Electronic protocol for suicide risk management in research participants.

OBJECTIVE: To describe an electronic, telephone-delivered, suicide risk management protocol (SRMP) that is designed to guide research staff and safely triage study participants who are at risk for self-harm. METHODS: We tested the SRMP in the context of the NIH-funded randomized clinical trial "Bypassing the Blues" in which 302 patients who had undergone coronary artery bypass graft surgery (CABG) were screened for depression and assessed by telephone 2-weeks following hospital discharge and at 2-, 4-, and 8-month follow-up. We programmed the SRMP to assign different risk levels based on patients' answers from none to imminent with action items for research staff keyed to each of them. We describe frequency of suicidal thinking, SRMP use, and completion of specific steps in the SRMP management process over the 8-month follow-up period. RESULTS: Suicidal ideation was expressed by 74 (25%) of the 302 study participants in 139 (13%) of the 1069 blinded telephone assessments performed by research staff. The SRMP was launched in 103 (10%) of assessments, and the suicidal risk level was classified as moderate or high in 10 (1%) of these assessments, thereby necessitating an immediate evaluation by a study psychiatrist. However, no hospitalizations, emergency room visits, or deaths ascribed to suicidal ideation were discovered during the study period. CONCLUSION: The SRMP was successful in systematically and safely guiding research staff lacking specialty mental health training through the standardized risk assessment and triaging research participants at risk for self-harm. TRIAL REGISTRATION: Clinicaltrials.gov Identifier: NCT00091962 (http://clinicaltrials.gov/ct2/show/NCT00091962?term=rollman+cabg&rank=1).

Benefits of collaborative care for post-CABG depression are not related to adjustments in antidepressant pharmacotherapy.

OBJECTIVE: To determine whether the use and adjustment of antidepressant pharmacotherapy accounted for the beneficial effects of collaborative care treatment on the improvement of mood symptoms and health-related quality of life (HRQoL) after coronary artery bypass graft (CABG) surgery. METHODS: In a post-hoc analysis of data from the Bypassing the Blues (BtB) trial we tested the impact of antidepressant medication on changes in depression and HRQoL from the early postoperative period to 8-month follow-up. Two hundred fifty-nine depressed post-CABG patients scoring ≥10 on the Patient Health Questionnaire-9 were classified in four groups according to whether or not they received antidepressants at baseline and 8-months following randomization. RESULTS: Patients using antidepressant pharmacotherapy at baseline and follow-up tended to be younger and female (p≤0.01), but were similar in various clinical characteristics. Just 24% (63/259) of patients were on an antidepressant at baseline which increased to 36% at follow-up (94/259). Compared to other groups, patients on antidepressants at both baseline and follow-up assessment showed the smallest improvement in mood symptoms and HRQoL. While multivariate analyses confirmed that randomization to collaborative care was associated with greater improvement in mood symptoms (odds ratio [OR]=3.1; 95%-confidence interval [CI]=1.8-5.4, p<0.0001) and mental HRQoL (OR=3.6, CI=1.4-9.3, p=0.01), use of antidepressant medication had no differential impact on either measure (p=0.06 and p=0.92, respectively). CONCLUSION: The beneficial effects of collaborative care for post-CABG depression were not generated by adjustments in antidepressant medication. TRIAL REGISTRATION: Clinicaltrials.gov Identifier: NCT00091962. (http://clinicaltrials.gov/ct2/show/NCT00091962?term=rollman+cabg&rank=1).

A positive 2-item Patient Health Questionnaire depression screen among hospitalized heart failure patients is associated with elevated 12-month mortality.

BACKGROUND: Given the association of depression with poorer cardiac outcomes, an American Heart Association Science Advisory has advocated routine screening of cardiac patients for depression using the 2-item Patient Health Questionnaire (PHQ-2) "at a minimum." However, the prognostic value of the PHQ-2 among HF patients is unknown. METHODS AND RESULTS: We screened hospitalized HF patients (ejection fraction [EF] <40%) that staff suspected may be depressed with the PHQ-2, and then determined vital status at up to 12-months follow-up. At baseline, PHQ-2 depression screen-positive patients (PHQ-2+; n = 371), compared with PHQ-2 screen-negative patients (PHQ-2-; n = 100), were younger (65 vs 70 years) and more likely to report New York Heart Association (NYHA) functional class III/IV than class II symptoms (67% vs. 39%) and lower levels of physical and mental health-related quality of life (all P ≤ .002); they were similar in other characteristics (65% male, 26% mean EF). At 12 months, 20% of PHQ-2+ versus 8% of PHQ-2- patients had died (P = .007) and PHQ-2 status remained associated with both all-cause (hazard ratio [HR] 3.1, 95% confidence interval [CI] 1.4-6.7; P = .003) and cardiovascular (HR 2.7, 95% CI 1.1-6.6; P = .03) mortality even after adjustment for age, gender, EF, NYHA functional class, and a variety of other covariates. CONCLUSIONS: Among hospitalized HF patients, a positive PHQ-2 depression screen is associated with an elevated 12-month mortality risk.

Optimism, response to treatment of depression, and rehospitalization after coronary artery bypass graft surgery.

OBJECTIVE: Optimism has been associated with a lower risk of rehospitalization after coronary artery bypass graft (CABG) surgery, but little is known about how optimism affects treatment of depression in post-CABG patients. METHODS: Using data from a collaborative care intervention trial for post-CABG depression, we conducted exploratory post hoc analyses of 284 depressed post-CABG patients (2-week posthospitalization score in the 9-item Patient Health Questionnaire ≥ 10) and 146 controls without depression who completed the Life Orientation Test - Revised (full scale and subscale) to assess dispositional optimism. We classified patients as optimists and pessimists based on the sample-specific Life Orientation Test - Revised distributions in each cohort (full sample, depressed, nondepressed). For 8 months, we assessed health-related quality of life (using the 36-item Short-Form Health Survey) and mood symptoms (using the Hamilton Rating Scale for Depression [HRS-D]) and adjudicated all-cause rehospitalization. We defined treatment response as a 50% or higher decline in HRS-D score from baseline. RESULTS: Compared with pessimists, optimists had lower baseline mean HRS-D scores (8 versus 15, p = .001). Among depressed patients, optimists were more likely to respond to treatment at 8 months (58% versus 27%, odds ratio = 3.02, 95% confidence interval = 1.28-7.13, p = .01), a finding that was not sustained in the intervention group. The optimism subscale, but not the pessimism subscale, predicted treatment response. By 8 months, optimists were less likely to be rehospitalized (odds ratio = 0.54, 95% confidence interval = 0.32-0.93, p = .03). CONCLUSIONS: Among depressed post-CABG patients, optimists responded to depression treatment at higher rates. Independent of depression, optimists were less likely to be rehospitalized by 8 months after CABG. Further research should explore the impact of optimism on these and other important long-term post-CABG outcomes.

Prevalence and correlates of complicated grief in adults who have undergone a coronary artery bypass graft.

BACKGROUND: Complicated grief (CG) is a recently described mental health condition that follows bereavement. CG is often comorbid with depression and may also be associated with poor health outcomes. However, CG has not been studied in depressed medically ill populations. This study examined the prevalence, correlates, and impact of CG in depressed post-coronary artery bypass graft surgery (CABG) patients. METHODS: A 5-item CG screen was administered to 302 depressed post-CABG patients participating in a comparative effectiveness intervention trial at 7 Pittsburgh-area hospitals from March 2004 to September 2007. Eligible patients were randomly assigned to either a telephone-delivered collaborative care intervention for depression or their primary care physicians' usual care. Measures examined depression, physical and mental health-related quality of life, and physical functioning over 8 months. RESULTS: Compared to CG screen-negative patients, CG screen-positive patients were younger, more likely to: be female, non-White, have lost a partner or child, and to have used tobacco or antidepressants. At baseline, they had significantly higher depression and lower mental health scores. At 8 months, screen-positives had poorer physical functioning and marginally higher depression scores. LIMITATIONS: The study lacked a definitive measure of CG. Moreover, the CG-positive group was relatively small, reducing the power to detect differences between groups or control for the possible influence of other variables on identified results. CONCLUSIONS: CG in depressed post-CABG patients is associated with negative health and mental health outcomes. These results underscore the importance of identifying and treating CG in depressed medically ill populations.

Treating post-CABG depression with telephone-delivered collaborative care: does patient age affect treatment and outcome?

OBJECTIVE: To determine the nature of telephone-delivered collaborative care intervention provided to patients younger than and older than 60 years experiencing clinically significant depressive symptoms after coronary artery bypass graft (CABG) surgery and whether patient age is related to response and remission rates and delivery of care at 8-month follow-up. DESIGN: : Exploratory post-hoc analysis of data collected in a randomized controlled trial (RCT). SETTING: Seven Pittsburgh-area general hospitals. PARTICIPANTS: Fifty-eight depressed post-CABG patients younger than 60 and 92 comparable patients age 60 years and older randomized to the RCT's intervention arm. MEASUREMENTS: : Components of collaborative care provided to patients over the 8-month study period and Hamilton Rating Scale for Depression scores at 8-month follow-up to determine response and remission status. RESULTS: There were no differences in the cumulative 8-month rates at which the components of collaborative care were delivered to the two age groups. Similar response and remission rates were also achieved by these groups. CONCLUSION: Older and younger patients experiencing clinical depression after CABG surgery can be treated with comparable components of collaborative care, and both age groups will achieve clinical outcomes that do not differ significantly from each other.

Sleep variability, health-related practices, and inflammatory markers in a community dwelling sample of older adults.

OBJECTIVE: To explore relationships between wake- and sleep-related health behaviors and circulating concentrations of inflammatory markers (interleukin [IL]-6 and tumor necrosis factor [TNF]-α) in a cohort of community dwelling older adults. Low-grade chronic inflammation is an important risk factor for age-related morbidity. Health behaviors, including average aggregate measures of sleep, have been linked to increased inflammation in older adults. Variability in sleep timing may also be associated with increased inflammation. METHOD: Participants were community dwelling older adults ≥ 60 years (n = 222: 39 bereaved, 55 caregivers, 52 with insomnia, and 76 good sleepers). Mean values and intraindividual variability in sleep, as well as caffeine and alcohol use, exercise, and daytime napping, were assessed by sleep diaries. Blood samples were obtained in the morning. RESULTS: Several interactions were noted between sleep behaviors, inflammatory markers, and participant group. Greater variability in wake time and time in bed was associated with higher IL-6 among good sleepers relative to caregivers and older adults with insomnia. Good sleepers who consumed moderate amounts of alcohol had the lowest concentrations of IL-6 compared with the other three groups who consumed alcohol. Insomnia subjects, but not good sleepers, showed increased concentrations of IL-6 associated with caffeine use. Caregivers showed increased concentrations of TNF-α with alcohol use relative to good sleepers. Greater variability in bedtime, later wake times, and longer time in bed was associated with higher TNF-α regardless of group. CONCLUSIONS: Moderation and regularity in the practice of certain health behaviors, including sleep practices, were associated with lower plasma levels of inflammatory markers in older adults. Life circumstances and specific sleep disorders may modify these associations.

The impact of pain and depression on recovery after coronary artery bypass grafting.

OBJECTIVE: To describe the relationship between pain and depression on recovery after coronary artery bypass grafting (CABG). METHODS: A secondary data analysis on 453 depressed and nondepressed post-CABG patients enrolled in a randomized, controlled, effectiveness trial of telephone-delivered collaborative care for depression. Outcome measures were collected from March 2004 to September 2007 and included pain, physical function, and mood symptoms. RESULTS: Depressed patients (baseline Patient Health Questionnaire-9 score ≥10) versus those without depression reported significantly worse pain scores on the 36-Item Short Form Health Survey Bodily Pain Scale at baseline and up to 12 months post-CABG, p < .05. Among patients with depression, those who received collaborative care reported significantly better pain scores at each time point between 2 and 12 months post-CABG versus depressed patients randomized to the usual care control group, p < .05. Regardless of intervention status, depressed participants with at least moderate pain at baseline reported significantly lower functional status (measured by the Duke Activity Status Index) at 8 and 12 months versus depressed patients with none or mild pain, p < .05. Depressed patients with at least moderate pain at baseline were also significantly less likely to show improvement of depressive symptoms throughout the course of follow-up versus depressed patients with little or no pain, p < .05. These findings controlled for age, gender, education, race, comorbid conditions, and baseline pain diagnosis. CONCLUSIONS: Depression and pain seem to influence functional recovery post-CABG. The relationship between these two conditions and 12-month outcomes should be considered by clinicians when planning treatment.

Telephone-delivered collaborative care for treating post-CABG depression: a randomized controlled trial.

CONTEXT: Depressive symptoms commonly follow coronary artery bypass graft (CABG) surgery and are associated with less positive clinical outcomes. OBJECTIVE: To test the effectiveness of telephone-delivered collaborative care for post-CABG depression vs usual physician care. DESIGN, SETTING, AND PARTICIPANTS: Single-blind effectiveness trial at 7 university-based and community hospitals in or near Pittsburgh, Pennsylvania. Participants were 302 post-CABG patients with depression (150, intervention; 152, usual care) and a comparison group of 151 randomly sampled post-CABG patients without depression recruited between March 2004 and September 2007 and observed as outpatients until June 2008. INTERVENTION: Eight months of telephone-delivered collaborative care provided by nurses working with patients' primary care physicians and supervised by a psychiatrist and primary care physician from this study. MAIN OUTCOME MEASURES: Mental health-related quality of life (HRQL) measured by the Short Form-36 Mental Component Summary (SF-36 MCS) at 8-month follow-up; secondary outcome measures included assessment of mood symptoms (Hamilton Rating Scale for Depression [HRS-D]), physical HRQL (SF-36 PCS), and functional status (Duke Activity Status Index [DASI]); and hospital readmissions. RESULTS: The intervention patients reported greater improvements in mental HRQL (all P < or = .02) (SF-36 MCS: Delta, 3.2 points; 95% confidence interval [CI], 0.5-6.0), physical functioning (DASI: Delta, 4.6 points; 95% CI, 1.9-7.3), and mood symptoms (HRS-D: Delta, 3.1 points; 95% CI, 1.3-4.9); and were more likely to report a 50% or greater decline in HRS-D score from baseline (50.0% vs 29.6%; number needed to treat, 4.9 [95% CI, 3.2-10.4]) than usual care patients (P < .001). Men with depression were particularly likely to benefit from the intervention (SF-36 MCS: Delta, 5.7 points; 95% CI, 2.2-9.2; P = .001). However, the mean HRQL and physical functioning of intervention patients did not reach that of the nondepressed comparison group. CONCLUSION: Compared with usual care, telephone-delivered collaborative care for treatment of post-CABG depression resulted in improved HRQL, physical functioning, and mood symptoms at 8-month follow-up. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00091962.

The Bypassing the Blues treatment protocol: stepped collaborative care for treating post-CABG depression.

OBJECTIVE: To present the design of the Bypassing the Blues (BtB) study to examine the impact of a collaborative care strategy for treating depression among patients with cardiac disease. Coronary artery bypass graft (CABG) surgery is one of the most common and costly medical procedures performed in the US. Up to half of post-CABG patients report depressive symptoms, and they are more likely to experience poorer health-related quality of life (HRQoL), worse functional status, continued chest pains, and higher risk of cardiovascular morbidity independent of cardiac status, medical comorbidity, and the extent of bypass surgery. METHODS: BtB was designed to enroll 450 post-CABG patients from eight Pittsburgh-area hospitals including: (1) 300 patients who expressed mood symptoms preceding discharge and at 2 weeks post hospitalization (Patient Health Questionnaire (PHQ-9) >or=10); and (2) 150 patients who served as nondepressed controls (PHQ-9 <5). Depressed patients were randomized to either an 8-month course of nurse-delivered telephone-based collaborative care supervised by a psychiatrist and primary care expert, or to their physicians' "usual care." The primary hypothesis will test whether the intervention can produce an effect size of >or=0.5 improvement in HRQoL at 8 months post CABG, as measured by the SF-36 Mental Component Summary score. Secondary hypotheses will examine the impact of our intervention on mood symptoms, cardiovascular morbidity, employment, health services utilization, and treatment costs. RESULTS: Not applicable. CONCLUSIONS: This effectiveness trial will provide crucial information on the impact of a widely generalizable evidence-based collaborative care strategy for treating depressed patients with cardiac disease.

Risk factors for falls during treatment of late-life depression.

BACKGROUND: Prior studies have found that antidepressant medications are associated with an increased risk of falling in elderly persons. However, little is known about the prevention of falls during treatment for depression in elderly persons. This study evaluated the time course and potential risk factors for falls in a treatment protocol for late-life depression to identify specific at-risk periods and risk factors for falls in this population. METHOD: One hundred four subjects aged 69 years and over were treated in a protocolized manner using paroxetine and interpersonal psychotherapy. Those who did not respond received augmentation therapy with bupropion, nortriptyline, or lithium. Subjects were assessed at baseline and weekly during treatment; demographic and clinical characteristics of those who experienced a fall during treatment were compared with those who did not fall. Cox proportional hazards models were used to define risk factors for falls in univariate and multivariate models. RESULTS: During a mean of 21 weeks of treatment, 40 subjects (38%) fell. About half (53%) of the subjects fell during the first 6 weeks of treatment. In the multivariate model, memory impairment and orthostatic changes in blood pressure during treatment were risk factors for falling. Additionally, augmentation with bupropion appeared to be a risk factor for falls in univariate analysis, but this result is preliminary due to the small number of subjects who took bupropion. CONCLUSION: Increased monitoring for falls is warranted during the acute treatment of late-life depression. When treating such patients, clinicians should be especially watchful of those with memory impairments or those who develop orthostatic blood pressure changes; orthostatic blood pressure should be measured throughout acute treatment. Additionally, augmenting paroxetine with bupropion may also increase the risk of falls, and this medication combination should be used with caution in elderly patients.