Methodological challenges in systematic reviews of mHealth interventions: Survey and consensus-based recommendations.

OBJECTIVE: Mobile Health (mHealth) refers to using mobile devices to support health. This study aimed to identify specific methodological challenges in systematic reviews (SRs) of mHealth interventions and to develop guidance for addressing selected challenges. STUDY DESIGN AND SETTING: Two-phase participatory research project. First, we sent an online survey to corresponding authors of SRs of mHealth interventions. On a five-category scale, survey respondents rated how challenging they found 24 methodological aspects in SRs of mHealth interventions compared to non-mHealth intervention SRs. Second, a subset of survey respondents participated in an online workshop to discuss recommendations to address the most challenging methodological aspects identified in the survey. Finally, consensus-based recommendations were developed based on the workshop discussion and subsequent interaction via email with the workshop participants and two external mHealth SR authors. RESULTS: We contacted 953 corresponding authors of mHealth intervention SRs, of whom 50 (5 %) completed the survey. All the respondents identified at least one methodological aspect as more or much more challenging in mHealth intervention SRs than in non-mHealth SRs. A median of 11 (IQR 7.25-15) out of 24 aspects (46 %) were rated as more or much more challenging. Those most frequently reported were: defining intervention intensity and components (85 %), extracting mHealth intervention details (71 %), dealing with dynamic research with evolving interventions (70 %), assessing intervention integrity (69 %), defining the intervention (66 %) and maintaining an updated review (65 %). Eleven survey respondents participated in the workshop (five had authored more than three mHealth SRs). Eighteen consensus-based recommendations were developed to address issues related to mHealth intervention integrity and to keep mHealth SRs up to date. CONCLUSION: mHealth SRs present specific methodological challenges compared to non-mHealth interventions, particularly related to intervention integrity and keeping SRs current. Our recommendations for addressing these challenges can improve mHealth SRs.

Role of Heart Rate Variability in the Association between Myocardial Infarction Severity and Post-Myocardial Infarction Distress.

OBJECTIVE: Myocardial infarction (MI) results in mental health consequences, including depression and post-traumatic stress disorder (PTSD). The risk and protective factors of such mental consequences are not fully understood. This study examined the relation between MI severity and future mental health consequences and the moderating role of vagal nerve activity. METHODS: In a reanalysis of data from the Myocardial Infarction-Stress Prevention Intervention (MI-SPRINT) study, 154 post-MI patients participated. MI severity was measured by the Killip Scale and by troponin levels. Depression and PTSD symptoms were assessed with valid questionnaires, both at 3 and 12 months. Vagal nerve activity was indexed by the heart rate variability (HRV) parameter of the root-mean square of successive R-R differences (RMSSD). Following multivariate analyses, the association between MI severity and distress was examined in patients with low and high HRV (RMSSD = 30 ms). RESULTS: In the full sample, the Killip index predicted post-MI distress only at 3 months, while troponin predicted distress at 3- and 12-months post-MI. However, HRV moderated the effects of the Killip classification; Killip significantly predicted symptoms of depression and PTSD at 3- and 12-months post-MI, but only in patients with low HRV. Such moderation was absent for troponin. CONCLUSION: MI severity (Killip classification) predicted post-MI depression and PTSD symptoms, but only in patients with low HRV, suggesting that the vagal nerve is a partial protective (moderating) factor in the relation between Killip score and post-MI distress.

Positive psychosocial factors and the development of symptoms of depression and posttraumatic stress symptoms following acute myocardial infarction.

Introduction: Acute myocardial infarction (MI) is a potentially fatal condition, leading to high psychological distress and possibly resulting in the development of depressive symptoms and posttraumatic stress symptoms (PTSS). The aim of this study was to investigate the association of clusters of positive psychosocial factors (resilience, task-oriented coping, positive affect and social support) with both MI-induced depressive symptoms and PTSS, independent of demographic factors. Methods: We investigated 154 consecutive patients with MI, 3 and 12 months after hospital discharge. All patients completed the short version of the German Resilience Scale, the Coping Inventory for Stressful Situations (CISS), the Enriched Social Support Inventory (ESSI) and the Global Mood Scale (GMS). The level of interviewer-rated MI-induced posttraumatic stress disorder (PTSD) symptoms at 3- and 12-months follow-up was evaluated through the Clinician-Administered PTSD Scale (CAPS). Depressive symptoms were assessed at 3- and 12-month follow-up with the Beck Depression Inventory (BDI-II). Results: Three different clusters were revealed: (1) lonely cluster: lowest social support, resilience and average task-oriented coping and positive affect; (2) low risk cluster: highest resilience, task-oriented coping, positive affect and social support; (3) avoidant cluster: lowest task-oriented coping, positive affect, average resilience and social support. The clusters differed in depressive symptoms at 3 months (F = 5.10; p < 0.01) and 12 months follow-up (F = 7.56; p < 0.01). Cluster differences in PTSS were significant at 3 months (F = 4.78, p < 0.05) and 12 months (F = 5.57, p < 0.01) follow-up. Differences in PTSS subscales were found for avoidance (F = 4.8, p < 0.05) and hyperarousal (F = 5.63, p < 0.05), but not re-experiencing, at 3 months follow-up. At 12 months follow-up, cluster differences were significant for re-experiencing (F = 6.44, p < 0.01) and avoidance (F = 4.02, p < 0.05) but not hyperarousal. Discussion: The present study contributes to a better understanding of the relationships among different positive psychosocial factors, depressive symptoms and PTSS following acute MI. Future interventions may benefit from taking into account positive psychosocial factors to potentially reduce patients' depressive symptoms and PTSS after MI.

Longitudinal association between positive affect and blood lipids in patients following acute myocardial infarction.

OBJECTIVE: Unfavorable blood lipid profiles are robust risk factors in predicting atherosclerotic disease. Studies have shown that positive affect (PA) is associated with a favorable lipid profile. However, longitudinal studies regarding the course of PA and lipid profiles in myocardial infarction (MI) patients are lacking. Therefore, the aim of this study was to prospectively explore the association between PA and blood lipid levels across three inv estigations over 12 months following acute MI. METHODS: Patients following an acute MI were examined at hospital admission (n = 190), and at 3 months (n = 154) and 12 months (n = 106) thereafter. Linear mixed effect regression models were used to evaluate the relation between PA, assessed with the Global Mood Scale, and blood lipid levels. Potential confounding variables were controlled for in the analysis. RESULTS: Higher PA was significantly associated with higher high-density lipoprotein cholesterol (HDL-C) levels and a lower total cholesterol (TC)/HDL-C ratio over time, independent of demographic factors, indices of cardiac disease severity, comorbidity, medication use, health behaviors, serum cortisol and negative affect (p≤0.040). No association was found between PA and the two blood lipids low-density lipoprotein-cholesterol (LDL-C) and triglycerides (TG). CONCLUSIONS: Positive affect was independently associated with HDL-C levels and the TC/HDL-C ratio in patients up to 1 year after MI. The findings support a potential role of PA for cardiovascular health through an association with a favorable blood lipid profile.

Pharmacological memory modulation to augment trauma-focused psychotherapy for PTSD: a systematic review of randomised controlled trials.

Trauma-focused psychotherapy (tf-PT) is the first-line treatment for posttraumatic stress disorder (PTSD). Tf-PT focuses on processing and modulating trauma memories. Not all patients benefit, however, and there is room for improvement of efficacy. Pharmacologically augmenting trauma memory modulation in the context of tf-PT may help optimise treatment outcome. To systematically review effects of pharmacologically augmented memory modulation in the context of tf-PT for PTSD (PROSPERO preregistration ID: CRD42021230623). We conducted a systematic review of randomised controlled trials of psychotherapy treatment for PTSD. We included placebo-controlled studies that augmented at least one treatment session pharmacologically targeting memory extinction or reconsolidation. We calculated post-treatment between group (pharmacological augmentation vs placebo control) effect sizes of PTSD symptom severity. We included 13 RCTs. There was large heterogeneity in augmentation procedure and methodological quality. Four studies showed significantly greater PTSD symptom reduction in the pharmacological augmentation group (propranolol, hydrocortisone, dexamethasone, D-cycloserine) compared to placebo. Seven studies showed no significant effect of pharmacological augmentation compared to placebo (D-cycloserine, rapamycin, mifepristone, propranolol, mifepristone combined with D-cycloserine, methylene blue). Two studies showed significantly smaller PTSD symptom reduction in the pharmacological augmentation group (D-cycloserine, dexamethasone) compared to placebo. Results of pharmacological augmentation were mixed overall and heterogenous for the pharmacological agents tested in more than one study. Additional studies and replications are needed to identify which pharmacological agents work, in which combination and to identify patient groups that benefit most to tailor PTSD treatment.

Cancer survival stories: Perception, creation, and potential use case.

BACKGROUND: Cancer patients often search for information about their health conditions online. Cancer patient narratives have established themselves as a way of providing information and education but also as an effective approach to improving coping with the disease. OBJECTIVE: We investigated how people affected by cancer perceive cancer patient narratives and whether such stories can potentially improve coping during their own cancer journeys. Additionally, we reflected on whether our co-creative citizen science approach can contribute to gaining knowledge about cancer survival stories and providing peer support. DESIGN, SETTING AND STAKEHOLDERS: We applied a co-creative citizen science approach by using quantitative and qualitative research methods with stakeholders (i.e., cancer patients, their relatives, friends and health professionals). MAIN OUTCOME MEASURES: Understandability and perceived benefits of cancer survival stories, coping, emotional reactions to the stories and helpful characteristics of the stories. RESULTS: Cancer survival stories were considered intelligible and beneficial, and they potentially support positive emotions and coping in people affected by cancer. Together with the stakeholders, we identified four main characteristics that evoked positive emotions and that were considered especially helpful: (1) positive attitudes towards life, (2) encouraging cancer journeys, (3) individual coping strategies for everyday challenges and (4) openly shared vulnerabilities. CONCLUSIONS: Cancer survival stories potentially support positive emotions and coping in people affected by cancer. A citizen science approach is suitable for identifying relevant characteristics of cancer survival stories and may become a helpful educational peer support resource for people coping with cancer. PATIENT OR PUBLIC CONTRIBUTIONS: We adopted a co-creative citizen science approach, wherein citizens and researchers were equally involved throughout the entire project.

Acupuncture for the prevention of chemotherapy-induced nausea and vomiting in cancer patients: A systematic review and meta-analysis.

PURPOSE: To assess the effectiveness and safety of acupuncture for the prevention of chemotherapy-induced nausea and vomiting (CINV), with a specific intention on exploring sources of between-study variation in treatment effects. METHODS: MEDLINE, EMBASE, Cochrane CENTRAL, CINAHL, Chinese Biomedical Literature Database, VIP Chinese Science and Technology Periodicals Database, China National Knowledge Infrastructure, and Wanfang were searched to identify randomized controlled trials (RCTs) that compared acupuncture to sham acupuncture or usual care (UC). The main outcome is complete control (no vomiting episodes and/or no more than mild nausea) of CINV. GRADE approach was used to rate the certainty of evidence. RESULTS: Thirty-eight RCTs with a total of 2503 patients were evaluated. Acupuncture in addition to UC may increase the complete control of acute vomiting (RR, 1.13; 95% CI, 1.02 to 1.25; 10 studies) and delayed vomiting (RR, 1.47; 95% CI, 1.07 to 2.00; 10 studies) when compared with UC only. No effects were found for all other review outcomes. The certainty of evidence was generally low or very low. None of the predefined moderators changed the overall findings, but in an exploratory moderator analysis we found that an adequate reporting of planned rescue antiemetics might decrease the effect size of complete control of acute vomiting (p = 0.035). CONCLUSION: Acupuncture in addition to usual care may increase the complete control of chemotherapy-induced acute vomiting and delayed vomiting but the certainty of evidence was very low. Well-designed RCTs with larger sample sizes, standardized treatment regimens, and core outcome measures are needed.

Association of positive psychological well-being with circulating inflammatory markers: A systematic review and meta-analysis.

Accumulating evidence shows a protective effect of positive psychological well-being (PPWB) on health outcomes. However, the underlying mechanisms remain poorly understood. One pathway relates to enhanced immune functioning (Boehm, 2021). The aim of this project was to conduct a systematic review and meta-analysis of the association between PPWB and circulating inflammatory biomarkers and determine the magnitude of this association. After examining 748 references, 29 studies were included. Results from over 94'700 participants revealed a significant association between PPWB and reduced levels of interleukin (IL)- 6 (r = -0.05; P < .001) and C-reactive protein (CRP) (r = -0.06; P < .001) with a heterogeneity of I2 = 31.5% and I2 = 84.5%, respectively. Only the association of PPWB with CRP was independent of co-variates included in the individual studies (r = -0.04; P = .027). The findings of this systematic review and meta-analysis suggest that PPWB is associated with lower levels of inflammatory biomarkers IL-6 and CRP in the circulation. Such relationships with inflammatory biomarkers may partly explain positive effects of PPWB on health.

Acupuncture in chemotherapy-induced dysgeusia (AcuDysg): study protocol of a randomised controlled trial.

INTRODUCTION: Dysgeusia is a common side effect of chemotherapy in patients with cancer, but to date, there is no effective treatment. Many patients with cancer request complementary medicine treatment in addition to their cancer treatments, and acupuncture is highly accepted for patients with cancer; however, evidence regarding the effectiveness of acupuncture for dysgeusia is scarce.The study investigates the effectiveness of an additional dysgeusia-specific acupuncture plus self-acupressure intervention compared with supportive acupuncture plus self-acupressure intervention alone for chemotherapy-induced dysgeusia in patients with cancer. METHODS AND ANALYSIS: This is a multicentre, randomised, controlled and two-armed parallel-group, single-blind trial involving 130 patients. Both groups will receive eight sessions of acupuncture treatment over a period of 8 weeks and will be trained to perform self-acupressure (eLearning combined with therapist instruction) at predefined acupressure points once a day during the whole treatment period. Patients in the control group will receive supportive routine care acupuncture and self-acupressure treatment only; in addition to this treatment, the intervention group will receive the dysgeusia-specific acupuncture and acupressure within the same treatment session. The primary outcome is the perceived dysgeusia over 8 weeks, measured weekly after the acupuncture treatment. Secondary outcomes include the indices from the objective taste and smell test, weight loss, perceived dysgeusia, fatigue, distress, nausea and vomiting, odynophagia, xerostomia and polyneuropathy, as well as quality of life at the different time points. ETHICS AND DISSEMINATION: The study has been approved by the Cantonal Ethics Committee (CEC) (Kanton Zürich Kantonale Ethikkommission) (approval no. KEK-ZH-Nr. 2020-01900). The results will be submitted to a peer-reviewed journal for publication. TRIAL REGISTRATION NUMBERS: DRKS00023348, SNCTP000004128.

Reply to Sopek Merkas, I.; Lakusic, N. Comment on "von Känel et al. Early Trauma-Focused Counseling for the Prevention of Acute Coronary Syndrome-Induced Posttraumatic Stress: Social and Health Care Resources Matter. J. Clin. Med. 2022, 11, 1993".

We thank Merkas and Lakusic for commenting on our recently published paper; in the paper, we suggested that resources in a patient's social environment may moderate the benefit of one single-session trauma-focused counseling in the prevention of acute coronary syndrome (ACS)-induced posttraumatic stress disorder (PTSD) symptoms [...].

Smartphone-RCCT: an online repository of randomized controlled clinical trials of smartphone applications for chronic conditions.

BACKGROUND: Chronic health conditions have a big impact on disability, morbidity, and mortality worldwide. Smartphone health applications (apps) can improve the health of patients with chronic conditions and enhance the quality and efficiency of healthcare. The number of randomized controlled trials (RCTs) of smartphone health apps is increasing, but a collection of the available evidence into a single database is still missing. The purpose of this study is to describe Smartphone-RCCT, which is an in-progress database of RCTs of smartphone apps for chronic conditions. METHODS: For a study to be included in the database, the following criteria had to be met: (a) RCT published in a peer-reviewed journal; (b) population: adult study participants with one or several chronic conditions that represent the main health problem addressed by the study intervention; (c) intervention: smartphone health app used by the patient; (d) comparator: any control condition; (e) outcomes: any patient-reported health outcome (studies exclusively measuring the patients' knowledge about the chronic conditions or their satisfaction with the smartphone app were excluded); (f) sample size: at least 15 participants per study arm. We searched in electronic databases and other resources to identify relevant studies. Two reviewers selected the studies and extracted data independently. Annual updates are planned. RESULTS: The proposed database is called Smartphone-RCCT, an open-access repository collecting bibliographic references and important characteristics of RCTs of smartphone apps for chronic conditions. The database is available for free in Open Science Framework (OSF): https://osf.io/nxerf/ . To date, it includes 70 trials. Their references can be exported to standard reference management software and the extracted data is available in a Microsoft Excel file. CONCLUSIONS: Smartphone-RCCT is the first systematic open-access database collecting peer-reviewed publications of RCTs of smartphone apps for patients with chronic conditions. The database accelerates the delivery of evidence-based information in a dynamic research field. It represents an essential resource for different stakeholders, such as professionals working in evidence synthesis, meta-epidemiological studies, or planning an RCT.

Comparability of Patients in Trials of eHealth and Face-to-Face Psychotherapeutic Interventions for Depression: Meta-synthesis.

BACKGROUND: Depressive disorders (DDs) are a public health problem. Face-to-face psychotherapeutic interventions are a first-line option for their treatment in adults. There is a growing interest in eHealth interventions to maximize accessibility for effective treatments. Thus, the number of randomized controlled trials (RCTs) of eHealth psychotherapeutic interventions has increased, and these interventions are being offered to patients. However, it is unknown whether patients with DDs differ in internet-based and face-to-face intervention trials. This information is essential to gain knowledge about eHealth trials' external validity. OBJECTIVE: We aimed to compare the baseline characteristics of patients with DDs included in the RCTs of eHealth and face-to-face psychotherapeutic interventions with a cognitive component. METHODS: In this meta-epidemiological study, we searched 5 databases between 1990 and November 2017 (MEDLINE, Embase, PsycINFO, Google Scholar, and the database of Cuijpers et al). We included RCTs of psychotherapeutic interventions with a cognitive component (eg, cognitive therapy, cognitive behavioral therapy [CBT], or interpersonal therapy) delivered face-to-face or via the internet to adults with DDs. Each included study had a matching study for predefined criteria to allow a valid comparison of characteristics and was classified as a face-to-face (CBT) or eHealth (internet CBT) intervention trial. Two authors selected the studies, extracted data, and resolved disagreements by discussion. We tested whether predefined baseline characteristics differed in face-to-face and internet-based trials using a mixed-effects model and testing for differences with z tests (statistical significance set at .05). For continuous outcomes, we also estimated the difference in means between subgroups with 95% CI. RESULTS: We included 58 RCTs (29 matching pairs) with 3846 participants (female: n=2803, 72.9%) and mean ages ranging from 20-74 years. White participants were the most frequent (from 63.6% to 100%). Other socioeconomic characteristics were poorly described. The participants presented DDs of different severity measured with heterogeneous instruments. Internet CBT trials had a longer depression duration at baseline (7.19 years higher, CI 95% 2.53-11.84; 10.0 vs 2.8 years; P=.002), but the proportion of patients with previous depression treatment was lower (24.8% vs 42%; P=.04). Subgroup analyses found no evidence of differences for the remaining baseline characteristics: age, gender, education, living area, depression severity, history of depression, actual antidepressant medication, actual physical comorbidity, actual mental comorbidity, study dropout, quality of life, having children, family status, and employment. We could not compare proficiency with computers due to the insufficient number of studies. CONCLUSIONS: The baseline characteristics of patients with DDs included in the RCTs of eHealth and face-to-face psychotherapeutic interventions are generally similar. However, patients in eHealth trials had a longer duration of depression, and a lower proportion had received previous depression treatment, which might indicate that eHealth trials attract patients who postpone earlier treatment attempts. TRIAL REGISTRATION: PROSPERO CRD42019085880; https://tinyurl.com/4xufwcyr.

The RIPI-f (Reporting Integrity of Psychological Interventions delivered face-to-face) checklist was developed to guide reporting of treatment integrity in face-to-face psychological interventions.

OBJECTIVES: Intervention integrity is the degree to which the study intervention is delivered as intended. This article presents the RIPI-f checklist (Reporting Integrity of Psychological Interventions delivered face-to-face) and summarizes its development methods. RIPI-f proposes guidance for reporting intervention integrity in evaluative studies of face-to-face psychological interventions. STUDY DESIGN AND SETTING: We followed established procedures for developing reporting guidelines. We examined 56 documents (reporting guidelines, bias tools, and methodological guidance) for relevant aspects of face-to-face psychological intervention integrity. Eighty four items were identified and grouped as per the template for intervention description and replication (TIDieR) domains. Twenty nine experts from psychology and medicine and other scholars rated the relevance of each item in a single-round Delphi survey. A multidisciplinary panel of 11 experts discussed the survey results in three online consensus meetings and drafted the final version of the checklist. RESULTS: We propose RIPI-f, a checklist with 50 items. Our checklist enhances TIDieR with important extensions, such as therapeutic alliance, provider's allegiance, and the adherence of providers and participants. CONCLUSION: RIPI-f can improve the reporting of face-to-face psychological interventions. The tool can help authors, researchers, systematic reviewers, and guideline developers. We suggest using RIPI-f alongside other reporting guidelines.

Effect of Early Psychological Counseling for the Prevention of Posttraumatic Stress Induced by Acute Coronary Syndrome at Long-Term Follow-Up.

Objective: Psychological consequences of myocardial infarction (MI) are substantial, as 4% of all MI patients develop posttraumatic stress disorder (PTSD) and 12% clinically relevant posttraumatic stress symptoms (PTSS). The study investigated the course and development within 12 months of MI-induced PTSS to gain novel insights in potentially delayed response to early trauma-focused counseling aimed at preventing the incidence of MI-induced PTSS. Methods: In the MI-SPRINT two-group randomized controlled trial, 190 MI-patients were randomly allocated to receive a single-session intervention of either trauma-focused counseling or an active control intervention targeting the general role of stress in patients with heart disease. Blind interviewer-rated PTSS (primary outcome) and additional health outcomes were assessed at 12-month follow-up. Results: 12-month follow-up of outcomes were available for 106 (55.8%) of 190 participants: In the entire sample, one patient (0·5%, 1/190) who received trauma-focused counseling developed full PTSD. There was no significant difference between trauma-focused counseling and stress counseling regarding total score of interviewer-rated PTSS (p > 0.05). The only group difference emerged in terms of more severe hyperarousal symptoms in the trauma-focused counseling group in the ITT analysis, but not in the completer analysis. Conclusions: No benefits were found for trauma-focused counseling after 12 months when compared with an active control intervention. PTSD prevalence in the present study was low highlighting a potential beneficial effect of both interventions. Further studies are needed to determine the most accurate approach of counseling.

Sleep disturbance after acute coronary syndrome: A longitudinal study over 12 months.

BACKGROUND: Sleep disturbance has been associated with poor prognosis in patients with acute coronary syndrome (ACS). This study examined the course of sleep disturbance and associated factors in patients with ACS who were followed for one year. METHODS: Study participants were 180 patients (mean age 59.6 years, 81.7% men) with ACS admitted to a tertiary hospital to undergo acute coronary intervention. Sleep disturbance was interviewer-assessed at admission (n = 180), at 3 months (n = 146), and at 12 months (n = 101) using the Jenkins Sleep Scale (JSS)-4, with a total of 414 assessments over one year. Random linear mixed regression models were used to evaluate the relationship between sociodemographic factors, cardiac diseases severity, perceived distress during ACS, comorbidities, medication, health behaviors, and sleep disturbance over time. RESULTS: At admission, 3 months, and 12 months, 56.7%, 49.3%, and 49.5% of patients, respectively, scored above the mean value for sleep disturbance in the general population (JSS-4 score ≥5). There was a significant decrease in continuous JSS-4 scores over time [estimate (SE) = -0.211 (0.074), p = 0.005]. Female sex [0.526 (0.206), p = 0.012], greater fear of dying [0.074 (0.026), p = 0.004], helplessness during ACS [0.062 (0.029), p = 0.034], and a history of depression [0.422 (0.171), p = 0.015] were independently associated with higher JSS-4 scores over time. CONCLUSION: Despite a decrease from admission to 3 months, sleep disturbance is prevalent in the first year after ACS. Female sex, depression history, and distress during ACS identify patients at increased risk of developing persistent sleep disturbance and may inform interventions to prevent sleep disturbance.

Association Between Changes in Post-hospital Cardiac Symptoms and Changes in Acute Coronary Syndrome-Induced Symptoms of Post-traumatic Stress.

Background: After acute coronary syndrome (ACS), one in eight patients develops clinically significant symptoms of Post-traumatic stress disorder (PTSD). We hypothesized that changes in cardiac symptoms from 3 to 12 months after ACS are associated with changes in ACS-induced PTSD symptoms. Methods: At 3 (n = 154) and/or 12 months (n = 106) post-ACS, patients (n = 156, mean age 59 years, 85% men) completed a clinical interview assessing chest tightness/pain (at rest and/or during exertion), heartbeat symptoms (heart palpitations, racing of heart, heart stumbling or skipping a beat) and PTSD symptoms during the prior 4 weeks. Random mixed regression models examined the association between the onset (or remission) from 3 to 12 months in cardiac symptoms with changes in PTSD symptoms, adjusting for a range of potential predictors of ACS-induced PTSD symptoms. Results: The onset of chest tightness/pain [estimate = 0.588, 95% confidence interval: 0.275, 0.090; p < 0.001] and of heartbeat symptoms [0.548 (0.165, 0.931); p = 0.005] from 3 to 12 months was independently associated with an increase in total PTSD symptoms. There were also independent associations between the onset of chest tightness/pain and heartbeat symptoms with an increase in PTSD symptom clusters. Specifically, the onset of chest tightness/pain showed associations with an increase in re-experiencing [0.450 (0.167, 0.733); p = 0.027] and avoidance/numbing [0.287 (0.001, 0.574); p = 0.049]. The onset of heartbeat symptoms showed associations with an increase in re-experiencing [0.392 (0.045, 0.739); p = 0.002], avoidance/numbing [0.513 (0.161, 0.864); p = 0.004] and hyperarousal [0.355 (0.051, 0.659); p = 0.022]. An increase in the total number of cardiac symptoms (score range 0-6) was also associated with an increase in total PTSD symptoms [0.343 (0.202, 0.484); p < 0.001]. Psychotherapy in the post-hospital period moderated the association between the change in heartbeat symptoms and the change in total PTSD symptoms [-0.813 (-1.553, -0.074); p = 0.031 for interaction]; the association between the onset of heart beat symptoms and an increase in total PTSD symptoms was weaker in patients who attended psychotherapy [0.437 (-0.178, 1.052); p = 0.16] than in those who did not [0.825 (0.341, 1.309); p < 0.001]. Conclusion: Changes in cardiac symptoms between 3 and 12 months after hospitalization are associated with changes in ACS-induced PTSD symptoms. ClinicalTrials.gov #NCT01781247.

Relationship between a Self-Reported History of Depression and Persistent Elevation in C-Reactive Protein after Myocardial Infarction.

Background: Elevated levels of C-reactive protein (CRP) are associated with both an increased risk of cardiovascular disease (CVD) and depression. We aimed to test the hypothesis that a self-report history of depression is associated with a smaller decrease in CRP levels from hospital admission to 3-month follow-up in patients with acute myocardial infarction (MI). Methods: We assessed 183 patients (median age 59 years; 84% men) with verified MI for a self-report history of lifetime depression and plasma CRP levels within 48 h of an acute coronary intervention and again for CRP levels at three months. CRP values were categorized according to their potential to predict CVD risk at hospital admission (acute inflammatory response: 0 to <5 mg/L, 5 to <10 mg/L, 10 to <20 mg/L, and ≥20 mg/L) and at 3 months (low-grade inflammation: 0 to <1 mg/L, 1 to <3 mg/L, and ≥3 mg/L). Additionally, in a subsample of 84 patients showing admission CRP levels below 20 mg/L, changes in continuous CRP values over time were also analyzed. Results: After adjustment for a range of potentially important covariates, depression history showed a significant association with a smaller decrease in both CRP risk categories (r = 0.261, p < 0.001) and log CRP levels (r = 0.340, p = 0.005) over time. Conclusions: Self-reported history of depression may be associated with persistently elevated systemic inflammation three months after MI. This finding warrants studies to test whether lowering of inflammation in patients with an acute MI and a history of depression may improve prognosis.

Do patients' pre-treatment expectations about acupuncture effectiveness predict treatment outcome in patients with chronic low back pain? A secondary analysis of data from a randomised controlled clinical trial.

OBJECTIVE: This secondary analysis of a randomised controlled patient-blinded trial comparing effectiveness and side effect briefings in patients with chronic low back pain (CLBP) investigated the association between patients' pre-treatment expectations about minimal acupuncture treatment and pain intensity as outcome during and after the end of the treatment. METHODS: Chronic low back pain patients with a pain intensity of at least 4 on a numeric rating scale from 0 to 10 received eight sessions of minimal acupuncture treatment over 4 weeks. The primary outcome was change in pain intensity rated on a Numerical Rating Scale (NRS 0-10) from inclusion visit to treatment session 4 and to the end of the treatment. Patients' expectations about the effectiveness of acupuncture were assessed using the Expectation for Treatment Scale (ETS) before randomization. Linear regression was applied to investigate whether patients' pre-treatment expectations predicted changes in pain intensity during and after treatment. RESULTS: A total of 142 CLBP patients (40.1 ± 12.5 years; 65.5% female) were included in our analysis. Patients' pre-treatment expectations about acupuncture treatment were associated with changes in pain intensity after four sessions of minimal acupuncture treatment (b = -0.264, p = 0.002), but not after the end of the treatment. This association was found in females and males. CONCLUSIONS: Our results imply that higher pre-treatment expectations only lead to larger reductions in pain intensity in the initial phase of a treatment, with a similar magnitude for both females and males. As the treatment progresses in the second half of the treatment, adapted expectations or other non-specific effects might play a more important role in predicting treatment outcome.