Impact of Treating Depression on Associated Comorbidities: A Systematic Literature Review.

Objective: To identify and summarize data that describe the impact of effectively treating major depressive disorder (MDD) on the severity or risk of serious comorbidities.Data Sources: MEDLINE, Embase, PsycINFO, Cochrane Database of Systematic Reviews, and several congresses were searched. Searches included terms related to MDD, randomized controlled trials (RCTs), and physical comorbidities and were restricted to English-language publications. Searches were conducted in November 2019 for the previous 2 years for conference proceedings; no date restriction was applied to the database searches.Study Selection: Included studies were RCTs or meta-analyses that assessed depression therapies. Studies were required to report a statistically significant improvement in depression scores as well as the concurrent impact on comorbidities. A total of 1,997 articles were initially identified for screening.Data Extraction: Two investigators extracted data and assessed study quality.Results: A total of 30 studies, including 24 RCTs (N = 6,333) and 6 meta/pooled analyses of RCTs, were included. Findings in several comorbidity categories were mixed; for example, in half (4 of 8) of the identified studies in people with cardiovascular disease and depression, individuals who received treatment leading to reduced depressive symptoms compared with a control arm also had a significantly decreased incidence of cardiovascular events or significantly improved cardiac disease symptom/severity scores compared with controls. Significant improvements in comorbid disease severity observed alongside improvements in depressive symptoms were also noted in studies of comorbid Parkinson's disease, multiple sclerosis, chronic pain and fibromyalgia, and chronic obstructive pulmonary disease.Conclusions: Effective treatment of MDD may lead to a reduction in the severity of certain serious comorbidities. These results highlight the importance of appropriate and timely treatment of MDD.

Impact of Major Depressive Disorder on Comorbidities: A Systematic Literature Review.

Objective: To summarize the breadth of data exploring the relationship between major depressive disorder (MDD) and both the incidence and the disease course of a range of comorbidities.Data Sources: The authors searched MEDLINE, Embase, PsycINFO, Cochrane Database of Systematic Reviews, and several prespecified congresses. Searches included terms related to MDD and several comorbidity categories, restricted to those published in the English language from 2005 onward.Study Selection: Eligibility criteria included observational studies within North America and Europe that examined the covariate-adjusted impact of MDD on the risk and/or severity of comorbidities. A total of 6,811 articles were initially identified for screening.Data Extraction: Two investigators extracted data and assessed study quality.Results: In total, 199 articles were included. Depression was significantly (P < .05) associated with an increased incidence of dementia and Alzheimer's disease as well as cognitive decline in individuals with existing disease; increased incidence and worsening of cardiovascular disease/events (although mixed results were found for stroke); worsening of metabolic syndrome; increased incidence of diabetes, particularly among men, and worsening of existing diabetes; increased incidence of obesity, particularly among women; increased incidence and worsening of certain autoimmune diseases; increased incidence and severity of HIV/AIDS; and increased incidence of drug abuse and severity of both alcohol and drug abuse.Conclusions: The presence of MDD was identified as a risk factor for both the development and the worsening of a range of comorbidities. These results highlight the importance of addressing depression early in its course and the need for integrating mental and general health care.

The Appalachia Mind Health Initiative (AMHI): a pragmatic randomized clinical trial of adjunctive internet-based cognitive behavior therapy for treating major depressive disorder among primary care patients.

BACKGROUND: Major depressive disorder (MDD) is a leading cause of disease morbidity. Combined treatment with antidepressant medication (ADM) plus psychotherapy yields a much higher MDD remission rate than ADM only. But 77% of US MDD patients are nonetheless treated with ADM only despite strong patient preferences for psychotherapy. This mismatch is due at least in part to a combination of cost considerations and limited availability of psychotherapists, although stigma and reluctance of PCPs to refer patients for psychotherapy are also involved. Internet-based cognitive behaviorial therapy (i-CBT) addresses all of these problems. METHODS: Enrolled patients (n = 3360) will be those who are beginning ADM-only treatment of MDD in primary care facilities throughout West Virginia, one of the poorest and most rural states in the country. Participating treatment providers and study staff at West Virginia University School of Medicine (WVU) will recruit patients and, after obtaining informed consent, administer a baseline self-report questionnaire (SRQ) and then randomize patients to 1 of 3 treatment arms with equal allocation: ADM only, ADM + self-guided i-CBT, and ADM + guided i-CBT. Follow-up SRQs will be administered 2, 4, 8, 13, 16, 26, 39, and 52 weeks after randomization. The trial has two primary objectives: to evaluate aggregate comparative treatment effects across the 3 arms and to estimate heterogeneity of treatment effects (HTE). The primary outcome will be episode remission based on a modified version of the patient-centered Remission from Depression Questionnaire (RDQ). The sample was powered to detect predictors of HTE that would increase the proportional remission rate by 20% by optimally assigning individuals as opposed to randomly assigning them into three treatment groups of equal size. Aggregate comparative treatment effects will be estimated using intent-to-treat analysis methods. Cumulative inverse probability weights will be used to deal with loss to follow-up. A wide range of self-report predictors of MDD heterogeneity of treatment effects based on previous studies will be included in the baseline SRQ. A state-of-the-art ensemble machine learning method will be used to estimate HTE. DISCUSSION: The study is innovative in using a rich baseline assessment and in having a sample large enough to carry out a well-powered analysis of heterogeneity of treatment effects. We anticipate finding that self-guided and guided i-CBT will both improve outcomes compared to ADM only. We also anticipate finding that the comparative advantages of adding i-CBT to ADM will vary significantly across patients. We hope to develop a stable individualized treatment rule that will allow patients and treatment providers to improve aggregate treatment outcomes by deciding collaboratively when ADM treatment should be augmented with i-CBT. TRIAL REGISTRATION: ClinicalTrials.gov NCT04120285 . Registered on October 19, 2019.

High-Deductible Health Plans Paired With Health Savings Accounts Increased Medication Cost Burden Among Individuals With Bipolar Disorder.

Objective: High-deductible health plans paired with health savings accounts (HSA-HDHPs) require substantial out-of-pocket spending for most services, including medications. We examined effects of HSA-HDHPs on medication out-of-pocket spending and use among people with bipolar disorder.Methods: This quasi-experimental study used claims data for January 2003 through December 2014. We studied a national sample of 348 members with bipolar disorder (defined based on International Classification of Diseases, 9th Revision), aged 12 to 64 years, who were continuously enrolled for 1 year in a low-deductible plan (≤ $500) then 1 year in an HSA-HDHP (≥ $1,000) after an employer-mandated switch. HSA-HDHP members were matched to 4,087 contemporaneous controls who remained in low-deductible plans. Outcome measures included out-of-pocket spending and use of bipolar disorder medications, non-bipolar psychotropics, and all other medications.Results: Mean pre-to-post out-of-pocket spending per person for bipolar disorder medications increased by 149.7% among HSA-HDHP versus control members (95% confidence interval [CI], 109.9% to 189.5%). Specifically, out-of-pocket spending increased for antipsychotics (220.9% [95% CI, 150.0% to 291.8%]) and anticonvulsants (109.6% [95% CI, 67.3% to 152.0%]). Both higher-income and lower-income HSA-HDHP members experienced increases in out-of-pocket spending for bipolar disorder medications (135.2% [95% CI, 86.4% to 184.0%] and 164.5% [95% CI, 100.9% to 228.1%], respectively). We did not detect statistically significant changes in use of bipolar disorder medications, non-bipolar psychotropics, or all other medications in this study population of HSA-HDHP members.Conclusions: HSA-HDHP members with bipolar disorder experienced substantial increases in out-of-pocket burdens for medications essential for their functioning and well-being. Although HSA-HDHPs were not associated with detectable reductions in medication use, high out-of-pocket costs could cause financial strain for lower-income enrollees.

The post COVID-19 healthcare landscape and the use of long-acting injectable antipsychotics for individuals with schizophrenia and bipolar I disorder: the importance of an integrated collaborative-care approach.

BACKGROUND: Long-acting injectable antipsychotics (LAIs) are an essential maintenance treatment option for individuals with schizophrenia or bipolar I disorder (BP-I). This report summarizes a roundtable discussion on the impact of COVID-19 on the mental healthcare landscape and use of LAIs for individuals with schizophrenia or BP-I. METHODS: Ten experts and stakeholders from diverse fields of healthcare participated in a roundtable discussion on the impact of the COVID-19 pandemic, treatment challenges, and gaps in healthcare for individuals with schizophrenia or BP-I, informed by a literature search. RESULTS: Individuals with schizophrenia or BP-I are at increased risk of COVID-19 infection and increased risk of mortality after COVID-19 diagnosis. LAI prescriptions decreased early on in the pandemic, driven by a decrease in face-to-face consultations. Mental healthcare services are adapting with increased use of telehealth and home-based treatment. Clinical workflows to provide consistent, in-person LAI services include screening for COVID-19 exposure and infection, minimizing contact, and ensuring mask-wearing by individuals and staff. The importance of continued in-person visits for LAIs needs to be discussed so that staff can share that information with patients, their caregivers, and families. A fully integrated, collaborative-care model is the most important aspect of care for individuals with schizophrenia or BP-I during and after the COVID-19 pandemic. CONCLUSIONS: The COVID-19 pandemic has highlighted the importance of a fully integrated collaborative-care model to ensure regular, routine healthcare contact and access to prescribed treatments and services for individuals with schizophrenia and BP-I.

"Supporting Wellness": A depression and bipolar support alliance mixed-methods investigation of lived experience perspectives and priorities for mood disorder treatment.

BACKGROUND: The lived experience of people with mood disorders may be leveraged to inform priorities for research, define key treatment outcomes, and support decision-making in clinical care. The aim of this mixed-methods project was to provide insight into how people with depression and bipolar disorder experience the impact of symptoms, their treatment preferences, and their definitions of wellness. METHODS: The project was implemented in two phases. In Phase 1, community-based participatory research was used to develop a web-based survey enquiring about living with a mood disorder, treatment experiences, and wellness priorities. In Phase 2, a series of focus groups were conducted to explore aspects of wellness in greater detail. RESULTS: Respondents (n= 6153) described the symptoms of mood disorders as having a significant, chronic impact on their lives. A holistic approach to treatment was desired by participants, but not necessarily experienced. Qualitative findings were used to further describe four highly ranked wellness priorities identified in the survey: ability to act independently or according to my own will; purpose in life; getting through the day; and contentment. LIMITATIONS: Experience of a mood disorder was self-reported, and no formal confirmation of diagnosis occurred. Although the survey could not incorporate all possible wellness definitions, this was supplemented by qualitative focus groups. CONCLUSION: The present findings provide important insights from the perspectives of individuals with lived experience of mood disorders. Implications of this for research and clinical practice are discussed, particularly with regards to measurement-based care and use of wellness-oriented clinical outcome assessments.

Impact of High-Deductible Health Plans on Medication Use Among Individuals With Bipolar Disorder.

OBJECTIVE: High-deductible health plans (HDHPs) require substantial out-of-pocket spending for most services, although medications may be subject to traditional copayment arrangements. This study examined effects of HDHPs on medication out-of-pocket spending and use and quality of care among individuals with bipolar disorder. METHODS: This quasi-experimental study used claims data (2003-2014) for a national sample of 3,532 members with bipolar disorder, ages 12-64, continuously enrolled for 1 year in a low-deductible plan (≤$500) and then for 1 year in an HDHP (≥$1,000) after an employer-mandated switch. HDHP members were matched to 18,923 contemporaneous individuals in low-deductible plans (control group). Outcome measures were out-of-pocket spending and use of bipolar disorder medications, psychotropics for other disorders, and all other medications and appropriate laboratory monitoring for psychotropics. RESULTS: Relative to the control group, annual out-of-pocket spending per person for bipolar disorder medications increased 20.8% among HDHP members (95% confidence interval [CI]=14.9%-26.7%), and the absolute increase was $36 (95% CI=$25.9-$45.2). Specifically, out-of-pocket spending increased for antipsychotics (27.1%; 95% CI=17.4%-36.7%) and anticonvulsants (19.2%; 95% CI=11.9%-26.6%) but remained stable for lithium (-3.7%; 95% CI=-12.2% to 4.8%). No statistically significant changes were detected in use of bipolar disorder medications, other psychotropics, or all other medications or in appropriate laboratory monitoring for bipolar disorder medications. CONCLUSIONS: HDHP members with bipolar disorder experienced a moderate increase in out-of-pocket spending for medications but preserved bipolar disorder medication use. Findings may reflect individuals' perceptions of the importance of these medications for their functioning and well-being.

Experiences of health care costs among people with employer-sponsored insurance and bipolar disorder.

BACKGROUND: Cost-sharing disproportionately affects people with chronic illnesses needing more care. Our qualitative study examined lived experiences navigating insurance benefits and treatment for bipolar disorder, which requires ongoing access to behavioral specialists and psychotropic medications. METHODS: Forty semi-structured telephone interviews with individuals with bipolar disorder and employer-sponsored health insurance, or their family caregivers, explored health care needs, coverage details, out-of-pocket (OOP) costs, and perspectives on value. An iterative analytic approach identified salient themes. RESULTS: Most individuals in our sample faced an annual insurance deductible, from $350-$10,000. OOP costs for specialist visits ranged from $0-$450 and for monthly psychotropic medications from $0-$1650. Acute episodes and care for comorbidities, including medication side effects, added to cost burdens. Medication nonadherence due to OOP costs was rare; respondents frequently pointed to the necessity of medications: "whatever it takes to get those"; "it's a life or death situation." Respondents also prioritized visits to psychiatrist prescribers, though visits were maximally spaced because of cost. Psychotherapy was often deemed unaffordable and forgone, despite perceived need. Interviewees cited limited networks and high out-of-network costs as barriers to specialists. Cost-sharing sometimes led to debt, skimping on nonbehavioral care or other necessities, exacerbated or prolonged mood symptoms, and stress at home. LIMITATIONS: Volunteer respondents may not fully represent the target population. CONCLUSIONS: Many people with bipolar disorder in US employer-sponsored plans experience undertreatment, hardship, and adverse health consequences due to high cost-sharing. More nuanced insurance benefit designs should accommodate the needs of individuals with complex conditions.

Integrating Stakeholder Engagement With Claims-Based Research on Health Insurance Design and Bipolar Disorder.

Researchers increasingly recognize that stakeholder involvement enhances research relevance and validity. However, reports of patient engagement in research that relies on administrative records data are rare. The authors' collaborative project combined quantitative and qualitative studies of costs and access to care among U.S. adults with employer-sponsored insurance. The authors analyzed insurance claims to estimate the impacts on enrollee costs and utilization after patients with bipolar disorder were switched from traditional coverage to high-deductible health plans. In parallel, in-depth interviews explored people's experiences accessing treatment for bipolar disorder. Academic investigators on the research team partnered with the Depression and Bipolar Support Alliance (DBSA), a national advocacy organization for people with mood disorders. Detailed personal stories from DBSA-recruited volunteers informed and complemented the claims analyses. Several DBSA audience forums and a stakeholder advisor panel contributed regular feedback on study issues. These multiple engagement modes drew inputs of varying intensity from diverse community segments. Efforts to include new voices must acknowledge individuals' distinct interests and barriers to research participation. Strong engagement leadership roles ensure productive communication between researchers and stakeholders. The involvement of people with direct experience of care is especially necessary in research that uses secondary data. Longitudinal, adaptable partnerships enable colearning and higher-quality research that captures the manifold dimensions of patient experiences.

Development of a patient decision aid for treatment resistant depression.

BACKGROUND: Shared decision-making (SDM) involves patients and clinicians choosing treatment jointly. SDM in mental health is hampered by lack of well-developed supporting tools. We describe an evidence-based patient decision aid (PDA) to facilitate SDM for treatment-resistant depression (TRD) following US National Quality Forum standards which are based upon the International Patient Decision Aid Standards (IPDAS). METHODS: A web-based PDA was developed by a multidisciplinary steering committee of clinicians, patient advocates, patients and a decision scientist. Development included creating content consistent with decision-making domains that are impacted by patient preference in TRD. Development was guided by literature review, group conference calls/discussions, patient and clinician interviews (N = 8), high and lower literacy focus groups (N = 11) and pilot study (N = 5). The PDA presents risk-benefit information on domains (e.g., effectiveness, mode of administration, side effects, cost) and includes values clarification exercises. Pilot study patients were administered the Decisional Conflict Scale (DCS) and Decision Self-Efficacy Scale (DSES) prior to and following PDA interaction and clinician SDM. RESULTS: During the pilot, prior to PDA interaction, mean (standard deviation) DCS score was 42.2 (14.4) and DSES score was 86.0 (14.6) out of 100. Following PDA interaction and SDM, DCS decreased (improved) to 28.1 (SD 4.1) and DSES increased to 95.5 (6.7). All patients endorsed that the PDA helped them to: recognize pros and cons of options; understand how treatments were administered, possible side-effects, and likelihood of benefit; recognize what was important relative to the decision; organize thoughts and prepare for a discussion with their clinician. CONCLUSIONS: This PDA may support SDM in TRD. A future trial to determine impact of the present SMD on decision-making quality is warranted. It also highlights gaps in comparative effectiveness trials that could guide equitable shared decision-making.

Effect of high-deductible insurance on health care use in bipolar disorder.

OBJECTIVES: To determine the impact of high-deductible health plans (HDHPs) on health care use among individuals with bipolar disorder. STUDY DESIGN: Interrupted time series with propensity score-matched control group design, using a national health insurer's claims data set with medical, pharmacy, and enrollment data. METHODS: The intervention group was composed of 2862 members with bipolar disorder who were enrolled for 1 year in a low-deductible (≤$500) plan and then 1 year in an HDHP (≥$1000) after an employer-mandated switch. HDHP members were propensity score matched 1:3 to contemporaneous controls in low-deductible plans. The main outcomes included out-of-pocket spending per health care service, mental health-related outpatient visits (subclassified as visits to nonpsychiatrist mental health providers and to psychiatrists), emergency department (ED) visits, and hospitalizations. RESULTS: Mean pre- to post-index date out-of-pocket spending per visit on all mental health office visits, nonpsychiatrist mental health provider visits, and psychiatrist visits increased by 21.9% (95% CI, 15.1%-28.6%), 33.8% (95% CI, 2.0%-65.5%), and 17.8% (95% CI, 12.2%-23.4%), respectively, among HDHP vs control members. The HDHP group experienced a -4.6% (95% CI, -11.7% to 2.5%) pre- to post change in mental health outpatient visits relative to controls, a -10.9% (95% CI, -20.6% to -1.3%) reduction in nonpsychiatrist mental health provider visits, and unchanged psychiatrist visits. ED visits and hospitalizations were also unchanged. CONCLUSIONS: After a mandated switch to HDHPs, members with bipolar disorder experienced an 11% decline in visits to nonpsychiatrist mental health providers but unchanged psychiatrist visits, ED visits, and hospitalizations. HDHPs do not appear to have a "blunt instrument" effect on health care use in bipolar disorder; rather, patients might make trade-offs to preserve important care.