Blended Collaborative Care to Treat Heart Failure and Comorbid Depression: Rationale and Study Design of the Hopeful Heart Trial.

OBJECTIVE: Despite numerous improvements in care, morbidity from heart failure (HF) has remained essentially unchanged in recent years. One potential reason is that depression, which is comorbid in approximately 40% of hospitalized HF patients and associated with adverse HF outcomes, often goes unrecognized and untreated. The Hopeful Heart Trial is the first study to evaluate whether a widely generalizable telephone-delivered collaborative care program for treating depression in HF patients improves clinical outcomes. METHODS: The Hopeful Heart Trial aimed to enroll 750 patients with reduced ejection fraction (HFrEF) (ejection fraction ≤ 45%) including the following: (A) 625 patients who screened positive for depression both during their hospitalization (Patient Health Questionnaire [PHQ-2]) and two weeks following discharge (PHQ-9 ≥ 10); and (B) 125 non-depressed control patients (PHQ-2(-)/PHQ-9 < 5). We randomized depressed patients to either their primary care physician's "usual care" (UC) or to one of two nurse-delivered 12-month collaborative care programs for (a) depression and HFrEF ("blended") or (b) HrEFF alone (enhanced UC). Our co-primary hypotheses will test whether "blended" care can improve mental health-related quality of life versus UC and versus enhanced UC, respectively, on the Mental Component Summary of the Short-Form 12 Health Survey. Secondary hypotheses will evaluate the effectiveness of our interventions on mood, functional status, hospital readmissions, deaths, provision of evidence-based care for HFrEF, and treatment costs. RESULTS: Not applicable. CONCLUSIONS: The Hopeful Heart Trial will determine whether "blended" collaborative care for depression and HFrEF is more effective at improving patient-relevant outcomes than collaborative care for HFrEF alone or doctors' UC for HFrEF. TRIAL REGISTRATION: ClinicalTrials.gov identifier NCT02044211.

The Association Between Increased Levels of Patient Engagement With an Internet Support Group and Improved Mental Health Outcomes at 6-Month Follow-Up: Post-Hoc Analyses From a Randomized Controlled Trial.

BACKGROUND: We recently reported that depressed and anxious primary care patients randomized to a moderated internet support group (ISG) plus computerized cognitive behavioral therapy (cCBT) did not experience improvements in depression and anxiety over cCBT alone at 6-month follow-up. OBJECTIVE: The 1% rule posits that 1% of participants in online communities generate approximately 90% of new user-created content. The aims of this study were to apply the 1% rule to categorize patient engagement with the ISG and identify whether any patient subgroups benefitted from ISG use. METHODS: We categorized the 302 patients randomized to the ISG as: superusers (3/302, 1.0%), top contributors (30/302, 9.9%), contributors (108/302, 35.8%), observers (87/302, 28.8%) and those who never logged in (74/302, 24.5%). We then applied linear mixed models to examine associations between engagement and 6-month changes in health-related quality of life (HRQoL; Short Form Health Survey Mental Health Component, SF-12 MCS) and depression and anxiety symptoms (Patient-Reported Outcomes Measurement Information System, PROMIS). RESULTS: At baseline, participant mean age was 42.6 years, 81.1% (245/302) were female, and mean Patient Health Questionnaire (PHQ-9), Generalized Anxiety Disorder scale (GAD-7), and SF-12 MCS scores were 13.4, 12.6, and 31.7, respectively. Of the 75.5% (228/302) who logged in, 61.8 % (141/228) created ≥1 post (median 1, interquartile range, IQR 0-5); superusers created 42.3 % (630/1488) of posts (median 246, IQR 78-306), top contributors created 34.6% (515/1488; median 11, IQR 10-18), and contributors created 23.1 % (343/1488; median 3, IQR 1-5). Compared to participants who never logged in, the combined superuser + top contributor subgroup (n=33) reported 6-month improvements in anxiety (PROMIS: -11.6 vs -7.8; P=.04) and HRQoL (SF-12 MCS: 16.1 vs 10.1; P=.01) but not in depression. No other subgroup reported significant symptom improvements. CONCLUSIONS: Patient engagement with the ISG was more broadly distributed than predicted by the 1% rule. The 11% of participants with the highest engagement levels reported significant improvements in anxiety and HRQoL. TRIAL REGISTRATION: ClinicalTrials.gov NCT01482806; https://clinicaltrials.gov/ct2/show/NCT01482806 (Archived by WebCite at http://www.webcitation.org/708Bjlge9).

Depression Subtypes in Systolic Heart Failure: A Secondary Analysis From a Randomized Controlled Trial.

BACKGROUND: Heart failure (HF) is associated with an elevated risk of morbidity, mortality, hospitalization, and impaired quality of life. One potential contributor to these poor outcomes is depression. Yet the effectiveness of treatments for depression in patients with HF is mixed, perhaps due to the heterogeneity of depression. METHODS: This secondary analysis applied latent class analysis (LCA) to data from a clinical trial to classify patients with systolic HF and comorbid depression into LCA subtypes based on depression symptom severity, and then examined whether these subtypes predicted treatment response and mental and physical health outcomes at 12 months follow-up. RESULTS: In LCA of 629 participants (mean age 63.6 ± 12.9; 43% females), we identified 4 depression subtypes: mild (prevalence 53%), moderate (30%), moderately severe (12%), and severe (5%). The mild subtype was characterized primarily by somatic symptoms of depression (e.g., energy loss, sleep disturbance, poor appetite), while the remaining LCA subtypes additionally included nonsomatic symptoms of depression (e.g., depressed mood, anhedonia, worthlessness). At 12 months, LCA subtypes with more severe depressive symptoms reported significantly greater improvements in mental quality of life and depressive symptoms compared to the LCA mild subtype, but the incidence of cardiovascular- and noncardiovascular-related readmissions, and mortality was similar among all subtypes. CONCLUSIONS: In patients with depression and systolic heart failure those with the LCA mild depression subtype may not meet full criteria for major depressive disorder, given the overlap between HF and somatic symptoms of depression. We recommend requiring depressed mood or anhedonia as a necessary symptom for major depressive disorder in patients with HF.

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.

Efficacy of Blended Collaborative Care for Patients With Heart Failure and Comorbid Depression: A Randomized Clinical Trial.

Importance: Depression is often comorbid in patients with heart failure (HF) and is associated with worse clinical outcomes. However, depression generally goes unrecognized and untreated in this population. Objective: To determine whether a blended collaborative care program for treating both HF and depression can improve clinical outcomes more than collaborative care for HF only and physicians' usual care (UC). Design, Setting, and Participants: This 3-arm, single-blind, randomized effectiveness trial recruited 756 participants with HF with reduced left ventricular ejection fraction (<45%) from 8 university-based and community hospitals in southwestern Pennsylvania between March 2014 and October 2017 and observed them until November 2018. Participants included 629 who screened positive for depression during hospitalization and 2 weeks postdischarge and 127 randomly sampled participants without depression to facilitate further comparisons. Key analyses were performed November 2018 to March 2019. Interventions: Separate physician-supervised nurse teams provided either 12 months of collaborative care for HF and depression ("blended" care) or collaborative care for HF only (enhanced UC [eUC]). Main Outcomes and Measures: The primary outcome was mental health-related quality of life (mHRQOL) as measured by the Mental Component Summary of the 12-item Short Form Health Survey (MCS-12). Secondary outcomes included mood, physical function, HF pharmacotherapy use, rehospitalizations, and mortality. Results: Of the 756 participants (mean [SD] age, 64.0 [13.0] years; 425 [56%] male), those with depression reported worse mHRQOL, mood, and physical function but were otherwise similar to those without depression (eg, mean left ventricular ejection fraction, 28%). At 12 months, blended care participants reported a 4.47-point improvement on the MCS-12 vs UC (95% CI, 1.65 to 7.28; P = .002), but similar scores as the eUC arm (1.12; 95% CI, -1.15 to 3.40; P = .33). Blended care participants also reported better mood than UC participants (Patient-Reported Outcomes Measurement Information System-Depression effect size, 0.47; 95% CI, 0.28 to 0.67) and eUC participants (0.24; 95% CI, 0.07 to 0.41), but physical function, HF pharmacotherapy use, rehospitalizations, and mortality were similar by both baseline depression and randomization status. Conclusions and Relevance: In this randomized clinical trial of patients with HF and depression, telephone-delivered blended collaborative care produced modest improvements in mHRQOL, the primary outcome, on the MCS-12 vs UC but not eUC. Although blended care did not differentially affect rehospitalization and mortality, it improved mood better than eUC and UC and thus may enable organized health care systems to provide effective first-line depression care to medically complex patients. Trial Registration: ClinicalTrials.gov Identifier: NCT02044211.

Telephone-delivered lifestyle support with action planning and motivational interviewing techniques to improve rehabilitation outcomes.

OBJECTIVE: In this randomized controlled trial, we evaluated the effectiveness of a telephone-delivered intervention based on the Health Action Process Approach (HAPA) after discharge from inpatient rehabilitation to address behavior change, emotional status, and glycemic control in patients with Type 2 diabetes. DESIGN: In a German rehabilitation center, 249 patients with Type 2 diabetes were separated into randomized groups, either a 12-month telephone follow-up support group or the usual care group. The counselor identified personal target areas and intervention modules and developed with the patient an individualized action plan for the telephone support. To enhance motivational processes, they used motivational interviewing techniques. Counselors called patients monthly to support the implementation of the personal plans into the patients' daily routines and to screen for emotional problems. Assessments measured exercise, diet, medication adherence, psychological variables, body mass index, HbA1c, and cardiovascular risk. RESULTS: Twelve months after inpatient rehabilitation, the telephone group's rate of physical activity rose by 26% compared with the usual care group's 10%. Patients in the intervention group exhibited greater improvements in terms of their illness burden, psychological well-being, and depression. HbA1c fell in the telephone group but increased in the usual care group (-0.68% vs. 0.12%). The intervention group's cardiovascular risk fell, whereas the usual care group's rose (-0.57 vs. 0.23). CONCLUSION: A theory-based telephone-delivered follow-up intervention utilizing motivational interviewing techniques and focusing on personalized action planning demonstrated improvements in patients' level of activity and health status 12-months postrehabilitation discharge and may be a beneficial supplement to rehabilitation programs. (PsycINFO Database Record

My care manager, my computer therapy and me: The relationship triangle in computerized cognitive behavioural therapy.

Previous research has reported mixed findings regarding the relationship between therapeutic alliance, engagement and outcomes in e-mental health. This study aims to overcome some of the methodological limitations of previous research and extend our understanding of alliance-outcome relationships in e-mental health by exploring the nature of the relationship triangle between the patient, their care manager and their computerized cognitive behavioural therapy (CCBT) program, accessed with or without an Internet Support Group (ISG). Positive patient-rated alliance with both their care manager and the CCBT program itself was found and these were significantly associated with measures of engagement and clinical outcome. The magnitude of this association was moderate, and within the range of that reported for traditional face-to-face psychotherapies in recent meta-analyses. Limitations of the study, including the reliance on completer data and a cross-sectional design, and directions for future research are presented. Our findings suggest that both the training and supervision of support staff and the optimization of CCBT interventions themselves to enhance alliance and experience may lead to improved engagement and outcomes. TRIAL REGISTRATION: Clinicaltrials.gov Identifier: NCT01482806https://www.clinicaltrials.gov/ct2/show/NCT01482806?term=rollman&rank=4.

Effectiveness of Online Collaborative Care for Treating Mood and Anxiety Disorders in Primary Care: A Randomized Clinical Trial.

Importance: Collaborative care for depression and anxiety is superior to usual care from primary care physicians for these conditions; however, challenges limit its provision in routine practice and at scale. Advances in technology may overcome these barriers but have yet to be tested. Objective: To examine the effectiveness of combining an internet support group (ISG) with an online computerized cognitive behavioral therapy (CCBT) provided via a collaborative care program for treating depression and anxiety vs CCBT alone and whether providing CCBT in this manner is more effective than usual care. Design, Setting, and Participants: In this 3-arm randomized clinical trial with blinded outcome assessments, primary care physicians from 26 primary care practices in Pittsburgh, Pennsylvania, referred 2884 patients aged 18 to 75 years in response to an electronic medical record prompt from August 2012 to September 2014. Overall, 704 patients (24.4%) met all eligibility criteria and were randomized to CCBT alone (n = 301), CCBT+ISG (n = 302), or usual care (n = 101). Intent-to-treat analyses were conducted November 2015 to January 2017. Interventions: Six months of guided access to an 8-session CCBT program provided by care managers who informed primary care physicians of their patients' progress and promoted patient engagement with our online programs. Main Outcomes and Measures: Mental health-related quality of life (12-Item Short-Form Health Survey Mental Health Composite Scale) and depression and anxiety symptoms (Patient-Reported Outcomes Measurement Information System) at 6-month follow-up, with treatment durability assessed 6 months later. Results: Of the 704 randomized patients, 562 patients (79.8%) were female, and the mean (SD) age was 42.7 (14.3) years. A total of 604 patients (85.8%) completed our primary 6-month outcome assessment. At 6-month assessment, 254 of 301 patients (84.4%) receiving CCBT alone started the program (mean [SD] sessions completed, 5.4 [2.8]), and 228 of 302 patients (75.5%) in the CCBT+ISG cohort logged into the ISG at least once, of whom 141 (61.8%) provided 1 or more comments or posts (mean, 10.5; median [range], 3 [1-306]). Patients receiving CCBT+ISG reported similar 6-month improvements in mental health-related quality of life, mood, and anxiety symptoms compared with patients receiving CCBT alone. However, compared with patients receiving usual care, patients in the CCBT alone cohort reported significant 6-month effect size improvements in mood (effect size, 0.31; 95% CI, 0.09-0.53) and anxiety (effect size, 0.26; 95% CI, 0.05-0.48) that persisted 6 months later, and completing more CCBT sessions produced greater effect size improvements in mental health-related quality of life and symptoms. Conclusions and Relevance: While providing moderated access to an ISG provided no additional benefit over guided CCBT at improving mental health-related quality of life, mood, and anxiety symptoms, guided CCBT alone is more effective than usual care for these conditions. Trial Registration: clinicaltrials.gov Identifier: NCT01482806.

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).

A contemporary protocol to assist primary care physicians in the treatment of panic and generalized anxiety disorders.

Anxiety disorders are prevalent in primary care practice and generate a significant excess of morbidity, health services utilization, and health care expenditures. Complexities in delivering effective care for such disorders have led to stepped collaborative care models that involve nonphysician care managers following guideline-based protocols under the direction of patients' primary care physicians and a medical specialist. With the goal of aiding colleagues attempting to improve the primary care for panic and generalized anxiety disorders, we detail the collaborative care strategy for treatment of these conditions used by our National Institute of Mental Health (NIMH)-funded clinical trial in which a telephone-based care manager performs timely, patient-specific clinical and case management tasks. We illustrate the clinical considerations underlying the steps taken to implement and then sustain our care manager intervention at four geographically dispersed primary care practices linked by a common electronic medical record system and the modifications made as we encountered clinical situations common to typical practice settings. This report serves to familiarize physicians contemplating use of a similar strategy for improving the quality of primary care for an anxiety disorder or any other chronic mental health condition.

Impact of physician counseling and perception of teratogenic risks: a survey of 96 nonpregnant women with anxiety.

OBJECTIVE: To examine the impact of physician counseling on perceived risks, benefits, and likelihood of use of anxiolytic pharmacotherapy during pregnancy among women with a history of anxiety. METHOD: We surveyed 96 nonpregnant women, aged 21-45 years, with panic disorder and/or generalized anxiety disorder (DSM-IV criteria) recruited by their family physicians to participate in an anxiety treatment trial from 7 primary care practices in Pittsburgh, Pennsylvania. Trained research assistants telephoned study participants to assess sociodemographics, psychiatric history, comorbidities, and anxiety severity. Respondents were asked to assess risks, benefits, and likelihood of taking a prescribed anxiolytic during pregnancy using 3 Likert scales at baseline. Respondents were then asked to indicate whether their perceptions would change with (1) a US Food and Drug Administration (FDA) warning reporting a 5% chance of birth defects with use and (2) physician counseling that the medication was safe during pregnancy despite the warning. Data were collected from January 1, 2005, through December 30, 2007. RESULTS: In this study, 46% (44/96) of respondents had generalized anxiety disorder, 14% (14/96) had panic disorder, and 40% (38/96) had both generalized anxiety disorder and panic disorder. The mean baseline Hamilton Anxiety Rating Scale score was 25.6 (SD = 8.4). Respondents were less likely to perceive risk if counseled by their primary care physicians that medication use was safe despite FDA warning. They also saw more benefit in use and reported being more likely to take anxiolytic medications during pregnancy if counseled that doing so was safe. Age, ethnicity, and severity of anxiety did not modify the effect of physician counseling. However, college educated women were less likely to be reassured by primary care physician counseling (P = .05) that anxiolytic use during pregnancy was safe. CONCLUSIONS: Women with anxiety disorders are often hesitant to use anxiolytic medications during pregnancy. Physician counseling may change some women's perceptions of risk and decisions regarding use during pregnancy. TRIAL REGISTRATION: Clinicaltrials.gov Identifier: NCT00158327.