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Open Access 01-12-2021 | Insomnia | Study protocol

Efficacy and cost-effectiveness of a Transdiagnostic group-based exercise intervention: study protocol for a pragmatic multi-site randomized controlled trial

Authors: Sebastian Wolf, Britta Seiffer, Johanna-Marie Zeibig, Jana Welkerling, Leonie Louisa Bauer, Anna Katharina Frei, Thomas Studnitz, Stephanie Rosenstiel, David Victor Fiedler, Florian Helmhold, Andreas Ray, Eva Herzog, Keisuke Takano, Tristan Nakagawa, Saskia Kropp, Sebastian Franke, Stefan Peters, Nadja El-Kurd, Lena Zwanzleitner, Leonie Sundmacher, Ander Ramos-Murguialday, Martin Hautzinger, Gorden Sudeck, Thomas Ehring

Published in: BMC Psychiatry | Issue 1/2021

Abstract

Background

Mental disorders are prevalent and cause considerable burden of disease. Exercise has been shown to be efficacious to treat major depressive disorders, insomnia, panic disorder with and without agoraphobia and post traumatic stress disorder (PTSD).

Methods

This pragmatic, two arm, multi-site randomised controlled trial will evaluate the efficacy and cost-effectiveness of the manualized, group-based six-months exercise intervention “ImPuls”, among physically inactive patients with major depressive disorders, insomnia, panic disorder, agoraphobia and PTSD within a naturalistic outpatient context in Germany. A minimum of 375 eligible outpatients from 10 different study sites will be block-randomized to either ImPuls in addition to treatment as usual (TAU) or TAU only. ImPuls will be conducted by trained exercise therapists and delivered in groups of six patients. The program will combine (a) moderate to vigorous aerobic exercise carried out two-three times a week for at least 30 min with (b) behavior change techniques for sustained exercise behavior change. All outcomes will be assessed pre-treatment, post-treatment (six months after randomization) and at follow-up (12 months after randomization). Primary outcome will be self-reported global symptom severity assessed with the Brief Symptom Inventory (BSI-18). Secondary outcomes will be accelerometry-based moderate to vigorous physical activity, self-reported exercise, disorder-specific symptoms, quality-adjusted life years (QALY) and healthcare costs. Intention-to-treat analyses will be conducted using mixed models. Cost-effectiveness and cost-utility analysis will be conducted using incremental cost-effectiveness and cost-utility ratios.

Discussion

Despite its promising therapeutic effects, exercise programs are currently not provided within the outpatient mental health care system in Germany. This trial will inform service providers and policy makers about the efficacy and cost-effectiveness of the group-based exercise intervention ImPuls within a naturalistic outpatient health care setting. Group-based exercise interventions might provide an option to close the treatment gap within outpatient mental health care settings.

Trial registration

The study was registered in the German Clinical Trials Register (ID: DRKS00024152, 05/02/2021).

Available only for authorised users

Global Burden of Disease Collaborative Network. Global Burden of Disease Study 2019 (GBD 2019) Results [http://ghdx.healthdata.org/gbd-results-tool. Accessed 09 August 2021].

Boehm K. Gesundheit [Health]. In: Data Report 2021 [Datenreport 2021]. Germany: Destatis [Statistisches Bundesamt]; 2021. p. 325–45.

Hajak G. Epidemiology of severe insomnia and its consequences in Germany. Eur Arch Psychiatry Clin Neurosci. 2001;251(2):49–56. https://doi.org/10.1007/s004060170052.CrossRefPubMed

Kessler RC, Chiu WT, Demler O, Merikangas KR, Walters EE. Prevalence, severity, and comorbidity of 12-month DSM-IV disorders in the National Comorbidity Survey Replication. Arch Gen Psychiatry. 2005;62(6):617–27. https://doi.org/10.1001/archpsyc.62.6.617.CrossRefPubMedPubMedCentral

Kendler KS, Karkowski LM, Prescott CA. Causal relationship between stressful life events and the onset of major depression. Am J Psychiatry. 1999;156(6):837–41. https://doi.org/10.1176/ajp.156.6.837.CrossRefPubMed

Moreno-Peral P, Conejo-Ceron S, Motrico E, Rodriguez-Morejon A, Fernandez A, Garcia-Campayo J, et al. Risk factors for the onset of panic and generalised anxiety disorders in the general adult population: a systematic review of cohort studies. J Affect Disord. 2014;168:337–48. https://doi.org/10.1016/j.jad.2014.06.021.CrossRefPubMed

Hall M, Thayer JF, Germain A, Moul D, Vasko R, Puhl M, et al. Psychological stress is associated with heightened physiological arousal during NREM sleep in primary insomnia. Behav Sleep Med. 2007;5(3):178–93. https://doi.org/10.1080/15402000701263221.CrossRefPubMed

Maciejewski PK, Prigerson HG, Mazure CM. Self-efficacy as a mediator between stressful life events and depressive symptoms. Differences based on history of prior depression. Br J Psychiatry. 2000;176(4):373–8. https://doi.org/10.1192/bjp.176.4.373.CrossRefPubMed

Iancu I, Bodner E, Ben-Zion IZ. Self esteem, dependency, self-efficacy and self-criticism in social anxiety disorder. Compr Psychiatry. 2015;58:165–71. https://doi.org/10.1016/j.comppsych.2014.11.018.CrossRefPubMed

10.

Harvey AG. A cognitive model of insomnia. Behav Res Ther. 2002;40(8):869–93. https://doi.org/10.1016/s0005-7967(01)00061-4.CrossRefPubMed

11.

Naragon-Gainey K. Meta-analysis of the relations of anxiety sensitivity to the depressive and anxiety disorders. Psychol Bull. 2010;136(1):128–50. https://doi.org/10.1037/a0018055.CrossRefPubMed

12.

Coles ME, Schubert JR, Nota JA. Sleep, circadian rhythms, and anxious traits. Curr Psychiatry Rep. 2015;17(9):73. https://doi.org/10.1007/s11920-015-0613-x.CrossRefPubMed

13.

Olatunji BO, Wolitzky-Taylor KB. Anxiety sensitivity and the anxiety disorders: a meta-analytic review and synthesis. Psychol Bull. 2009;135(6):974–99. https://doi.org/10.1037/a0017428.CrossRefPubMed

14.

Wahl K, Ehring T, Kley H, Lieb R, Meyer A, Kordon A, et al. Is repetitive negative thinking a transdiagnostic process? A comparison of key processes of RNT in depression, generalized anxiety disorder, obsessive-compulsive disorder, and community controls. J Behav Ther Exp Psychiatry. 2019;64:45–53. https://doi.org/10.1016/j.jbtep.2019.02.006.CrossRefPubMed

15.

Rehm J, Shield KD. Global burden of disease and the impact of mental and addictive disorders. Curr Psychiatry Rep. 2019;21(2):10. https://doi.org/10.1007/s11920-019-0997-0.CrossRefPubMed

16.

Destatis [Statistisches Bundesamt]. Health Costs [Gesundheistkosten] [https://www.destatis.de/DE/Themen/Gesellschaft-Umwelt/Gesundheit/Krankheitskosten/Tabellen/krankheitsklassen-alter.html;jsessionid=7FF730CB0621F34573C01BA9DF4766BC.live731. ] Accessed 09 August 2021.

17.

De Hert M, Detraux J, Vancampfort D. The intriguing relationship between coronary heart disease and mental disorders. Dialogues Clin Neurosci. 2018;20(1):31–40. https://doi.org/10.31887/DCNS.2018.20.1/mdehert.CrossRefPubMedPubMedCentral

18.

Federal Institute for Occupational Safety and Health [Bundesanstalt für Arbeitsschutz und Arbeitsmedizin (BAuA)]. Economic costs due to Incapacity to work 2019 [Volkswirtschaftliche Kosten durch Arbeitsunfähigkeit 2019] [https://www.baua.de/DE/Themen/Arbeitswelt-und-Arbeitsschutz-im-Wandel/Arbeitsweltberichterstattung/Kosten-der-AU/pdf/Kosten-2019.pdf?__blob=publicationFile&v=3. ] Accessed 08 August 2021.

19.

Rabe-Menssen C, Dazer A, Maaß E. Report Psychotherapy [Report Psychotherapie 2021]. 2nd ed. Berlin: German Psychotherapists Association [Deutsche Psychotherapeuten Vereinigung (DPtV)]; 2021.

20.

Nübling R, T B, Jeschke K, M O, Sarubin N, Juergen S. Care of Mentally ill Adults in Germany - need and utilization as well as effectiveness and efficiency of psychotherapy [Versorgung psychisch kranker Erwachsener in Deutschland - Bedarf und Inanspruchnahme sowie Effektivität und Effizienz von Psychotherapie]. Psychotherapeutenjournal. 2014;13:389–97.

21.

Federal Chamber of Psychotherapists [Bundespsychotherapeutenkammer (BPtK)]. Months of waiting time for psychotherapy [BPtK-Auswertung: Monatelange Wartezeiten bei Psychotherapeut*innen] [https://www.bptk.de/wp-content/uploads/2021/03/20210329_pm_bptk_monatelange-Wartezeiten.pdf. ] Accessed 08 August 2021.

22.

Federal Chamber of Psychotherapists [Bundespsychotherapeutenkammer (BPtK)]. One year after the reform of the psychotherapy guidelines in GErmany [Ein Jahr nach der Reform der Psychotherapie-Richtlinie] [https://www.bptk.de/wp-content/uploads/2019/01/20180411_bptk_studie_wartezeiten_2018.pdf] Accessed 08 August 2021.

23.

Patel V. Global mental health: from science to action. Harv Rev Psychiatry. 2012;20(1):6–12. https://doi.org/10.3109/10673229.2012.649108.CrossRefPubMedPubMedCentral

24.

Caspersen CJ, Powell KE, Christenson GM. Physical activity, exercise, and physical fitness: definitions and distinctions for health-related research. Public Health Rep. 1985;100(2):126–31.PubMedPubMedCentral

25.

Ashdown-Franks G, Firth J, Carney R, Carvalho AF, Hallgren M, Koyanagi A, et al. Exercise as medicine for mental and substance use disorders: a Meta-review of the benefits for neuropsychiatric and cognitive outcomes. Sports Med. 2020;50(1):151–70. https://doi.org/10.1007/s40279-019-01187-6.CrossRefPubMed

26.

Morres ID, Hatzigeorgiadis A, Stathi A, Comoutos N, Arpin-Cribbie C, Krommidas C, et al. Aerobic exercise for adult patients with major depressive disorder in mental health services: a systematic review and meta-analysis. Depress Anxiety. 2018;36(1):39–53. https://doi.org/10.1002/da.22842.CrossRefPubMed

27.

Banno M, Harada Y, Taniguchi M, Tobita R, Tsujimoto H, Tsujimoto Y, et al. Exercise can improve sleep quality: a systematic review and meta-analysis. PeerJ. 2018;6:e5172. https://doi.org/10.7717/peerj.5172.CrossRefPubMedPubMedCentral

28.

Rosenbaum S, Vancampfort D, Steel Z, Newby J, Ward PB, Stubbs B. Physical activity in the treatment of post-traumatic stress disorder: a systematic review and meta-analysis. Psychiatry Res. 2015;230(2):130–6. https://doi.org/10.1016/j.psychres.2015.10.017.CrossRefPubMed

29.

Goldstein LA, Mehling WE, Metzler TJ, Cohen BE, Barnes DE, Choucroun GJ, et al. Veterans group exercise: a randomized pilot trial of an integrative exercise program for veterans with posttraumatic stress. J Affect Disord. 2018;227:345–52. https://doi.org/10.1016/j.jad.2017.11.002.CrossRefPubMed

30.

Powers MB, Medina JL, Burns S, Kauffman BY, Monfils M, Asmundson GJ, et al. Exercise augmentation of exposure therapy for PTSD: rationale and pilot efficacy data. Cogn Behav Ther. 2015;44(4):314–27. https://doi.org/10.1080/16506073.2015.1012740.CrossRefPubMedPubMedCentral

31.

Broocks A, Bandelow B, Pekrun G, George A, Meyer T, Bartmann U, et al. Comparison of aerobic exercise, clomipramine, and placebo in the treatment of panic disorder. Am J Psychiatry. 1998;155(5):603–9. https://doi.org/10.1176/ajp.155.5.603.CrossRefPubMed

32.

Esquivel G, Diaz-Galvis J, Schruers K, Berlanga C, Lara-Munoz C, Griez E. Acute exercise reduces the effects of a 35% CO2 challenge in patients with panic disorder. J Affect Disord. 2008;107(1–3):217–20. https://doi.org/10.1016/j.jad.2007.07.022.CrossRefPubMed

33.

Gaudlitz K, Plag J, Dimeo F, Strohle A. Aerobic exercise training facilitates the effectiveness of cognitive behavioral therapy in panic disorder. Depress Anxiety. 2015;32(3):221–8. https://doi.org/10.1002/da.22337.CrossRefPubMed

34.

Legrand FD, Neff EM. Efficacy of exercise as an adjunct treatment for clinically depressed inpatients during the initial stages of antidepressant pharmacotherapy: an open randomized controlled trial. J Affect Disord. 2016;191:139–44. https://doi.org/10.1016/j.jad.2015.11.047.CrossRefPubMed

35.

Aylett E, Small N, Bower P. Exercise in the treatment of clinical anxiety in general practice - a systematic review and meta-analysis. BMC Health Serv Res. 2018;18(1):559. https://doi.org/10.1186/s12913-018-3313-5.CrossRefPubMedPubMedCentral

36.

Jacquart J, Dutcher CD, Freeman SZ, Stein AT, Dinh M, Carl E, et al. The effects of exercise on transdiagnostic treatment targets: a meta-analytic review. Behav Res Ther. 2019;115:19–37. https://doi.org/10.1016/j.brat.2018.11.007.CrossRefPubMed

37.

Morres ID, Hatzigeorgiadis A, Stathi A, Comoutos N, Arpin-Cribbie C, Krommidas C, et al. Aerobic exercise for adult patients with major depressive disorder in mental health services: a systematic review and meta-analysis. Depress Anxiety. 2019;36(1):39–53. https://doi.org/10.1002/da.22842.CrossRefPubMed

38.

Stubbs B, Vancampfort D, Hallgren M, Firth J, Veronese N, Solmi M, et al. EPA guidance on physical activity as a treatment for severe mental illness: a meta-review of the evidence and position statement from the European psychiatric association (EPA), supported by the International Organization of Physical Therapists in mental health (IOPTMH). Eur Psychiatry. 2018;54:124–44. https://doi.org/10.1016/j.eurpsy.2018.07.004.CrossRefPubMed

39.

Naci H, Ioannidis JP. Comparative effectiveness of exercise and drug interventions on mortality outcomes: metaepidemiological study. Br J Sports Med. 2015;49(21):1414–22. https://doi.org/10.1136/bjsports-2015-f5577rep.CrossRefPubMed

40.

Fiuza-Luces C, Garatachea N, Berger N, Lucia A. Exercise is the real polypill. Physiology. 2013;28(5):330–58. https://doi.org/10.1152/physiol.00019.2013.CrossRefPubMed

41.

Schuch F, Vancampfort D, Firth J, Rosenbaum S, Ward P, Reichert T, et al. Physical activity and sedentary behavior in people with major depressive disorder: a systematic review and meta-analysis. J Affect Disord. 2017;210:139–50. https://doi.org/10.1016/j.jad.2016.10.050.CrossRefPubMed

42.

Kramer LV, Helmes AW, Seelig H, Fuchs R, Bengel J. Correlates of reduced exercise behaviour in depression: the role of motivational and volitional deficits. Psychol Health. 2014;29(10):1206–25. https://doi.org/10.1080/08870446.2014.918978.CrossRefPubMed

43.

Fuchs R, Seelig H, Gohner W, Burton NW, Brown WJ. Cognitive mediation of intervention effects on physical exercise: causal models for the adoption and maintenance stage. Psychol Health. 2012;27(12):1480–99. https://doi.org/10.1080/08870446.2012.695020.CrossRefPubMed

44.

Zhang CQ, Zhang R, Schwarzer R, Hagger MS. A meta-analysis of the health action process approach. Health Psychol. 2019;38(7):623–37. https://doi.org/10.1037/hea0000728.CrossRefPubMed

45.

Abraham C, Kelly MP, West R, Michie S. The UK National Institute for health and clinical excellence public health guidance on behaviour change: a brief introduction. Psychol Health Med. 2009;14(1):1–8. https://doi.org/10.1080/13548500802537903.CrossRefPubMed

46.

Michie S, Ashford S, Sniehotta FF, Dombrowski SU, Bishop A, French DP. A refined taxonomy of behaviour change techniques to help people change their physical activity and healthy eating behaviours: the CALO-RE taxonomy. Psychol Health. 2011;26(11):1479–98. https://doi.org/10.1080/08870446.2010.540664.CrossRefPubMed

47.

Wolf S, Zeibig J-M, Hautzinger M, Sudeck G. Psychische Gesundheit durch Bewegung. ImPuls: Ein sport- und bewegungstherapeutisches Programm für Menschen mit psychischen Erkrankungen. Weinheim: Julius Beltz GmbH & Co. KG; 2020.

48.

Zeibig J-M, Seiffer B-A, Sudeck G, Rösel I, Hautzinger M, Wolf S. Transdiagnostic efficacy of a group exercise intervention for outpatients with Heterogenous psychiatric disorders: a randomized controlled trial. BMC Psychiatry. 2021;21(1):313. https://doi.org/10.1186/s12888-021-03307-x.CrossRefPubMedPubMedCentral

49.

Hoffmann T, Glasziou P, Boutron I, Milne R, Perera R, Moher D, et al. Die TIDieR Checkliste und Anleitung – ein Instrument für eine verbesserte Interventionsbeschreibung und Replikation, vol. 78; 2016.

50.

Slade SC, Dionne CE, Underwood M, Buchbinder R. Consensus on exercise reporting template (CERT): explanation and elaboration statement. Br J Sports Med. 2016;50(23):1428–37. https://doi.org/10.1136/bjsports-2016-096651.CrossRefPubMed

51.

Thomas S, Reading J, Shephard RJ. Revision of the physical activity readiness questionnaire (PAR-Q). Can J Sport Sci. 1992;17(4):338–45.PubMed

52.

Beesdo-Baum K, Zaudig M, Wittchen H-U, SCID-5-CV. Strukturiertes Klinisches Interview für DSM-5®-Störungen – Klinische Version Deutsche Bearbeitung des Structured Clinical Interview for DSM-5® Disorders – Clinician Version von Michael B. First, Janet B.W. Williams, Rhonda S. Karg, Robert L. Spitzer. Göttingen: Hogrefe; 2019.

53.

Harris PA, Taylor R, Thielke R, Payne J, Gonzalez N, Conde JG. Research electronic data capture (REDCap)--a metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed Inform. 2009;42(2):377–81. https://doi.org/10.1016/j.jbi.2008.08.010.CrossRefPubMed

54.

Harris PA, Taylor R, Minor BL, Elliott V, Fernandez M, O'Neal L, et al. The REDCap consortium: Building an international community of software platform partners. J Biomed Inform. 2019;95:103208. https://doi.org/10.1016/j.jbi.2019.103208.CrossRefPubMedPubMedCentral

55.

Faul F, Erdfelder E, Buchner A, Lang A-G. Statistical power analyses using G*power 3.1: tests for correlation and regression analyses. Behav Res Methods. 2009;41(4):1149–60. https://doi.org/10.3758/BRM.41.4.1149.CrossRefPubMed

56.

Faul F, Erdfelder E, Lang A-G, AJBRM B. G*Power 3: A flexible statistical power analysis program for the social, behavioral, and biomedical sciences. 2007;39(2):175–91. https://doi.org/10.3758/bf03193146.

57.

Craig P, Dieppe P, Macintyre S, Michie S, Nazareth I, Petticrew M. Developing and evaluating complex interventions: the new Medical Research Council guidance. Int J Nurs Stud. 2013;50(5):587–92. https://doi.org/10.1016/j.ijnurstu.2012.09.010.CrossRefPubMed

58.

Derogatis LR, Fitzpatrick M. The SCL-90-R, the Brief Symptom Inventory (BSI), and the BSI-18. In: The use of psychological testing for treatment planning and outcomes assessment: Instruments for adults, vol. 3. 3rd ed. Mahwah: Lawrence Erlbaum Associates Publishers; 2004. p. 1–41.

59.

Zabora J, BrintzenhofeSzoc K, Jacobsen P, Curbow B, Piantadosi S, Hooker C, et al. A new psychosocial screening instrument for use with cancer patients. Psychosomatics. 2001;42(3):241–6. https://doi.org/10.1176/appi.psy.42.3.241.CrossRefPubMed

60.

Spitzer C, Hammer S, Lowe B, Grabe HJ, Barnow S, Rose M, et al. Franke GH: [the short version of the brief symptom inventory (BSI −18): preliminary psychometric properties of the German translation]. Fortschr Neurol Psychiatr. 2011;79(9):517–23. https://doi.org/10.1055/s-0031-1281602.CrossRefPubMed

61.

Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001;16(9):606–13. https://doi.org/10.1046/j.1525-1497.2001.016009606.x.CrossRefPubMedPubMedCentral

62.

Spitzer RL, Kroenke K, Williams JB. Validation and utility of a self-report version of PRIME-MD: the PHQ primary care study. Primary care evaluation of mental disorders. Patient health questionnaire. JAMA. 1999;282(18):1737–44. https://doi.org/10.1001/jama.282.18.1737.CrossRefPubMed

63.

Kroenke K, Spitzer RL, Williams JB, Lowe 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.CrossRefPubMed

64.

Levis B, Benedetti A, Thombs BD. Accuracy of patient health Questionnaire-9 (PHQ-9) for screening to detect major depression: individual participant data meta-analysis. BMJ. 2019;365:l1476. https://doi.org/10.1136/bmj.l1476.CrossRefPubMedPubMedCentral

65.

Kocalevent RD, Hinz A, Brahler E. Standardization of the depression screener patient health questionnaire (PHQ-9) in the general population. Gen Hosp Psychiatry. 2013;35(5):551–5. https://doi.org/10.1016/j.genhosppsych.2013.04.006.CrossRefPubMed

66.

Dieck A, Morin CM, Backhaus J. A German version of the insomnia severity index. Somnologie. 2018;22(1):27–35. https://doi.org/10.1007/s11818-017-0147-z.CrossRef

67.

Morin CM. Insomnia: psychological assessment and management. New York: Guilford Press; 1993.

68.

Buysse DJ, Reynolds CF 3rd, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh sleep quality index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989;28(2):193–213. https://doi.org/10.1016/0165-1781(89)90047-4.CrossRefPubMed

69.

Backhaus J, Junghanns K, Broocks A, Riemann D, Hohagen F. Test-retest reliability and validity of the Pittsburgh sleep quality index in primary insomnia. J Psychosom Res. 2002;53(3):737–40. https://doi.org/10.1016/s0022-3999(02)00330-6.CrossRefPubMed

70.

Lowe B, Decker O, Muller S, Brahler E, Schellberg D, Herzog W, et al. Validation and standardization of the generalized anxiety disorder screener (GAD-7) in the general population. Med Care. 2008;46(3):266–74. https://doi.org/10.1097/MLR.0b013e318160d093.CrossRefPubMed

71.

Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006;166(10):1092–7. https://doi.org/10.1001/archinte.166.10.1092.CrossRefPubMed

72.

Kroenke K, Spitzer RL, Williams JB, Monahan PO, Lowe B. Anxiety disorders in primary care: prevalence, impairment, comorbidity, and detection. Ann Intern Med. 2007;146(5):317–25. https://doi.org/10.7326/0003-4819-146-5-200703060-00004.CrossRefPubMed

73.

Plummer F, Manea L, Trepel D, McMillan D. Screening for anxiety disorders with the GAD-7 and GAD-2: a systematic review and diagnostic metaanalysis. Gen Hosp Psychiatry. 2016;39:24–31. https://doi.org/10.1016/j.genhosppsych.2015.11.005.CrossRefPubMed

74.

Hinz A, Klein AM, Brahler E, Glaesmer H, Luck T, Riedel-Heller SG, et al. Psychometric evaluation of the generalized anxiety disorder screener GAD-7, based on a large German general population sample. J Affect Disord. 2017;210:338–44. https://doi.org/10.1016/j.jad.2016.12.012.CrossRefPubMed

75.

von Brachel R, Bieda A, Margraf J, Hirschfeld G. Longitudinal measurement invariance of the brief symptom inventory (BSI)-18 in psychotherapy patients. Eur J Psychol Assess. 2020;36(1):12–8. https://doi.org/10.1027/1015-5759/a000480.CrossRef

76.

Andreu Y, Galdon MJ, Dura E, Ferrando M, Murgui S, Garcia A, et al. Psychometric properties of the brief symptoms Inventory-18 (Bsi-18) in a Spanish sample of outpatients with psychiatric disorders. Psicothema. 2008;20(4):844–50.PubMed

77.

Kruger-Gottschalk A, Knaevelsrud C, Rau H, Dyer A, Schafer I, Schellong J, et al. The German version of the posttraumatic stress disorder checklist for DSM-5 (PCL-5): psychometric properties and diagnostic utility. BMC Psychiatry. 2017;17(1):379. https://doi.org/10.1186/s12888-017-1541-6.CrossRefPubMedPubMedCentral

78.

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.CrossRefPubMedPubMedCentral

79.

Hinz A, Kohlmann T, Stobel-Richter Y, Zenger M, Brahler E. The quality of life questionnaire EQ-5D-5L: psychometric properties and normative values for the general German population. Qual Life Res. 2014;23(2):443–7. https://doi.org/10.1007/s11136-013-0498-2.CrossRefPubMed

80.

Bilbao A, Martin-Fernandez J, Garcia-Perez L, Mendezona JI, Arrasate M, Candela R, et al. Psychometric properties of the EQ-5D-5L in patients with major depression: factor analysis and Rasch analysis. J Ment Health. 2021:1–11. https://doi.org/10.1080/09638237.2021.1875422.

81.

Fuchs R, Klaperski S, Gerber M, Seelig H. Messung der Bewegungs- und Sportaktivität mit dem BSA-Fragebogen. Zeitschrift für Gesundheitspsychologie. 2015;23(2):60–76. https://doi.org/10.1026/0943-8149/a000137.CrossRef

82.

Anastasopoulou P, Tansella M, Stumpp J, Shammas L, Hey S. Classification of human physical activity and energy expenditure estimation by accelerometry and barometry. Annu Int Conf IEEE Eng Med Biol Soc. 2012;2012:6451–4. https://doi.org/10.1109/EMBC.2012.6347471.CrossRefPubMed

83.

Schulte D. Messung der Therapieerwartung und Therapieevaluation von Patienten (PATHEV). Z Klin Psychol Psychother. 2005;34(3):176–87. https://doi.org/10.1026/1616-3443.34.3.176.CrossRef

84.

Schulz H, Nübling R, Rüddel H. Entwicklung einer Kurzform eines Fragebogens zur Psychotherapiemotivation. Verhaltenstherapie. 1995;5(2):89–95. https://doi.org/10.1159/000258901.CrossRef

85.

Oei TPS, Green AL. The satisfaction with therapy and therapist scale--revised (STTS-R) for group psychotherapy: psychometric properties and confirmatory factor analysis. Prof Psychol Res Pract. 2008;39(4):435–42. https://doi.org/10.1037/0735-7028.39.4.435.CrossRef

86.

Steinmayr R, Spinath B. Construction and first validation of a scale for the assessment of subjective school values (SESSW) [Konstruktion und erste Validierung einer Skala zur Erfassung subjektiver schulischer Werte (SESSW)]. Diagnostica. 2010;56(4):195–211. https://doi.org/10.1026/0012-1924/a000023.CrossRef

87.

Peters MAJ, Harmsen M, Laurant MGH, Wensing M. Barriers and facilitators assessment instrument. In: Radboud. Nijmegen: Centre for Quality of Care Research (WOK); 2002.

88.

Wolf S, Zeibig J-M, Hautzinger M, Sudeck G. Mental Health Through Exercise. ImPuls: an Exercise Intervention for Individuals with Psychiatric Disorders [Psychische Gesundheit durch Bewegung. ImPuls: Ein sport- und bewegungstherapeutisches Programm für Menschen mit psychischen Erkrankungen]. 1st ed. Weinheim: Julius Beltz GmbH & Co. KG; 2020.

89.

Geidl W, Hofmann J, Gohner W, Sudeck G, Pfeifer K. Behaviour-orientated exercise therapy--initiating and maintaining a physically active lifestyle. Rehabilitation (Stuttg). 2012;51(4):259–68. https://doi.org/10.1055/s-0031-1280803.CrossRef

90.

Borg GA. Psychophysical bases of perceived exertion. Med Sci Sports Exerc. 1982;14(5):377–81. https://doi.org/10.1249/00005768-198205000-00012.CrossRefPubMed

91.

Garber CE, Blissmer B, Deschenes MR, Franklin BA, Lamonte MJ, Lee IM, et al. American College of Sports M: American College of Sports Medicine position stand. Quantity and quality of exercise for developing and maintaining cardiorespiratory, musculoskeletal, and neuromotor fitness in apparently healthy adults: guidance for prescribing exercise. Med Sci Sports Exerc. 2011;43(7):1334–59. https://doi.org/10.1249/MSS.0b013e318213fefb.CrossRefPubMed

92.

Lee H, Herbert RD, McAuley JH. Mediation analysis. JAMA. 2019;321(7):697–8. https://doi.org/10.1001/jama.2018.21973.CrossRefPubMed

93.

Goldsmith KA, MacKinnon DP, Chalder T, White PD, Sharpe M, Pickles A. Tutorial: the practical application of longitudinal structural equation mediation models in clinical trials. Psychol Methods. 2018;23(2):191–207. https://doi.org/10.1037/met0000154.CrossRefPubMed

94.

Usami S, Murayama K, Hamaker EL. A unified framework of longitudinal models to examine reciprocal relations. Psychol Methods. 2019;24(5):637–57. https://doi.org/10.1037/met0000210.CrossRefPubMed

95.

Balkin RS, Lenz AS. Contemporary issues in reporting statistical, practical, and clinical significance in counseling research. J Couns Dev. 2021;99(2):227–37. https://doi.org/10.1002/jcad.12370.CrossRef

96.

Jacobson NS, Truax P. Clinical significance : A statistical approach to defining meaningful change in psychotherapy research. In: Methodological issues & strategies in clinical research. Washington, DC: American Psychological Association; 1992. p. 631–48.CrossRef

97.

Zahra D, Hedge C. The reliable change index: why isn't it more popular in academic psychology? PsyPag Quarterly. 2010;76:15.

98.

Jacobson NS, Follette WC, Revenstorf D. Psychotherapy outcome research: methods for reporting variability and evaluating clinical significance. Behav Ther. 1984;15(4):336–52. https://doi.org/10.1016/s0005-7894(84)80002-7.CrossRef

Title: Efficacy and cost-effectiveness of a Transdiagnostic group-based exercise intervention: study protocol for a pragmatic multi-site randomized controlled trial
Authors: Sebastian Wolf
Britta Seiffer
Johanna-Marie Zeibig
Jana Welkerling
Leonie Louisa Bauer
Anna Katharina Frei
Thomas Studnitz
Stephanie Rosenstiel
David Victor Fiedler
Florian Helmhold
Andreas Ray
Eva Herzog
Keisuke Takano
Tristan Nakagawa
Saskia Kropp
Sebastian Franke
Stefan Peters
Nadja El-Kurd
Lena Zwanzleitner
Leonie Sundmacher
Ander Ramos-Murguialday
Martin Hautzinger
Gorden Sudeck
Thomas Ehring
Publication date: 01-12-2021
Publisher: BioMed Central
Keywords: Insomnia
Post-Traumatic Stress Disorder
Mood Disorders
Panic Disorder
Exercise Therapy
Care
Exercise Therapy
Affective Disorder
Agoraphobia
Published in: BMC Psychiatry / Issue 1/2021
Electronic ISSN: 1471-244X
DOI: https://doi.org/10.1186/s12888-021-03541-3

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Efficacy and cost-effectiveness of a Transdiagnostic group-based exercise intervention: study protocol for a pragmatic multi-site randomized controlled trial

Abstract

Background

Methods

Discussion

Trial registration

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Abstract

Background

Methods

Discussion

Trial registration

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