Skip to main content

Advertisement

SpringerLink
Log in

Understanding the relationships between health outcomes in generalized anxiety disorder clinical trials

  • Published:
Quality of Life Research Aims and scope Submit manuscript

Abstract

Background and Aims

The Wilson–Cleary health outcomes model is a hypothesized pathway linking traditional clinical variables to health-related quality of life (HRQL). This study tested the application of the Wilson–Cleary model to a patient population with generalized anxiety disorder (GAD) using longitudinal clinical trial data.

Methods

These secondary analyses pooled data from three similar 8-week, placebo-controlled, double-blind, randomized, multicenter trials of quetiapine XR therapy in GAD. Relevant health assessments for the model concepts included the Clinical Global Impression-Severity of Illness, Hamilton Rating Scale for Anxiety, the Pittsburgh Sleep Quality Index and Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form. A lagged path model tested whether the hypothesized relationships at baseline and week 8 between the concepts of the adapted Wilson–Cleary model were consistent with the observed data.

Results

The resulting model fit the data (RMSEA = 0.077; CFI = 0.98; NFI = 0.96) and explained 56% of the variance in overall quality of life assessment at baseline and 69% of the variance in this assessment at week 8. Moderate to strong relationships between the adjacent hypothesized concepts support the specified model.

Conclusion

This adapted Wilson–Cleary model for health outcomes validated in GAD should improve the understanding and usefulness of health status measurements in this condition and increase the applications of this model to other clinical trial data.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Log in via an institution

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

Fig. 1
Fig. 2

Similar content being viewed by others

References

  1. American Psychiatric Association. (1994). Diagnostic and Statistical Manual of Mental Disorders. 4th ed. Washington, DC: American Psychiatric Press.

  2. Arnold, R., Ranchor, A. V., Koeter, G. H., de Jongste, M. J., & Sanderman, R. (2005). Consequences of chronic obstructive pulmonary disease and chronic heart failure: The relationship between objective and subjective health. Social Science and Medicine, 61(10), 2144–2154.

    Article  PubMed  Google Scholar 

  3. Astrom, A. N., & Kida, I. A. (2007). Perceived dental treatment need among older Tanzanian adults—a cross-sectional study. BMC Oral Health, 7, 9.

    Article  PubMed  Google Scholar 

  4. Atkinson, S., Khan, A., Joyce, M., Eggens, I., Baldytcheva, I., & Brecher, M. (2008). Efficacy and tolerability of once-daily extended release quetiapine fumarate (quetiapine XR) monotherapy in patients with generalised anxiety disorder. International Journal of Neuropsychopharmacology, 11(Suppl 1), 277.

    Google Scholar 

  5. Bandelow, B., Chouinard, G., Bobes, J., Ahokas, A., Eggens, I., Liu, S., et al. (2010). Extended-release quetiapine fumarate (quetiapine XR): A once-daily monotherapy effective in generalized anxiety disorder data from a randomized double-blind placebo- and active-controlled study. International Journal of Neuropsychopharmacology, 13(3), 305–320.

    Article  CAS  PubMed  Google Scholar 

  6. Barger, S. D., & Sydeman, S. J. (2005). Does generalized anxiety disorder predict coronary heart disease risk factors independently of major depressive disorder? Journal of Affective Disorders, 88(1), 87–91.

    Article  PubMed  Google Scholar 

  7. Bennett, S. J., Perkins, S. M., Lane, K. A., Deer, M., Brater, D. C., & Murray, M. D. (2001). Social support and health-related quality of life in chronic heart failure patients. Quality of Life Research, 10(8), 671–682.

    Article  CAS  PubMed  Google Scholar 

  8. Bentler, P. M., & Bonnet, D. C. (1980). Significance tests and goodness of fit in the analysis of covariance structures. Psychological Bulletin, 88(3), 588–606.

    Article  Google Scholar 

  9. Buysse, D. J., Reynolds, C. F, 3rd, Monk, T. H., Berman, S. R., & Kupfer, D. J. (1989). The Pittsburgh Sleep Quality Index: A new instrument for psychiatric practice and research. Psychiatry Research, 28(2), 193–213.

    Article  CAS  PubMed  Google Scholar 

  10. Chrischilles, E. A., Rubenstein, L. M., Voelker, M. D., Wallace, R. B., & Rodnitzky, R. L. (2002). Linking clinical variables to health-related quality of life in Parkinson’s disease. Parkinsonism & Related Disorders, 8(3), 199–209.

    Article  Google Scholar 

  11. Cohen, J. (1988). Statistical power analysis for the behavioral sciences (2nd ed.). Hillsdale, NJ: Lawrence Earlbaum.

    Google Scholar 

  12. Cosby, C., Holzemer, W. L., Henry, S. B., & Portillo, C. J. (2000). Hematological complications and quality of life in hospitalized AIDS patients. AIDS Patient Care STDS, 14(5), 269–279.

    Article  CAS  PubMed  Google Scholar 

  13. Cunningham, W. E., Crystal, S., Bozzette, S., & Hays, R. D. (2005). The association of health-related quality of life with survival among persons with HIV infection in the United States. Journal of General Internal Medicine, 20(1), 21–27.

    Article  PubMed  Google Scholar 

  14. Demyttenaere, K., Andersen, H. F., & Reines, E. H. (2008). Impact of escitalopram treatment on Quality of Life Enjoyment and Satisfaction Questionnaire scores in major depressive disorder and generalized anxiety disorder. International Clinical Psychopharmacology, 23(5), 276–286.

    Article  PubMed  Google Scholar 

  15. Endicott, J., Nee, J., Harrison, W., & Blumenthal, R. (1993). Quality of Life Enjoyment and Satisfaction Questionnaire: A new measure. Psychopharmacology Bulletin, 29(2), 321–326.

    CAS  PubMed  Google Scholar 

  16. Endicott, J., Rajagopalan, K., Minkwitz, M., & Macfadden, W. (2007). A randomized, double-blind, placebo-controlled study of quetiapine in the treatment of bipolar I and II depression: Improvements in quality of life. International Clinical Psychopharmacology, 22(1), 29–37.

    Article  PubMed  Google Scholar 

  17. Endicott, J., Russell, J. M., Raskin, J., et al. (2007). Duloxetine treatment for role functioning improvement in generalized anxiety disorder: Three independent studies. The Journal of Clinical Psychiatry, 68(4), 518–524.

    Article  CAS  PubMed  Google Scholar 

  18. ESEMeD/MHEDEA 2000 Investigators. (2004). Prevalence of mental disorders in Europe: Results from the European Study of the Epidemiology of Mental Disorders (ESEMeD) project. Acta Psychiatrica Scandinavica,109(suppl 1):21–27.

    Google Scholar 

  19. Faravelli, C., Guerrini Degl’Innocenti, B., & Giardinelli, L. (1989). Epidemiology of anxiety disorders in Florence. Acta Psychiatrica Scandinavica, 79(4), 308–312.

    Article  CAS  PubMed  Google Scholar 

  20. Grant, B. F., Hasin, D. S., Stinson, F. S., et al. (2005). Prevalence, correlates, co-morbidity, and comparative disability of DSM-IV generalized anxiety disorder in the USA: Results from the National Epidemiologic Survey on Alcohol and Related Conditions. Psychological Medicine, 35(12), 1747–1759.

    Article  PubMed  Google Scholar 

  21. Guy, W. (1976). Clinical global impressions. ECDEU Assessment Manual for Psychopharmacology (pp. 218–222). Rockville, MD: National Institute for Mental Health.

    Google Scholar 

  22. Hamilton, M. (1959). The assessment of anxiety states by rating. British Journal of Medical Psychology, 32(1), 50–55.

    CAS  PubMed  Google Scholar 

  23. Hays, R. D., Cunningham, W. E., Sherbourne, C. D., et al. (2000). Health-related quality of life in patients with human immunodeficiency virus infection in the United States: Results from the HIV Cost and Services Utilization Study. American Journal of Medicine, 108(9), 714–722.

    Article  CAS  PubMed  Google Scholar 

  24. Henning, E. R., Turk, C. L., Mennin, D. S., Fresco, D. M., & Heimberg, R. G. (2007). Impairment and quality of life in individuals with generalized anxiety disorder. Depress Anxiety, 24(5), 342–349.

    Article  PubMed  Google Scholar 

  25. Heo, S., Moser, D. K., Riegel, B., Hall, L. A., & Christman, N. (2005). Testing a published model of health-related quality of life in heart failure. Journal of Cardiac Failure, 11(5), 372–379.

    Article  PubMed  Google Scholar 

  26. Hoyer, J., Becker, E. S., & Margraf, J. (2002). Generalized anxiety disorder and clinical worry episodes in young women. Psychological Medicine, 32(7), 1227–1237.

    Article  CAS  PubMed  Google Scholar 

  27. Hu, L. T., & Bentler, P. M. (1999). Cutoff criteria for fit indexes in covariance structure analysis: Conventional criteria versus new alternatives. Structural Equation Modeling, 6(1), 1–55.

    Article  Google Scholar 

  28. Jöreskog, K. G., & Sörbom, D. (2006). LISREL 8.80 for Windows [Computer Software]. Lincolnwood, IL: Scientific Software International.

    Google Scholar 

  29. Kessler, R. C., DuPont, R. L., Berglund, P., & Wittchen, H. U. (1999). Impairment in pure and comorbid generalized anxiety disorder and major depression at 12 months in two national surveys. American Journal of Psychiatry, 156(12), 1915–1923.

    CAS  PubMed  Google Scholar 

  30. Kessler, R. C., Keller, M. B., & Wittchen, H. (2001). The epidemiology of generalized anxiety disorder. In O. Brawman-Mintzer (Ed.), The psychiatric clinics of North America: Generalized anxiety disorder (pp. 19–40). Philadelphia: W.B. Saunders.

    Google Scholar 

  31. Kessler, R. C., & Wittchen, H. U. (2002). Patterns and correlates of generalized anxiety disorder in community samples. Journal of Clinical Psychiatry, 63(Suppl 8), 4–10.

    PubMed  Google Scholar 

  32. Lee, D. T., Yu, D. S., Woo, J., & Thompson, D. R. (2005). Health-related quality of life in patients with congestive heart failure. European Journal of Heart Failure, 7(3), 419–422.

    Article  PubMed  Google Scholar 

  33. MacCallum, R. C., Browne, M. W., & Sugawara, H. M. (1996). Power analysis and determination of sample size for covariance structure modeling. Psychological Methods, 1(2), 130–149.

    Article  Google Scholar 

  34. Masoudi, F. A., Rumsfeld, J. S., Havranek, E. P., et al. (2004). Age, functional capacity, and health-related quality of life in patients with heart failure. Journal of Cardiac Failure, 10(5), 368–373.

    Article  PubMed  Google Scholar 

  35. Massion, A. O., Warshaw, M. G., & Keller, M. B. (1993). Quality of life and psychiatric morbidity in panic disorder and generalized anxiety disorder. American Journal of Psychiatry, 150(4), 600–607.

    CAS  PubMed  Google Scholar 

  36. Mathisen, L., Andersen, M. H., Veenstra, M., Wahl, A. K., Hanestad, B. R., & Fosse, E. (2007). Quality of life can both influence and be an outcome of general health perceptions after heart surgery. Health Qual Life Outcomes, 5, 27.

    Article  PubMed  Google Scholar 

  37. Merideth, C., Cutler, A., Neijber, A., et al. (2008). Efficacy and tolerability of extended release quetiapine fumarate (quetiapine XR) monotherapy in the treatment of generalised anxiety disorder. European Neuropsychopharmacology, 18(suppl 4), S499.

    Article  Google Scholar 

  38. Mick, E., Faraone, S. V., Spencer, T., Zhang, H. F., & Biederman, J. (2008). Assessing the validity of the Quality of Life Enjoyment, Satisfaction Questionnaire Short Form in adults with ADHD. Journal of Attention Disorders, 11(4), 504–509.

    Article  PubMed  Google Scholar 

  39. Norman, G., & Streiner, D. (2000). Biostatistics: The bare essentials. Toronto: Decker.

    Google Scholar 

  40. Olsson, I., Mykletun, A., & Dahl, A. A. (2005). The Hospital Anxiety and Depression Rating Scale: A cross-sectional study of psychometrics and case finding abilities in general practice. BMC Psychiatry, 5, 46.

    Article  PubMed  Google Scholar 

  41. Orfila, F., Ferrer, M., Lamarca, R., Tebe, C., Domingo-Salvany, A., & Alonso, J. (2006). Gender differences in health-related quality of life among the elderly: The role of objective functional capacity and chronic conditions. Social Science and Medicine, 63(9), 2367–2380.

    Article  PubMed  Google Scholar 

  42. Phaladze, N. A., Human, S., Dlamini, S. B., et al. (2005). Quality of life and the concept of “living well” with HIV/AIDS in sub-Saharan Africa. Journal of Nursing Scholarship, 37(2), 120–126.

    Article  PubMed  Google Scholar 

  43. Revicki, D. A., Brandenburg, N., Matza, L., Hornbrook, M. C., & Feeny, D. (2008). Health-related quality of life and utilities in primary-care patients with generalized anxiety disorder. Quality of Life Research, 17(10), 1285–1294.

    Article  PubMed  Google Scholar 

  44. Ritsner, M., Kurs, R., Gibel, A., Ratner, Y., & Endicott, J. (2005). Validity of an abbreviated Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q-18) for schizophrenia, schizoaffective, and mood disorder patients. Quality of Life Research, 14(7), 1693–1703.

    Article  PubMed  Google Scholar 

  45. Sheehan, D. V., Meyers, A. L., Prakash, A., et al. (2008). The relationship between functional outcomes and the treatment of anxious and painful somatic symptoms in patients with generalized anxiety disorder. Current Medical Research and Opinion, 24(9), 2457–2466.

    Article  PubMed  Google Scholar 

  46. Sousa, K. H., Holzemer, W. L., Henry, S. B., & Slaughter, R. (1999). Dimensions of health-related quality of life in persons living with HIV disease. Journal of Advanced Nursing, 29(1), 178–187.

    Article  CAS  PubMed  Google Scholar 

  47. Sousa, K. H., & Kwok, O. M. (2006). Putting Wilson and Cleary to the test: Analysis of a HRQOL conceptual model using structural equation modeling. Qual Life Re, 15(4), 725–737.

    Article  Google Scholar 

  48. Straits-Troster, K., Fields, J. A., Wilkinson, S. B., et al. (2000). Health-related quality of life in Parkinson’s disease after pallidotomy and deep brain stimulation. Brain and Cognition, 42(3), 399–416.

    Article  CAS  PubMed  Google Scholar 

  49. Wettergren, L., Bjorkholm, M., Axdorph, U., & Langius-Eklof, A. (2004). Determinants of health-related quality of life in long-term survivors of Hodgkin’s lymphoma. Quality of Life Research, 13(8), 1369–1379.

    Article  CAS  PubMed  Google Scholar 

  50. Wilson, I. B., & Cleary, P. D. (1995). Linking clinical variables with health-related quality of life: A conceptual model of patient outcomes. JAMA, 273(1), 59–65.

    Article  CAS  PubMed  Google Scholar 

  51. Wilson, I. B., & Cleary, P. D. (1996). Clinical predictors of functioning in persons with acquired immunodeficiency syndrome. Medical Care, 34(6), 610–623.

    Article  CAS  PubMed  Google Scholar 

  52. Wilson, I. B., & Cleary, P. D. (1997). Clinical predictors of declines in physical functioning in persons with AIDS: Results of a longitudinal study. Journal of Acquired Immune Deficiency Syndromes and Human Retrovirology, 16(5), 343–349.

    CAS  PubMed  Google Scholar 

  53. Wittchen, H. U. (2002). Generalized anxiety disorder: Prevalence, burden, and cost to society. Depress Anxiety, 16(4), 162–171.

    Article  PubMed  Google Scholar 

  54. Wittchen, H. U., Carter, R. M., Pfister, H., Montgomery, S. A., & Kessler, R. C. (2000). Disabilities and quality of life in pure and comorbid generalized anxiety disorder and major depression in a national survey. International Clinical Psychopharmacology, 15(6), 319–328.

    Article  CAS  PubMed  Google Scholar 

  55. Wyrwich, K. W., Harnam, N., Revicki, D. A., et al. (2009). Assessing health-related quality of life in generalized anxiety disorder using the Quality of Life Enjoyment and Satisfaction Questionnaire. International Clinical Psychopharmacology, 24(6), 289–295.

    Article  PubMed  Google Scholar 

Download references

Acknowledgments

This work was funded by AstraZeneca.

Author information

Authors and Affiliations

  1. United BioSource Corporation, 7101 Wisconsin Ave. Suite 600, Bethesda, MD, 20814, USA

    Kathleen W. Wyrwich, Neesha Harnam & Dennis A. Revicki

  2. AstraZeneca Pharmaceuticals LP, Wilmington, Delaware, USA

    Julie C. Locklear

  3. AstraZeneca R&D, Mölndal, Sweden

    Henrik Svedsäter

Authors
  1. Kathleen W. Wyrwich
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Neesha Harnam
    View author publications

    You can also search for this author in PubMed Google Scholar

  3. Julie C. Locklear
    View author publications

    You can also search for this author in PubMed Google Scholar

  4. Henrik Svedsäter
    View author publications

    You can also search for this author in PubMed Google Scholar

  5. Dennis A. Revicki
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to Kathleen W. Wyrwich.

Rights and permissions

Reprints and permissions

About this article

Cite this article

Wyrwich, K.W., Harnam, N., Locklear, J.C. et al. Understanding the relationships between health outcomes in generalized anxiety disorder clinical trials. Qual Life Res 20, 255–262 (2011). https://doi.org/10.1007/s11136-010-9734-1

Download citation

  • Accepted:

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s11136-010-9734-1

Keywords

Search

Navigation