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. Author manuscript; available in PMC: 2020 Jan 1.
Published in final edited form as: Health Psychol. 2018 Nov 1;38(1):1–11. doi: 10.1037/hea0000684

BRIGHTEN Heart Intervention for Depression in Minority Older Adults: Randomized Controlled Trial.

Erin E Emery-Tiburcio 1, Steven K Rothschild 2, Elizabeth Avery 3, Yamin Wang 4, Laurin Mack 5, Robyn L Golden 6, Lucie Holmgren 7, Stevan Hobfoll 8, DeJuran Richardson 9, Lynda H Powell 10
PMCID: PMC6444895  NIHMSID: NIHMS1015513  PMID: 30382712

Abstract

Objective:

Assess the effectiveness of an interdisciplinary geriatric team intervention in decreasing symptoms of depression among urban minority older adults in primary care. Secondary outcomes included cardiometabolic syndrome and trauma.

Methods:

250 African American and Hispanic older adults with PHQ-9 scores ≥8 and BMI ≥25 were recruited from six underserved urban primary care clinics. Intervention arm participants received the BRIGHTEN Heart team intervention plus membership in Generations, an older adult educational activity program; control participants received only Generations.

Results:

Both arms demonstrated clinically significant improvements in PHQ-9 scores at six months (−5 points, intervention and control) and 12 months (−7 points intervention, −6.5 points control); there was no significant difference in change scores between groups on depression or cardiometabolic syndrome at six months; there was a small difference in depression trajectory at 12 months (p < 0.001). More participants in the treatment group (70.7%) had greater than 50% reduction in PHQ-9 scores than the control group (56.3%) (p=.036). For those with higher PTSD symptoms (PCL-C6), improvement in depression was significantly better in the intervention arm than the control arm, regardless of baseline PHQ-9 (p=.001). In mixed models, those with higher PTSD symptoms (β=−0.012, p = < 0.001) in the intervention arm showed greater depression improvement than those with lower PTSD symptoms (β =−0.004, p = 0.001).

Conclusions:

The BRIGHTEN Heart intervention may be effective in reducing depression for urban minority older adults. Further research on team care interventions and screening for PTSD symptoms in primary care is warranted.

Keywords: depression, collaborative care, minority health, older adult, PTSD

Major depression is less prevalent among older adults than younger adults across ethnic and racial groups (Hybels, Blazer, & Pieper, 2001; Kessler et al. 2010; Sutin et al. 2013; Williams et al., 2007), but is more prevalent among minorities (Williams et al., 2007). Studies of African American older adults have documented higher rates than whites (Glymour et al. 2012), although others report similar prevalence as whites (e.g., Woodward, Taylor, Abelson & Matusko, 2013). Prevalence rates of depression among Hispanic older adults range from 11.4% - 25.6% (Black, Markides & Miller 1998; Swenson et al. 2000), with the highest rates among those with lower English language proficiency (Black, et al., 1998; Swenson et al. 2000). Reasons for these differences include access to treatment (Alegría et al. 2008; Williams et al. 2007), lower socioeconomic status (SES) (Koster et al. 2006; Brenes et al. 2008), and increased stressful life experience exposure (Monroe & Hadjiyannakis 2002; Sapolsky, 2004).

The adverse health impact of both major depression and subsyndromal depressive symptoms in the development of coronary heart disease (CHD) are well documented (Davidson, et al., 2010; Lett, et al., 2004). Further, older adults experience increased functional decline, health service utilization, and mortality with minor depression (Cui, Lyness, Tang, Tu, & Conwell, 2008; Vahia et al., 2010). The impact may be particularly pronounced among minority populations. In examining the relationship of poverty to ischemic heart disease risk in an urban minority population, Schulz and colleagues (2005) identified depression as one of four primary predictive pathways, along with physical inactivity, increased waist circumference, and smoking.

Frequently co-morbid with depression, Post-Traumatic Stress Disorder (PTSD) is (Rytwinski, Scur, Feeny, & Youngstrom, 2013) an independent risk factor for cardiovascular morbidity and mortality (e.g., Boscarino, 2006; Dedert, Calhoun, Watkins, Sherwood, & Beckham, 2010). Among urban minority adults, the lifetime prevalence of PTSD ranges from 33-43%, (Gillespie et al., 2009; Liebschutz et al., 2007) in contrast to lifetime prevalence in the general population of 10.1% (Kessler, Petukhova, Sampson, Zaslavsky, & Wittchen, 2012). Adverse physical health consequences are greatest in the context of comorbid depression (Runnals et al., 2013), making the combination of depression and PTSD a “perfect storm,” with devastating impact on health. Effective behavioral interventions to address the mental health of older minorities experiencing depression that are consistent with trauma-informed care may therefore be critical to the elimination of disparities in cardiovascular morbidity and mortality.

According to a recent Cochrane review, there is strong evidence to support the efficacy of collaborative care models (CCMs) in the treatment of depression (Archer et al., 2012). Collaborative care is a multidisciplinary approach to the management of chronic conditions in primary care that includes streamlined communication between providers and utilization of protocols for patient care plans and follow-ups (Archer et al., 2012; Gunn 2006). Multiple studies have investigated the efficacy of CCM for depression co-occurring with chronic illnesses such as diabetes and coronary heart disease. The results of a large multi-site RCT of IMPACT showed that the CCM was an effective treatment for depression in older adults compared to usual care (Unützer et al., 2002), including patients who were experiencing comorbid medical conditions such as diabetes and arthritis (Lin et al., 2003; Williams et al., 2004). Other RCTs evaluating CCMs in the treatment of depression and comorbid cardiac disease also showed improvement in depression (Davidson, et al., 2010; Katon et al., 2010; Rollman et al., 2009). It is notable that some evidence suggests that, among older adults, younger age predicts better response to psychotherapy (Payne & Marcus, 2008). Despite the accumulating evidence of the benefits of CCM for treatment of depression comorbid with chronic illness, few studies have evaluated such models for minority older adults with depression and cardiometabolic syndrome.

The primary aim of this randomized controlled trial was to test the efficacy of the BRIGHTEN Heart multidisciplinary virtual team intervention in reducing depression symptoms in low-income older African Americans and Hispanics with cardiometabolic syndrome, relative to an attention control group. A secondary aim was to determine if the intervention resulted in reductions in the prevalence of cardiometabolic syndrome as compared to the control. An exploratory aim sought to explore the impact of trauma and major life stressors on the results.

Method

Design and Participants

The study protocol was reviewed and approved by the institutional review board of Rush University Medical Center, the sponsoring institution, as well as that of participating community sites. Details of the study protocol and baseline characteristics of the population have been published previously (Rothschild et al., 2016), and are described here in brief.

Recruitment and Screening

Participants were 250 individuals recruited from six primary care clinics serving low-income populations in Chicago (Figure 1). Clinic staff screened all patients over age 60 using the four-item Patient Health Questionnaire – 4 item (PHQ-4) questionnaire (Lowe et al., 2010) and, if positive, referred the individual to the study for consideration with patient consent. Research assistants (RA) conducted telephone screening with referred patients to verify eligibility; eligible participants self-identified as African American or Hispanic, 60 years of age or older, with a BMI greater than 25.0, and symptoms of depression as documented by a PHQ-9 score greater than or equal to 8. Persons already receiving psychotherapy were excluded (n=2), as were those without a working telephone (n=1) or if they had plans to leave the area during the next six months (n=7), as these conditions would adversely impact intervention and control fidelity. Following consent, research assistants screened for the following study exclusion criteria; impaired decisional capacity (as evaluated by their ability to repeat back a description of the study in their own terms), evidence of delusions or active psychosis, or active suicidal ideation verbalized on the PHQ-9 at the time of consent; no potential participants were excluded any of these criteria. Participants were blinded to the study hypotheses; they were told that the study compared two forms of health intervention for depression and cardiovascular risk factors.

Figure 1:

Figure 1:

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Study Consort Diagram

a. Patients who refused intervention were continued in follow-up until they completed, died, fully withdrew, or were lost to follow-up.

b. Follow-up at 12 months

c. Primary analysis at 6 months

Data Collection and Measures

Baseline assessments, including all measures below, were conducted in the participant’s primary care clinic via structured interview. After consent and completion of the baseline assessment, RAs notified the independent Data Management Center (DMC) that the participant was ready to be randomized. The DMC then verified that all inclusion and exclusion criteria had been met. Participants were allocated to intervention and control conditions in a 1:1 ratio using a 4/6 random block design stratified by recruitment site. This ensured that each clinic had equal numbers of participants in each group. The DMC then notified participants and their physicians of their group assignment, and provided a written letter explaining subsequent procedures.

Follow up assessments were conducted by a blinded RA at in the participant’s clinic six and 12 months post randomization. To reduce the risk of missing data and track treatment response, the RA administered a PHQ-9 by telephone at six-week intervals.

Depression.

The Patient Health Questionnaire-9 (PHQ-9) is a 9-item measure of depression that has been validated with older adults (Phelan et al., 2010), ethnically diverse populations (Huang, Chung, Kroenke, & Spitzer, 2006), and in Spanish (Diez-Quevedo, Rangil, Sanchez-Planell, Kroenke, & Spitzer, 2001). A standard minimum score of 10 has been utilized in many studies. In a sample of patients from primary care and obstetrics-gynecology clinics, the PHQ-9 was shown to be a reliable (chronbach’s α=0.89 among primary care participants) and valid (≥10 on the PHQ-9 had specificity of .88) measure of depression severity. (Kroenke, Spitzer, & Williams, 2001). Older adults experience increased functional decline, health service utilization, and mortality with minor depression, however (Cui et al., 2008; Vahia et al., 2010), thus a minimum score of 8 was chosen for study inclusion.

Secondary outcomes.

To determine if the BRIGHTEN Heart team intervention influenced biological, as well as behavioral, risk factors in depressed older adults, prevalence of the cardiometabolic syndrome was used as a secondary trial outcome. The syndrome represents a cluster of metabolic risk factors associated with insulin resistance and the development of atherosclerotic cardiovascular disease (Alberti et al., 2009; Ervin, 2009). Although several definitions have been popularized, investigators used the widely accepted NHLBI / American Heart Association criteria (Grundy, et al., 2005). According to this definition, cardiometabolic syndrome is diagnosed when three of the following five criteria are met: elevated waist circumference (men ≥102 cm; women ≥88 cm), elevated blood pressure (≥130/85 mmHg or taking antihypertensive medication), reduced HDL-cholesterol (men <40mg/dL; women < 50mg/dL, or on lipid lowering medications), elevated triglycerides (≥150 mg/dL or on drug treatment), and elevated fasting blood glucose (≥ 100mg/dl or on glucose lowering medications). To reduce variability and the impact of time since last meal on glucose levels, Hemoglobin A1c ≥ 5.7 was selected as a surrogate for elevated fasting blood glucose.

RAs collected height, weight, waist circumference, and blood pressure measurements. Height and weight were collected using balance beam scales and stadiometers in the patient’s primary care clinic; shoes were removed, as were heavy articles of clothing. Blood pressure was measured using the Omron HEM-907XL automated sphygmomanometer (Omron Healthcare, Kyoto Japan). After measuring the participant’s upper arm circumference to determine the correct cuff size, the RA positioned the participant in a seated position with back and arm supported for 10 minutes. Three readings were taken at two minute intervals, with reporting of the average of the 2nd and 3rd measures. Mean Arterial Pressure was calculated by the standard formula: DBP + 1/3 (SBP – DBP). Hemoglobin A1c, Total Cholesterol, HDL-Cholesterol, LDL-Cholesterol, and Triglycerides were measured from five 50-80 μL Dried Blood Sample Spots collected via finger stick. Standard procedure assays were completed by ZRT laboratory, a CLIA certified diagnostic laboratory.

Measures of trauma and major life stressors included the PTSD Checklist-Civilian Short Form (PCL-C6), Past Stressor Events Form (PSE), and the Life Events Checklist (LEC). The PCL-C6 is a 6-item screen for symptoms of posttraumatic stress disorder. A score of 14 or greater indicates a positive screen for PTSD (Lang & Stein, 2005, Lang et al., 2012). When used in a sample of primary care patients, the PCL-C6 has been shown to have adequate sensitivity of 0.92 and reliability (α=0.78; Lang et al., 2012). The LEC (Blake et al., 1995) is a measure of lifetime trauma exposure with all-item mean kappa of 0.61, and the retest correlation of r=.82, p<.001 (Gray, Litz, Hsu & Lombardo, 2004). The PSE is a 10-item measure of stressful events in the last year adequate reliability (α=0.88; Boardman, Finch, Ellison, Williams, & Jackson, 2001).

Treatment Protocols

Intervention.

The development of the BRIGHTEN program (Emery et al., 2012) and the BRIGHTEN Heart intervention (Rothschild et al., 2016) have been detailed elsewhere. The components of the intervention are as follows. Step 1: Assessment. Semi-structured assessment of mental health and cardiovascular risk with a bilingual Program Coordinator (PC; a geriatric social worker). Step 2: Virtual Team Case Review. BRIGHTEN Heart “virtual team” members review the data via a secure internet-based platform. Virtual team members included a geropsychologist, psychiatrist, social worker, chaplain, dietitian, pharmacist, occupational therapist, and the participant’s own primary care provider (PCP). Team members each provided recommendations for the participant’s overall health, and specifically regarding depression and cardiometabolic syndrome. All virtual team members provided recommendations for each participant, with the exception of the PCPs, who rarely responded to multiple requests. Step 3: Recommendations. The PC reviewed all recommendations with the participant, and together, they prioritized the recommendations and formulated a patient-centered Action Plan. Treatment adherence was measured by Action Plan completion. BRIGHTEN Heart provided the participant’s Action Plan to the PCP, but did not dictate any primary care services provided, including decisions about antidepressant medication. Step 4: Care management. The PC connected participants to all Action Plan services, and provided ongoing care management as needed (referrals to health and community resources, benefits checkups, facilitated communication between health care providers) throughout the one-year program, including monthly phone calls. Psychotherapy was recommended for all participants to address both depression and health behaviors, as well as any relevant issues, including trauma. Step 5: Psychotherapy. Participants accepting psychotherapy engaged in either cognitive behavioral therapy (CBT; 81%) (Serfaty et al., 2009) or interpersonal psychotherapy (IPT; 19%) (van Schaik et al., 2006) in their native English or Spanish language with doctoral psychology or master’s level social work fellows. Psychotherapy type was determined by the interventionist depending on the primary presenting concerns of the participant. Treatment duration was determined by clinical judgment related to symptom remission and relapse prevention and ranged from 1-39 sessions. All psychotherapy was supervised by senior investigators (EET and RLG) and was provided with sensitivity about traumatic life events; psychotherapy explicitly for PTSD was not provided. Additional services recommended by virtual team members and provided outside of the BRIGHTEN Heart core team, such as physical therapy, or participation in chronic disease self-management courses, were tracked by participant self-report. In addition, the intervention cohort was given free membership in the Generations program.

Comparison arm.

The comparison group for this intervention received membership in the Generations health education program. Generations provides health education, social support, and supportive services without the comprehensive assessment and treatment program for depression and cardiometabolic syndrome. Comparison group participants were encouraged but not required to attend Generations events.

Intervention fidelity.

Conduct and completion of steps 1 - 3 of the intervention were monitored by the Data Management Center. Steps 4 and 5 were monitored by one hour each of individual and group supervision weekly by the unblinded co-Principal Investigator (EE-T) and a co-Investigator (RG). Supervisors also listened to a random sample of session recordings to check for fidelity to theoretical base. The DMC prepared monthly control reports of all steps to ensure that the intervention was delivered as intended.

Engagement.

To maintain participant engagement, all participants were asked for at least two alternate telephone contacts at the time of enrollment. Blinded RAs contacted participants by phone every six weeks and sent birthday and holiday cards. Participants not reached by phone were sent registered letters asking them to contact the RA. Stepped incentives included $20 for baseline measures, and $30 and $50 at six and twelve month visits, respectively.

Adverse events.

Participants were asked during 6-week calls about ED visits and hospitalizations since the preceding call. If events were reported, the DMC requested records from the hospital, and the deidentified record was reviewed by two blinded investigators to ascertain if the event was related to study participation. ED visits and hospitalizations were infrequent, and no disagreements were noted between adjudicators.

In addition, the PHQ-9 was administered by phone at each 6-week call. A safety protocol was put in place for any participant who endorsed suicidal ideation: an immediate call was placed from the RA to the clinical supervisor for consultation while the participant was in the room. The clinical supervisor spoke to the participant via phone to assess safety and establish as plan, which included involving licensed staff in the clinic where assessments were completed.

Data Analytic Plan

Statistical analyses were performed using SAS Version 9.3 (Carey, NC). In general, categorical variables were compared between treatment and control arms using chi-square tests, while comparisons of continuous variables used two-sample t-tests, except in instances where non-parametric tests were warranted. All outcomes were analyzed according to the intent-to-treat principle and using all available data.

Change in depressive symptoms.

The primary outcome of this study is change in PHQ-9 from baseline to six months, with sustainability to 12 months. With N=250 participants and an assumed attrition rate of 20%, the study was powered at 85% detect a difference in the mean change in PHQ-9 at 6 months of 2.7 points between the two treatment arms (full details calculation can be found in Rothschild et al., 2016). Wilcoxon rank-sum statistics were used to compare changes at 6 and 12 months between arms, as the change values were non-normally distributed, and Rosenthal’s non-parametric effect size r = Z/√N was utilized. Chi-square tests were used to compare the proportion of participants in each arm who made clinically meaningful changes at 6 and 12 months: 1) the proportion of participants whose PHQ-9 score decreased by 5 points and 2) the proportion whose scores decreased by 50% (McMillon, Gilbody & Richards, 2010). Generalized linear mixed models (GLMMs) were used to analyze PHQ-9 measures over time. A Poisson distribution (Cabrera, Hoge, Bliese, Castro & Messer, 2007; Atkins, Baldwin, Zheng, Gallop, & Neighbors, 2013) and unstructured covariance matrix was assumed. Models included a random intercept and fixed effects for time in weeks, treatment group, and a time by treatment group interaction. Analyses were conducted first using six months data then repeated using 12 month data. Conservatively assuming missing PHQ-9 measures were not missing at random, pattern mixture methods were utilized to assess the influence of missing data. Last observation carried forward (LOCF) and multiple imputation (MI) procedures were included as further sensitivity analyses. The influence of pre-specified covariates (age, gender, ethnicity, PSE, LEC, PCL-C6) on PHQ-9 was assessed using backward elimination, retaining only covariates achieving a p-value <0.20 at each iteration. To evaluate the exploratory aim of the study, PSE, LEC, PCL-C6 (both continuous and positive screen cut point of 14) and age, gender and ethnicity were also separately evaluated as treatment moderators; by adding the following to relevant models to test for differential treatment effects: the variable as a main effect, its two-way interaction with both treatment and time, and a three-way interaction with treatment and time. If the three-way interaction was significant, then a stratified analysis was performed to further investigate the effect of the moderator.

Change in cardiometabolic syndrome components.

The prevalence of cardiometabolic syndrome at six months and 12 months was compared between the arms using chi-square tests. The change in each of the 5 components (waist circumference, blood pressure, HDL, triglycerides, and HbA1c) from baseline to six months and 12 months was compared between arms using either t-tests or Wilcoxon tests, as appropriate. An assumption of no change was imputed for participants with missing follow-up data as a sensitivity measure.

Results

Sample Characteristics

Baseline characteristics of the population appear in Table 1. Intervention and control arms did not differ on any measures. The population was evenly divided between African American and Hispanics. Median age was 68.3 years, and the majority were women (80.4%). Participants were of low SES status, and most did not complete high school. The majority scored in the mild to moderate depressive symptoms range on PHQ-9. Remarkably, 30% had a PTSD positive screen on the PCL-C6 (scores ≥14). Per design, the population was at high cardiometabolic risk, with 86.2% meeting the AHA/NHLBI criteria for Metabolic Syndrome.

Table 1.

Participant Baseline Characteristics

Total Sample (N=250) Treatment (N=126) Control (N=124) p-valuea
Demographics
Female, n (%) 201 (80.4) 100 (79.4) 101 (81.5) 0.680
Age, median (q1, q3) 68.3 (5.7) 68.1 (5.7) 68.5 (5.8) 0.570
Hispanic, n (%) 125 (50.0) 63 (50.0) 62 (50.0) > 0.999
African American, n (%) 125 (50.0) 63 (50.0) 62 (50.0)
Education, categorized, n (%) 0.541
 Less than high school 141 (56.4) 72 (57.1) 69 (55.7)
 High School 37 (14.8) 21 (16.7) 16 (12.9) .
 Some college 52 (20.8) 22 (17.5) 30 (24.2) .
 College or graduate degree 20 (8.0) 11 (8.7) 9 (7.3) .
Relationship status, n (%) 0.131
 Single 50 (20.0) 22 (17.5) 28 (22.6)
 Living with spouse/life partner 77 (30.8) 46 (36.5) 31 (25) .
 Divorced/Separated 71 (28.4) 30 (23.8) 41 (33.1) .
 Widowed 52 (20.8) 28 (22.2) 24 (19.4) .
Average annual income b, n (%) 0.601
 <10,000k 98 (40.0) 47 (38.2) 51 (41.8)
 10,000-19,999k 99 (40.4) 54 (43.9) 45 (36.9) .
 >20,000k 45 (18.4) 20 (16.3) 25 (20.5) .
 Unknown/No answer given 3 (1.2) 2 (1.6) 1 (0.8) .
Insurance c, n (%)
 Medicare only 60 (24.9) 32 (26.4) 28 (23.3) 0.990
 Medicaid only 19 (7.9) 10 (8.3) 9 (7.5) .
 Medicare plus private 25 (10.4) 12 (9.9) 13 (10.8) .
 Medicare plus Medicaid 45 (18.7) 21 (17.4) 24 (20) .
 No insurance 60 (24.9) 30 (24.8) 30 (25) .
 Other/private 32 (13.3) 16 (13.2) 16 (13.3) .
Employment, n (%) 0.137
 Employed or care-giver 24 (9.8) 7 (5.7) 17 (13.9)
 Retired 134 (54.7) 72 (58.5) 62 (50.8) .
 Unemployed/disabled 79 (32.2) 41 (33.3) 38 (31.1) .
 Refused/do not know 8 (3.3) 3 (2.4) 5 (4.1) .
Depression symptoms
 PHQ-9, median (q1, q3) d 11 (9 - 14) 11 (9 - 14) 11 (9 - 15) 0.417
 PHQ-9 categorized, n (%)d 0.708
  8 - 9 86 (34.4) 47 (37.3) 39 (31.5)
  10 - 14 102 (40.8) 50 (39.7) 52 (41.9) .
  15 - 19 47 (18.8) 23 (18.3) 24 (19.4) .
  >=20 15 (6.0) 6 (4.8) 9 (7.3) .
Other Psychosocial Factors
 Major Life Event in Last Year (PSE) median (q1, q3) e 2.5 (1 - 4) 2 (1 - 3) 3 (1 - 4) 0.461
 Lifetime Traumatic Events (TSE), median (q1, q3) f 5 (3 - 9) 5.5 (3 - 9) 5 (3 - 10.5) 0.991
 PTSD symptoms, median (q1, q3) g 11 (8 - 15) 12 (8 - 15) 10 (7 - 14.5) 0.136
 PTSD score ≥ 14, n (%) g 75 (30.0) 41 (32.5) 34 (27.4) 0.377
Cardiometabolic syndrome factors
 Overweight / obesity , n(%) 222 (89.5) 112 (89.6) 110 (89.4) 0.965
 Glucose intolerance h, n(%) 184 (78.6) 92 (78) 92 (79.3) 0.802
 Low HDL cholesteroli, n(%) 172 (68.8) 87 (69.0) 85 (68.5) 0.932
 Elevated triglyceridesj, n(%) 154 (67.8) 78 (69.0) 76 (66.7) 0.706
 Elevated blood pressurek, n(%) 222 (88.8) 116 (92.1) 106 (85.5) 0.099
Cardiometabolic syndromel, n(%) 193 (86.2) 95 (85.6) 98 (86.7) 0.805
Waist circumference (cm), mean(std)m 107.3 (14.7) 109.0 (14.8) 105.5 (14.4)
Blood Pressure (BP)
 Systolic BP (mm Hg), mean(std) 140.6 (20.9) 142.2 (21.4) 139 (20.4) 0.230
 Diastolic BP (mm Hg), mean(std) 77.2 (11.9) 77.5 (11.2) 76.9 (12.7) 0.678
Lipids
 Total cholesterol (mg/dL), median (q1, q3) 189 (163 - 223) 189 (167 - 217) 188.5 (161 - 223) 0.629
 HDL cholesterol (mg/dL), median (q1, q3) 49 (40.5 - 61) 49 (41 - 62) 49 (40 - 60) 0.547
 Triglycerides (mg/dL), median (q1, q3) 153 (111 - 215) 154 (115 - 232) 145 (100 - 206) 0.218
HBA1c, median (q1, q3) 6.4 (5.7 - 7.6) 6.4 (5.7 - 7.8) 6.3 (5.7 - 7.5) 0.853
Medications
 Glucose lowering, n(%) 95 (42.4) 49 (43.4) 46 (41.4) 0.771
 HDL raising, n(%) 87 (38.8) 43 (38.1) 44 (39.6) 0.808
 Triglyceride lowering, n(%) 87 (38.8) 43 (38.1) 44 (39.6) 0.808
 Blood pressure lowering, n(%) 178 (79.5) 92 (81.4) 86 (77.5) 0.466
 Anti-depressant, n(%) 52 (23.2) 29 (25.7) 23 (20.7) 0.381
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a

Wilcoxon used for comparing non-normal data, Chi-square used for categorical data, t-tests used for normally distributed continuous data, Fisher’s exact test used for categorical data with cell counts < 5.

b

Total family income before taxes

c

n=6 participants did not know their insurance status

d

Patient Health Questionnaire-9, 9 items, range 0-3 (Not at all to nearly every day). Higher scores indicate greater depression severity.

e

Past Stressor Events Form, response format: yes, no, refuse, higher score indicates experiencing more stressful events over past year.

f

Traumatic Stress Checklist, response format: yes, no, don’t know, refuse, higher score indicated experiencing more stressful events over a lifetime.

g

PCL-Civilian Short Form, response format: range 1-5 (not at all to extremely), score range: 0-30. Higher scores indicate more severe symptoms of PTSD. A score of greater than 14 indicates moderate to severe PTSD

h

Hemoglobin A1c ≥5.7 or on Glucose-lowering medications, missing data (n=21)

i

<1.0 mmol/L (40 mg/dL) (men); <1.3 mmol/L (50 mg/dL) (women), missing data (n=18)

j

≥1.7 mmol/L (150 mg/dL) or on lipid lowering medicines, missing data (n=30)

k

≥130/85 mmHg or on blood pressure lowering medicines, missing data (n=3)

l

≥3 risk factors cardiometabolic syndrome missing data (n=26)

m

Waist ≥102 cm (men) or ≥88 cm (women), missing data (n=2)

Treatment Fidelity

Of the 126 randomized to the treatment arm, 116 (92%) completed an initial evaluation with the PC. Of those, 7 (6%) completed all monthly calls from the PC, 43 (37%) completed 75 - 99% of calls, 50 (43%) completed 50 - 74% of calls, 13 (11%) completed 25-49% of calls, and 3 (3%) completed less than 25% of calls. For the 114 participants for whom psychotherapy was recommended, 92 (80.7%) accepted the recommendation, of whom 48 (52%) completed more than 75% of scheduled sessions and 26 (28.2%) completed between 50-75%. Both intervention and control groups were provided with free membership in the Generations program. Data on attendance at program activities is not available due to changes in the way that Generations attendance data was collected by program staff (outside of study control) during the study period.

Primary Outcome

At six months, both arms had median 5 point reductions (reflecting a decrease in severity category) in PHQ-9 scores from baseline with no statistical difference between intervention and control (p=0.226, effect size = 0.056) as seen in Table 2. The reductions continued at 12 months but without significant difference between arms. Similarly, the proportion that achieved a 5 point reduction in PHQ-9 score was not significantly different between the two arms at six months (T: 55.6%; C: 51.5%) and 12 months (T: 75.8%; C: 63.5%). At 12 months, however, significantly more participants in the treatment group (69.7%) than control (52.1%) had achieved a 50% or greater reduction in depressive symptoms (p=0.012).

Table 2.

Change in outcome variables at 6 month and 12 month follow-up

6 months 12 months
Treatment (N=108) Control (N=103) p-valuea Treatment (N=99) Control (N=96) p-valuea
Depression symptoms
 PHQ-9 b, median (q1, q3) −5 (−8,−3) −5 (−8,−1) 0.226 −7 (−9,−5) −6.5 (−9,−3) 0.227
Cardiometabolic syndrome factors
 Waist Circumference, mean(std) − 1.0 (5.9) 0.1 (8.4) 0.326 −2.1 (7.4) −1.8 (8.4) 0.806
 Systolic BP (mm Hg), median (q1, q3) −5.5 (−21.8, 6.0) −4.5 (−16 , 5.0) 0.692 −3.0 (−10.0,5.0) −2.5 (−17, 6.5) 0.769
 Diastolic BP (mm Hg), median (q1, q3) −2.0 (−11.3, 4.0) −2.3 (−9.0, 3.0) 0.961 −3.0 (−10.0,5.0) −3.5 (−12, 4) 0.466
 HDL (mg/dL), median (q1, q3) 7 (−4, 16) 10 (−1, 18) 0.411 2 (−4, 18) 5 (−3, 15) 0.845
 Triglycerides (mg/dL), mean(std) 7.4 (139.4) 24.0 (119.6) 0.409 −13.3 (119.7) 19.0 (135.3) 0.115
 HBA1c, mean(std) −0.1 (0.9) 0.0 (0.8) 0.376 −0.2 (1.2) −0.3 (1.3) 0.840
Medication Adherence
 Medication Adherence, n(%) 0.142 0.942
  Decline in adherence 28 (29.5) 23 (24.2) 27 (28.4) 29 (30.5)
  Improvement in adherence 22 (23.2) 14 (14.7) 13 (13.7) 12 (12.6)
  No change in adherence 45 (47.4) 58 (61.0) 55 (57.9) 54 (56.8)
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a

Wilcoxon used for comparing non-normal data where median (q1, q3) reported , Chi-square used for categorical data, t-tests used for normally distributed continuous data where mean(std) reported

b

Patient Health Questionnaire-9, 9 items, range 0-3 (Not at all to nearly every day). Higher scores indicate greater depression severity.

Mixed-modeling of change in depressive symptoms from baseline showed a significant decrease in PHQ-9 scores at six months, but with no significant difference in trajectory between the two arms. However, at 12 months, a significant difference in trajectories between the two arms was detected (Tx*weeks :p < 0.001 β = −0.008; see Figure 2a). Pattern mixture methods, LOCF and MI procedures were utilized to assess the influence of missing data as sensitivity analysis and yielded the same results.

Figure 2. Predicted PHQ-9 Values.

Figure 2.

Open in a new tab

a Based on a GLMM model with a Poisson distribution, unstructured covariance matrix and random intercept predicting PHQ-9 over 12 months. β coefficients on a linear-predictor scale (ie log of outcome). Similar results were found after adjusting for Age, gender and ethnicity. Beta coefficients are on a linear-predictor scale (i.e. log of outcome) and should be interpreted as the percent difference.

Analyses to identify possible treatment moderators among those specified a priori (age, gender, ethnicity, trauma and major life stressors measured byPCL-C6, PSE, LEC) indicated no difference in response to treatment with respect to age, gender, traumatic life events, past stressor events or ethnicity, although ethnic differences in severity of symptoms were observed at baseline (Rothschild et al., 2016). However, differential treatment effects were indicated with respect to participants with baseline PTSD symptoms as measured by PCL-C6 score (Tx*Time* PCL-C6 p<0.001). In order to illustrate this complex interaction, the model was run with an interaction of participants with PTSD positive screen, PCL-C6 score ≥ 14, with similar significance (Tx*Time* PCL-C6 ≥ 14: β = −0.008 p<0.001). As seen in Figure 2b, participants with PTSD positive screen showed significantly greater reductions in PHQ-9 score within the treatment arm compared to the control arm. A significant treatment by time interaction (p = 0.001) implied that this effect increased over time.

Secondary Outcomes: Metabolic Syndrome

Table 2 shows changes in the Metabolic Syndrome components of blood pressure, waist circumference, lipids, and Hemoglobin A1c from baseline. None of these reached statistical or clinical significance at six or 12 months. Neither arm showed changes in prevalence of the Metabolic Syndrome, at six months (Tx: 85.7%m C:80.9%) or at 12 months (Tx: 82.6%m C:79.6%), and no significant difference was found between the two arms.

Adverse Events

A total of 86 adverse events were identified and reviewed, affecting 26 participants in the intervention arm and 32 in the control arm. Adverse events in the intervention arm consisted of 19 Emergency Department visits, 25 hospitalizations, and no deaths; 19 participants had one adverse event, 5 participants had two events, and 2 had three or more events. In the control arm, participants experienced 25 Emergency Department visits, 25 hospitalizations, and 1 death. No adverse events, including the death, were adjudicated to be due to participation in the trial. No significant difference in adverse events between the two study arms.

Discussion

The BRIGHTEN Heart trial tested whether a virtual interdisciplinary intervention in primary care would have a positive impact on depression and cardiometabolic risk when compared to a control condition. The intervention arm participants showed clinically significant improvements in depressive symptoms at six and 12 months (PHQ-9-5 and -7 points, respectively); similar improvements were also noted in the comparison arm (−5 points and −6.5 points respectively). Post-hoc analysis, however, showed a 50% reduction in PHQ-9 scores from baseline to 12 months was achieved significantly more often among participants in the treatment group (70.7%) than the control group (56.3%) (p=0.036). Thus, while both groups showed clinical improvement, intervention participants were more likely to have major reductions in PHQ-9 scores. It is also notable given that the IMPACT program, now widely regarded as the standard CCM for older adults, reported that 45% of intervention arm participants experienced a 50% reduction in depression symptoms as their main outcome (Unützer et al., 2002).

Within the cohort with a positive PTSD screen, improvements in depression scores were significantly better in the intervention arm than the control arm, regardless of baseline PHQ-9 score. Further, among those in the intervention arm with a positive PTSD screen, participants with higher baseline PCL-C6 scores demonstrated greater depression improvements than those with lower scores. There was no difference in completion of monthly case management calls, psychotherapy attendance, and treatment plan by positive PTSD screen within the intervention arm. Unfortunately, due to the lack of fidelity information in the control, we cannot assess if there was a difference in fidelity between arms due to PTSD symptom level. Thus, those with the most complex mental health issues benefitted most from a highly individually tailored program with multiple layers of intervention. While trauma was not the focus of treatment, this finding suggests that particularly vulnerable older adults may respond well to an integrated team approach with a team who is sensitive to the needs of individuals with a trauma history.

Observed improvements in both arms were seen largely during the first month of study participation, suggesting that some participants benefitted simply by enrolling in the study. This has been described by others in the process of psychotherapy (e.g., Stiles et al., 2003) and results in a non-linear treatment response curve. This might be addressed in subsequent trials by building in a wash out period between baseline assessment and randomization; individuals who improve spontaneously between the two time points would be excluded from randomization. Another approach to this challenge would be to require a higher baseline depression score. Based on data showing that older adults with subsyndromal depression experienced decreased functional status, a PHQ-9 score of 8 was set as the threshold for study inclusion (Lyness et al., 2007); requiring higher baseline scores, consistent with moderate or severe depression, would reduce the risk of spontaneous improvement in depression. Alternatively, independent diagnostic confirmation of Major Depressive Disorder via Structured Clinical Interview for DSM-5 (SCID-5) could also be used as an enrollment criterion; such an approach however would limit generalizability and practical application in under-resourced primary care settings.

Integration of the virtual team with the primary care team posed benefits and challenges. Unique members of a primary care team, particularly the chaplain, provided highly nuanced recommendations that helped the team to engage participants and align participant values with health behavior. Challenges included availability of space in the clinic, and the high patient volumes within safety net primary care practices. For some participants, this led to a one month delay in starting psychotherapy. Primary care providers were inconsistently engaged with the BRIGHTEN team because of their own workloads, and there was a low rate of participation in the care planning process. Future implementation research should focus on strategies to reduce the delays in beginning care planning and treatment, improve participation by clinic staff, and facilitate on-going communications around progress towards goals for depression and CHD risk.

Psychotherapy in BRIGHTEN Heart had a very high attendance rate. In general, community mental health attendance rates are near 50% (Williston, Block-Lerner, Wolanin, & Gardner, 2014) for adults. By comparison, our low SES, minority older adults with multiple medical problems had an overall show rate of 73%, with 51.6% completing more than 75% of sessions. Thus, those with the greatest barriers to engagement had higher rates than community adults with therapists who were not age, race, or culture-matched. While there may be many variables contributing to this pattern, participant report suggests that our team’s approach of patient-centered care, addressing multiple medical issues in addition to mental health, destigmatized participation in psychotherapy and increased engagement in the BRIGHTEN Heart program. It is particularly encouraging that both African American and Hispanic participants were receptive to the intervention and to psychotherapy, and both cohorts showed comparable response to the BRIGHTEN Heart intervention.

The results of this study have several implications for further research and clinical practice. The fact that participants in both the intervention and comparison arms showed improvement in depression symptoms suggests that some older adults may show spontaneous improvements in mild to moderate depressive symptoms with lower intensity interventions. Further research could elucidate if the resource-intensive BRIGHTEN Heart intervention is effective in persons whose depressive symptoms persist over time. Second, findings highlight the importance of screening for trauma in primary care, particularly as PTSD and trauma-exposed individuals are common in this setting, especially among urban minority populations (Gillock, Zayfert, Hegel, & Ferguson, 2005; Kartha et al., 2008; Liebschutz et al., 2007). Those with higher levels of PTSD symptoms may benefit more from a more intensive, integrated team approach (Unützer, et al., 2002) with trauma informed care (Amaro, et al., 2007). Further studies are warranted to test these concepts.

Acknowledgments

This research was part of the Rush Center for Urban Health Equity, which was funded by the National Institutes of Health (NIH) through the National Institute for Heart Lung and Blood (NHLBI), grant number 1P50HL105189-01. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health. Isaura Gandarilla, Joyce Alvarado, Lindsey Mitchell, David Mata, Serena Silvestry, and Syed Quadri provided assistance with data collection.

Footnotes

TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT01428791

Contributor Information

Erin E. Emery-Tiburcio, Behavioral Sciences, Rush University Medical Center

Steven K. Rothschild, Preventive Medicine, Rush University Medical Center

Elizabeth Avery, Preventive Medicine, Rush University Medical Center.

Yamin Wang, Preventive Medicine, Rush University Medical Center.

Laurin Mack, Behavioral Sciences, Rush University Medical Center.

Robyn L. Golden, Health & Aging, Rush University Medical Center

Lucie Holmgren, Behavioral Sciences, Rush University Medical Center; Psychological Science, Gustavus Adolphus College.

Stevan Hobfoll, Behavioral Sciences, Rush University Medical Center.

DeJuran Richardson, Preventive Medicine, Rush University Medical Center.

Lynda H. Powell, Preventive Medicine, Rush University Medical Center

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