Mental health specialist video consultations versus treatment as usual in patients with depression or anxiety disorders in primary care: study protocol for an individually randomised superiority trial (the PROVIDE-C trial).
Anxiety
Depression
Integrated care
Primary care
Randomised controlled trial
Telepsychiatry
Videoconferencing
Journal
Trials
ISSN: 1745-6215
Titre abrégé: Trials
Pays: England
ID NLM: 101263253
Informations de publication
Date de publication:
05 May 2021
05 May 2021
Historique:
received:
21
08
2020
accepted:
23
04
2021
entrez:
6
5
2021
pubmed:
7
5
2021
medline:
22
6
2021
Statut:
epublish
Résumé
Most people with mental disorders, including those with severe and chronic disorders, are treated solely by their general practitioner (GP). Nevertheless, specialised mental health care may be required for specific patients. Notably, the accessibility of mental health specialist care is mainly complicated by (a) long waiting times for an appointment with specialists, (b) long travel distances to specialists, particularly in rural and remote areas, and (c) patients' reservations about mental health specialist care (including fear of being stigmatised by seeking such care). To mitigate those barriers, technology-based integrated care models have been proposed. The purpose of this study is to examine the effectiveness and cost-effectiveness of a mental health specialist video consultations model versus treatment as usual in patients with depression or anxiety disorders in primary care. In an individually randomised, prospective, two-arm superiority trial with parallel group design, N = 320 patients with anxiety and/or depressive disorder will be recruited in general practices in Germany. The intervention includes a newly developed treatment model based on video consultations with focus on diagnostics, treatment planning, and short-term intervention by mental health specialists. We will systematically compare the effectiveness, cost-effectiveness, and adverse effects of this new model with usual care by the GP: the primary outcome is the absolute change in the mean depressive and anxiety symptom severity measured on the Patient Health Questionnaire Anxiety and Depression Scale (PHQ-ADS) from baseline to 6 months after baseline assessment. Follow-up in both groups will be conducted by blinded outcome assessors at 6 months and 12 months after baseline. The main analysis will be based on the intention-to-treat principle. We will optimise the likelihood of treatment effectiveness by strict inclusion criteria for patients, enhanced intervention integrity, and conducting a process evaluation. To the best of our knowledge, this is the first confirmatory study on a video-based, integrated care model for the treatment of anxiety and depressive disorders in GP patients in Germany. ClinicalTrials.gov, United States National Institutes of Health NCT04316572 . Prospectively registered on 20 March 2020.
Sections du résumé
BACKGROUND
BACKGROUND
Most people with mental disorders, including those with severe and chronic disorders, are treated solely by their general practitioner (GP). Nevertheless, specialised mental health care may be required for specific patients. Notably, the accessibility of mental health specialist care is mainly complicated by (a) long waiting times for an appointment with specialists, (b) long travel distances to specialists, particularly in rural and remote areas, and (c) patients' reservations about mental health specialist care (including fear of being stigmatised by seeking such care). To mitigate those barriers, technology-based integrated care models have been proposed. The purpose of this study is to examine the effectiveness and cost-effectiveness of a mental health specialist video consultations model versus treatment as usual in patients with depression or anxiety disorders in primary care.
METHODS
METHODS
In an individually randomised, prospective, two-arm superiority trial with parallel group design, N = 320 patients with anxiety and/or depressive disorder will be recruited in general practices in Germany. The intervention includes a newly developed treatment model based on video consultations with focus on diagnostics, treatment planning, and short-term intervention by mental health specialists. We will systematically compare the effectiveness, cost-effectiveness, and adverse effects of this new model with usual care by the GP: the primary outcome is the absolute change in the mean depressive and anxiety symptom severity measured on the Patient Health Questionnaire Anxiety and Depression Scale (PHQ-ADS) from baseline to 6 months after baseline assessment. Follow-up in both groups will be conducted by blinded outcome assessors at 6 months and 12 months after baseline. The main analysis will be based on the intention-to-treat principle. We will optimise the likelihood of treatment effectiveness by strict inclusion criteria for patients, enhanced intervention integrity, and conducting a process evaluation.
DISCUSSION
CONCLUSIONS
To the best of our knowledge, this is the first confirmatory study on a video-based, integrated care model for the treatment of anxiety and depressive disorders in GP patients in Germany.
TRIAL REGISTRATION
BACKGROUND
ClinicalTrials.gov, United States National Institutes of Health NCT04316572 . Prospectively registered on 20 March 2020.
Identifiants
pubmed: 33952313
doi: 10.1186/s13063-021-05289-3
pii: 10.1186/s13063-021-05289-3
pmc: PMC8097128
doi:
Banques de données
ClinicalTrials.gov
['NCT04316572']
Types de publication
Clinical Trial Protocol
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
327Références
World Health Organization. Depression and other common mental disorders: global health estimates: World Health Organization; 2017. p. 24.
Vos T, Barber RM, Bell B, Bertozzi-Villa A, Biryukov S, Bolliger I, et al. Global, regional, and national incidence, prevalence, and years lived with disability for 301 acute and chronic diseases and injuries in 188 countries, 1990–2013: a systematic analysis for the Global Burden of Disease Study 2013. Lancet. 2015;386(9995):743–800. https://doi.org/10.1016/S0140-6736(15)60692-4 .
doi: 10.1016/S0140-6736(15)60692-4
Patel V, Chisholm D, Parikh R, Charlson FJ, Degenhardt L, Dua T, et al. Addressing the burden of mental, neurological, and substance use disorders: key messages from Disease Control Priorities, 3rd edition. Lancet. 2016;387(10028):1672–85. https://doi.org/10.1016/S0140-6736(15)00390-6 .
doi: 10.1016/S0140-6736(15)00390-6
pubmed: 26454360
Cunningham PJ. Beyond parity: primary care physicians’ perspectives on access to mental health care. Health Aff (Millwood). 2009;28(Supplement 1):w490–501. https://doi.org/10.1377/hlthaff.28.3.w490 .
doi: 10.1377/hlthaff.28.3.w490
pubmed: 19366722
Wang PS, Lane M, Olfson M, Pincus HA, Wells KB, Kessler RC. Twelve-month use of mental health services in the United States: results from the National Comorbidity Survey Replication. Arch Gen Psychiatry. 2005;62(6):629–40. https://doi.org/10.1001/archpsyc.62.6.629 .
doi: 10.1001/archpsyc.62.6.629
pubmed: 15939840
Thornicroft G, Chatterji S, Evans-Lacko S, Gruber M, Sampson N, Aguilar-Gaxiola S, et al. Undertreatment of people with major depressive disorder in 21 countries. Br J Psychiatry. 2017;210(2):119–24. https://doi.org/10.1192/bjp.bp.116.188078 .
doi: 10.1192/bjp.bp.116.188078
pubmed: 27908899
pmcid: 5288082
Greenhalgh T, Shaw S, Wherton J, Vijayaraghavan S, Morris J, Bhattacharya S, et al. Real-world implementation of video outpatient consultations at macro, meso, and micro levels: mixed-method study. J Med Internet Res. 2018;20(4):e150. https://doi.org/10.2196/jmir.9897 .
doi: 10.2196/jmir.9897
pubmed: 29625956
pmcid: 5930173
Angermeyer MC, van der Auwera S, Carta MG, Schomerus G. Public attitudes towards psychiatry and psychiatric treatment at the beginning of the 21st century: a systematic review and meta-analysis of population surveys. World Psychiatry. 2017;16(1):50–61. https://doi.org/10.1002/wps.20383 .
doi: 10.1002/wps.20383
pubmed: 28127931
pmcid: 5269489
Rechel B, Grundy E, Robine J-M, Cylus J, Mackenbach JP, Knai C, et al. Ageing in the European Union. Lancet. 2013;381(9874):1312–22. https://doi.org/10.1016/S0140-6736(12)62087-X .
doi: 10.1016/S0140-6736(12)62087-X
pubmed: 23541057
Wang PS, Aguilar-Gaxiola S, Alonso J, Angermeyer MC, Borges G, Bromet EJ, et al. Use of mental health services for anxiety, mood, and substance disorders in 17 countries in the WHO world mental health surveys. Lancet Lond Engl. 2007;370(9590):841–50. https://doi.org/10.1016/S0140-6736(07)61414-7 .
doi: 10.1016/S0140-6736(07)61414-7
Gaebel W, Kowitz S, Fritze J, Zielasek J. Use of health care services by people with mental illness: secondary data from three statutory health insurers and the German Statutory Pension Insurance Scheme. Dtsch Ärztebl Int. 2013;110(47):799–808. https://doi.org/10.3238/arztebl.2013.0799 .
doi: 10.3238/arztebl.2013.0799
pubmed: 24314623
pmcid: 3859909
Lester H, Tritter JQ, Sorohan H. Patients’ and health professionals’ views on primary care for people with serious mental illness: focus group study. BMJ. 2005;330(7500):1122. https://doi.org/10.1136/bmj.38440.418426.8F .
doi: 10.1136/bmj.38440.418426.8F
pubmed: 15843427
pmcid: 557894
Kendrick T, King F, Albertella L, Smith PW. GP treatment decisions for patients with depression: an observational study. Br J Gen Pract. 2005;55:280–306.
pubmed: 15826435
pmcid: 1463130
Trautmann S, Beesdo-Baum K. The treatment of depression in primary care. Dtsch Ärztebl Int. 2017;114(43):721–8. https://doi.org/10.3238/arztebl.2017.0721 .
doi: 10.3238/arztebl.2017.0721
pubmed: 29143731
pmcid: 5696564
Moussavi S, Chatterji S, Verdes E, Tandon A, Patel V, Ustun B. Depression, chronic diseases, and decrements in health: results from the World Health Surveys. Lancet. 2007;370(9590):851–8. https://doi.org/10.1016/S0140-6736(07)61415-9 .
doi: 10.1016/S0140-6736(07)61415-9
pubmed: 17826170
Ring A, Dowrick CF, Humphris GM, Davies J, Salmon P. The somatising effect of clinical consultation: what patients and doctors say and do not say when patients present medically unexplained physical symptoms. Soc Sci Med. 2005;61(7):1505–15. https://doi.org/10.1016/j.socscimed.2005.03.014 .
doi: 10.1016/j.socscimed.2005.03.014
pubmed: 15922499
Hoffmann M, Hartmann M, Wensing M, Friederich H-C, Haun MW. Potential for integrating mental health specialist video consultations in office-based routine primary care: cross-sectional qualitative study among family physicians. J Med Internet Res. 2019;21(8):e13382. https://doi.org/10.2196/13382 .
doi: 10.2196/13382
pubmed: 31429419
pmcid: 6718083
Crowley RA, Kirschner N. The integration of care for mental health, substance abuse, and other behavioral health conditions into primary care: executive summary of an american college of physicians position. Ann Intern Med. 2015;163(4):298–9. https://doi.org/10.7326/M15-0510 .
doi: 10.7326/M15-0510
pubmed: 26121401
Archer J, Bower P, Gilbody S, Lovell K, Richards D, Gask L, et al. Collaborative care for depression and anxiety problems. Cochrane Database Syst Rev. 2012;10:CD006525.
pubmed: 23076925
Coventry PA, Hudson JL, Kontopantelis E, Archer J, Richards DA, Gilbody S, et al. Characteristics of effective collaborative care for treatment of depression: a systematic review and meta-regression of 74 randomised controlled trials. PloS One. 2014;9(9):e108114. https://doi.org/10.1371/journal.pone.0108114 .
doi: 10.1371/journal.pone.0108114
pubmed: 25264616
pmcid: 4180075
Reiter JT, Dobmeyer AC, Hunter CL. The Primary Care Behavioral Health (PCBH) model: an overview and operational definition. J Clin Psychol Med Settings. 2018;25(2):109–26. https://doi.org/10.1007/s10880-017-9531-x .
doi: 10.1007/s10880-017-9531-x
pubmed: 29480434
Kanapaux W. The road to integrated care: commitment is the key; Tennessee CMHC demonstrates promise of co-located behavioral and primary care. Behav Healthc Tomorrow. 2004;13:10–5.
pubmed: 15119120
Miller-Matero LR, Khan S, Thiem R, DeHondt T, Dubaybo H, Moore D. Integrated primary care: patient perceptions and the role of mental health stigma. Prim Health Care Res Dev. 2018;20:1–4.
Sandoval BE, Bell J, Khatri P, Robinson PJ. Toward a Unified integration approach: uniting diverse primary care strategies under the Primary Care Behavioral Health (PCBH) Model. J Clin Psychol Med Settings. 2018;25(2):187–96. https://doi.org/10.1007/s10880-017-9516-9 .
doi: 10.1007/s10880-017-9516-9
pubmed: 29234927
Richards DA, Hill JJ, Gask L, Lovell K, Chew-Graham C, Bower P, et al. Clinical effectiveness of collaborative care for depression in UK primary care (CADET): cluster randomised controlled trial. BMJ. 2013;347(aug19 1):f4913. https://doi.org/10.1136/bmj.f4913 .
doi: 10.1136/bmj.f4913
pubmed: 23959152
pmcid: 3746956
Gensichen J, von Korff M, Peitz M, Muth C, Beyer M, Güthlin C, et al. Case management for depression by health care assistants in small primary care practices. Ann Intern Med. 2009;151(6):369–80. https://doi.org/10.7326/0003-4819-151-6-200909150-00001 .
doi: 10.7326/0003-4819-151-6-200909150-00001
pubmed: 19755362
Schoen C, Osborn R, Doty MM, Squires D, Peugh J, Applebaum S. A survey of primary care physicians in eleven countries, 2009: Perspectives on care, costs, and experiences. Health Aff (Millwood). 2009;28:1171–83.
doi: 10.1377/hlthaff.28.6.w1171
Kringos DS, Boerma WGW, Hutchinson A, Saltman RB. Building primary care in a changing Europe case studies [Internet]. 2015 [cited 2020 May 31]. Available from: http://www.euro.who.int/en/about-us/partners/observatory/publications/studies/building-primary-care-in-a-changing-europe-case-studies
Fortney JC, Pyne JM, Turner EE, Farris KM, Normoyle TM, Avery MD, et al. Telepsychiatry integration of mental health services into rural primary care settings. Int Rev Psychiatry. 2015;27(6):525–39. https://doi.org/10.3109/09540261.2015.1085838 .
doi: 10.3109/09540261.2015.1085838
pubmed: 26634618
Hilty DM, Rabinowitz T, McCarron RM, Katzelnick DJ, Chang T, Bauer AM, et al. An update on telepsychiatry and how it can leverage collaborative, stepped, and integrated services to primary care. Psychosomatics. 2018;59(3):227–50. https://doi.org/10.1016/j.psym.2017.12.005 .
doi: 10.1016/j.psym.2017.12.005
pubmed: 29544663
Hilty DM, Yellowlees PM, Cobb HC, Bourgeois JA, Neufeld JD, Nesbitt TS. Models of telepsychiatric consultation--liaison service to rural primary care. Psychosomatics. 2006;47(2):152–7. https://doi.org/10.1176/appi.psy.47.2.152 .
doi: 10.1176/appi.psy.47.2.152
pubmed: 16508028
Ratzliff A, Sunderji N. Tele-behavioral health, collaborative care, and integrated care: learning to leverage scarce psychiatric resources over distance, populations, and time. Acad Psychiatry. 2018;42(6):834–40. https://doi.org/10.1007/s40596-018-0984-5 .
doi: 10.1007/s40596-018-0984-5
pubmed: 30338461
Hilty DM, Sunderji N, Suo S, Chan S, McCarron RM. Telepsychiatry and other technologies for integrated care: evidence base, best practice models and competencies. Int Rev Psychiatry. 2018;30(6):292–309. https://doi.org/10.1080/09540261.2019.1571483 .
doi: 10.1080/09540261.2019.1571483
pubmed: 30821540
Massoudi B, Holvast F, Bockting CLH, Burger H, Blanker MH. The effectiveness and cost-effectiveness of e-health interventions for depression and anxiety in primary care: a systematic review and meta-analysis. J Affect Disord. 2019;245:728–43. https://doi.org/10.1016/j.jad.2018.11.050 .
doi: 10.1016/j.jad.2018.11.050
pubmed: 30447572
Turvey C, Fortney J. The use of telemedicine and mobile technology to promote population health and population management for psychiatric disorders. Curr Psychiatry Rep. 2017;19(11):88. https://doi.org/10.1007/s11920-017-0844-0 .
doi: 10.1007/s11920-017-0844-0
pubmed: 29035422
Fortney JC, Pyne JM, Edlund MJ, Williams DK, Robinson DE, Mittal D, et al. A randomized trial of telemedicine-based collaborative care for depression. J Gen Intern Med. 2007;22(8):1086–93. https://doi.org/10.1007/s11606-007-0201-9 .
doi: 10.1007/s11606-007-0201-9
pubmed: 17492326
pmcid: 2305730
Fortney JC, Pyne JM, Kimbrell TA, Hudson TJ, Robinson DE, Schneider R, et al. Telemedicine-based collaborative care for posttraumatic stress disorder: a randomized clinical trial. JAMA Psychiatry. 2015;72(1):58–67. https://doi.org/10.1001/jamapsychiatry.2014.1575 .
doi: 10.1001/jamapsychiatry.2014.1575
pubmed: 25409287
Morriss R, Patel S, Malins S, Guo B, Higton F, James M, et al. Clinical and economic outcomes of remotely delivered cognitive behaviour therapy versus treatment as usual for repeat unscheduled care users with severe health anxiety: a multicentre randomised controlled trial. BMC Med. 2019;17(1):16. https://doi.org/10.1186/s12916-019-1253-5 .
doi: 10.1186/s12916-019-1253-5
pubmed: 30670044
pmcid: 6343350
Tönnies J, Hartmann M, Wensing M, Szecsenyi J, Icks A, Friederich H-C, et al. Mental health specialist video consultations for patients with depression or anxiety disorders in primary care: protocol for a randomised controlled feasibility trial. BMJ Open. 2019;9(9):e030003. https://doi.org/10.1136/bmjopen-2019-030003 .
doi: 10.1136/bmjopen-2019-030003
pubmed: 31488484
pmcid: 6731787
Tönnies J, Hartmann M, Wensing M, Szecsenyi J, Peters-Klimm F, Brinster R, Weber D, Vomhof M, Icks A, Friederich HC, Haun MW. Mental health specialist video consultations versus treatment-as-usual for patients with depression or anxiety disorders in primary care: randomized controlled feasibility trial. JMIR Ment Health. 2021;8(3):e22569. https://doi.org/10.2196/22569 .
Chan A-W, Tetzlaff JM, Gøtzsche PC, Altman DG, Mann H, Berlin JA, et al. SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials. BMJ. 2013;346(jan08 15):e7586. https://doi.org/10.1136/bmj.e7586 .
doi: 10.1136/bmj.e7586
pubmed: 23303884
pmcid: 3541470
Montgomery P, Grant S, Mayo-Wilson E, Macdonald G, Michie S, Hopewell S, et al. Reporting randomised trials of social and psychological interventions: the CONSORT-SPI 2018 Extension. Trials. 2018;19(1):407. https://doi.org/10.1186/s13063-018-2733-1 .
doi: 10.1186/s13063-018-2733-1
pubmed: 30060754
pmcid: 6066921
Cavelti M, Wirtz M, Corrigan P, Vauth R. Recovery assessment scale: examining the factor structure of the German version (RAS-G) in people with schizophrenia spectrum disorders. Eur Psychiatry. 2017;41(1):60–7. https://doi.org/10.1016/j.eurpsy.2016.10.006 .
doi: 10.1016/j.eurpsy.2016.10.006
pubmed: 28049083
Kroenke K, Baye F, Lourens SG. Comparative validity and responsiveness of PHQ-ADS and other composite anxiety-depression measures. J Affect Disord. 2019;246:437–43. https://doi.org/10.1016/j.jad.2018.12.098 .
doi: 10.1016/j.jad.2018.12.098
pubmed: 30599366
The Commonwealth Fund. International Health Care System Profiles: Germany. https://www.commonwealthfund.org/international-health-policy-center/countries/germany . Accessed 07 April 2021.
INVOLVE. Briefing notes for researchers: involving the public in NHS, public health and social care research. Eastleigh, UK: INVOLVE; 2012.
Kroenke K, Spitzer RL, Williams JB, Löwe B. The patient health questionnaire somatic, anxiety, and depressive symptom scales: a systematic review. Gen Hosp Psychiatry. 2010;32(4):345–59. https://doi.org/10.1016/j.genhosppsych.2010.03.006 .
doi: 10.1016/j.genhosppsych.2010.03.006
pubmed: 20633738
Bower P, Gask L. The changing nature of consultation-liaison in primary care: bridging the gap between research and practice. Gen Hosp Psychiatry. 2002;24(2):63–70. https://doi.org/10.1016/S0163-8343(01)00183-9 .
doi: 10.1016/S0163-8343(01)00183-9
pubmed: 11869739
Craske MG. Transdiagnostic treatment for anxiety and depression. Depress Anxiety. 2012;29(9):749–53. https://doi.org/10.1002/da.21992 .
doi: 10.1002/da.21992
pubmed: 22949272
Newby JM, McKinnon A, Kuyken W, Gilbody S, Dalgleish T. Systematic review and meta-analysis of transdiagnostic psychological treatments for anxiety and depressive disorders in adulthood. Clin Psychol Rev. 2015;40:91–110. https://doi.org/10.1016/j.cpr.2015.06.002 .
doi: 10.1016/j.cpr.2015.06.002
pubmed: 26094079
Zhang A, Franklin C, Jing S, Bornheimer LA, Hai AH, Himle JA, et al. The effectiveness of four empirically supported psychotherapies for primary care depression and anxiety: a systematic review and meta-analysis. J Affect Disord. 2019;245:1168–86. https://doi.org/10.1016/j.jad.2018.12.008 .
doi: 10.1016/j.jad.2018.12.008
pubmed: 30699860
Fonagy P. Achieving evidence-based psychotherapy practice: a psychodynamic perspective on the general acceptance of treatment manuals. Clin Psychol Sci Pract. 1999;6:442–4.
Carroll KM, Nuro KF. One size cannot fit all: a stage model for psychotherapy manual development. Clin Psychol Sci Pract. 2002;9:396–406.
doi: 10.1093/clipsy.9.4.396
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
Mark TL, Levit KR, Buck JA. Datapoints: psychotropic drug prescriptions by medical specialty. Psychiatr Serv. 2009;60(9):1167. https://doi.org/10.1176/ps.2009.60.9.1167 .
doi: 10.1176/ps.2009.60.9.1167
pubmed: 19723729
Marcus SC, Olfson M. National trends in the treatment for depression from 1998 to 2007. Arch Gen Psychiatry. 2010;67(12):1265–73. https://doi.org/10.1001/archgenpsychiatry.2010.151 .
doi: 10.1001/archgenpsychiatry.2010.151
pubmed: 21135326
Kilbourne AM, Neumann MS, Pincus HA, Bauer MS, Stall R. Implementing evidence-based interventions in health care: application of the replicating effective programs framework. Implement Sci. 2007;2(1):42. https://doi.org/10.1186/1748-5908-2-42 .
doi: 10.1186/1748-5908-2-42
pubmed: 18067681
pmcid: 2248206
Bellg AJ, Borrelli B, Resnick B, Hecht J, Minicucci DS, Ory M, et al. Enhancing treatment fidelity in health behavior change studies: best practices and recommendations from the NIH Behavior Change Consortium. Health Psychol. 2004;23(5):443–51. https://doi.org/10.1037/0278-6133.23.5.443 .
doi: 10.1037/0278-6133.23.5.443
pubmed: 15367063
Bower P, Gilbody S, Richards D, Fletcher J, Sutton A. Collaborative care for depression in primary care. Making sense of a complex intervention: systematic review and meta-regression. Br J Psychiatry. 2006;189(6):484–93. https://doi.org/10.1192/bjp.bp.106.023655 .
doi: 10.1192/bjp.bp.106.023655
pubmed: 17139031
Diener MJ, Hilsenroth MJ, Weinberger J. Therapist affect focus and patient outcomes in psychodynamic psychotherapy: a meta-analysis. Am J Psychiatry. 2007;164(6):936–41. https://doi.org/10.1176/ajp.2007.164.6.936 .
doi: 10.1176/ajp.2007.164.6.936
pubmed: 17541054
Allen JD, Shelton RC, Emmons KM, Linnan LA. Fidelity and its relationship to implementation effectiveness, adaptation, and dissemination. In: Brownson RC, Colditz GA, Proctor EK, editors. Dissem Implement Res Health - Transl Sci Pract. New York, NY: Oxford University Press; 2018. p. 267–84.
Kroenke K, Wu J, Yu Z, Bair MJ, Kean J, Stump T, et al. Patient health questionnaire anxiety and depression scale: initial validation in three clinical trials. Psychosom Med. 2016;78(6):716–27. https://doi.org/10.1097/PSY.0000000000000322 .
doi: 10.1097/PSY.0000000000000322
pubmed: 27187854
pmcid: 4927366
Chilcot J, Hudson JL, Moss-Morris R, Carroll A, Game D, Simpson A, et al. Screening for psychological distress using the Patient Health Questionnaire Anxiety and Depression Scale (Phq-ads): initial validation of structural validity in dialysis patients. Gen Hosp Psychiatry. 2018;50:15–9. https://doi.org/10.1016/j.genhosppsych.2017.09.007 .
doi: 10.1016/j.genhosppsych.2017.09.007
pubmed: 28985589
Vickers AJ, Altman DG. Statistics notes: analysing controlled trials with baseline and follow up measurements. BMJ. 2001;323(7321):1123–4. https://doi.org/10.1136/bmj.323.7321.1123 .
doi: 10.1136/bmj.323.7321.1123
pubmed: 11701584
pmcid: 1121605
Gunn J, Elliott P, Densley K, Middleton A, Ambresin G, Dowrick C, et al. A trajectory-based approach to understand the factors associated with persistent depressive symptoms in primary care. J Affect Disord. 2013;148(2-3):338–46. https://doi.org/10.1016/j.jad.2012.12.021 .
doi: 10.1016/j.jad.2012.12.021
pubmed: 23375580
Toussaint A, Murray AM, Voigt K, Herzog A, Gierk B, Kroenke K, et al. Development and validation of the somatic symptom disorder–B Criteria Scale (SSD-12). Psychosom Med. 2016;78(1):5–12. https://doi.org/10.1097/PSY.0000000000000240 .
doi: 10.1097/PSY.0000000000000240
pubmed: 26461855
Ware JE Jr, Kosinski M, Keller SD. A 12-Item Short-Form Health Survey: construction of scales and preliminary tests of reliability and validity. Med Care. 1996;34(3):220–33. https://doi.org/10.1097/00005650-199603000-00003 .
doi: 10.1097/00005650-199603000-00003
pubmed: 8628042
Greiner W, Claes C, Busschbach JJV, von der Schulenburg JMG. Validating the EQ-5D with time trade off for the German population. Eur J Health Econ. 2005;6(2):124–30. https://doi.org/10.1007/s10198-004-0264-z .
doi: 10.1007/s10198-004-0264-z
pubmed: 19787848
Goetz K, Freund T, Gensichen J, Miksch A, Szecsenyi J, Steinhaeuser J. Adaptation and psychometric properties of the PACIC short form. Am J Manag Care. 2012;18(2):e55–60.
pubmed: 22435885
Ladwig I, Rief W, Nestoriuc Y. Welche Risiken und Nebenwirkungen hat Psychotherapie?-Entwicklung des Inventars zur Erfassung Negativer Effekte von Psychotherapie (INEP). Verhaltenstherapie. 2014;24(4):252–63. https://doi.org/10.1159/000367928 .
doi: 10.1159/000367928
Grupp H, König H-H, Riedel-Heller S, Konnopka A. FIMPsy–Fragebogen zur Inanspruchnahme medizinischer und nicht medizinischer Versorgungsleistungen bei psychischen Erkrankungen: Entwicklung und Verwendung. Psychiatr Prax. 2018;45(2):87–94. https://doi.org/10.1055/s-0042-118033 .
doi: 10.1055/s-0042-118033
pubmed: 28125848
Salisbury C, O’Cathain A, Edwards L, Thomas C, Gaunt D, Hollinghurst S, et al. Effectiveness of an integrated telehealth service for patients with depression: a pragmatic randomised controlled trial of a complex intervention. Lancet Psychiatry. England. 2016;3(6):515–25. https://doi.org/10.1016/S2215-0366(16)00083-3 .
doi: 10.1016/S2215-0366(16)00083-3
Ioannidis JPA. Most psychotherapies do not really work, but those that might work should be assessed in biased studies. Epidemiol Psychiatr Sci. 2016;25(5):436–8. https://doi.org/10.1017/S2045796015000888 .
doi: 10.1017/S2045796015000888
pubmed: 26952766
pmcid: 7137590
Hüsing P, Bassler M, Löwe B, Koch S, Toussaint A. Validity and sensitivity to change of the somatic symptom disorder–B Criteria Scale (SSD-12) in a clinical population. Gen Hosp Psychiatry. 2018;55:20–6. https://doi.org/10.1016/j.genhosppsych.2018.08.006 .
doi: 10.1016/j.genhosppsych.2018.08.006
pubmed: 30232051
Ludwig K. Graf von der Schulenburg JM, Greiner W. German value set for the EQ-5D-5L. Pharmacoeconomics. 2018;36(6):663–74. https://doi.org/10.1007/s40273-018-0615-8 .
doi: 10.1007/s40273-018-0615-8
pubmed: 29460066
pmcid: 5954069
Chernyak N, Ernsting C, Icks A. Pre-test of questions on health-related resource use and expenditure, using behaviour coding and cognitive interviewing techniques. BMC Health Serv Res. 2012;12(1):303. https://doi.org/10.1186/1472-6963-12-303 .
doi: 10.1186/1472-6963-12-303
pubmed: 22950744
pmcid: 3470966
Moore GF, Audrey S, Barker M, Bond L, Bonell C, Hardeman W, et al. Process evaluation of complex interventions: Medical Research Council guidance. BMJ. 2015;350(mar19 6):h1258. https://doi.org/10.1136/bmj.h1258 .
doi: 10.1136/bmj.h1258
pubmed: 25791983
pmcid: 4366184
Atkins S, Odendaal W, Leon N, Lutge E, Lewin S. Qualitative process evaluation for complex interventions. In: Richards DA, Hallberg IR, editors. Complex Interv Health. New York, NY: Routledge; 2015. p. 239–47.
Vis C, Ruwaard J, Finch T, Rapley T, de Beurs D, van Stel H, et al. Toward an objective assessment of implementation processes for innovations in health care: psychometric evaluation of the normalization measure development (Nomad) questionnaire among mental health care professionals. J Med Internet Res. 2019;21(2):e12376. https://doi.org/10.2196/12376 .
doi: 10.2196/12376
pubmed: 30785402
pmcid: 6401675
Koller M. robustlmm: an r package for robust estimation of linear mixed-effects models. J Stat Softw. 2016;75:1–24.
Lakens D. Calculating and reporting effect sizes to facilitate cumulative science: a practical primer for t-tests and ANOVAs. Front Psychol. 2013;4. https://doi.org/10.3389/fpsyg.2013.00863 .
R Core Team. R: a language and environment for statistical computing [Internet]. Vienna, Austria: R Foundation for Statistical Computing; 2020. Available from: https://www.R-project.org/
van Buuren S. Multiple imputation of discrete and continuous data by fully conditional specification. Stat Methods Med Res. 2007;16(3):219–42. https://doi.org/10.1177/0962280206074463 .
doi: 10.1177/0962280206074463
pubmed: 17621469
Drummond MF. In: Drummond MF, editor. Methods for the economic evaluation of health care programmes. 3. ed., reprint. Oxford: Oxford University Press; 2007.
Gold MR, editor. Cost-effectiveness in health and medicine. New York: Oxford University Press; 1996.
Hunink MGM, Bult JR, De Vries J, Weinstein MC. Uncertainty in decision models analyzing cost-effectiveness: the joint distribution of incremental costs and effectiveness evaluated with a nonparametric bootstrap method. Med Decis Making. 1998;18(3):337–46. https://doi.org/10.1177/0272989X9801800312 .
doi: 10.1177/0272989X9801800312
pubmed: 9679999
Briggs AH, Wonderling DE, Mooney CZ. Pulling cost-effectiveness analysis up by its bootstraps: a non-parametric approach to confidence interval estimation. Health Econ. 1997;6(4):327–40. https://doi.org/10.1002/(SICI)1099-1050(199707)6:4<327::AID-HEC282>3.0.CO;2-W .
doi: 10.1002/(SICI)1099-1050(199707)6:4<327::AID-HEC282>3.0.CO;2-W
Black WC. The CE plane: a graphic representation of cost-effectiveness. Med Decis Making. 1990;10(3):212–4. https://doi.org/10.1177/0272989X9001000308 .
doi: 10.1177/0272989X9001000308
pubmed: 2115096
Fenwick E, O’Brien BJ, Briggs A. Cost-effectiveness acceptability curves– facts, fallacies and frequently asked questions. Health Econ. 2004;13(5):405–15. https://doi.org/10.1002/hec.903 .
doi: 10.1002/hec.903
pubmed: 15127421
Fenwick E, Claxton K, Sculpher M. Representing uncertainty: the role of cost-effectiveness acceptability curves. Health Econ. 2001;10(8):779–87. https://doi.org/10.1002/hec.635 .
doi: 10.1002/hec.635
pubmed: 11747057
Van Hout BA, Al MJ, Gordon GS, Rutten FFH. Costs, effects and C/E-ratios alongside a clinical trial. Health Econ. 1994;3(5):309–19. https://doi.org/10.1002/hec.4730030505 .
doi: 10.1002/hec.4730030505
pubmed: 7827647
Ioannidis JPA. Better reporting of harms in randomized trials: an extension of the consort statement. Ann Intern Med. 2004;141(10):781–8. https://doi.org/10.7326/0003-4819-141-10-200411160-00009 .
doi: 10.7326/0003-4819-141-10-200411160-00009
pubmed: 15545678
Jacobsen P, Wood L. Risk of contamination when planning psychological therapy trials can be assessed using a simple framework. J Clin Epidemiol. 2020;124:8–15. https://doi.org/10.1016/j.jclinepi.2020.04.005 .
doi: 10.1016/j.jclinepi.2020.04.005
pubmed: 32289353
Watson M, Kendrick D, Woods A, Dewey M. Measuring contamination in an injury prevention randomized controlled trial. Int J Inj Contr Saf Promot. 2005;12(3):197–9. https://doi.org/10.1080/17457300500088949 .
doi: 10.1080/17457300500088949
pubmed: 16335439
Torgerson DJ. Contamination in trials: is cluster randomisation the answer? BMJ. 2001;322(7282):355–7. https://doi.org/10.1136/bmj.322.7282.355 .
doi: 10.1136/bmj.322.7282.355
pubmed: 11159665
pmcid: 1119583
Sheikh A, Smeeth L, Ashcroft R. Randomised controlled trials in primary care: scope and application. Br J Gen Pract. 2002;52(482):746–51.
pubmed: 12236280
pmcid: 1314417
Gilbody S, Bower P, Torgerson D, Richards D. Cluster randomized trials produced similar results to individually randomized trials in a meta-analysis of enhanced care for depression. J Clin Epidemiol. 2008;61(2):160–8. https://doi.org/10.1016/j.jclinepi.2007.04.015 .
doi: 10.1016/j.jclinepi.2007.04.015
pubmed: 18177789
Taljaard M, Weijer C, Grimshaw J. Ethical issues in cluster-randomized trials in knowledge translation. In: Straus SE, Tetroe J, Graham ID, editors. Knowledge Translation in Health Care. Chichester, UK: John Wiley & Sons; 2013. p. 378–91. https://doi.org/10.1002/9781118413555.ch34 .
doi: 10.1002/9781118413555.ch34
Edwards L, Salisbury C, Horspool K, Foster A, Garner K, Montgomery AA. Increasing follow-up questionnaire response rates in a randomized controlled trial of telehealth for depression: three embedded controlled studies. Trials. 2016;17(1):107. https://doi.org/10.1186/s13063-016-1234-3 .
doi: 10.1186/s13063-016-1234-3
pubmed: 26912230
pmcid: 4765058