Skip to main content
Key Specialties
Cardiology Diabetology Endocrinology Gastroenterology Geriatrics and Gerontology Gynecology and Obstetrics Hematology Infectious Disease Internal Medicine Nephrology Neurology Oncology Pediatrics Respiratory Medicine Rheumatology Surgery
Congress Coverage
2024 ACC Congress 2023 ESMO Congress 2023 EASD Congress 2023 ERS Congress 2023 ESC Congress 2023 EHA Congress 2023 ASCO Annual Meeting
Clinical Collections
Advances in Alzheimer’s

At a glance: The ONWARDS insulin icodec trials

A round-up of the ONWARDS phase 3 clinical trials evaluating the novel weekly insulin icodec in people with diabetes.
ADVANCED SEARCH
Log in
Top
Psychiatric Quarterly
Published in: Psychiatric Quarterly 1/2018

01-03-2018 | Original Paper

Minimal Clinically Important Differences (MCID) in Assessing Outcomes of Post-Traumatic Stress Disorder

Authors: Elina A. Stefanovics, Robert A. Rosenheck, Karen M. Jones, Grant Huang, John H. Krystal

Published in: Psychiatric Quarterly | Issue 1/2018

Login to get access

Abstract

This study sought to determine the minimal clinically important difference (MCID) for two frequently used measures of symptom severity in Post-Traumatic Stress Disorder: the Clinician Administered PTSD Scale (CAPS) and the PTSD Symptom Checklist (PCL). Data from a randomized clinical trial of antipsychotic medication in military-related treatment-resistant PTSD (N= 267) included assessments 4 times over 26 weeks. Methods for estimating the MCID were based on both the anchor-based approach, using the Clinical Global Impressions (CGI) severity and improvement scales, rated by both clinicians and patients; and the distribution-based approach (based on standardized z-scores). Severity and change scores on the CAPS and PCL were converted to z-scores and compared across CGI levels using analysis of variance. The average difference in CAPS z-scores between each of three CGI levels between “moderate” to “severe” and from “no change” to “much improved” was 0.758 for clinician CGI ratings and 0.525 for patient CGI ratings and were similar for the PCL (0.483 and 0.471) with all differences significant at p<.0001). Clinically meaningful CAPS and PCL severity and change z-scores range between 0.5–0.8 standard deviations. The MCID estimates suggested here provide an empirical basis for determining whether statistically significant changes in CAPS and PCL scores are clinically meaningful.
Literature
1.
Breslau, N., Davis, G. C., Andreski, P., & Peterson, E. (1991). Traumatic events and posttraumatic stress disorder in an urban population of young adults. Archives of general psychiatry, 48(3), 216–222.CrossRefPubMed
2.
Kessler, R. C., Sonnega, A., Bromet, E., Hughes, M., & Nelson, C. B. (1995). Posttraumatic stress disorder in the National Comorbidity Survey. Archives of general psychiatry, 52(12), 1048–1060.CrossRefPubMed
3.
Brown, P. J., Recupero, P. R., & Stout, R. (1995). PTSD substance abuse comorbidity and treatment utilization. Addictive behaviors, 20(2), 251–254.CrossRefPubMed
4.
Brown, P. J., Stout, R. L., & Mueller, T. (1999). Substance use disorder and posttraumatic stress disorder comorbidity: Addiction and psychiatric treatment rates. Psychology of Addictive Behaviors, 13(2), 115.CrossRef
5.
Seal, K. H., Bertenthal, D., Miner, C. R., Sen, S., & Marmar, C. (2007). Bringing the war back home: Mental health disorders among 103 788 US veterans returning from Iraq and Afghanistan seen at Department of Veterans Affairs Facilities. Archives of Internal Medicine, 167(5), 476–482.CrossRefPubMed
6.
Association, A. P. (2013). Diagnostic and Statistical Manual of Mental Disorders (DSM-5®): American Psychiatric Pub.CrossRef
7.
DSM-5. (2013). Diagnostic and statistical manual of mental disorders (DSM-5®): American Psychiatric Pub.
8.
Tanielian, T. L., & Jaycox, L. (2008). Invisible wounds of war: Psychological and cognitive injuries, their consequences, and services to assist recovery (Vol. 1): Rand Corporation.
9.
Hermes, E. D., Rosenheck, R. A., Desai, R., & Fontana, A. F. (2012a). Recent trends in the treatment of posttraumatic stress disorder and other mental disorders in the VHA. Psychiatric Services.
10.
Marmar, C. R., Schlenger, W., Henn-Haase, C., Qian, M., Purchia, E., Li, M.,. .. Horesh, D. (2015). Course of posttraumatic stress disorder 40 years after the Vietnam War: Findings from the National Vietnam Veterans Longitudinal Study. JAMA Psychiatry, 72(9), 875–881.
11.
Forneris, C. A. (2002). Outpatient care use among female veterans: Differences between mental health and non-mental health users. Military medicine, 167(1), 10.PubMed
12.
Berg, A., Breslau, N., Goodman, S., Lezak, M., Matchar, D., Mellman, T.,. .. Vega, W. (2008). Treatment of posttraumatic stress disorder: an assessment of the evidence. Institute of.
13.
Creamer, M., & Forbes, D. (2004). Treatment of posttraumatic stress disorder in military and veteran populations. Psychotherapy: Theory, Research, Practice, Training, 41(4), 388.
14.
Blake, D., Weathers, F., Nagy, L., Kaloupek, D., Klauminzer, G., Charney, D., & Keane, T. (1990). A clinician rating scale for assessing current and lifetime PTSD: The CAPS-1.
15.
Blake, D. D., Weathers, F. W., Nagy, L. M., Kaloupek, D. G., Gusman, F. D., Charney, D. S., & Keane, T. M. (1995). The development of a clinician-administered PTSD scale. Journal of traumatic stress, 8(1), 75–90.CrossRefPubMed
16.
Weathers, F. W., Keane, T. M., & Davidson, J. R. (2001). Clinician-Administered PTSD Scale: A review of the first ten years of research. Depression and anxiety, 13(3), 132–156.CrossRefPubMed
17.
Hermes, E. D., Sokoloff, D., Stroup, T. S., & Rosenheck, R. A. (2012b). Minimum clinically important difference in the Positive and Negative Syndrome Scale with data from the Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE). The Journal of clinical psychiatry, 73(4), 1,478–532.CrossRef
18.
Leucht, S., Kane, J. M., Kissling, W., Hamann, J., Etschel, E., & Engel, R. R. (2005b). What does the PANSS mean? Schizophrenia research, 79(2), 231–238.CrossRefPubMed
19.
Church, D., Geronilla, L., & Dinter, I. (2009). Psychological symptom change in veterans after six sessions of Emotional Freedom Techniques (EFT): An observational study. Electronic journal article]. International Journal of Healing and Caring, 9(1).
20.
Pigeon, W. R., Campbell, C. E., Possemato, K., & Ouimette, P. (2013). Longitudinal relationships of insomnia, nightmares, and PTSD severity in recent combat veterans. Journal of psychosomatic research, 75(6), 546–550.CrossRefPubMed
21.
Difede, J., Malta, L. S., Best, S., Henn-Haase, C., Metzler, T., Bryant, R., & Marmar, C. (2007). A randomized controlled clinical treatment trial for World Trade Center attack-related PTSD in disaster workers. The Journal of nervous and mental disease, 195(10), 861–865.CrossRefPubMed
22.
Hien, D. A., Jiang, H., Campbell, A. N., Hu, M.-C., Miele, G. M., Cohen, L. R.,. .. Robinson, J. (2010). Do treatment improvements in PTSD severity affect substance use outcomes? A secondary analysis from a randomized clinical trial in NIDA's Clinical Trials Network. American journal of Psychiatry.
23.
Copay, A. G., Subach, B. R., Glassman, S. D., Polly, D. W., & Schuler, T. C. (2007). Understanding the minimum clinically important difference: a review of concepts and methods. The Spine Journal, 7(5), 541–546.CrossRefPubMed
24.
Hays, R. D., & Woolley, J. M. (2000). The concept of clinically meaningful difference in health-related quality-of-life research. Pharmacoeconomics, 18(5), 419–423.CrossRefPubMed
25.
Guyatt, G., Walter, S., & Norman, G. (1987). Measuring change over time: assessing the usefulness of evaluative instruments. Journal of chronic diseases, 40(2), 171–178.CrossRefPubMed
26.
Jaeschke, R., Singer, J., & Guyatt, G. H. (1989). Measurement of health status: ascertaining the minimal clinically important difference. Controlled clinical trials, 10(4), 407–415.CrossRefPubMed
27.
Revicki, D., Hays, R. D., Cella, D., & Sloan, J. (2008). Recommended methods for determining responsiveness and minimally important differences for patient-reported outcomes. Journal of clinical epidemiology, 61(2), 102–109.CrossRefPubMed
28.
Wells, G., Beaton, D., Shea, B., Boers, M., Simon, L., Strand, V.,. .. Tugwell, P. (2001). Minimal clinically important differences: review of methods. The Journal of rheumatology, 28(2), 406–412.
29.
Crosby, R. D., Kolotkin, R. L., & Williams, G. R. (2003). Defining clinically meaningful change in health-related quality of life. Journal of clinical epidemiology, 56(5), 395–407.CrossRefPubMed
30.
Lydick, E., & Epstein, R. (1993). Interpretation of quality of life changes. Quality of life research, 2(3), 221–226.CrossRefPubMed
31.
Leddy-Stacy, M. A., & Rosenheck, R. (2016). Obtaining employment as an anchor for estimating the minimum clinically important difference on the Positive and Negative Syndrome Scale (PANSS) in schizophrenia. Psychiatry research, 238, 304–309.CrossRefPubMed
32.
de Vet, H. C., Ostelo, R. W., Terwee, C. B., van der Roer, N., Knol, D. L., Beckerman, H.,. .. Bouter, L. M. (2007). Minimally important change determined by a visual method integrating an anchor-based and a distribution-based approach. Quality of life research, 16(1), 131–142.
33.
Cohen, J. (1977). Statistical power analysis for the behavioral sciences (rev: Lawrence Erlbaum Associates, Inc.
34.
Deyo, R. A., Diehr, P., & Patrick, D. L. (1991). Reproducibility and responsiveness of health status measures statistics and strategies for evaluation. Controlled clinical trials, 12(4), S142-S158.CrossRef
35.
Kazis, L. E., Anderson, J. J., & Meenan, R. F. (1989). Effect sizes for interpreting changes in health status. Medical Care, 27(3), S178-S189.CrossRefPubMed
36.
Sloan, J., Vargas-Chanes, D., Kamath, C., Sargent, D., Novotny, P., Atherton, P.,. .. Loprinzi, C. (2003). Detecting worms, ducks and elephants: a simple approach for defining clinically relevant effects in quality-of-life measures. J Cancer Integr Med, 1(1), 41–47.
37.
Walters, S. J., & Brazier, J. E. (2005). Comparison of the minimally important difference for two health state utility measures: EQ-5D and SF-6D. Quality of life research, 14(6), 1523–1532.CrossRefPubMed
38.
Krystal, J. H., Rosenheck, R. A., Cramer, J. A., Vessicchio, J. C., Jones, K. M., Vertrees, J. E.,. .. Group, V. A. C. S. N. (2011). Adjunctive risperidone treatment for antidepressant-resistant symptoms of chronic military service–related PTSD: a randomized trial. Jama, 306(5), 493–502.
39.
Hovens, J., Van der Ploeg, H., Klaarenbeek, M., Bramsen, I., Schreuder, J., & Rivero, V. V. (1994). The assessment of posttraumatic stress disorder: with the Clinician Administered PTSD Scale: Dutch results. Journal of clinical psychology, 50(3), 325–340.CrossRefPubMed
40.
Paunović, N., & Öst, L. G. (2005). Psychometric properties of a Swedish translation of the Clinician-Administered PTSD Scale-Diagnostic Version. Journal of traumatic stress, 18(2), 161–164.CrossRefPubMed
41.
Schnyder, U., & Moergeli, H. (2002). German version of clinician-administered PTSD scale. Journal of traumatic stress, 15(6), 487–492.CrossRefPubMed
42.
Lillywhite, A., & Neal, L. (1993). The importance of severity as a factor in post-traumatic stress disorder.
43.
Gearon, J. S., Bellack, A. S., & Tenhula, W. N. (2004). Preliminary reliability and validity of the Clinician-Administered PTSD Scale for schizophrenia. Journal of consulting and clinical psychology, 72(1), 121.CrossRefPubMed
44.
Lee, B. Y., Kim, Y., Yi, S. M., Eun, H. J., Kim, D. I., & Kim, J. Y. (1999). A reliability and validity study of a clinician-administered PTSD scale. Journal of Korean Neuropsychiatric Association, 38(3), 514–522.
45.
Newman, E., Kaloupek, D. G., & Keane, T. M. (1996). Assessment of posttraumatic stress disorder in clinical and research settings.
46.
Weathers, F., Litz, B., Huska, J., & Keane, T. (1994b). PTSD Checklist—Military Version (PCL-M) for DSM-IV. Boston: National Center for PTSD—Behavioral Science Division.
47.
Weathers, F., Litz, B., Herman, D., Huska, J., & Keane, T. (1994a). The PTSD checklist-civilian version (PCL-C). Boston, MA: National Center for PTSD.
48.
Weathers, F. W., Litz, B. T., Herman, D. S., Huska, J. A., & Keane, T. M. (1993). The PTSD Checklist (PCL): Reliability, validity, and diagnostic utility. Paper presented at the Annual Convention of the International Society for Traumatic Stress Studies.
49.
Association, A. P. (1987). Diagnostic and Statistical Manual of Mental Disorders-Revision: American Psychiatric Association.
50.
Creamer, M., Bell, R., & Failla, S. (2003). Psychometric properties of the impact of event scale—revised. Behaviour research and therapy, 41(12), 1489–1496.CrossRefPubMed
51.
Forbes, D., Creamer, M., & Biddle, D. (2001). The validity of the PTSD checklist as a measure of symptomatic change in combat-related PTSD. Behaviour research and therapy, 39(8), 977–986.CrossRefPubMed
52.
Dobie, D. J., Kivlahan, D. R., Maynard, C., Bush, K. R., McFall, M., Epler, A. J., & Bradley, K. A. (2002). Screening for post-traumatic stress disorder in female Veteran’s Affairs patients: validation of the PTSD checklist. General Hospital Psychiatry, 24(6), 367–374.CrossRefPubMed
53.
Lang, A. J., Laffaye, C., Satz, L. E., Dresselhaus, T. R., & Stein, M. B. (2003). Sensitivity and specificity of the PTSD checklist in detecting PTSD in female veterans in primary care. Journal of traumatic stress, 16(3), 257–264.CrossRefPubMed
54.
Walker, E. A., Newman, E., Dobie, D. J., Ciechanowski, P., & Katon, W. (2002). Validation of the PTSD checklist in an HMO sample of women. General Hospital Psychiatry, 24(6), 375–380.CrossRefPubMed
55.
Guy, W. (1976). Clinical global impression scale. The ECDEU Assessment Manual for Psychopharmacology-Revised Volume DHEW Publ No ADM, 76(338), 218–222.
56.
Hale, A., Corral, R.-M., Mencacci, C., Ruiz, J. S., Severo, C. A., & Gentil, V. (2010). Superior antidepressant efficacy results of agomelatine versus fluoxetine in severe MDD patients: a randomized, double-blind study. International clinical psychopharmacology, 25(6), 305–314.CrossRefPubMed
57.
Hsieh, M.-H., Lin, W.-W., Chen, S.-T., Chen, K.-C., Chen, K.-P., Chiu, N.-Y.,. .. Lai, T.-J. (2010). A 64-week, multicenter, open-label study of aripiprazole effectiveness in the management of patients with schizophrenia or schizoaffective disorder in a general psychiatric outpatient setting. Annals of General Psychiatry, 9(1), 1.
58.
Bandelow, B., Baldwin, D. S., Dolberg, O. T., Andersen, H. F., & Stein, D. J. (2006). What is the threshold for symptomatic response and remission for major depressive disorder, panic disorder, social anxiety disorder, and generalized anxiety disorder? The Journal of clinical psychiatry, 67(9), 1428–1434.CrossRefPubMed
59.
Leucht, S., & Engel, R. R. (2006). The relative sensitivity of the Clinical Global Impressions Scale and the Brief Psychiatric Rating Scale in antipsychotic drug trials. Neuropsychopharmacology, 31(2), 406–412.CrossRefPubMed
60.
Leucht, S., Kane, J. M., Kissling, W., Hamann, J., Etschel, E., & Engel, R. (2005a). Clinical implications of brief psychiatric rating scale scores. The British Journal of Psychiatry, 187(4), 366–371.CrossRefPubMed
61.
Spielmans, G. I., & McFall, J. P. (2006). A comparative meta-analysis of clinical global impressions change in antidepressant trials. The Journal of nervous and mental disease, 194(11), 845–852.CrossRefPubMed
62.
Zaider, T. I., Heimberg, R. G., Fresco, D., Schneier, F., & Liebowitz, M. (2003). Evaluation of the clinical global impression scale among individuals with social anxiety disorder. Psychological medicine, 33(04), 611–622.CrossRefPubMed
63.
Beck, A. T., Steer, R. A., & Brown, G. K. (1996). Beck depression inventory-II. San Antonio, TX, 78204–72498.
64.
Hamilton, M. (1967). Development of a rating scale for primary depressive illness. British journal of social and clinical psychology, 6(4), 278–296.CrossRefPubMed
65.
Kørner, A., Lauritzen, L., Abelskov, K., Gulmann, N. C., Brodersen, A.-M., Wedervang-Jensen, T., & Kjeldgaard, K. M. (2007). Rating scales for depression in the elderly: external and internal validity. The Journal of clinical psychiatry, 68(3), 384–389.CrossRefPubMed
66.
Montgomery, S. A., & Asberg, M. (1979). A new depression scale designed to be sensitive to change. The British Journal of Psychiatry, 134(4), 382–389.CrossRefPubMed
67.
Riedel, M., Möller, H.-J., Obermeier, M., Schennach-Wolff, R., Bauer, M., Adli, M.,. .. Laux, G. (2010). Response and remission criteria in major depression–a validation of current practice. Journal of psychiatric research, 44(15), 1063–1068.
68.
Samsa, G., Edelman, D., Rothman, M. L., Williams, G. R., Lipscomb, J., & Matchar, D. (1999). Determining clinically important differences in health status measures. Pharmacoeconomics, 15(2), 141–155.CrossRefPubMed
69.
Spearman, C. (1904). The proof and measurement of association between two things. The American journal of psychology, 15(1), 72–101.CrossRef
70.
SAS Institute, I. (2011). SAS® 9.3: Software. SAS Institute, Inc. Cary, NC.
71.
Cohen, J. (1988). Statistical Power Analysis for the Behavioral Sciences. 2nd edn. Hillsdale, New Jersey: L: Erlbaum.
72.
Steenkamp, M. M., Litz, B. T., Hoge, C. W., & Marmar, C. R. (2015). Psychotherapy for military-related PTSD: A review of randomized clinical trials. Jama, 314(5), 489–500.CrossRefPubMed
73.
Davidson, J. R., Rothbaum, B. O., van der Kolk, B. A., Sikes, C. R., & Farfel, G. M. (2001). Multicenter, double-blind comparison of sertraline and placebo in the treatment of posttraumatic stress disorder. Archives of general psychiatry, 58(5), 485–492.CrossRefPubMed
74.
Marshall, R. D., Beebe, K. L., Oldham, M., & Zaninelli, R. (2001). Efficacy and safety of paroxetine treatment for chronic PTSD: a fixed-dose, placebo-controlled study. American journal of Psychiatry, 158(12), 1982–1988.CrossRefPubMed
75.
Schnurr, P. P., Friedman, M. J., Foy, D. W., Shea, M. T., Hsieh, F. Y., Lavori, P. W.,. .. Bernardy, N. C. (2003). Randomized trial of trauma-focused group therapy for posttraumatic stress disorder: Results from a Department of Veterans Affairs cooperative study. Archives of general psychiatry, 60(5), 481–489.
76.
Schnurr, P. P., Friedman, M. J., Engel, C. C., Foa, E. B., Shea, M. T., Chow, B. K.,. .. Haug, R. (2007). Cognitive behavioral therapy for posttraumatic stress disorder in women: a randomized controlled trial. Jama, 297(8), 820–830.
77.
Sloan, J. A., Cella, D., & Hays, R. D. (2005). Clinical significance of patient-reported questionnaire data: another step toward consensus. Journal of clinical epidemiology, 58(12), 1217–1219.CrossRefPubMed
78.
Dworkin, R. H., Turk, D. C., Wyrwich, K. W., Beaton, D., Cleeland, C. S., Farrar, J. T.,. .. Ader, D. N. (2008). Interpreting the clinical importance of treatment outcomes in chronic pain clinical trials: IMMPACT recommendations. The Journal of Pain, 9(2), 105–121.
79.
Wisco, B. E., Marx, B. P., Miller, M. W., Wolf, E. J., Mota, N. P., Krystal, J. H.,. .. Pietrzak, R. H. (2016). Probable posttraumatic stress disorder in the US veteran population according to DSM-5: results from the National Health and Resilience in Veterans Study. The Journal of clinical psychiatry, 77(11), 1503–1510.
80.
Zoellner, L. A., Pruitt, L. D., Farach, F. J., & Jun, J. J. (2014). Understanding heterogeneity in PTSD: fear, dysphoria, and distress. Depression and anxiety, 31(2), 97–106.CrossRefPubMed
81.
Haagsma, J. A., Polinder, S., Olff, M., Toet, H., Bonsel, G. J., & van Beeck, E. F. (2012). Posttraumatic stress symptoms and health-related quality of life: a two year follow up study of injury treated at the emergency department. BMC psychiatry, 12(1), 1.CrossRefPubMedPubMedCentral
Metadata
Title
Minimal Clinically Important Differences (MCID) in Assessing Outcomes of Post-Traumatic Stress Disorder
Authors
Elina A. Stefanovics
Robert A. Rosenheck
Karen M. Jones
Grant Huang
John H. Krystal
Publication date
01-03-2018
Publisher
Springer US
Published in
Psychiatric Quarterly / Issue 1/2018
Print ISSN: 0033-2720
Electronic ISSN: 1573-6709
DOI
https://doi.org/10.1007/s11126-017-9522-y

Other articles of this Issue 1/2018

Psychiatric Quarterly 1/2018 Go to the issue

Original Paper

Impact of a Program for the Management of Aggressive Behaviors on Seclusion and Restraint Use in Two High-Risk Units of a Mental Health Institute

Original Paper

Social Workers’ Perceptions of the Association Between Role Playing Games and Psychopathology

Original Paper

Facebook for Supporting a Lifestyle Intervention for People with Major Depressive Disorder, Bipolar Disorder, and Schizophrenia: an Exploratory Study

Original Paper

Improved Sleep, Diet, and Exercise in Adults with Serious Mental Illness: Results from a Pilot Self-Management Intervention

Original Paper

Elder Mistreatment Perpetrators with Substance Abuse and/or Mental Health Conditions: Results from the National Elder Mistreatment Study

Original Paper

The Impact of ‘Being There’: Psychiatric Staff Attitudes on the Use of Restraint