Well-Being Therapy and Lifestyle Intervention in Type 2 Diabetes: A Pilot Randomized Controlled Trial.

OBJECTIVE: This pilot randomized controlled trial evaluates the preliminary efficacy of a 4-month well-being therapy (WBT) and lifestyle intervention among adults with type 2 diabetes and overweight/obesity. METHODS: Fifty-eight patients were recruited from two outpatient clinics and randomized to receive the WBT-lifestyle intervention or the lifestyle intervention alone. Data were collected at baseline (T0), immediate postintervention (T1), 6-month follow-up (T2), and 12-month follow-up (T3). Primary efficacy outcomes included changes in weight, psychological distress, and well-being, whereas secondary efficacy outcomes included changes in lifestyle and physiological parameters. RESULTS: Compared with the lifestyle-alone intervention, the WBT-lifestyle intervention showed greater improvements in depression (p = .009, d = -0.6), hostility (p = .018, d = -0.6), and personal growth (p = .026, d = 0.5) at T1, in self-reported physical activity at T2 (p = .013, d = 0.7) and T3 (p = .040, d = 0.5), and in triglycerides (p = .019, d = -1.12) at T3. There were no differences between treatment groups in weight and other physiological parameters. CONCLUSIONS: These findings suggest that WBT may be a valuable addition to lifestyle interventions for improving short-term psychological outcomes and promoting long-term healthy changes in physical activity, with a potential impact on physiological outcomes.Trial Registration:ClinicalTrials.gov identifier: NCT03609463.

Withdrawal Symptoms after Serotonin-Noradrenaline Reuptake Inhibitor Discontinuation: Systematic Review.

BACKGROUND: Serotonin-noradrenaline reuptake inhibitors (SNRI) are widely used in medical practice. Their discontinuation has been associated with a wide range of symptoms. The aim of this paper is to identify the occurrence, frequency, and features of withdrawal symptoms after SNRI discontinuation. METHODS: PRISMA guidelines were followed to conduct a systematic review. Electronic databases included PubMed, the Cochrane Library, Web of Science, and MEDLINE from the inception of each database to June 2017. Titles, abstracts, and topics were searched using a combination of the following terms: "duloxetine" OR "venlafaxine" OR "desvenlafaxine" OR "milnacipran" OR "levomilnacipran" OR "SNRI" OR "second generation antidepressant" OR "serotonin norepinephrine reuptake inhibitor" AND "discontinuation" OR "withdrawal" OR "rebound." Only published trials in the English language were included. RESULTS: Sixty-one reports met the criteria for inclusion. There were 22 double-blind randomized controlled trials, 6 studies where patients were treated in an open fashion and then randomized to a double-blind controlled phase, 8 open trials, 1 prospective naturalistic study, 1 retrospective study, and 23 case reports. Withdrawal symptoms occurred after discontinuation of any type of SNRI. The prevalence of withdrawal symptoms varied across reports and appeared to be higher with venlafaxine. Symptoms typically ensued within a few days from discontinuation and lasted a few weeks, also with gradual tapering. Late onset and/or a longer persistence of disturbances occurred as well. CONCLUSIONS: Clinicians need to add SNRI to the list of drugs potentially inducing withdrawal symptoms upon discontinuation, together with other types of psychotropic drugs. The results of this study challenge the use of SNRI as first-line treatment for mood and anxiety disorders.

Benzodiazepines as a Monotherapy in Depressive Disorders: A Systematic Review.

BACKGROUND: The aim of this paper was to perform a systematic review and, when feasible, a meta-analysis of randomized controlled trials (RCT) which used benzodiazepines (BZD) as a monotherapy versus placebo, antidepressant drugs (AD), or both. METHODS: Keyword searches were conducted for identifying RCT comparing BZD and AD, and/or placebo in the treatment of depression, using electronic databases from their inception up to April 2017. We selected reports of RCT in which BZD were compared to AD and/or placebo in the treatment of adult patients with a primary diagnosis of depressive disorder or anxious depression. When feasible, data were subjected to meta-analysis. RESULTS: A total of 38 studies met the criteria for inclusion and were then included in the systematic review. Only 1 study concerned a newer AD, fluvoxamine. For the meta-analysis, we submitted data on response rate from 22 RCT, considering BZD versus placebo (8 comparisons) and BZD versus tricyclic antidepressants (TCA) (20 comparisons). There was a lack of significant differences as to response rate between BZD and placebo, as well as between BZD and TCA. Analysis of individual studies disclosed that, in more than half of the studies comparing BZD to TCA and/or placebo, BZD were significantly more effective than placebo and as effective as TCA. CONCLUSIONS: BZD are a therapeutic option in anxious depression and there are no indications that AD are preferable. There is a pressing need for RCT of adequate methodological quality and follow-up comparing BZD to second-generation AD and placebo in anxious depression.

Behavioral Toxicity Revisited: Iatrogenic Comorbidity in Psychiatric Evaluation and Treatment.

In 1968, DiMascio and Shader provided a conceptual framework for behavioral toxicity of psychotropic drugs (ie, the pharmacological actions of a drug that, within the dose range in which it has been found to possess clinical utility, may produce alterations in mood, perceptual, cognitive, and psychomotor functions that limit the capacity of the individual or constitute a hazard to one's well-being). A drug effect such as sedation or motor stimulation may be considered adverse for one patient and yet therapeutic and desired for another patient; within the same patient, it may be of value at one stage of one's illness and adverse at a later stage. The concept of behavioral toxicity encompasses adverse events that may be limited to the period of drug administration and/or persist long after their discontinuation. These latter phenomena can be subsumed under the rubric of iatrogenic comorbidity. Behavioral toxicity may ensue with any type of medical drug. Examples related to antidepressant drug use (onset of suicidality and aggression, switching from unipolar to bipolar course, withdrawal phenomena upon discontinuation, postwithdrawal persistent disorders) are discussed. Consideration of potential vulnerability to adverse events including behavioral toxicity should be placed in the context of the benefits that treatment may entail.

Use of the Psychosocial Index: A Sensitive Tool in Research and Practice.

BACKGROUND: The Psychosocial Index (PSI) is a self-rating scale based on clinimetric principles that is simple to use in a busy clinical setting. It can be integrated by observer-rated clinical judgment, providing a first-line, comprehensive assessment of stress, well-being, distress, illness behavior, and quality of life. By calculation of scores, it can be used for conventional psychological measurements. Its clinical applications and clinimetric properties are reviewed. The present version of the PSI has been slightly revised. In addition, a modified version for use in adolescents and young adults (PSI-Young; PSI-Y) is also included. METHODS: Articles that involved the use of the PSI were identified by searching the Web of Science database from 1998 to February 2016 and by a manual search of the literature. RESULTS: A total of 20 studies reporting results from the use of PSI were included. The PSI has been employed in various clinical populations in different countries and showed high sensitivity. It significantly discriminated varying degrees of psychosocial impairment in different populations. When subjects were identified by categorical criteria (presence of allostatic overload, psychosomatic syndromes, psychiatric disorders), the PSI scores were significantly different across subgroups. CONCLUSIONS: In clinical practice, scanning the list of symptoms allows clinicians to assess rapidly which symptoms and problems are perceived as most troublesome. In research settings, the use of scores makes the PSI a valid and sensitive tool in differentiating levels of psychosocial variables among groups.

Discriminating the Presence of Psychological Distress in Patients Suffering from Psoriasis: An Application of the Clinimetric Approach in Dermatology.

Psoriasis is a chronic dermatologic disease that negatively impacts physical and mental health of patients as well as their social and work life. The aim of this study is to illustrate, by a clinimetric approach the differences in psychological distress and well-being between patients with mild and moderate to severe psoriasis. Seventy patients with psoriasis were evaluated using the Structured Clinical Interview for DSM-IV (SCID-I), the Diagnostic Criteria for Psychosomatic Research (DCPR), along with the following self-report instruments: the Symptoms Questionnaire (SQ), the Psychological Well-being scales (PWB) and the Temperament and Character Inventory (TCI). Illness severity was evaluated using the Psoriasis Area and Severity Index (PASI). While no differences were reported between groups in terms of psychiatric diagnoses, patients with greater severity (PASI <10) presented higher rates of demoralization (61.5%) and Type A behavior (53.8%) than subjects with mild severity (17.5% and 21.1%, respectively). Patients with moderate/severe psoriasis also reported impaired levels of psychological well-being in terms of lower autonomy, environmental mastery, personal growth and purpose in life. Furthermore, according to TCI, patients with severe psoriasis reported greater harm avoidance and lower self-directness than individuals with milder psoriasis levels. Overall results highlighted the need in psoriasis care of a more comprehensive psychological and psychosomatic assessment not limited to the customary psychiatric diagnostic criteria.

Results from the Trial Using Motivational Interviewing, Positive Affect, and Self-Affirmation in African Americans with Hypertension (TRIUMPH).

OBJECTIVE: Our objective was to determine the effectiveness of combining positive affect and self-affirmation strategies with motivational interviewing in achieving blood pressure control among hypertensive African Americans (AA) compared with AA hypertensives in an education-only control group. DESIGN: Randomized trial. SETTING: Ambulatory practices in the South Bronx and Harlem, New York City. PARTICIPANTS: African American adults with uncontrolled hypertension. INTERVENTIONS: Participants were randomized to a positive affect and self-affirmation intervention or an education control group. The positive affect and self-affirmation intervention involved having participants think about things that made them happy and that reminded them of their core values on a daily basis. These strategies were reinforced every two months through motivational interviewing. The control arm received a workbook of strategies on blood pressure control. All participants were called every two months for one year. MAIN OUTCOMES: Blood pressure control rate. RESULTS: A total of 238 participants were randomized. The average age was 56 ± 11 years, approximately 70% were female, 80% were not married, and up to 70% had completed high school. There was no difference in control rates between the intervention and the control group. However, at one year, female participants were more likely to be controlled. Participants with high depressive symptoms or high perceived stress at baseline were less likely to be controlled. CONCLUSIONS: While this study did not demonstrate an intervention effect, it does provide important insight into the psychosocial factors that may underlie blood pressure control in African Americans. Implications for future behavioral intervention trials are discussed.

Withdrawal Symptoms after Selective Serotonin Reuptake Inhibitor Discontinuation: A Systematic Review.

Background: Selective serotonin reuptake inhibitors (SSRI) are widely used in medical practice. They have been associated with a broad range of symptoms, whose clinical meaning has not been fully appreciated. Methods: The PRISMA guidelines were followed to conduct a systematic review of the literature. Titles, abstracts, and topics were searched using the following terms: 'withdrawal symptoms' OR 'withdrawal syndrome' OR 'discontinuation syndrome' OR 'discontinuation symptoms', AND 'SSRI' OR 'serotonin' OR 'antidepressant' OR 'paroxetine' OR 'fluoxetine' OR 'sertraline' OR 'fluvoxamine' OR 'citalopram' OR 'escitalopram'. The electronic research literature databases included CINAHL, the Cochrane Library, PubMed and Web-of-Science from inception of each database to July 2014. Results: There were 15 randomized controlled studies, 4 open trials, 4 retrospective investigations, and 38 case reports. The prevalence of the syndrome was variable, and its estimation was hindered by a lack of case identification in many studies. Symptoms typically occur within a few days from drug discontinuation and last a few weeks, also with gradual tapering. However, many variations are possible, including late onset and/or longer persistence of disturbances. Symptoms may be easily misidentified as signs of impending relapse. Conclusions: Clinicians need to add SSRI to the list of drugs potentially inducing withdrawal symptoms upon discontinuation, together with benzodiazepines, barbiturates, and other psychotropic drugs. The term 'discontinuation syndrome' that is currently used minimizes the potential vulnerabilities induced by SSRI and should be replaced by 'withdrawal syndrome'. © 2015 S. Karger AG, Basel.

Five-factor model personality traits as predictors of incident coronary heart disease in the community: a 10.5-year cohort study based on the Baltimore epidemiologic catchment area follow-up study.

OBJECTIVE: Certain personality and behavioral traits (e.g., type A and type D) have been reported to be associated with development and progression of coronary heart disease (CHD), but few have examined the relationship using a comprehensive assessment of personality along with a structured assessment of psychiatric disorders. METHODS: Based on participants (age: 47.3 ± 12.8; female: 62.6%) of the Baltimore Epidemiologic Catchment Area follow-up study, we examined the relationship between the 5 major domains of personality traits (neuroticism, extraversion, openness, agreeableness, and conscientiousness) and incident CHD between Wave III (1993-1996) and Wave IV (2004-2005). RESULTS: Incident CHD developed in 65 participants during the follow-up. Those with incident CHD had lower on openness (44.06 ± 9.29 vs. 47.18 ± 8.80; p = 0.007) and extraversion (45.98 ± 9.25 vs. 49.12 ± 8.92; p = 0.007) scores than those without. Logistic regression models revealed an inverse association (OR = 0.73; 95% CI = 0.54-0.98) between openness factor z-scores and incident CHD after adjusting for putative confounding factors, including DSM III-R Major Depressive Disorder. CONCLUSION: High openness appears to be an independent protective factor for incident CHD in the community. Future studies should examine behavioral and pathophysiologic mechanisms underlying this association.

Psychological well-being in out-patients with eating disorders: a controlled study.

OBJECTIVE: Positive functioning is widely neglected in research on eating disorders (EDs). The aim of this exploratory study was to assess psychological well-being (PWB) in out-patients with ED and in controls. METHOD: The authors assessed PWB in 245 out-patients with EDs [105 with bulimia nervosa (BN), 57 with anorexia nervosa (AN), and 83 with binge eating disorder (BED) who met DSM-IV-TR] and 60 controls. They tested whether PWB was associated with eating attitude test (EAT) scores and if such associations differed among ED groups while taking into account confounding variables. RESULTS: Significant differences between groups in all PWB scales were found. While individuals with BN reported significantly lower scores in all PWB dimensions than healthy controls, patients with BED scored significantly lower than controls in PWB autonomy, environmental mastery, and self-acceptance scales. Patients with AN showed similar scores to controls in all PWB dimensions, except for positive relationships and self-acceptance. In all ED groups, most PWB dimensions resulted significantly and negatively associated with EAT scales, except for AN where oral control was found to positively correlate with a high sense of purpose in life. All results were maintained even after adjusting for possible confounding variables. DISCUSSION: Patients with EDs reported an impairment in PWB. The paucity of PWB was not necessarily dependent on the presence of high levels of psychological distress and on the severity of the disorder. Such assessments may therefore yield a more comprehensive evaluation in this clinical population.

Efficacy and tolerability of benzodiazepines versus antidepressants in anxiety disorders: a systematic review and meta-analysis.

BACKGROUND: Placebo-controlled trials showed that both benzodiazepines (BDZ) and antidepressant drugs (AD) are effective in treating anxiety disorders. However, in the last years a progressive shift in the prescribing pattern from BDZ to newer AD has taken place. The aim of this systematic review and meta-analysis is to analyze whether controlled comparisons support such a shift. METHODS: CINHAL, the Cochrane Library, MEDLINE, PubMed and Web of Science were searched from inception up to December 2012. A total of 22 studies met the criteria for inclusion. They were mostly concerned with tricyclic antidepressants (TCA; 18/22) and involved different anxiety disorders. In order to reduce clinical heterogeneity, only the 10 investigations that dealt with the comparison between TCA and BDZ in panic disorder were submitted to meta-analysis, whereas the remaining papers were individually summarized and critically examined. RESULTS: According to the systematic review, no consistent evidence emerged supporting the advantage of using TCA over BDZ in treating generalized anxiety disorder (GAD), complex phobias and mixed anxiety-depressive disorders. Indeed, BDZ showed fewer treatment withdrawals and adverse events than AD. In panic disorder with and without agoraphobia our meta-analysis found BDZ treatments more effective in reducing the number of panic attacks than TCA (risk ratio, RR = 1.13; 95% CI = 1.01-1.27). Furthermore, BDZ medications were significantly better tolerated than TCA drugs, causing less discontinuation (RR = 0.40; 95% CI = 0.20-0.57) and side effects (RR = 0.41; 95% CI = 0.34-0.50). As to newer AD, BDZ trials resulted in comparable or greater improvements and fewer adverse events in patients suffering from GAD or panic disorder. CONCLUSIONS: The change in the prescribing pattern favoring newer AD over BDZ in the treatment of anxiety disorders has occurred without supporting evidence. Indeed, the role and usefulness of BDZ need to be reappraised.

Excessive mood elevation and behavioral activation with antidepressant treatment of juvenile depressive and anxiety disorders: a systematic review.

BACKGROUND: The prevalence, characteristics and implications of excessive arousal-activation in children and adolescents treated with antidepressants for specific illnesses have not been systematically examined. METHODS: We compared reports of antidepressant trials (n = 6,767 subjects) in juvenile depressive (n = 17) and anxiety disorders (n = 25) for consensus-based indications of psychopathological mood elevation or behavioral activation. RESULTS: Rates of excessive arousal-activation during treatment with antidepressants were at least as high in juvenile anxiety (13.8%) as depressive (9.79%) disorders, and much lower with placebos (5.22 vs. 1.10%, respectively; both p < 0.0001). The antidepressant/placebo risk ratio for such reactions in paired comparisons was 3.50 (12.9/3.69%), and the meta-analytically pooled rate ratio was 1.7 (95% confidence interval: 1.2-2.2; both p ≤ 0.001). Overall rates for 'mania or hypomania', specifically, were 8.19% with and 0.17% without antidepressant treatment, with large drug/placebo risk ratios among depressive (10.4/0.45%) and anxiety (1.98/0.00%) disorder patients. CONCLUSIONS: Risks of excessive mood elevation during antidepressant treatment, including mania-hypomania, were much greater than with placebo, and similar in juvenile anxiety and depressive disorders. Excessive arousal-activation in children or adolescents treated with antidepressants for anxiety as well as depressive disorders calls for particular caution and monitoring for potential risk of future bipolar disorder.

Psychobiological correlates of allostatic overload in a healthy population.

The concept of allostatic load (AL) represents the cost of the continual adjustment of the internal milieu required by an organism to adapt to different challenges. The majority of studies concerning AL have focused mainly on identifying its biological components. Recently, new criteria for a clinimetric evaluation of AL have been introduced, adding a new definition of allostatic overload (AO). This study aims to identify psychological and biological correlates of AO in a population of blood donors, according to this new definition of AO. Participants included 240 blood donors recruited from May 2007 to December 2009 in 4 different blood Centers. Blood samples from each participant were collected for laboratory analysis and self-rating instruments were administered on the same day. Biological parameters included those usually assessed during blood donation. Individuals were selected based on the criteria for the clinimetric evaluation of AO. Differences in biomarkers between subjects with and without allostatic overload were performed using the GLM with biological measures as dependent variables, AO groups as the fixed factor and specific confounders as covariates. Based on the selection criteria for allostatic overload, 98 subjects have been identified as presenting with AO. Results showed that individuals with allostatic overload presented lower levels of serum proteins, erythrocytes and immune differential count than donors without allostatic overload. Further, greater mean corpuscular volume has been found in persons included in the AO group. The evaluation of the AO correlates, along with a biomarker profile, may help to identify those conditions that, by exceeding individual resources, may constitute a danger to health.

[Promoting psychosocial well-being in adolescence. A controlled study]. / La promozione del benessere psicologico nell'adolescenza. Uno studio controllato.

INTRODUCTION: In the recent years a large body of literature has focused its attention to the study of the positive aspects of adolescence, in particular quality of life, happiness and social functioning. The school is an ideal setting for promoting learning abilities, educational processes and also optimal human and social development. AIM: A new school program for the promotion of psychological well-being has been tested and compared to an attention-placebo intervention in a high school setting. METHODS: Nine classes (227 students) were enrolled in the study and randomized to: a) School Well-Being Therapy intervention (5 classes); b)attention-placebo (4 classes). 1) Symptom Questionnaire (SQ); 2) Psychological Well-Being Scales (PWB); 3) Revised Children's Manifest Anxiety Scale (RCMAS) were administered at pre- and post-intervention, and after six months. RESULTS: WBT school intervention was associated to an improved Personal Growth (PWB), and to decreased distress (Somatization (SQ), Physical Well-being (SQ), Anxiety (SQ), and RCMAS Physiological Anxiety). DISCUSSION AND CONCLUSIONS: A school intervention focused on the promotion of positive emotions and psychological well-being has resulted to be effective not only in increasing these dimensions in high school students, but also in decreasing distress, in particular anxiety and somatization.

Appropriate controls for digital therapeutic clinical trials: A narrative review of control conditions in clinical trials of digital therapeutics (DTx) deploying psychosocial, cognitive, or behavioral content.

Digital therapeutics (DTx) are software programs that treat a disease or condition. Increasingly, DTx are part of medical care, and in the US healthcare system they are regulated by the FDA as Software as a Medical Device (SaMD). Randomized controlled trials (RCT) remain a key evidence generation step for most DTx. However, developing a unified approach to the design of appropriate control conditions has been a challenge for two main reasons: (1) inheriting control condition definitions from pharmacotherapy and medical device RCT that may not directly apply, and (2) challenges in establishing control conditions for psychosocial interventions that build the core of many DTx. In our critical review we summarize different approaches to control conditions and patient blinding in RCT evaluating DTx with psychosocial, cognitive or behavioral content. We identify control condition choices, ranging from very minimal digital controls to more complex and stringent digital applications that contain aspects of "fake" therapy, general wellness content or games. Our review of RCTs reveals room for improvement in describing and naming control conditions more consistently. We further discuss challenges in defining placebo controls for DTx and ways in which control choices may have a therapeutic effect. While no one-size-fits-all control conditions and study designs will apply to all DTx, we propose points to consider for defining appropriate digital control conditions. At the same time, given the rapid iterative development and optimization of DTx, treatments with low risk profile may be evaluated with minimal digital controls followed by extensive real-world effectiveness trials.

[What are the differences between well-being therapy and anxiety management in the school setting?]. / La well-being therapy e le tecniche di gestione dell'ansia in ambito scolastico: quali differenze?

BACKGROUND: In the last decade there has been increasing interest in the potential of early preventive interventions capable of promoting psychological well being in order to reduce the risk of childhood psychological distress. This study analyzes the differential effects of strategies for promotion of psychological well-being (Well-Being Therapy, WBT) and removal of distress (Anxiety Management, AM) in a non clinical school setting. METHODS: Our sample consisted of eight classes (N=162 students) attending middle schools in Northern Italy which were randomly assigned to a protocol derived from WBT (4 classes) and to an anxiety-management protocol (AM) (4 classes). Immediately before and after both school interventions students were assessed using the Psychological Well-Being Scales (PWB), Kellner's Symptom Questionnaire (SQ) and the Revised Children's Manifest Anxiety Scale (R-CMAS). A six month follow-up was performed in the following school year, and students were re-assessed with the same psychometric instruments. RESULTS: Our results lend support to the possibility to change attitudes to psychological well-being and distress with brief interventions in school (both well-being improving and distress removing). CONCLUSIONS: Further investigations should determine whether the combined and sequential integration of well-being and symptom oriented strategies may yield more complete and lasting effects that each strategy alone.

[Ill-being and well-being: searching for biological correlates]. / Disagio e benessere: alla ricerca dei mediatori fisiologici.

AIM: The aim of the present study is to describe the relationship between psychological well-being, ill-being and biological correlates on a sample of Italian blood donors. Particularly, specific correlations with biological correlates were analysed. MATERIALS AND METHODS: Sample consisted of 58 blood donors. Biological parameters were assessed using the usual blood analyses. Psychological well-being, ill-being and stress were assessed respectively with the Psychological Well-Being scale (PWB), the Symptom Questionnaire (SQ), and the Psychosocial Index (PSI). Pearson Correlations were computed between these scores and biological indexes. RESULTS: A significant positive correlation between different scales of SQ and PSI and platelets was found, while the same parameter showed a significant negative correlation with the Environmental Mastery subscale (PWB). DISCUSSION: Results add clues to the growing literature concerning the link between health and well-being. Particularly, platelets data confirms previous literature on the relationship with the distress measures, but in this study it also displays an unexpected correlation with a well being dimension (Environmental Mastery).

Clinical characterization of allostatic overload.

Allostatic load reflects the cumulative effects of stressful experiences in daily life and may lead to disease over time. When the cost of chronic exposure to fluctuating or heightened neural and systemic physiologic responses exceeds the coping resources of an individual, this is referred to as "toxic stress" and allostatic overload ensues. Its determination has initially relied on measurements of an interacting network of biomarkers. More recently, clinical criteria for the determination of allostatic overload, that provide information on the underlying individual experiential causes, have been developed and used in a number of investigations. These clinimetric tools can increase the number of people screened, while putting the use of biomarkers in a psychosocial context. The criteria allow the personalization of interventions to prevent or decrease the negative impact of toxic stress on health, with particular reference to lifestyle modifications and cognitive behavioral therapy.

Impact of Depression and Demoralization on Blood Pressure Control in African Americans with Hypertension: Findings from the TRIUMPH Trial.

BACKGROUND: African Americans develop hypertension earlier and have worse cardiovascular outcomes than Caucasians. Accumulating evidence suggests that psychological distress may play a role in the observed racial differences in hypertension. Several studies have investigated the relationship between depression and hypertension while little is still known about the role of demoralization. METHODS: Using data from the Trial Using Motivational Interviewing, Positive Affect, and Self-affirmation in African Americans with Hypertension (TRIUMPH), logistic regression models were used to estimate differences in blood pressure control at 12 months among participants with demoralization, depression, and both conditions. RESULTS: Our logistic models showed that reported psychosocial symptoms significantly differed in predicting success in blood pressure control at 12 months. Contrast analyses showed that, after adjusting for sociodemographic, clinical, and psychosocial variables, demoralized patients were less likely to achieve blood pressure control than participants without affective conditions (p = 0.020). Similar results emerged for patients with depression (p = 0.042) and both conditions (p = 0.022). CONCLUSIONS: Depression can be extremely debilitating and has serious health consequence. Our findings confirm this result and show that, even though depression and demoralization share common features, they are two distinct clinical phenomena with similar negative impact on blood pressure control in African Americans.