M ILITARY M EDICINE, 180. 6:697, 2015
Mental Health Predictors of Veterans Willingness to Consider Research Participation Jennifer S. Funderburk, PhD*; Suzanne Spinola, M S f; Stephen A. Maisto, PhDf
ABSTRACT This study aimed to determine whether mental health factors predict Veterans’ willingness to hear about research participation opportunities. A sample of 954 Veterans completed measures to assess psychological functioning and were asked about interest in clinical research opportunities and willingness to share de-identified personal data with researchers. Of these Veterans, 75.8% were willing to listen to research opportunities at their local VA, and 100% agreed to share de-identified information. Poorer mental health correlated with a greater willingness to listen to research opportu nities implying that Veterans who are experiencing a greater degree of mental health impairment may be overrepresented in clinical studies.
INTRODUCTION When conducting clinical research with military men and women, a major question is the degree to which a study’s find ings are generalizable to the larger population of Veterans.1 A major variable in this regard is the degree of difficulty in recruiting representative samples of the Veteran population. Past research has investigated factors that may influ ence a participant’s willingness to engage in research. For instance, factors studied have included stigma of and nega tive attitudes toward research,2 the increased effort that research participation requires, such as scheduling con flicts, transportation difficulties,3-6 and the perception of risk in participating in clinical research.3,7 Any or all of these factors may lead Veterans to choose not to participate in research. One area that has not been studied, however, is whether an individual's mental health status or level of functioning is related to recruitment and/or research participation. This is surprising, considering that clinical research often focuses on specific aspects of health, such as studies that evaluate the efficacy of pharmacological or psychological treatments. Mental health disorders, such as post-traumatic stress dis order (PTSD), alcohol/drug dependence,8-12 depression,11' 12 generalized anxiety disorder (GAD),11' 12 panic disorder,12 and bipolar disorder13 are common within Veteran popula tions, such as those who served in Operation Iraqi Freedom/ Operation Enduring Freedom or in Vietnam. There are many ways symptoms of these disorders may positively or nega
*Syracuse Veterans' Association, Center for Integrated Healthcare, 800 Irving Avenue, Syracuse, NY 13210. ■(Department of Psychology, Syracuse University, 430 Huntington Hall. Syracuse, NY 13244. This article was presented in poster format at the VA Mental Health Conference, Title “Are there differences between veterans agreeing to hear about research and those who are not?”, Baltimore, MD, August 2011. The views expressed in this article are those of the authors and do not reflect the official policy of the Veterans' Affairs’ Department, the Department of Defense, or other departments of the U.S. Government. doi: 10.7205/MILMED-D-14-00478
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tively impact a Veterans’ willingness to listen to research opportunities and ultimately participate. For instance, many Veterans may experience functional disabilities because of such mental health disorders, which have the potential to limit their abilities to complete everyday tasks, such as trav eling to a VA to participate in a research study.14 It has also been suggested that individuals with certain mental health disorders, such as alcohol dependence (AD) or drug depen dence, may be more interested in a research study because of the monetary compensation often involved with participa tion.1'"’ Gaining a better understanding of whether mental health plays a role in an individual’s willingness to participate in research would help researchers to develop better Veteran recruitment strategies and to further specify the generalizability of research conducted within the Veteran population. The purpose of this study was to explore whether mental health variables predict Veterans’ willingness to listen to research opportunities at their local Veteran’s Health Admin istration clinic. If a Veteran is not willing to listen to the recruitment information, it eliminates any chance of the research staff recruiting that individual. Existing evidence suggests that age,4 gender,5 and race6 may be important pre dictors in Veterans’ research participation; therefore, they will be included in this study as well. As there is no existing research to guide the selection of mental health variables, the common quality-of-life questionnaire, the Short Form-12 (SF-12), was used to focus on the Veteran’s level of mental health functioning. The SF-12 focuses on functional impair ment without the potential for other specific symptoms to play a role in willingness. However, we also wanted to examine whether the presence of symptoms consistent with psychiatric disorders would be a significant predictor, as this data is readily accessible within the electronic medical record. Therefore, we focused on the presence, individual, and combined impact of symptoms of common psychiatric disorders, such as alcohol/drug dependence, PTSD, depres sion, GAD, panic disorder, and mania seen in Veteran's Health Administration primary care clinics on willingness to listen to research opportunities.
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Mental Health Predictors o f Veterans Willingness fo r Research Participation
METHODS R e c ru itm e n t
Behavioral Health Laboratory (BHL) called 954 (97.0% male, 60.1% manned, 92.5% white) Veterans between Octo ber 17, 2008 and November 1, 2010. The BHL, an extension of the Syracuse and Rochester Veteran Affair’s primary care clinics, employs health technicians who conduct comprehen sive clinical assessments of mental health symptoms16 with Veterans over the telephone as requested by their primary care providers. A total of 97.4% of Veterans sampled were called because their primary care providers requested that BHL conduct additional assessments if any primary care screen for hazardous or harmful alcohol misuse was positive (i.e., scores > 4 for men or scores > 3 for women on the AUDIT-C17). As a result, 37.9% of the Veterans recruited qualified as high-risk drinkers (i.e., males drinking >13 drinks per week or >3 drinks on any given occasion; females drinking >7 drinks per week or >2 drinks on any given occasion). Primary care providers referred the remaining Veterans to the BHL for further assessment of other con cerns (e.g., anxiety, depression). P ro c e d u re
Veterans were deemed suitable for the study if they were 18 years of age or older and did not report any gross neuro logical impairment as assessed by the Blessed Orientation Test (i.e., score < 8).18 Sampled Veterans were asked two questions at the end of their BHL interviews: (1) whether they would like to talk to research personnel to receive information about research opportunities at their local VA and (2) whether they would be willing to consent to allow basic demographic and health information that was col lected from the BHL assessment to be accessible to research staff, with the understanding that all information would be de-identified. The BHL interview took approximately 45 minutes to complete. The information was collected in the following order: demographic information, the MiniInternational Neuropsychiatric Interview (M.I.N.I.), the Patient Health Questionnaire-9 (PHQ-9), and the SF-12. The Syracuse Veterans Affairs Medical Center IRB approved all procedures. M e a s u re s
Demographic information was collected, including Veteran gender, age, and ethnicity. The M.l.N.I. is a structured diagnostic psychiatric interview designed to detect symptoms of a wide array of DSM-IV dis orders.19 In the BHL, they only used a portion of the M.l.N.I. focusing on the following disorders: mania, panic disorder, GAD, AD, drug dependence, and PTSD. The M.l.N.I has been found to have good validity and reliability in diagnosing different mental disorders.19,20 Sheehan20 found that diagnostic inter-rater reliability was high for most disorders (k > 0.76), as was diagnostically sensitive (sensitivity > 0.87).
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The PHQ-9 was administered to assess depression symp toms for depression based on criteria stated in the DSM-IV.21 Depression scores for Veterans were calculated based on the nine items being scored from 0 to 3. Scores above 14 were categorized as reporting symptoms of major depressive disor der. The PHQ-9 has been shown to have excellent reliability, with a test-retest correlation of 0.84 and Cronbach’s a = 0.89 in a primary care study; the criterion validity was also excel lent, with validity in diagnosing major depression of 0.95."' The SF-12 was administered to assess Veteran quality of life associated with measures of mental and physical health.22 We chose to focus on the mental health dimension of the assessment. Mental health composite total scores for Veterans were derived using the algorithms provided by the instrument developers, with higher scores indicating the highest level of health. The mental health composite has been shown to have decent reliability, with a test-retest correlation of 0.76 and high validity, with relative validity estimates of 0.97.22
D a ta A n a lys is
For level of mental health functioning, a hierarchical logistic regression analysis was conducted. For all logistic analyses (Models 1-9), demographics variables, such as age, gender, and race (white vs. nonwhite), were first entered into the analysis as covariates. Additional hierarchical logistic regres sion analyses were conducted for examining the predictor variables associated with the presence of symptoms associ ated with any of the 6 disorders assessed. To do these ana lyses, dichotomous variables were created for all of the disorders, so that Veterans indicating symptoms consistent with the disorder were coded as “ 1.” A dichotomous vari able identifying the presence of any disorder was created so that Veterans indicating symptoms of major depressive dis order (MDD), PTSD, GAD, AD, drug dependence, or panic disorder were coded as “ 1.” Because of the low rates of endorsement for symptoms of drug dependence ( n = 7) and panic disorder ( n = 8) within the total sample, these vari ables were not included in the subsequent analyses. Separate hierarchical logistic regression analyses were conducted to examine the predictive value of the presence of any symp toms, the individual types of symptoms, and the combined presentation on willingness to listen to research opportunities (0 = declined, 1 = agreed). However, descriptive statistics revealed high correlations between the variables identifying Veterans with symptoms consistent with MDD and PTSD ( r = 0.54), MDD and GAD ( r = 0.53), PTSD and GAD ( r = 0.53) creating a concern about multicollinearity when examining combined presentation. Therefore, we examined the prevalence of the different combinations of disorders in an effort to focus our analyses. Approximately 13% ( n = 123) of the patients reported symptoms of psychiatric disorders, with 42% ( n = 52) of them reporting symptoms of more than 1 psychiatric disorder. The most common combinations were patients reporting symptoms of MDD, PTSD. and GAD
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Mental Health Predictors of Veterans Willingness for Research Participation TABLE I.
N Age: M (SD); Range Gender Race SF-12 Mental Score M (SD); Range Number of Psychiatric Diagnoses M (SD); Range Symptoms of Any Psychiatric Dx Symptoms of AD Symptoms of PTSD Symptoms of MDD Symptoms of GAD
Description of the Sample Agreed to Hear
Declined Hearing
724 65.03 (16.64); 21.89-95.82 Male: 697 (96.3%) White: 662 (91.4%) 53.5 (10.46); 6.2-75.1 0.26 (0.73); 0-4 Yes: 105 Yes: 51 (7%) Yes: 47 (6.5%) Yes: 38 (5.2%) Yes: 49 (6.8%)
230 68.19 (16.51); 23.13-91.57 Male: 228 (99.1%) White: 220 (95.7%) 55.86 (8.70); 15.6-70.1 0.13 (0.53); 0-4 Yes: 18 Yes: 4 (1.7%) Yes: 7 (3%) Yes: 8 (3.5%) Yes: 11 (4.8%)
SF-12, Short Form-12; AD, alcohol dependence; PTSD, posttraumatic stress disorder; MDD, major depressive disorder; GAD, generalized anxiety disorder.
in =11), and all 4 disorders (n = 11). We decided to examine the predictive value of each disorder alone and then examined the impact of the presence of symptoms of multiple psychi atric disorders by summing the dichotomous variables identi fying Veterans reporting symptoms of PTSD, MDD, AD, and GAD (see Table I).
RESULTS All Veterans (N = 954) gave permission to research staff to use the data obtained by the BHL after identifying informa tion were removed. A majority of those Veterans (N = 724) also indicated they were interested in hearing about research opportunities at their local VA and gave permission for research staff to use the BHL obtained data. Table I provides a descriptive overview of the main vari ables used for this study. Results revealed nonsignificant associations (i.e., age [p = 0.07], gender [p = 0.07], and eth nicity [p = 0.10]) with agreement to hear about research (Models 1-9, Level 1). However, we continued to include them in the rest of the logistic analyses because of existing research establishing them as important predictors4' 6 and a trend of a significant relationship among all three variables and agreement to hear about research opportunities. SF-12 Mental Health Composite Score The logistic regression to further understand whether the Veterans’ mental health functioning was related to agreement to hear about research (Model 1, Level 2) revealed an inverse relationship between SF-12 mental health composite score and likelihood of agreement to hear about research (/) = -0.02; OR = 0.98; p < 0.05) after controlling for demo graphic variables. Results of this analysis are summarized in Table II. Presence of Symptoms of Any Psychiatric Diagnosis In a separate logistic regression analysis, we examined whether the presence of symptoms consistent with any psychiatric disorder would be related to the Veteran’s agreement to hear about research after adding demographic variables (Model 2,
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Level 2). When comparing Veterans with symptoms consis tent to a psychiatric diagnosis and those without, there was a statistical trend that those with symptoms consistent with a psychiatric diagnosis were more likely to agree to hear about research (fl = 0.53; OR = 1.7; p < 0.06). Results of this analy sis are summarized in Table II. Presence of Symptoms Consistent With Specific Psychiatric Diagnoses In a separate logistic regression analysis, we examined the relationships between the specific and combinations of psy chiatric diagnoses and their predictive value on Veterans’ Regression Results for the Final Models Predicting Agreement to Hear About Research (N = 954)
TABLE II.
Predictors Level 1 Age Gender Ethnicity Level 2, Model 1 Age Gender Ethnicity SF-12 Mental Score Level 2. Model 2 Age Gender Ethnicity Presence of Symptoms of Any Psychiatric Dx Level 2, Model 8 Age Gender Ethnicity Symptoms of AD Level 2, Model 9 Age Gender Ethnicity Summed Dx
P
SE
OR
P
-0.009 -1.341 -0.588
0.005 0.741 0.356
0.991 0.262 0.555
0.065 0.070 0.098
-0.007 -1.288 -0.502 -0.021
0.005 0.742 0.359 0.009
0.993 0.276 0.605 0.979
0.184 0.082 0.162 0.018
-0.007 -1.367 -0.483 0.533
0.005 0.741 0.361 0.278
0.993 0.255 0.617 1.704
0.176 0.065 0.181 0.056
-0.007 -1.387 -0.503 1.324
0.005 0.741 0.359 0.530
0.993 0.250 0.604 3.758
0.145 0.061 0.161 0.012
-0.007 -1.361 -0.504 0.257
0.005 0.741 0.360 0.147
0.993 0.257 0.604 1.292
0.157 0.066 0.161 0.080
SF-12, Short Form-12; AD = alcohol dependence.
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Mental Health Predictors of Veterans Willingness for Research Participation agreement to hear about research after adding the demo graphics (Models 2-8, Level 2). Analyses revealed a signifi cant relationship between those Veterans reporting symptoms consistent with AD and the agreement to hear about research opportunities at the VA (Model 8, Level 2; /3 = 1.324; OR = 3.76; p < 0.01). All other variables demonstrated non significant relationships. Results of these analyses are sum marized in Table II. Presence of Symptoms Consistent With Multiple Psychiatric Diagnoses In a separate logistic regression analysis, we examined whether the summed number of psychiatric diagnoses the Veteran reported symptoms consistent with predicted Veteran’s agree ment to hear about research after adding demographic vari ables (Model 9, Level 2). However, no significant relationship was found (as shown in Table II). DISCUSSION The purpose of this study was to determine whether mental health factors predict a Veterans’ willingness to hear about research studies at their local VA. Specifically, this study found that those Veterans with a lower score on the mental health subscale of the SF-12 were more likely to be willing to hear the description of current studies recruiting at their local VA. Similarly, those Veterans reporting symptoms consistent with AD were significantly more likely to be will ing to hear about research studies vs. those Veterans without a diagnosis of AD or those with symptoms of all four dis orders. These data suggest that those Veterans who are experiencing symptoms that more severely impact their daily functioning or those with symptoms of AD may be more likely to participate in research because of the fact that they are more willing to listen to the recruitment information. It is notable that none of the Veterans sampled refused to allow their health information to be collected through a chart review process. Even though a fair number of them were not willing to listen to current research studies being offered, these indirect efforts to assist in improving the care through research were supported. Even though certain individuals did not want to hear about participation in research, all were willing to allow the research team access to their medical records; this could indicate an overall desire to assist in the care of other Veterans despite ambivalence regarding their own participation in clinical studies. This study has several limitations. The only source of contacting Veterans was through BHL telephone surveys. Although a prominent clinical service to primary care and one that is initiated for Veterans often likely to endorse mental health symptoms, the BHL does not talk to every Veteran seen in primary care. In addition, this study included a larger number of Veterans specifically referred to BHL for additional assessment because of an unresolved positive AUDIT-C screen. Future research should continue to examine
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this question in other Veteran samples. In addition, the BHL is limited to asking the recruitment question via telephone. In this regard, the route of delivering the relevant questions may influence a Veteran's willingness to hear about or par ticipate in studies. Another limitation was that our sample consisted almost entirely of older white male Veterans from two primary care clinics in upstate New York, which limits our ability to generalize to other VA-based primary care clinics in the United States. The low number of female Vet erans included in the BHL assessments is surprising, when compared to the data suggesting 8% of Veterans served in Veterans Integrated Service Network 2 are females.23 In addi tion, the information related to mental health was obtained via self-report. Although this data provides preliminary guidance for how mental health may be affecting the generalizability of our research samples, additional research should be conducted to replicate the findings. Overall, additional research is needed to determine what initiatives can be used to help increase Veterans’ willingness to participate in clinical research studies, especially those who may be experiencing a greater level of mental health impairment. Researchers must aim to understand Veterans’ perceptions of health-related research and their motivations to participate in it in order to reach a larger and more repre sentative population of Veterans. Such understanding would likely increase Veteran participation in research and would enhance the research community’s ability to generate more effective Veteran health care services. ACKNOWLEDGMENT This material is based upon the work supported by the VA Center for Inte grated Healthcare.
REFERENCES 1. National Commission for the Protection of Human Subjects of Bio medical and Behavioral Research: The Belmont Report: Ethical Princi ples and Guidelines for the Protection of Human Subjects of Research. U.S. Department of Health and Human Services, 1979. Available at http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.html; accessed November 3, 2014. 2. Madsen SM, Holm S, Davidsen B, et al: Ethical aspects of clinical trials: the attitudes of participants in two non-cancer trials. J Int Med 2000; 248: 463-74. 3. Cunny K, Miller H: Participation in clinical drug studies: motivations and barriers. Clin Ther 1994; 16: 273-82. 4. Kirkpatrick MA: Factors that motivate healthy adults to participate in phase I drug trials. Drug Inform J 1991; 25: 109-13. 5. Schron EB, Wasserthel-Smoller S, Pressel S: Clinical trial participant satis faction: survey of SHEP enrollees. J Amer Geriatr Soc 1997; 45: 934-43. 6. Taylor RE: Pharmacological and cultural considerations in alcohol treatment clinical trials: issues in clinical research related to race and ethnicity. Alcohol Clin Exp Res 2003; 27: 1345-8. 7. Campbell HM. Raisch DW, Sather MR, Warren SR. Segal AR: A com parison of veteran and nonveteran motivations and reasons for partici pating in clinical trials. Mil Med 2007; 172: 27-9. 8. Boscarino J: Current excessive drinking among Vietnam veterans: a comparison with other veterans and non-veterans. Int J Soc Psychiatry 1981; 27: 204-12.
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Mental Health Predictors o f Veterans Willingness fo r Research Participation 9. Pietrzak RH, Goldstein MB. Malley JC, Johnson DC. Southwick SM: Subsyndromal posttraumatic stress disorder is associated with health and psychosocial difficulties in veterans of Operations Enduring Freedom and Iraqi Freedom. Depress Anxiety 2009; 26: 739-44. 10. Price JL: Findings from the National Veterans’ Readjustment Study. National Center for PTSD. United States Department of Veteran Affairs, 2007. Available at http://www.ptsd.va.gov/professional/research-bio/ research/vietnam-vets-study.asp; accessed November 3, 2014. 11. Seal KH. Bertenthal D. Miner CR, Sen S, Marmar CM: 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. Arch Intern Med 2007; 167: 476-82. 12. Adler DA. Possemato K, Mvandadi S, et al: Psychiatric status and work performance of veterans of Operations Enduring Freedom and Iraqi Freedom. Psychiatr Serv 2011; 62: 39-46. 13. Chwastiak LA, Rosenheck RA, Kazis LE: Utilization of primary care by veterans with psychiatric illness in the National Department of Veterans Affairs Health Care System. J Gen Intern Med 2008; 23: 1835-40. 14. Kessler RC: Posttraumatic stress disorder: the burden to the individual and to society. J Clin Psychiatry 2000; 61:4 -1 2 . 15. Sieber JE. Sorensen JL: Conducting social and behavioral AIDS research in drug treatment clinics. IRB 1992; 14(5): 1-5.
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16. Oslin D. Ross J, Sayers S. Murphy J. Kane V, Katz I: Screening, assessment, and management of depression in VA primary care clinics. J Gen Int Med 2006; 21(1): 46-50. 17. Bradley KA, DeBenedetti AF, Volk RJ. Williams EC. Frank D, Kivlahan DR: AUDIT-C as a brief screen for alcohol misuse in primary care. Alcohol Clin Exp Res 2007; 31: 1208-17. 18. Katzman R. Brown T. Fuld P. Peck A, Schechter R, Schimmel H: Vali dation of a short orientation-memory-concentration test of cognitive impairment. Am J Psychiatry 1983; 140: 734-9. 19. Sheehan DV, Lecrubier Y, Sheehan KH. et al: The Mini-International Neuropsychiatric Interview (M.I.N.I.): the development and validation of a structured diagnostic psychiatric interview for DSM-IV and ICD-10. J Clin Psychiatry 1998; 59: 22-33. 20. Sheehan DV, Lecrubier Y, Sheehan KH, et al: The validity of the MiniInternational Neuropsychiatric Interview (M.I.N.I) according to the SCID-P and its reliability. Eur Psychiat 1997; 12: 232-41. 21. Kroenke K. Spitzer RL. Williams JB: The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med 2001: 16: 606-13. 22. Ware JE, 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: 220-3. 23. Office of the Actuary: Veteran Population. Available at http://www.va .gov/vetdata/Veteran_Population.asp; accessed October 31. 2014.
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Mental Health Predictors of Veterans Willingness to Consider Research Participation Jennifer S. Funderburk, PhD*; Suzanne Spinola, M S f; Stephen A. Maisto, PhDf
ABSTRACT This study aimed to determine whether mental health factors predict Veterans’ willingness to hear about research participation opportunities. A sample of 954 Veterans completed measures to assess psychological functioning and were asked about interest in clinical research opportunities and willingness to share de-identified personal data with researchers. Of these Veterans, 75.8% were willing to listen to research opportunities at their local VA, and 100% agreed to share de-identified information. Poorer mental health correlated with a greater willingness to listen to research opportu nities implying that Veterans who are experiencing a greater degree of mental health impairment may be overrepresented in clinical studies.
INTRODUCTION When conducting clinical research with military men and women, a major question is the degree to which a study’s find ings are generalizable to the larger population of Veterans.1 A major variable in this regard is the degree of difficulty in recruiting representative samples of the Veteran population. Past research has investigated factors that may influ ence a participant’s willingness to engage in research. For instance, factors studied have included stigma of and nega tive attitudes toward research,2 the increased effort that research participation requires, such as scheduling con flicts, transportation difficulties,3-6 and the perception of risk in participating in clinical research.3,7 Any or all of these factors may lead Veterans to choose not to participate in research. One area that has not been studied, however, is whether an individual's mental health status or level of functioning is related to recruitment and/or research participation. This is surprising, considering that clinical research often focuses on specific aspects of health, such as studies that evaluate the efficacy of pharmacological or psychological treatments. Mental health disorders, such as post-traumatic stress dis order (PTSD), alcohol/drug dependence,8-12 depression,11' 12 generalized anxiety disorder (GAD),11' 12 panic disorder,12 and bipolar disorder13 are common within Veteran popula tions, such as those who served in Operation Iraqi Freedom/ Operation Enduring Freedom or in Vietnam. There are many ways symptoms of these disorders may positively or nega
*Syracuse Veterans' Association, Center for Integrated Healthcare, 800 Irving Avenue, Syracuse, NY 13210. ■(Department of Psychology, Syracuse University, 430 Huntington Hall. Syracuse, NY 13244. This article was presented in poster format at the VA Mental Health Conference, Title “Are there differences between veterans agreeing to hear about research and those who are not?”, Baltimore, MD, August 2011. The views expressed in this article are those of the authors and do not reflect the official policy of the Veterans' Affairs’ Department, the Department of Defense, or other departments of the U.S. Government. doi: 10.7205/MILMED-D-14-00478
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tively impact a Veterans’ willingness to listen to research opportunities and ultimately participate. For instance, many Veterans may experience functional disabilities because of such mental health disorders, which have the potential to limit their abilities to complete everyday tasks, such as trav eling to a VA to participate in a research study.14 It has also been suggested that individuals with certain mental health disorders, such as alcohol dependence (AD) or drug depen dence, may be more interested in a research study because of the monetary compensation often involved with participa tion.1'"’ Gaining a better understanding of whether mental health plays a role in an individual’s willingness to participate in research would help researchers to develop better Veteran recruitment strategies and to further specify the generalizability of research conducted within the Veteran population. The purpose of this study was to explore whether mental health variables predict Veterans’ willingness to listen to research opportunities at their local Veteran’s Health Admin istration clinic. If a Veteran is not willing to listen to the recruitment information, it eliminates any chance of the research staff recruiting that individual. Existing evidence suggests that age,4 gender,5 and race6 may be important pre dictors in Veterans’ research participation; therefore, they will be included in this study as well. As there is no existing research to guide the selection of mental health variables, the common quality-of-life questionnaire, the Short Form-12 (SF-12), was used to focus on the Veteran’s level of mental health functioning. The SF-12 focuses on functional impair ment without the potential for other specific symptoms to play a role in willingness. However, we also wanted to examine whether the presence of symptoms consistent with psychiatric disorders would be a significant predictor, as this data is readily accessible within the electronic medical record. Therefore, we focused on the presence, individual, and combined impact of symptoms of common psychiatric disorders, such as alcohol/drug dependence, PTSD, depres sion, GAD, panic disorder, and mania seen in Veteran's Health Administration primary care clinics on willingness to listen to research opportunities.
697
Mental Health Predictors o f Veterans Willingness fo r Research Participation
METHODS R e c ru itm e n t
Behavioral Health Laboratory (BHL) called 954 (97.0% male, 60.1% manned, 92.5% white) Veterans between Octo ber 17, 2008 and November 1, 2010. The BHL, an extension of the Syracuse and Rochester Veteran Affair’s primary care clinics, employs health technicians who conduct comprehen sive clinical assessments of mental health symptoms16 with Veterans over the telephone as requested by their primary care providers. A total of 97.4% of Veterans sampled were called because their primary care providers requested that BHL conduct additional assessments if any primary care screen for hazardous or harmful alcohol misuse was positive (i.e., scores > 4 for men or scores > 3 for women on the AUDIT-C17). As a result, 37.9% of the Veterans recruited qualified as high-risk drinkers (i.e., males drinking >13 drinks per week or >3 drinks on any given occasion; females drinking >7 drinks per week or >2 drinks on any given occasion). Primary care providers referred the remaining Veterans to the BHL for further assessment of other con cerns (e.g., anxiety, depression). P ro c e d u re
Veterans were deemed suitable for the study if they were 18 years of age or older and did not report any gross neuro logical impairment as assessed by the Blessed Orientation Test (i.e., score < 8).18 Sampled Veterans were asked two questions at the end of their BHL interviews: (1) whether they would like to talk to research personnel to receive information about research opportunities at their local VA and (2) whether they would be willing to consent to allow basic demographic and health information that was col lected from the BHL assessment to be accessible to research staff, with the understanding that all information would be de-identified. The BHL interview took approximately 45 minutes to complete. The information was collected in the following order: demographic information, the MiniInternational Neuropsychiatric Interview (M.I.N.I.), the Patient Health Questionnaire-9 (PHQ-9), and the SF-12. The Syracuse Veterans Affairs Medical Center IRB approved all procedures. M e a s u re s
Demographic information was collected, including Veteran gender, age, and ethnicity. The M.l.N.I. is a structured diagnostic psychiatric interview designed to detect symptoms of a wide array of DSM-IV dis orders.19 In the BHL, they only used a portion of the M.l.N.I. focusing on the following disorders: mania, panic disorder, GAD, AD, drug dependence, and PTSD. The M.l.N.I has been found to have good validity and reliability in diagnosing different mental disorders.19,20 Sheehan20 found that diagnostic inter-rater reliability was high for most disorders (k > 0.76), as was diagnostically sensitive (sensitivity > 0.87).
698
The PHQ-9 was administered to assess depression symp toms for depression based on criteria stated in the DSM-IV.21 Depression scores for Veterans were calculated based on the nine items being scored from 0 to 3. Scores above 14 were categorized as reporting symptoms of major depressive disor der. The PHQ-9 has been shown to have excellent reliability, with a test-retest correlation of 0.84 and Cronbach’s a = 0.89 in a primary care study; the criterion validity was also excel lent, with validity in diagnosing major depression of 0.95."' The SF-12 was administered to assess Veteran quality of life associated with measures of mental and physical health.22 We chose to focus on the mental health dimension of the assessment. Mental health composite total scores for Veterans were derived using the algorithms provided by the instrument developers, with higher scores indicating the highest level of health. The mental health composite has been shown to have decent reliability, with a test-retest correlation of 0.76 and high validity, with relative validity estimates of 0.97.22
D a ta A n a lys is
For level of mental health functioning, a hierarchical logistic regression analysis was conducted. For all logistic analyses (Models 1-9), demographics variables, such as age, gender, and race (white vs. nonwhite), were first entered into the analysis as covariates. Additional hierarchical logistic regres sion analyses were conducted for examining the predictor variables associated with the presence of symptoms associ ated with any of the 6 disorders assessed. To do these ana lyses, dichotomous variables were created for all of the disorders, so that Veterans indicating symptoms consistent with the disorder were coded as “ 1.” A dichotomous vari able identifying the presence of any disorder was created so that Veterans indicating symptoms of major depressive dis order (MDD), PTSD, GAD, AD, drug dependence, or panic disorder were coded as “ 1.” Because of the low rates of endorsement for symptoms of drug dependence ( n = 7) and panic disorder ( n = 8) within the total sample, these vari ables were not included in the subsequent analyses. Separate hierarchical logistic regression analyses were conducted to examine the predictive value of the presence of any symp toms, the individual types of symptoms, and the combined presentation on willingness to listen to research opportunities (0 = declined, 1 = agreed). However, descriptive statistics revealed high correlations between the variables identifying Veterans with symptoms consistent with MDD and PTSD ( r = 0.54), MDD and GAD ( r = 0.53), PTSD and GAD ( r = 0.53) creating a concern about multicollinearity when examining combined presentation. Therefore, we examined the prevalence of the different combinations of disorders in an effort to focus our analyses. Approximately 13% ( n = 123) of the patients reported symptoms of psychiatric disorders, with 42% ( n = 52) of them reporting symptoms of more than 1 psychiatric disorder. The most common combinations were patients reporting symptoms of MDD, PTSD. and GAD
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Mental Health Predictors of Veterans Willingness for Research Participation TABLE I.
N Age: M (SD); Range Gender Race SF-12 Mental Score M (SD); Range Number of Psychiatric Diagnoses M (SD); Range Symptoms of Any Psychiatric Dx Symptoms of AD Symptoms of PTSD Symptoms of MDD Symptoms of GAD
Description of the Sample Agreed to Hear
Declined Hearing
724 65.03 (16.64); 21.89-95.82 Male: 697 (96.3%) White: 662 (91.4%) 53.5 (10.46); 6.2-75.1 0.26 (0.73); 0-4 Yes: 105 Yes: 51 (7%) Yes: 47 (6.5%) Yes: 38 (5.2%) Yes: 49 (6.8%)
230 68.19 (16.51); 23.13-91.57 Male: 228 (99.1%) White: 220 (95.7%) 55.86 (8.70); 15.6-70.1 0.13 (0.53); 0-4 Yes: 18 Yes: 4 (1.7%) Yes: 7 (3%) Yes: 8 (3.5%) Yes: 11 (4.8%)
SF-12, Short Form-12; AD, alcohol dependence; PTSD, posttraumatic stress disorder; MDD, major depressive disorder; GAD, generalized anxiety disorder.
in =11), and all 4 disorders (n = 11). We decided to examine the predictive value of each disorder alone and then examined the impact of the presence of symptoms of multiple psychi atric disorders by summing the dichotomous variables identi fying Veterans reporting symptoms of PTSD, MDD, AD, and GAD (see Table I).
RESULTS All Veterans (N = 954) gave permission to research staff to use the data obtained by the BHL after identifying informa tion were removed. A majority of those Veterans (N = 724) also indicated they were interested in hearing about research opportunities at their local VA and gave permission for research staff to use the BHL obtained data. Table I provides a descriptive overview of the main vari ables used for this study. Results revealed nonsignificant associations (i.e., age [p = 0.07], gender [p = 0.07], and eth nicity [p = 0.10]) with agreement to hear about research (Models 1-9, Level 1). However, we continued to include them in the rest of the logistic analyses because of existing research establishing them as important predictors4' 6 and a trend of a significant relationship among all three variables and agreement to hear about research opportunities. SF-12 Mental Health Composite Score The logistic regression to further understand whether the Veterans’ mental health functioning was related to agreement to hear about research (Model 1, Level 2) revealed an inverse relationship between SF-12 mental health composite score and likelihood of agreement to hear about research (/) = -0.02; OR = 0.98; p < 0.05) after controlling for demo graphic variables. Results of this analysis are summarized in Table II. Presence of Symptoms of Any Psychiatric Diagnosis In a separate logistic regression analysis, we examined whether the presence of symptoms consistent with any psychiatric disorder would be related to the Veteran’s agreement to hear about research after adding demographic variables (Model 2,
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Level 2). When comparing Veterans with symptoms consis tent to a psychiatric diagnosis and those without, there was a statistical trend that those with symptoms consistent with a psychiatric diagnosis were more likely to agree to hear about research (fl = 0.53; OR = 1.7; p < 0.06). Results of this analy sis are summarized in Table II. Presence of Symptoms Consistent With Specific Psychiatric Diagnoses In a separate logistic regression analysis, we examined the relationships between the specific and combinations of psy chiatric diagnoses and their predictive value on Veterans’ Regression Results for the Final Models Predicting Agreement to Hear About Research (N = 954)
TABLE II.
Predictors Level 1 Age Gender Ethnicity Level 2, Model 1 Age Gender Ethnicity SF-12 Mental Score Level 2. Model 2 Age Gender Ethnicity Presence of Symptoms of Any Psychiatric Dx Level 2, Model 8 Age Gender Ethnicity Symptoms of AD Level 2, Model 9 Age Gender Ethnicity Summed Dx
P
SE
OR
P
-0.009 -1.341 -0.588
0.005 0.741 0.356
0.991 0.262 0.555
0.065 0.070 0.098
-0.007 -1.288 -0.502 -0.021
0.005 0.742 0.359 0.009
0.993 0.276 0.605 0.979
0.184 0.082 0.162 0.018
-0.007 -1.367 -0.483 0.533
0.005 0.741 0.361 0.278
0.993 0.255 0.617 1.704
0.176 0.065 0.181 0.056
-0.007 -1.387 -0.503 1.324
0.005 0.741 0.359 0.530
0.993 0.250 0.604 3.758
0.145 0.061 0.161 0.012
-0.007 -1.361 -0.504 0.257
0.005 0.741 0.360 0.147
0.993 0.257 0.604 1.292
0.157 0.066 0.161 0.080
SF-12, Short Form-12; AD = alcohol dependence.
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Mental Health Predictors of Veterans Willingness for Research Participation agreement to hear about research after adding the demo graphics (Models 2-8, Level 2). Analyses revealed a signifi cant relationship between those Veterans reporting symptoms consistent with AD and the agreement to hear about research opportunities at the VA (Model 8, Level 2; /3 = 1.324; OR = 3.76; p < 0.01). All other variables demonstrated non significant relationships. Results of these analyses are sum marized in Table II. Presence of Symptoms Consistent With Multiple Psychiatric Diagnoses In a separate logistic regression analysis, we examined whether the summed number of psychiatric diagnoses the Veteran reported symptoms consistent with predicted Veteran’s agree ment to hear about research after adding demographic vari ables (Model 9, Level 2). However, no significant relationship was found (as shown in Table II). DISCUSSION The purpose of this study was to determine whether mental health factors predict a Veterans’ willingness to hear about research studies at their local VA. Specifically, this study found that those Veterans with a lower score on the mental health subscale of the SF-12 were more likely to be willing to hear the description of current studies recruiting at their local VA. Similarly, those Veterans reporting symptoms consistent with AD were significantly more likely to be will ing to hear about research studies vs. those Veterans without a diagnosis of AD or those with symptoms of all four dis orders. These data suggest that those Veterans who are experiencing symptoms that more severely impact their daily functioning or those with symptoms of AD may be more likely to participate in research because of the fact that they are more willing to listen to the recruitment information. It is notable that none of the Veterans sampled refused to allow their health information to be collected through a chart review process. Even though a fair number of them were not willing to listen to current research studies being offered, these indirect efforts to assist in improving the care through research were supported. Even though certain individuals did not want to hear about participation in research, all were willing to allow the research team access to their medical records; this could indicate an overall desire to assist in the care of other Veterans despite ambivalence regarding their own participation in clinical studies. This study has several limitations. The only source of contacting Veterans was through BHL telephone surveys. Although a prominent clinical service to primary care and one that is initiated for Veterans often likely to endorse mental health symptoms, the BHL does not talk to every Veteran seen in primary care. In addition, this study included a larger number of Veterans specifically referred to BHL for additional assessment because of an unresolved positive AUDIT-C screen. Future research should continue to examine
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this question in other Veteran samples. In addition, the BHL is limited to asking the recruitment question via telephone. In this regard, the route of delivering the relevant questions may influence a Veteran's willingness to hear about or par ticipate in studies. Another limitation was that our sample consisted almost entirely of older white male Veterans from two primary care clinics in upstate New York, which limits our ability to generalize to other VA-based primary care clinics in the United States. The low number of female Vet erans included in the BHL assessments is surprising, when compared to the data suggesting 8% of Veterans served in Veterans Integrated Service Network 2 are females.23 In addi tion, the information related to mental health was obtained via self-report. Although this data provides preliminary guidance for how mental health may be affecting the generalizability of our research samples, additional research should be conducted to replicate the findings. Overall, additional research is needed to determine what initiatives can be used to help increase Veterans’ willingness to participate in clinical research studies, especially those who may be experiencing a greater level of mental health impairment. Researchers must aim to understand Veterans’ perceptions of health-related research and their motivations to participate in it in order to reach a larger and more repre sentative population of Veterans. Such understanding would likely increase Veteran participation in research and would enhance the research community’s ability to generate more effective Veteran health care services. ACKNOWLEDGMENT This material is based upon the work supported by the VA Center for Inte grated Healthcare.
REFERENCES 1. National Commission for the Protection of Human Subjects of Bio medical and Behavioral Research: The Belmont Report: Ethical Princi ples and Guidelines for the Protection of Human Subjects of Research. U.S. Department of Health and Human Services, 1979. Available at http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.html; accessed November 3, 2014. 2. Madsen SM, Holm S, Davidsen B, et al: Ethical aspects of clinical trials: the attitudes of participants in two non-cancer trials. J Int Med 2000; 248: 463-74. 3. Cunny K, Miller H: Participation in clinical drug studies: motivations and barriers. Clin Ther 1994; 16: 273-82. 4. Kirkpatrick MA: Factors that motivate healthy adults to participate in phase I drug trials. Drug Inform J 1991; 25: 109-13. 5. Schron EB, Wasserthel-Smoller S, Pressel S: Clinical trial participant satis faction: survey of SHEP enrollees. J Amer Geriatr Soc 1997; 45: 934-43. 6. Taylor RE: Pharmacological and cultural considerations in alcohol treatment clinical trials: issues in clinical research related to race and ethnicity. Alcohol Clin Exp Res 2003; 27: 1345-8. 7. Campbell HM. Raisch DW, Sather MR, Warren SR. Segal AR: A com parison of veteran and nonveteran motivations and reasons for partici pating in clinical trials. Mil Med 2007; 172: 27-9. 8. Boscarino J: Current excessive drinking among Vietnam veterans: a comparison with other veterans and non-veterans. Int J Soc Psychiatry 1981; 27: 204-12.
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Mental Health Predictors o f Veterans Willingness fo r Research Participation 9. Pietrzak RH, Goldstein MB. Malley JC, Johnson DC. Southwick SM: Subsyndromal posttraumatic stress disorder is associated with health and psychosocial difficulties in veterans of Operations Enduring Freedom and Iraqi Freedom. Depress Anxiety 2009; 26: 739-44. 10. Price JL: Findings from the National Veterans’ Readjustment Study. National Center for PTSD. United States Department of Veteran Affairs, 2007. Available at http://www.ptsd.va.gov/professional/research-bio/ research/vietnam-vets-study.asp; accessed November 3, 2014. 11. Seal KH. Bertenthal D. Miner CR, Sen S, Marmar CM: 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. Arch Intern Med 2007; 167: 476-82. 12. Adler DA. Possemato K, Mvandadi S, et al: Psychiatric status and work performance of veterans of Operations Enduring Freedom and Iraqi Freedom. Psychiatr Serv 2011; 62: 39-46. 13. Chwastiak LA, Rosenheck RA, Kazis LE: Utilization of primary care by veterans with psychiatric illness in the National Department of Veterans Affairs Health Care System. J Gen Intern Med 2008; 23: 1835-40. 14. Kessler RC: Posttraumatic stress disorder: the burden to the individual and to society. J Clin Psychiatry 2000; 61:4 -1 2 . 15. Sieber JE. Sorensen JL: Conducting social and behavioral AIDS research in drug treatment clinics. IRB 1992; 14(5): 1-5.
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16. Oslin D. Ross J, Sayers S. Murphy J. Kane V, Katz I: Screening, assessment, and management of depression in VA primary care clinics. J Gen Int Med 2006; 21(1): 46-50. 17. Bradley KA, DeBenedetti AF, Volk RJ. Williams EC. Frank D, Kivlahan DR: AUDIT-C as a brief screen for alcohol misuse in primary care. Alcohol Clin Exp Res 2007; 31: 1208-17. 18. Katzman R. Brown T. Fuld P. Peck A, Schechter R, Schimmel H: Vali dation of a short orientation-memory-concentration test of cognitive impairment. Am J Psychiatry 1983; 140: 734-9. 19. Sheehan DV, Lecrubier Y, Sheehan KH. et al: The Mini-International Neuropsychiatric Interview (M.I.N.I.): the development and validation of a structured diagnostic psychiatric interview for DSM-IV and ICD-10. J Clin Psychiatry 1998; 59: 22-33. 20. Sheehan DV, Lecrubier Y, Sheehan KH, et al: The validity of the MiniInternational Neuropsychiatric Interview (M.I.N.I) according to the SCID-P and its reliability. Eur Psychiat 1997; 12: 232-41. 21. Kroenke K. Spitzer RL. Williams JB: The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med 2001: 16: 606-13. 22. Ware JE, 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: 220-3. 23. Office of the Actuary: Veteran Population. Available at http://www.va .gov/vetdata/Veteran_Population.asp; accessed October 31. 2014.
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