Scaling Up Maternal Mental healthcare by Increasing access to Treatment (SUMMIT) through non-specialist providers and telemedicine: a study protocol for a non-inferiority randomized controlled trial.

BACKGROUND: Depression and anxiety impact up to 1 in 5 pregnant and postpartum women worldwide. Yet, as few as 20% of these women are treated with frontline interventions such as evidence-based psychological treatments. Major barriers to uptake are the limited number of specialized mental health treatment providers in most settings, and problems with accessing in-person care, such as childcare or transportation. Task sharing of treatment to non-specialist providers with delivery on telemedicine platforms could address such barriers. However, the equivalence of these strategies to specialist and in-person models remains unproven. METHODS: This study protocol outlines the Scaling Up Maternal Mental healthcare by Increasing access to Treatment (SUMMIT) randomized trial. SUMMIT is a pragmatic, non-inferiority test of the comparable effectiveness of two types of providers (specialist vs. non-specialist) and delivery modes (telemedicine vs. in-person) of a brief, behavioral activation (BA) treatment for perinatal depressive and anxiety symptoms. Specialists (psychologists, psychiatrists, and social workers with ≥ 5 years of therapy experience) and non-specialists (nurses and midwives with no formal training in mental health care) were trained in the BA protocol, with the latter supervised by a BA expert during treatment delivery. Consenting pregnant and postpartum women with Edinburgh Postnatal Depression Scale (EPDS) score of ≥ 10 (N = 1368) will be randomized to one of four arms (telemedicine specialist, telemedicine non-specialist, in-person specialist, in-person non-specialist), stratified by pregnancy status (antenatal/postnatal) and study site. The primary outcome is participant-reported depressive symptoms (EPDS) at 3 months post-randomization. Secondary outcomes are maternal symptoms of anxiety and trauma symptoms, perceived social support, activation levels and quality of life at 3-, 6-, and 12-month post-randomization, and depressive symptoms at 6- and 12-month post-randomization. Primary analyses are per-protocol and intent-to-treat. The study has successfully continued despite the COVID-19 pandemic, with needed adaptations, including temporary suspension of the in-person arms and ongoing randomization to telemedicine arms. DISCUSSION: The SUMMIT trial is expected to generate evidence on the non-inferiority of BA delivered by a non-specialist provider compared to specialist and telemedicine compared to in-person. If confirmed, results could pave the way to a dramatic increase in access to treatment for perinatal depression and anxiety. TRIAL REGISTRATION: ClinicalTrials.gov NCT04153864 . Registered on November 6, 2019.

Depression and Engagement in Care Among Newly Diagnosed HIV-Infected Adults in Johannesburg, South Africa.

Delayed engagement in HIV care threatens the success of HIV treatment programs in sub-Saharan Africa and may be influenced by depression. We examined the relationship between depression prior to HIV diagnosis and engagement in HIV care at a primary care clinic in Johannesburg, South Africa. We screened 1683 patients for depression prior to HIV testing using the Patient Health Questionnaire-9. Among patients who tested positive for HIV we assessed linkage to HIV care, defined as obtaining a CD4 count within 3 months. Among those who linked to care and were eligible for ART, we assessed ART initiation within 3 months. Multivariable Poisson regression with a robust variance estimator was used to assess the association between depression and linkage to care or ART initiation. The prevalence of HIV was 26 % (n = 340). Among HIV-infected participants, the prevalence of depression was 30 %. The proportion of linkage to care was 80 % among depressed patients and 73 % among patients who were not depressed (risk ratio 1.08; 95 % confidence interval 0.96, 1.23). Of the participants who linked to care, 81 % initiated ART within 3 months in both depressed and not depressed groups (risk ratio 0.99; 95 % confidence interval 0.86, 1.15). Depression was not associated with engagement in HIV care in this South African primary care setting. Our unexpected findings suggest that some depressed HIV-infected patients might be more likely to engage in care than their counterparts without depression, and highlight the complex relationship between depression and HIV infection. These findings have led us to propose a new framework relating HIV infection, depression, and the population under study.

Validity of the Patient Health Questionnaire-9 to screen for depression in a high-HIV burden primary healthcare clinic in Johannesburg, South Africa.

BACKGROUND: Integration of depression screening into primary care may increase access to mental health services in sub-Saharan Africa, but this approach requires validated screening instruments. We sought to validate the Patient Health Questionnaire-9 (PHQ-9) as a depression screening tool at a high HIV-burden primary care clinic in Johannesburg, South Africa. METHODS: We conducted a validation study of an interviewer-administered PHQ-9 among 397 patients. Sensitivity and specificity of the PHQ-9 were calculated with the Mini International Neuropsychiatric Interview (MINI) as the reference standard; receiver operating characteristic (ROC) curve analyses were performed. RESULTS: The prevalence of depression was 11.8%. One-third of participants tested positive for HIV. HIV-infected patients were more likely to be depressed (15%) than uninfected patients (9%; p=0.08). Using the standard cutoff score of ≥10, the PHQ-9 had a sensitivity of 78.7% (95% CI: 64.3-89.3) and specificity of 83.4% (95% CI: 79.1-87.2). The area under the ROC curve was 0.88 (95% CI: 0.83-0.92). Test performance did not vary by HIV status or language. In sensitivity analyses, reference test bias associated with the MINI appeared unlikely. LIMITATIONS: We were unable to conduct qualitative work to adapt the PHQ-9 to this cultural context. CONCLUSION: This is the first validation study of the PHQ-9 in a primary care clinic in sub-Saharan Africa. It highlights the potential for using primary care as an access point for identifying depressive symptoms during routine HIV testing. The PHQ-9 showed reasonable accuracy in classifying cases of depression, was easily implemented by lay health workers, and is a useful screening tool in this setting.

Is prior course of illness relevant to acute or longer-term outcomes in depressed out-patients? A STAR*D report.

BACKGROUND: Major depressive disorder (MDD) is commonly chronic and/or recurrent. We aimed to determine whether a chronic and/or recurrent course of MDD is associated with acute and longer-term MDD treatment outcomes. METHOD: This cohort study recruited out-patients aged 18-75 years with non-psychotic MDD from 18 primary and 23 psychiatric care clinics across the USA. Participants were grouped as: chronic (index episode >2 years) and recurrent (n = 398); chronic non-recurrent (n=257); non-chronic recurrent (n=1614); and non-chronic non-recurrent (n = 387). Acute treatment was up to 14 weeks of citalopram (≤ 60 mg/day) with up to 12 months of follow-up treatment. The primary outcomes for this report were remission [16-item Quick Inventory of Depressive Symptomatology - Self-Rated (QIDS-SR(16)) ≤ 5] or response (≥ 50% reduction from baseline in QIDS-SR(16)) and time to first relapse [first QIDS-SR16 by Interactive Voice Response (IVR) ≥ 11]. RESULTS: Most participants (85%) had a chronic and/or recurrent course; 15% had both. Chronic index episode was associated with greater sociodemographic disadvantage. Recurrent course was associated with earlier age of onset and greater family histories of depression and substance abuse. Remission rates were lowest and slowest for those with chronic index episodes. For participants in remission entering follow-up, relapse was most likely for the chronic and recurrent group, and least likely for the non-chronic, non-recurrent group. For participants not in remission when entering follow-up, prior course was unrelated to relapse. CONCLUSIONS: Recurrent MDD is the norm for out-patients, of whom 15% also have a chronic index episode. Chronic and recurrent course of MDD may be useful in predicting acute and long-term MDD treatment outcomes.

Progression to AIDS, a clinical AIDS condition and mortality: psychosocial and physiological predictors.

BACKGROUND: The primary aim of this study is to examine prospectively the association of stressful life events, social support, depressive symptoms, anger, serum cortisol and lymphocyte subsets with changes in multiple measures of human immunodeficiency virus (HIV) disease progression. METHODS: Ninety-six HIV-infected gay men without symptoms or anti-retroviral medication use at baseline were studied every 6 months for up to 9 years. Disease progression was defined in three ways using the Centers for Disease Control (CDC) classifications (e.g. AIDS, clinical AIDS condition and mortality). Cox regression models with time-dependent covariates were used, adjusting for control variables (e.g. race, age, baseline, CD4 T cells and viral load, number of anti-retroviral medications). RESULTS: Higher cumulative average stressful life events and lower cumulative average social support predicted faster progression to both the CDC AIDS classification and a clinical AIDS condition. Higher anger scores and CD8 T cells were associated with faster progression to AIDS, and depressive symptoms were associated with faster development of an AIDS clinical condition. Higher levels of serum cortisol predicted all three measures of disease progression. CONCLUSIONS: These results suggest that stressful life events, dysphoric mood and limited social support are associated with more rapid clinical progression in HIV infection, with serum cortisol also exerting an independent effect on disease progression.

Minor depression in family practice: functional morbidity, co-morbidity, service utilization and outcomes.

BACKGROUND: Minor depression is a disabling condition commonly seen in primary care settings. Although considerable impairment is associated with minor depression, little is known about the course of the illness. Using a variety of clinical and functional measurements, this paper profiles the course of minor depression over a 1 year interval among a cohort of primary care patients. METHOD: Patients at a university-based primary care facility were screened for potential cases of depression and selected into three diagnostic categories: an asymptomatic control group; patients with a diagnosis of major depression; and, a third category, defined as minor depression, consisting of patients who reported between two and four symptoms of depression, but who failed to qualify for a diagnosis of major depression. Functional status, service use, and physical, social and mental health were assessed at baseline and at 3-month intervals for the ensuing year. RESULTS: Respondents with a baseline diagnosis of minor depression exhibited marked impairment on most measures both at baseline and over the following four waves. Their responses in most respects were similar to, although not as severe as, those of respondents with a baseline diagnosis of major depression. Both groups were considerably more impaired than asymptomatic controls. CONCLUSIONS: Minor depression is a persistently disabling condition often seen in primary care settings. Although quantitatively less severe than major depression, it is qualitatively similar and requires careful assessment and close monitoring over the course of the illness.

General medical and specialty mental health service use for major depression.

OBJECTIVE: While major depression is common, many depressed persons receive, at best, inadequate treatment. A first step in remedying inadequate detection and treatment of major depression requires understanding the pathways into treatment-from situations of no care, to disease recognition, to referral and appropriate treatment-as well as identifying factors associated with movement between these several stages. METHODS: Using the Epidemiologic Catchment Area sample, we identified factors associated with treatment in the general medical or mental health specialist section, or no treatment in a subsample of individuals with current major depression. RESULTS: Strikingly, one-fourth of the sample received no services, over half received care in the general medical sector, and only one-fifth accessed a mental health specialist. Among those receiving any health services (general or mental), men and respondents reporting suicidal symptoms were at risk of receiving no care, while perceived poor health and a cluster of core depressive symptoms were associated with increased odds of service use (general or mental). Among respondents receiving general medical services, perceived poor health, core depressive symptoms, a history of depression, and comorbid mental conditions increased the odds of treatment in the specialty mental health sector. CONCLUSIONS: The findings emphasize the need for public health initiatives to 1) improve detection and movement into treatment among those at risk of receiving no care; and 2) insure that, once within the health care system, the processes of primary care treatment and specialty referrals conform to evidence-based treatment guidelines.

Impact of stressful life events, depression, social support, coping, and cortisol on progression to AIDS.

OBJECTIVE: This study examined prospectively the effects of stressful events, depressive symptoms, social support, coping methods, and cortisol levels on progression of HIV-1 infection. METHOD: Eighty-two homosexual men with HIV type-1 infection without AIDS or symptoms at baseline were studied every 6 months for up to 7. 5 years. Men were recruited from rural and urban areas in North Carolina, and none was using antiretroviral medications at entry. Disease progression was defined as CD4(+) lymphocyte count <200/microl or the presence of an AIDS indicator condition. RESULTS: Cox regression models with time-dependent covariates were used adjusting for race, baseline CD4(+) count and viral load, and cumulative average antiretroviral medications. Faster progression to AIDS was associated with higher cumulative average stressful life events, coping by means of denial, and higher serum cortisol as well as with lower cumulative average satisfaction with social support. Other background (e.g., age, education) and health habit variables (e.g., tobacco use, risky sexual behavior) did not significantly predict disease progression. The risk of AIDS was approximately doubled for every 1.5-unit decrease in cumulative average support satisfaction and for every cumulative average increase of one severe stressor, one unit of denial, and 5 mg/dl of cortisol. CONCLUSIONS: Further research is needed to determine if treatments based on these findings might alter the clinical course of HIV-1 infection.

A national survey of practice patterns of gastroenterologists with comparison to the past two decades.

Previous surveys on the practice of gastroenterology collected limited data on practice demographics. Gastroenterology practices may have changed over the past decade as a result of changes in health care delivery. The authors sought to describe the practice composition and demographics of today's gastroenterologist, and also to make comparisons to prior studies to determine whether changes have occurred. A nationwide cross-sectional survey was performed in 1997 of 900 American Gastroenterological Association (AGA) members selected randomly from the AGA directory. A total of 767 AGA members were eligible for the study, and 376 responded (response rate, 49%). The mean age was 46 years old and the mean year training was completed was 1982. The majority of gastroenterologists were in solo or group practice (57%) and in an urban setting (55%). Respondents were fairly equally represented from different regions of the country. The most common diagnosis seen was irritable bowel syndrome ([IBS] 19%), followed by esophageal reflux (17%) and inflammatory bowel disease (14%). Functional disorders as a group (IBS, nonulcer dyspepsia, and other functional disorders) were, by far, the most common disorders (35%), which is similar to findings in prior studies of gastrointestinal practices. Only 3% of gastroenterologists believed that managed care has made it easier to deliver quality health care to patients with IBS. Despite changes that have occurred in health care over the past decade, the types of diagnoses seen in gastroenterology practices has remained the same. Most gastroenterologists feel that managed care has not made it easier to deliver quality health care.

The role of psychosocial factors in irritable bowel syndrome.

Psychosocial factors, as appreciated within the context of the biopsychosocial model, are necessary for understanding the clinical expression of irritable bowel syndrome (IBS) by virtue of their key roles in the development, precipitation and perpetuation of IBS. Addressing psychosocial factors in assessment and management leads to improvement in the clinical outcome for IBS patients. Pertinent management components include adopting a 'care' approach within an ongoing collaborative treatment relationship; offering any psychological or psychiatric intervention as part of a multi-disciplinary treatment approach; providing education and reassurance; and using mental health professionals when indicated.

Does a coexisting anxiety disorder predict persistence of depressive illness in primary care patients with major depression?

We assessed whether a coexisting anxiety disorder predicts risk for persistent depression in primary care patients with major depression at baseline. Patients with major depression were identified in a 12-month prospective cohort study at a University-based family practice clinic. Presence of an anxiety disorder and other potential prognostic factors were measured at baseline. Persistent depressive illness (major depression, minor depression, or dysthymia) was determined at 12 months. Of 85 patients with major depression at baseline, 43 had coexisting anxiety disorder (38 with social phobia). The risk for persistent depression at 12 months was 44% greater [Risk Ratio (RR) = 1.44, 95% confidence interval (CI) 1.02-2.04] in those with coexisting anxiety. This risk persisted in stratified analysis controlling for other prognostic factors. Patients with coexisting anxiety had greater mean depressive severity [repeated measures analysis of variance (ANOVA), p < 0.04] and total disability days (54.9 vs 19.8, p < 0.02) over the 12-month study. Patients with social phobia had similar increased risk for persistent depression (RR = 1.40, 95% CI 0.98-2.00). A coexisting anxiety disorder indicates risk for persistent depression in primary care patients with major depression. Social phobia may be important to recognize in these patients. Identifying anxiety disorders can help primary care clinicians target patients needing more aggressive treatment for depression.

Chromium potentiation of antidepressant pharmacotherapy for dysthymic disorder in 5 patients.

BACKGROUND: Dysthymic disorder is a relatively common illness that is often treated with antidepressants. Compared with the study of major depression, there has been little systematic study of potentiation strategies for antidepressant-refractory dysthymic disorder. METHOD: Following a patient's report of dramatic response to the addition of chromium supplementation to sertraline pharmacotherapy for dysthymic disorder (DSM-IV), the authors initiated a series of single-blind and open-label trials of chromium picolinate or chromium polynicotinate in the treatment of antidepressant-refractory dysthymic disorder. RESULTS: In a series of 5 patients, chromium supplementation led to remission of dysthymic symptoms. Single-blind substitution of other dietary supplements in each of the patients demonstrated specificity of response to chromium supplementation. CONCLUSION: Preliminary observations suggest that chromium may potentiate antidepressant pharmacotherapy for dysthymic disorder. Controlled studies are indicated to test the validity of these initial observations.