Investigating patients´ views on screening for depression in cardiac practice: A qualitative interview study.

OBJECTIVE: Recommendations on screening for depression in patients with coronary heart disease (CHD) are highly debated. While recent research has prioritized efficacy studies, little is known about what is potentially required for screening to be efficacious. Expanding our knowledge of how patients with CHD view screening is likely to pose a first step towards addressing this gap. We aimed to investigate patients ́ views on routine screening for depression in cardiac practice. METHODS: This exploratory, qualitative study was conducted among 12 patients with CHD, who completed semi-structured interviews. We used a purposive sampling strategy to include patients within a range of ages, gender and self-reported depression. Thematic analysis was carried out. RESULTS: We identified four main themes: Acceptance, utility, barriers and expectations. Patients in this sample appeared to be in favor of standardized routine screening for depression in cardiac practice, if the rationale was disclosed. Patients reported that standardized screening addresses holistic care demands, promotes validation of individual symptom burden and legitimizes the display of psychological distress in cardiac practice. Yet, skepticism towards the validity of screening instruments and perceived stigmatization could pose a main barrier to screening efficacy. Patients expected to receive feedback on results and consecutive recommendations. CONCLUSION: We found that depression screening is endorsed by patients with CHD in this study sample. Standardized routine screening procedures could serve as a useful tool to combat stigmatization, and encourage patients to display symptoms of depression towards cardiologists. The efficacy of depression screening could potentially be enhanced by tailoring the screening process towards patients´ needs.

Comparison of efficacy and safety of complementary and alternative therapies for coronary heart disease complicated with anxiety or depression disorder: A protocol for Bayesian network meta-analysis.

BACKGROUND: With the acceleration of the pace of life, the phenomenon of anxiety and depression in patients with coronary heart disease (CHD) is more and more common, and "psycho-cardiology" arises spontaneously. At present, the drug treatments of psycho-cardiology are difficult to achieve satisfactory results, and the side effects are obvious. Complementary and replacement therapies of CHD complicated with anxiety or depression disorder play an increasingly positive role, but there is a lack of comparison among different complementary and alternative therapies. In this study, Bayesian network meta-analysis (NMA) analysis method will be used for the first time to synthesize all the evidences of direct and indirect comparison among a variety of interventions, and rank their effectiveness and safety. METHODS: Two independent researchers will search from the beginning to January 2021 mainly including randomized controlled trials (RCTs) and closely related ongoing RCTs of complementary and alternative therapies for CHD complicated with anxiety or depression disorder. And then identify, select and extract the data. The primary outcome measures are frequency of acute attack angina, severity of angina pectoris; the changed score in the validated scales, which can assess severity of anxiety or depression. Secondary outcomes include total efficacy rate, electrocardiogram improvement, traditional Chinese medicine symptoms score, changes of dosage of nitroglycerin and adverse effects. Using softwares WinBUGS 1.4.3 and STATA 16.0 for pairwise meta-analysis and NMA to comprehensively evaluate various interventions. The quality of evidences will be evaluated through the Grading of Recommendations Assessment, Development and Evaluation. RESULTS: This NMA will comprehensively compare and rank the efficacy and safety of a series of complementary and alternative therapies in the treatment of CHD complicated with anxiety or depression disorder. CONCLUSION: Supplementary and replacement therapies play an essential role in improving CHD complicated with anxiety or depression disorder. We expect that the NMA will provide reliable evidences of evidence-based medicine for treatment of CHD complicated with anxiety or depression disorder. PROTOCOL REGISTRATION NUMBER: INPLASY202120046. ETHICAL APPROVAL: This review does not require ethical approval.

Safety and effectiveness of a Tai Chi-based cardiac rehabilitation programme for chronic coronary syndrom patients: study protocol for a randomised controlled trial.

INTRODUCTION: Preliminary evidence from clinical observations suggests that Tai Chi exercise may offer potential benefits for patients with chronic coronary syndrom (CCS). However, the advantages for CCS patients to practice Tai Chi exercise as rehabilitation have not been rigorously tested and there is a lack of consensus on its benefits. This study aims to develop an innovative Tai Chi Cardiac Rehabilitation Program (TCCRP) for CCS patients and to assess the efficacy, safety and acceptability of the programme. METHODS AND ANALYSIS: We propose to conduct a multicentre randomised controlled clinical trial comprising of 150 participants with CCS. The patients will be randomly assigned in a 1:1 ratio into two groups. The intervention group will participate in a supervised TCCRP held three times a week for 3 months. The control group will receive supervised conventional exercise rehabilitation held three times a week for 3 months. The primary and secondary outcomes will be assessed at baseline, 1 month, 3 months after intervention and after an additional 3-month follow-up period. Primary outcome measures will include a score of 36-Item Short Form Survey and Chinese Perceived Stress Scale. The secondary outcome measures will include body composition, cardiopulmonary exercise test, respiratory muscle function, locomotor skills, echocardiogram, New York Heart Association classification, heart rate recovery time and laboratory examination. Other measures also include Seattle Angina Scale, Pittsburgh Sleep Quality Index, Patient Health Questionnaire-9, Generalized Anxiety Disorder-7 and Berg Balance Scale. All adverse events will be recorded and analysed. ETHICS AND DISSEMINATION: This study conforms to the principles of the Declaration of Helsinki and relevant ethical guidelines. Ethical approval has been obtained from the Ethics Committee of Chinese People's Libration Army General Hospital (approval number: S2019-060-02). Findings from this study will be published and presented at conferences for widespread dissemination of the results. TRIAL REGISTRATION NUMBER: NCT03936504.

A Randomized Placebo-Controlled Trial of Omega-3 and Sertraline in Depressed Patients With or at Risk for Coronary Heart Disease.

OBJECTIVE: Studies of depressed psychiatric patients have suggested that antidepressant efficacy can be increased by adding eicosapentaenoic acid (EPA), one of the omega-3 fatty acids found in fish oils. The purpose of this study was to determine whether the addition of EPA improves the response to sertraline in depressed patients with or at high risk for coronary heart disease (CHD). METHODS: Between May 2014 and June 2018, 144 patients with DSM-5 major depressive disorder seen at the Washington University School of Medicine with or at high risk for CHD were randomized to receive either 50 mg/d of sertraline and 2 g/d of EPA or 50 mg/d of sertraline and corn oil placebo capsules for 10 weeks. The Beck Depression Inventory II (BDI-II) was the primary outcome measure. RESULTS: After 10 weeks of treatment, there were no differences between the arms on the mean baseline-adjusted BDI-II (placebo, 10.3; EPA, 12.1; P = .22), the 17-item Hamilton Depression Rating Scale (placebo, 7.2; EPA, 8.0; P = .40), or the 10-week remission rate (BDI-II score ≤ 8: placebo, 50.6%; EPA, 46.7%; odds ratio = 0.85; 95% CI, 0.43 to 1.68; P = .63). CONCLUSIONS: Augmentation of sertraline with 2 g/d of EPA for 10 weeks did not result in greater improvement in depressive symptoms compared to sertraline and corn oil placebo in patients with major depressive disorder and CHD or CHD risk factors. Identifying the characteristics of cardiac patients whose depression may benefit from omega-3 and clarifying the pathways linking omega-3 to improvement in depression symptoms are important directions for future research. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT02021669; FDA IND registration number: 121107.

The effects of probiotic and selenium co-supplementation on mental health parameters and metabolic profiles in type 2 diabetic patients with coronary heart disease: A randomized, double-blind, placebo-controlled trial.

BACKGROUND AND AIMS: The objective of this investigation was to assess the effects of probiotic and selenium co-supplementation on indicators of mental health and metabolic profiles in diabetic people with coronary heart disease (CHD). METHODS: This randomized, double-blind, placebo-controlled trial was conducted among 54 diabetic people with CHD. Patients were randomly allocated into two groups to receive either 200 µg/day selenium plus 8 × 109 CFU/day probiotic (n = 27) or placebo (n = 27) for 12 weeks. RESULTS: Probiotic and selenium co-supplementation significantly decreased Beck Depression Inventory index (ß -1.46; 95% CI, -2.61, -0.31; P = 0.01) and Beck Anxiety Inventory index (ß -1.23; 95% CI, -2.33, -0.12; P = 0.02) compared with the placebo. Consuming probiotic plus selenium lowered fasting plasma glucose (ß -10.80 mg/dL; 95% CI, -17.68, -3.92; P = 0.003), serum insulin levels (ß -3.42 µIU/mL; 95% CI, -4.93, -1.90; P < 0.001), insulin resistance (ß -0.96; 95% CI, -1.45, -0.47; P < 0.001), and enhanced insulin sensitivity (ß 0.01; 95% CI, 0.007, 0.01; P < 0.001) compared with the placebo. Additionally, co-supplementation reduced triglycerides (ß -34.45 mg/dL; 95% CI, -56.18, -12.72; P = 0.003), VLDL- (ß -6.89 mg/dL; 95% CI, -11.23, -2.54; P = 0.003), total cholesterol (ß -18.13 mg/dL; 95% CI, -23.42, -2.83; P = 0.02) and high sensitivity C-reactive protein (ß -1043.28 ng/mL; 95% CI, -1929.67, -156.89; P = 0.02), and increased nitric oxide (ß 7.86 µmol/L; 95% CI, 5.63, 10.09; P < 0.001), total antioxidant capacity (ß 119.30 mmol/L; 95% CI, 63.04, 175.57; P < 0.001) and total glutathione (ß 154.16 µmol/L; 95% CI, 82.57, 225.74; P < 0.001) compared with the placebo. CONCLUSIONS: Probiotic and selenium co-supplementation to diabetic people with CHD improved indicators of mental health and metabolic profiles. Registered under Clinical Trials.gov Identifier no. http://www.irct.ir: IRCT20170513033941N28.

Religion, Spirituality and Risk of Coronary Heart Disease: A Matched Case-Control Study and Meta-Analysis.

Although the association between religion/spirituality (R/S) and psychological outcomes is well established, current understanding of the association with cardiovascular disease remains limited. We sought to investigate the association between Islamic R/S and coronary heart disease (CHD), and place these findings in light of a meta-analysis. In this case-control study, 190 cases with non-fatal CHD were identified and individually matched with 383 hospital-based controls. R/S was measured by self-administered 102 items questionnaire. A tabular meta-analysis was performed of observational studies on R/S (high level versus low level) and CHD. In addition, a dose-response meta-analysis was conducted using generalized least-squares regression. Participants in the top quartile had decreased odds of CHD comparing to participants in the lowest quartile of religious belief (OR 0.20, 95% confidence interval (CI) 0.06-0.59), religious commitment (OR 0.36, CI 95% 0.13-0.99), religious emotions (OR 0.39, CI 95% 0.18-0.87), and total R/S score (OR 0.30, CI 95% 0.13-0.67). The meta-analysis study showed a significant relative risk of 0.88 (CI 95% 0.77-1.00) comparing individuals in high level versus low level of R/S. In dose-response meta-analysis, comparing people with no religious services attendance, the relative risks of CHD were 0.77 (CI 95% 0.65-0.91) for one times attendance and 0.27 (CI 95% 0.11-0.65) for five times attendance per month. R/S was associated with a significantly decreased risk of CHD. The possible causal nature of the observed associations warrants randomized clinical trial with large sample size.

Effectiveness and safety of modified 'Huoxue Shugan' formulas on coronary heart disease combined with depression: protocol for a systematic review.

OBJECTIVE: To assess the clinical effectiveness and safety of modified 'Huoxue Shugan' (HXSG) formulas used as Chinese herbal medicine in treating patients with coronary heart disease (CHD) and depression. METHODS: A systematic literature search of articles up to March 2018 will be performed in the following electronic databases: PubMed, Embase, the Cochrane Library, China National Knowledge Infrastructure, Chinese Scientific Journals Database, Chinese Biomedical Database, Chinese Biomedical Literature Service System and Wanfang Database. Inclusion criteria are as follows: randomised controlled trials of modified HXSG formulas in patients with CHD and depression. The primary outcome measures will be CHD-related clinical evaluation (frequency of acute angina, severity of angina pectoris, ECG changes, dose of nitroglycerin) and the scores or amount of reduction in scales measuring depression (ie, the Hamilton Depression Scale or other widely used depression scales). The safety outcome measures will be adverse events, liver and kidney function. RevMan V.5.3 software will be used for data synthesis, sensitivity analyses, subgroup analyses and risk of bias assessment. A funnel plot will be developed to evaluate reporting bias. Stata V.12.0 will be used for meta-regression and Egger tests. We will use the Grading of Recommendations Assessment, Development and Evaluation system to assess the quality of evidence. ETHICS AND DISSEMINATION: This systematic review does not require ethics approval and will be submitted to a peer-reviewed journal. PROSPERO REGISTRATION NUMBER: CRD42018089641.

Treatment of Anxiety in Patients With Coronary Heart Disease: A Systematic Review.

BACKGROUND: Anxiety is common in patients with coronary heart disease (CHD) and is associated with an increased risk for adverse outcomes. There has been a relative paucity of studies concerning treatment of anxiety in patients with CHD. OBJECTIVE: We conducted a systematic review to organize and assess research into the treatment of anxiety in patients with CHD. METHODS: We searched CCTR/CENTRAL, MEDLINE, EMBASE, PsycINFO, and CINAHL for randomized clinical trials conducted before October 2016 that measured anxiety before and after an intervention for patients with CHD. RESULTS: A total of 475 articles were subjected to full text review, yielding 112 publications that met inclusion criteria plus an additional 7 studies from reference lists and published reviews, yielding 119 studies. Sample size, country of origin, study quality, and demographics varied widely among studies. Most studies were conducted with nonanxious patients. The Hospital Anxiety and Depression Scale and State-Trait Anxiety Inventory were the most frequently used instruments to assess anxiety. Interventions included pharmacological, counseling, relaxation-based, educational, or "alternative" therapies. Forty (33% of total) studies reported that the interventions reduced anxiety; treatment efficacy varied by study and type of intervention. Elevated anxiety was an inclusion criterion in only 4 studies, with inconsistent results. CONCLUSION: Although there have been a number of randomized clinical trials of patients with CHD that assessed anxiety, in most cases anxiety was a secondary outcome, and only one-third found that symptoms of anxiety were reduced with treatment. Future studies need to target anxious patients and evaluate the effects of treatment on anxiety and relevant clinical endpoints.

Main active constituent identification in Guanxinjing capsule, a traditional Chinese medicine, for the treatment of coronary heart disease complicated with depression.

Guanxinjing capsules (GXJCs) are used in traditional Chinese medicine as a common therapy for coronary heart disease (CHD) complicated with depression. In this study, we aimed to identify the main active constituents in GXJCs and to investigate the mechanisms of GXJC action on CHD complicated with depression. The chemical constituent profile of the GXJC was identified by UHPLC-LTQ-Orbitrap assay, and oral bioavailability was evaluated to screen the GXJC drug-like chemical constituents. A total of 16 GXJC drug-like chemical constituents were identified. Then, putative targets of the GXJC drug-like chemical constituents were predicted using MedChem Studio, with 870 genes found to be the putative targets of these molecules. After that, a GXJC putative target-known CHD/depression therapeutic target network was constructed, and four topological features, including degree, betweenness, closeness and K-coreness, were calculated. According to the topological feature values of the GXJC putative targets, 14 main active constituents were identified because their corresponding putative targets had topological importance in the GXJC putative target-known CHD/depression therapeutic target network, which were defined as the candidate targets of GXJC against CHD complicated with depression. Functionally, these candidate targets were significantly involved in several CHD/depression-related pathways, including repairing pathological vascular changes, reducing platelet aggregation and inflammation, and affecting patient depression. This study identified a list of main active constituents of GXJC acting on CHD complicated with depression using an integrative pharmacology-based approach that combined active chemical constituent identification, drug target prediction and network analysis. This method may offer an efficient way to understand the pharmacological mechanisms of traditional Chinese medicine prescriptions.

Prevalence and predictors of complementary and alternative medicine use among people with coronary heart disease or at risk for this in the sixth Tromsø study: a comparative analysis using protection motivation theory.

BACKGROUND: Engagement in healthy lifestyle behaviors, such as healthy diet and regular physical activity, are known to reduce the risk of developing coronary heart disease (CHD). Complementary and alternative medicine (CAM) is known to be associated with having a healthy lifestyle. The primary aim of this study was to examine the prevalence and predictors of CAM use in CHD patients, and in those without CHD but at risk for developing CHD, using Protection Motivation Theory (PMT) as a guiding conceptual framework. METHOD: Questionnaire data were collected from 12,981 adult participants in the cross-sectional sixth Tromsø Study (2007-8). Eligible for analyses were 11,103 participants who reported whether they had used CAM or not. Of those, 830 participants reported to have or have had CHD (CHD group), 4830 reported to have parents, children or siblings with CHD (no CHD but family risk), while 5443 reported no CHD nor family risk of CHD. We first compared the patterns of CAM use in each group, and then examined the PMT predictors of CAM use. Health vulnerability from the threat appraisal process of PMT was assessed by self-rated health and expectations for future health. Response efficacy from the coping appraisal process of PMT was assessed as preventive health beliefs and health behavior frequency. RESULTS: Use of CAM was most commonly seen in people with no CHD themselves, but family risk of developing CHD (35.8%), compared to people already diagnosed with CHD (30.2%) and people with no CHD nor family risk (32.1%). All four of the PMT factors; self-rated health, expectations for future health, preventive health beliefs, and the health behavior index - were predictors for CAM use in the no CHD but family risk group. CONCLUSION: These findings suggest that people use CAM in response to a perceived risk of developing CHD, and to prevent disease and to maintain health.

[Advance in diagnosis and treatment of psycho-cardiological abnormality of patients with coronary heart disease with traditional Chinese medicines].

To discuss the etiology, pathogenesis, therapies and prescriptions of psycho-cardiological abnormality of patients with coronary heart disease. According to the advance in modern diagnosis and treatment, the authors believed that psycho-cardiological abnormality of patients with coronary heart disease is closely related with mental stresses, like anxiety, depression and insomnia. It is mostly caused by emotional injury and expressed in heart, liver, spleen and kidney. The pathogenesis is heart-liver hyperactivity, yin deficiency in heart and kidney, and insufficiency in heart and spleen. The full recognition of etiology and pathogenesis of psycho-cardiological abnormality of patients with coronary heart disease and the combined treatment of disease and syndromes are of great significance to reduce mental stress and other risk factors, prevent and treat coronary heart disease and improve prognosis.

Effects of massage on the anxiety of patients receiving percutaneous coronary intervention.

BACKGROUND: This study aimed to explore the effects of massage on the state anxiety of patients receiving percutaneous coronary intervention (PCI). SUBJECTS AND METHODS: In accordance with the principle of the minimum allocation of imbalance index for comparability, a total of 117 cases that were ready to receive PCI were divided into two groups (59 in the intervention group and 58 in the control group). The patients in the control group received routine care, whereas the patients in the observation group were given massage intervention. The state anxiety, heart rate, and blood pressure of the two groups were observed and compared. RESULTS: Massage treatments reduced the emergency response and level of anxiety of cardiovascular patients before PCI. The post-intervention blood pressure, heart rate, and pain score of the intervention group were significantly better than those of the control group (P<0.05). CONCLUSIONS: Health professionals should pay attention to and strengthen the exploration of the effects of reasonable care intervention mode under PCI to promote the physical and mental health of patients, as well as improve their medical care satisfaction.

Spirituality and Negative Emotions in Individuals With Coronary Heart Disease.

Many individuals with coronary heart disease (CHD) experience disease-related anxiety, depressive symptoms, and anger. Spirituality may be helpful to cope with these negative emotions. Research findings on the role of spirituality in dealing with negative emotions are inconsistent. In this study, we examined the associations between 7 dimensions of spirituality (ie, meaningfulness, trust, acceptance, caring for others, connectedness with nature, transcendent experiences, and spiritual activities) and negative emotions among individuals with CHD in Indonesia, controlling for perceived social support as well as demographic and clinical characteristics. In total, 293 individuals with CHD were recruited from the 3 largest hospitals in Bandung, Indonesia. They completed the Spiritual Attitude and Involvement List, the Beck Depression Inventory-II, the Trait Anxiety Scale of the State Trait Anxiety Inventory, the Multidimensional Anger Inventory, and the Multidimensional Scale of Perceived Social Support. Hierarchical linear regression analyses indicated that a higher overall level of spirituality was associated with lower levels of depressive symptoms, less anxiety, and less anger. Specifically, a higher level of trust was significantly associated with both less depressive symptoms and less anxiety. Higher levels of caring for others and spiritual activities were associated with less anxiety, and a higher level of connectedness with nature was associated with less anger. These findings underscore the importance of specific dimensions of spirituality as a potentially independent buffer against negative emotions in individuals with CHD.

Social integration and mortality in patients with coronary heart disease: findings from the Heart and Soul Study.

OBJECTIVE: To determine why lower social integration predicts higher mortality in patients with coronary heart disease (CHD). METHODS: The association between social integration and mortality was examined prospectively in 1019 outpatients with stable CHD from the Heart and Soul Study. Baseline social integration was assessed with the Berkman Social Network Index. Cox proportional hazards models were used to determine the extent to which demographic and disease-relevant confounders and potential biological, behavioral, and psychological mediators explained the association between social integration and mortality. RESULTS: During a mean (standard deviation) follow-up period of 6.7 (2.3) years, the age-adjusted annual rate of mortality was 6.3% among socially isolated patients and 4.1% among nonisolated patients (age-adjusted hazard ratio [HR] = 1.61, 95% confidence interval [CI] = 1.26-2.05, p < .001). After adjustment for demographic and disease-relevant confounders, socially isolated patients had a 50% greater risk of death than did nonisolated patients (HR = 1.50, 95% CI = 1.07-2.10). Separate adjustment for potential biological (HR = 1.53, CI = 1.05-2.25) and psychological mediators (HR = 1.52, CI = 1.08-2.14) did not significantly attenuate this association, whereas adjustment for potential behavioral mediators did (HR = 1.30, CI = 0.91-1.86). C-reactive protein and hemoglobin A1c were identified as important biological and omega-3 fatty acids, smoking, and medication adherence as important behavioral potential mediators, with smoking making the largest contribution. CONCLUSIONS: In this sample of outpatients with baseline stable CHD, the association between social integration and mortality was largely explained by health-related behavioral pathways, particularly smoking.

A mixed-methods pilot study of the acceptability and effectiveness of a brief meditation and mindfulness intervention for people with diabetes and coronary heart disease.

Mindfulness-based interventions can successfully target negative perseverative cognitions such as worry and thought suppression, but their acceptability and effectiveness in people with long-term conditions is uncertain. We therefore pilot tested a six-week meditation and mindfulness intervention in people (n = 40) with diabetes mellitus and coronary heart disease. We used a sequential mixed-methods approach that measured change in worry and thought suppression and qualitatively explored acceptability, feasibility, and user experience with a focus group (n = 11) and in-depth interviews (n = 16). The intervention was highly acceptable, with 90% completing ≥5 sessions. Meditation and mindfulness skills led to improved sleep, greater relaxation, and more-accepting approaches to illness and illness experience. At the end of the six-week meditation course, worry, and thought suppression were significantly reduced. Positive impacts of mindfulness-based interventions on psychological health may relate to acquisition and development of meta-cognitive skills but this needs experimental confirmation.

Improving coronary heart disease self-management using mobile technologies (Text4Heart): a randomised controlled trial protocol.

BACKGROUND: Cardiac rehabilitation (CR) is a secondary prevention program that offers education and support to assist patients with coronary heart disease (CHD) make lifestyle changes. Despite the benefits of CR, attendance at centre-based sessions remains low. Mobile technology (mHealth) has potential to reach more patients by delivering CR directly to mobile phones, thus providing an alternative to centre-based CR. The aim of this trial is to evaluate if a mHealth comprehensive CR program can improve adherence to healthy lifestyle behaviours (for example, physically active, fruit and vegetable intake, not smoking, low alcohol consumption) over and above usual CR services in New Zealand adults diagnosed with CHD. METHODS/DESIGN: A two-arm, parallel, randomised controlled trial will be conducted at two Auckland hospitals in New Zealand. One hundred twenty participants will be randomised to receive a 24-week evidence- and theory-based personalised text message program and access to a supporting website in addition to usual CR care or usual CR care alone (control). The primary outcome is the proportion of participants adhering to healthy behaviours at 6 months, measured using a composite health behaviour score. Secondary outcomes include overall cardiovascular disease risk, body composition, illness perceptions, self-efficacy, hospital anxiety/depression and medication adherence. DISCUSSION: This study is one of the first to examine an mHealth-delivered comprehensive CR program. Strengths of the trial include quality research design and in-depth description of the intervention to aid replication. If effective, the trial has potential to augment standard CR practices and to be used as a model for other disease prevention or self-management programs. TRIAL REGISTRY: Australian New Zealand Clinical Trials Registry: ACTRN12613000901707.

The ACTonHEART study: rationale and design of a randomized controlled clinical trial comparing a brief intervention based on Acceptance and Commitment Therapy to usual secondary prevention care of coronary heart disease.

BACKGROUND: Modifiable risk factors, including life-style habits and psychological variables, have been increasingly demonstrated to have an important role in influencing morbidity and mortality in cardiovascular patients, and to account for approximately 90% of the population risk for cardiac events.Acceptance and Commitment Therapy (ACT) has shown effectiveness in promoting healthy behaviors, and improving psychological well-being in patients with chronic physical conditions. Moreover, a first application of an acceptance-based program in cardiac patients has revealed high treatment satisfaction and initial evidences of effectiveness in increasing heart-healthy behaviour. However, no clinical trial to date has evaluated the efficacy of an acceptance-based program for the modification of cardiovascular risk factors and the improvement of psychological well-being, compared to usual secondary prevention care. METHODS: Approximately 168 patients will be recruited from an outpatient cardiac rehabilitation unit and randomly assigned to receive usual care or usual care + a brief ACT-based intervention. The ACT group will be administered five group therapy sessions integrating educational topics on heart-healthy behaviours with acceptance and mindfulness skills. Participants will be assessed at baseline, six weeks later (post treatment for the ACT condition), at six and twelve months follow-up.A partially-nested design will be used to balance effects due to clustering of participants into small therapy groups. Primary outcome measures will include biological indicators of cardiovascular risk and self-reported psychological well-being. Treatment effects will be tested via multilevel modeling after which the mediational role of psychological flexibility will be evaluated. DISCUSSION: The ACTonHEART study is the first randomized clinical trial designed to evaluate the efficacy of a brief group-administered, ACT-based program to promote health behavior change and psychological well-being among cardiac patients. Results will address the effectiveness of a brief treatment created to simultaneously impact multiple cardiovascular risk factors. Conducted in the context of clinical practice, this trial will potentially offer empirical support to alternative interventions to improve quality of life and reduce mortality and morbidity rates among cardiac patients. TRIAL REGISTRATION: clinicaltrials.gov/ (NCT01909102).

Posttraumatic stress disorder and cardiometabolic disease.

The need for addressing posttraumatic stress disorder (PTSD) among combat veterans returning from Afghanistan and Iraq is a growing public health concern. Current PTSD management addresses psychiatric parameters of this condition. However, PTSD is not simply a psychiatric disorder. Traumatic stress increases the risk for inflammation-related somatic diseases and early mortality. The metabolic syndrome reflects the increased health risk associated with combat stress and PTSD. Obesity, dyslipidemia, hypertension, diabetes mellitus, and cardiovascular disease are prevalent among PTSD patients. However, there has been little appreciation for the need to address these somatic PTSD comorbidities. Medical professionals treating this vulnerable population should screen patients for cardiometabolic risk factors and avail themselves of existing preventive diet, exercise, and pharmacologic modalities that will reduce such risk factors and improve overall long-term health outcomes and quality of life. There is the promise that cardiometabolic preventive therapy complementing psychiatric intervention may, in turn, help improve the posttraumatic stress system dysregulation and favorably impact psychiatric and neurologic function. © 2013 S. Karger AG, Basel.

Music for stress and anxiety reduction in coronary heart disease patients.

BACKGROUND: Individuals with coronary heart disease (CHD) often suffer from severe distress due to diagnosis, hospitalization, surgical procedures, uncertainty of outcome, fear of dying, doubts about progress in recovery, helplessness and loss of control. Such adverse effects put the cardiac patient at greater risk for complications, including sudden cardiac death. It is therefore of crucial importance that the care of people with CHD focuses on psychological as well as physiological needs.Music interventions have been used to reduce anxiety and distress and improve physiological functioning in medical patients; however its efficacy for people with CHD needs to be evaluated. OBJECTIVES: To update the previously published review that examined the effects of music interventions with standard care versus standard care alone on psychological and physiological responses in persons with CHD. SEARCH METHODS: We searched the Cochrane Central Register of Controlled Trials (CENTRAL) on The Cochrane Library (2012, Issue 10), MEDLINE (OvidSP, 1950 to October week 4 2012), EMBASE (OvidSP, 1974 to October week 5 2012), CINAHL (EBSCOhost, 1982 to 9 November 2012), PsycINFO (OvidSP, 1806 to October week 5 2012), LILACS (Virtual Health Library, 1982 to 15 November 2012), Social Science Citation Index (ISI, 1974 to 9 November 2012), a number of other databases, and clinical trial registers. We also conducted handsearching of journals and reference lists. We applied no language restrictions. SELECTION CRITERIA: We included all randomized controlled trials and quasi-randomized trials that compared music interventions and standard care with standard care alone for persons with confirmed CHD. DATA COLLECTION AND ANALYSIS: Two review authors independently extracted data and assessed methodological quality, seeking additional information from the trial researchers when necessary. We present results using weighted mean differences for outcomes measured by the same scale, and standardized mean differences for outcomes measured by different scales. We used post-intervention scores. In cases of significant baseline difference, we used change scores (changes from baseline). MAIN RESULTS: We identified four new trials for this update. In total, the evidence for this review rests on 26 trials (1369 participants). Listening to music was the main intervention used, and 23 of the studies did not include a trained music therapist.Results indicate that music interventions have a small beneficial effect on psychological distress in people with CHD and this effect is consistent across studies (MD = -1.26, 95% CI -2.30 to -0.22, P = 0.02, I² = 0%). Listening to music has a moderate effect on anxiety in people with CHD; however results were inconsistent across studies (SMD = -0.70, 95% CI -1.17 to -0.22, P = 0.004, I² = 77%). Studies that used music interventions in people with myocardial infarction found more consistent anxiety-reducing effects of music, with an average anxiety reduction of 5.87 units on a 20 to 80 point score range (95% CI -7.99 to -3.75, P < 0.00001, I² = 53%). Furthermore, studies that used patient-selected music resulted in greater anxiety-reducing effects that were consistent across studies (SMD = -0.89, 95% CI -1.42 to -0.36, P = 0.001, I² = 48%). Findings indicate that listening to music reduces heart rate (MD = -3.40, 95% CI -6.12 to -0.69, P = 0.01), respiratory rate (MD = -2.50, 95% CI -3.61 to -1.39, P < 0.00001) and systolic blood pressure (MD = -5.52 mmHg, 95% CI - 7.43 to -3.60, P < 0.00001). Studies that included two or more music sessions led to a small and consistent pain-reducing effect (SMD = -0.27, 95% CI -0.55 to -0.00, P = 0.05). The results also suggest that listening to music may improve patients' quality of sleep following a cardiac procedure or surgery (SMD = 0.91, 95% CI 0.03 to 1.79, P = 0.04).We found no strong evidence for heart rate variability and depression. Only one study considered hormone levels and quality of life as an outcome variable. A small number of studies pointed to a possible beneficial effect of music on opioid intake after cardiac procedures or surgery, but more research is needed to strengthen this evidence. AUTHORS' CONCLUSIONS: This systematic review indicates that listening to music may have a beneficial effect on anxiety in persons with CHD, especially those with a myocardial infarction. Anxiety-reducing effects appear to be greatest when people are given a choice of which music to listen to.Furthermore, listening to music may have a beneficial effect on systolic blood pressure, heart rate, respiratory rate, quality of sleep and pain in persons with CHD. However, the clinical significance of these findings is unclear. Since many of the studies are at high risk of bias, these findings need to be interpreted with caution. More research is needed into the effects of music interventions offered by a trained music therapist.