rev. 2017;25(6):512–23. https://doi.org/10.1002/erv.2542 .
doi: 10.1002/erv.2542
pubmed: 28944595
Schlegl S, Neumayr C, Voderholzer U. Therapist-guided smartphone-based aftercare for inpatients with severe anorexia nervosa (SMART-AN): study protocol of a randomized controlled trial. Int J Eat Disord. 2020;53(10):1739–45. https://doi.org/10.1002/eat.23357 .
doi: 10.1002/eat.23357
pubmed: 32735053
Giel KE, Leehr EJ, Becker S, Herzog W, Junne F, Schmidt U, et al. Relapse prevention via videoconference for anorexia nervosa - findings from the RESTART pilot study. Psychother Psychosom. 2015;84(6):381–3. https://doi.org/10.1159/000431044 .
doi: 10.1159/000431044
pubmed: 26402321
Schmidt U, Treasure J. Anorexia nervosa: valued and visible. A cognitive-interpersonal maintenance model and its implications for research and practice. Br J Clin Psychol. 2006;45(Pt 3):343–66. https://doi.org/10.1348/014466505X53902 .
doi: 10.1348/014466505X53902
pubmed: 17147101
Schmidt U, Magill N, Renwick B, Keyes A, Kenyon M, Dejong H, et al. The Maudsley outpatient study of treatments for anorexia nervosa and related conditions (MOSAIC): comparison of the Maudsley model of anorexia nervosa treatment for adults (MANTRA) with specialist supportive clinical management (SSCM) in outpatients with broadly defined anorexia nervosa: a randomized controlled trial. J Consult Clin Psychol. 2015;83(4):796–807. https://doi.org/10.1037/ccp0000019 .
doi: 10.1037/ccp0000019
pubmed: 25984803
Schmidt U, Ryan EG, Bartholdy S, Renwick B, Keyes A, O'Hara C, et al. Two-year follow-up of the MOSAIC trial: a multicenter randomized controlled trial comparing two psychological treatments in adult outpatients with broadly defined anorexia nervosa. Int J Eat Disord. 2016;49(8):793–800. https://doi.org/10.1002/eat.22523 .
doi: 10.1002/eat.22523
pubmed: 27061709
Zipfel S, Wild B, Gross G, Friederich HC, Teufel M, Schellberg D, et al. Focal psychodynamic therapy, cognitive behaviour therapy, and optimised treatment as usual in outpatients with anorexia nervosa (ANTOP study): randomised controlled trial. Lancet. 2014;383(9912):127–37. https://doi.org/10.1016/S0140-6736(13)61746-8 .
doi: 10.1016/S0140-6736(13)61746-8
pubmed: 24131861
Chan AW, Tetzlaff JM, Altman DG, Laupacis A, Gotzsche PC, Krleza-Jeric K, et al. SPIRIT 2013 statement: defining standard protocol items for clinical trials. Ann Intern Med. 2013;158(3):200–7. https://doi.org/10.7326/0003-4819-158-3-201302050-00583 .
doi: 10.7326/0003-4819-158-3-201302050-00583
pubmed: 23295957
pmcid: 5114123
Hoffmann TC, Glasziou PP, Boutron I, Milne R, Perera R, Moher D, et al. Better reporting of interventions: template for intervention description and replication (TIDieR) checklist and guide. BMJ. 2014;348(mar07 3):g1687. https://doi.org/10.1136/bmj.g1687 .
doi: 10.1136/bmj.g1687
pubmed: 24609605
pmcid: 24609605
Herpertz-Dahlmann B, Schwarte R, Krei M, Egberts K, Warnke A, Wewetzer C, et al. Day-patient treatment after short inpatient care versus continued inpatient treatment in adolescents with anorexia nervosa (ANDI): a multicentre, randomised, open-label, non-inferiority trial. Lancet. 2014;383(9924):1222–9. https://doi.org/10.1016/S0140-6736(13)62411-3 .
doi: 10.1016/S0140-6736(13)62411-3
pubmed: 24439238
American Psychiatric Association, editor. Diagnostic and statistical manual of mental disorders: DSM-5. Washington: American Psychiatric Assoc; 2013.
American Psychological Association (APA). Practice Guideline for the Treatment of Patients with Eating Disorders 2006 [Available from: https://psychiatryonline.org/pb/assets/raw/sitewide/practice_guidelines/guidelines/eatingdisorders.pdf .
Carroll K, Nuro K. One size cannot fit all: a stage model for psychotherapy manual development. Clin Psychol Sci Pract. 2006;9(4):396–406.
doi: 10.1093/clipsy.9.4.396
Kaplan AS, Walsh BT, Olmsted M, Attia E, Carter JC, Devlin MJ, et al. The slippery slope: prediction of successful weight maintenance in anorexia nervosa. Psychol Med. 2009;39(6):1037–45. https://doi.org/10.1017/S003329170800442X .
doi: 10.1017/S003329170800442X
pubmed: 18845008
Byrne S, Wade T, Hay P, Touyz S, Fairburn C, Treasure J, et al. A randomised controlled trial of three psychological treatments for anorexia nervosa. Psychol Med. 2017;47(16):2823–33. https://doi.org/10.1017/S0033291717001349 .
doi: 10.1017/S0033291717001349
pubmed: 28552083
Hilbert A, Tuschen-Caffier B. Eating Disorder Examniation. Tübingen: dgvt-Verlag; 2016.
Hilbert A, Tuschen-Caffier B. Eating Disorder Examination-Questionnaire. Tübingen: dgvt-Verlag; 2016.
Clement U, Löwe B. Fragebogen zum Körperbild. Göttingen: Hogrefe; 1996.
Beesdo-Baum K, Zaudig M, Wittchen H. Strukturiertes Klinisches Interview für DSM-5®-Störungen – Klinische Version. Göttingen: Hogrefe; 2019.
Löwe B, Spitzer R, Zipfel S, Herzog W. Gesundheitsfragebogen für Patienten (PHQ D). Karlsruhe: Pfizer; 2002.
Herdman M, Gudex C, Lloyd A, Janssen M, Kind P, Parkin D, et al. Development and preliminary testing of the new five-level version of EQ-5D (EQ-5D-5L). Qual Life Res. 2011;20(10):1727–36. https://doi.org/10.1007/s11136-011-9903-x .
doi: 10.1007/s11136-011-9903-x
pubmed: 21479777
pmcid: 3220807
Tagay S, Schlegl S, Senf W. Validation of the German translation of the eating disorders quality of life (EDQOL). Psychother Psychosom Med Psychol. 2011;61(1):16–24. https://doi.org/10.1055/s-0029-1243195 .
doi: 10.1055/s-0029-1243195
pubmed: 20127614
Mander J, Wittorf A, Teufel M, Schlarb A, Hautzinger M, Zipfel S, et al. Patients with depression, somatoform disorders, and eating disorders on the stages of change: validation of a short version of the URICA. Psychotherapy (Chic). 2012;49(4):519–27. https://doi.org/10.1037/a0029563 .
doi: 10.1037/a0029563
Prochaska JO, DiClemente CC. Stages and process of self-change in smoking: toward an integrative model of change. J Consult Clin Psychol. 1983;5:390–5.
doi: 10.1037/0022-006X.51.3.390
Wilmers F, Munder T, Leonhart R, Herzog T, Plassmann R, Barth J, et al. Die deutschsprachige Version des Working Alliance Inventory – short revised (WAI-SR) – Ein schulenübergreifendes, ökonomisches und empirisch validiertes Instrument zur Erfassung der therapeutischen Allianz. Klin Diagn Eval. 2008;1:343–58.
Grupp H, König HH, Riedel-Heller S, Konnopka A. FIMPsy - questionnaire for the assessment of medical and non medical resource utilisation in mental disorders: development and application. Psychiatr Prax. 2018;45(2):87–94. https://doi.org/10.1055/s-0042-118033 .
doi: 10.1055/s-0042-118033
pubmed: 28125848
Rote Liste Service GmbH. Rote Liste 2018. Frankfurt/Main: Rote Liste Service GmbH; 2018.
Hoch JS, Briggs AH, Willan AR. Something old, something new, something borrowed, something blue: a framework for the marriage of health econometrics and cost-effectiveness analysis. Health Econ. 2002;11(5):415–30. https://doi.org/10.1002/hec.678 .
doi: 10.1002/hec.678
pubmed: 12112491
Stinnett AA, Mullahy J. Net health benefits: a new framework for the analysis of uncertainty in cost-effectiveness analysis. Med Decis Mak. 1998;18:S168–S80.
doi: 10.1177/0272989X98018002S09
Ahmadiankalati M, Steins-Loeber S, Paslakis G. Review of randomized controlled trials using e-health interventions for patients with eating disorders. Front Psychiatry. 2020;11:568. https://doi.org/10.3389/fpsyt.2020.00568 .
doi: 10.3389/fpsyt.2020.00568
pubmed: 32595546
pmcid: 7304304
Castellini G, Cassioli E, Rossi E, Innocenti M, Gironi V, Sanfilippo G, et al. The impact of COVID-19 epidemic on eating disorders: a longitudinal observation of pre versus post psychopathological features in a sample of patients with eating disorders and a group of healthy controls. Int J Eat Disord. 2020;53(11):1855–62. https://doi.org/10.1002/eat.23368 .
doi: 10.1002/eat.23368
pubmed: 32856333
Schlegl S, Maier J, Meule A, Voderholzer U. Eating disorders in times of the COVID-19 pandemic-results from an online survey of patients with anorexia nervosa. Int J Eat Disord. 2020;53(11):1791–800. https://doi.org/10.1002/eat.23374 .
doi: 10.1002/eat.23374
pubmed: 32841413
Fernandez-Aranda F, Casas M, Claes L, Bryan DC, Favaro A, Granero R, et al. COVID-19 and implications for eating disorders. Eur Eat Disord Rev. 2020;28(3):239–45. https://doi.org/10.1002/erv.2738 .
doi: 10.1002/erv.2738
pubmed: 32346977
pmcid: 7267370
Taylor CB, Fitzsimmons-Craft EE, Graham AK. Digital technology can revolutionize mental health services delivery: the COVID-19 crisis as a catalyst for change. Int J Eat Disord. 2020;53(7):1155–7. https://doi.org/10.1002/eat.23300 .
doi: 10.1002/eat.23300
pubmed: 32449523