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The Positive Emotions after Acute Coronary Events behavioral health intervention: Design, rationale, and preliminary feasibility of a factorial design study.

ABSTRACT: BACKGROUND:Positive psychological constructs, such as optimism, are associated with greater participation in cardiac health behaviors and improved cardiac outcomes. Positive psychology interventions, which target psychological well-being, may represent a promising approach to improving health behaviors in high-risk cardiac patients. However, no study has assessed whether a positive psychology intervention can promote physical activity following an acute coronary syndrome. OBJECTIVE:In this article we will describe the methods of a novel factorial design study to aid the development of a positive psychology-based intervention for acute coronary syndrome patients and aim to provide preliminary feasibility data on study implementation. METHODS:The Positive Emotions after Acute Coronary Events III study is an optimization study (planned N?=?128), subsumed within a larger multiphase optimization strategy iterative treatment development project. The goal of Positive Emotions after Acute Coronary Events III is to identify the ideal components of a positive psychology-based intervention to improve post-acute coronary syndrome physical activity. Using a 2?×?2?×?2 factorial design, Positive Emotions after Acute Coronary Events III aims to: (1) evaluate the relative merits of using positive psychology exercises alone or combined with motivational interviewing, (2) assess whether weekly or daily positive psychology exercise completion is optimal, and (3) determine the utility of booster sessions. The study's primary outcome measure is moderate-to-vigorous physical activity at 16?weeks, measured via accelerometer. Secondary outcome measures include psychological, functional, and adherence-related behavioral outcomes, along with metrics of feasibility and acceptability. For the primary study outcome, we will use a mixed-effects model with a random intercept (to account for repeated measures) to assess the main effects of each component (inclusion of motivational interviewing in the exercises, duration of the intervention, and inclusion of booster sessions) from a full factorial model controlling for baseline activity. Similar analyses will be performed on self-report measures and objectively-measured medication adherence over 16?weeks. We hypothesize that the combined positive psychology and motivational interviewing intervention, weekly exercises, and booster sessions will be associated with superior physical activity. RESULTS:Thus far, 78 participants have enrolled, with 72% of all possible exercises fully completed by participants. CONCLUSION:The Positive Emotions after Acute Coronary Events III study will help to determine the optimal content, intensity, and duration of a positive psychology intervention in post-acute coronary syndrome patients prior to testing in a randomized trial. This study is novel in its use of a factorial design within the multiphase optimization strategy framework to optimize a behavioral intervention and the use of a positive psychology intervention to promote physical activity in high-risk cardiac patients.

SUBMITTER: Huffman JC

PROVIDER: S-EPMC5376225 | biostudies-literature | 2017 Apr

REPOSITORIES: biostudies-literature

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The Positive Emotions after Acute Coronary Events behavioral health intervention: Design, rationale, and preliminary feasibility of a factorial design study.

Huffman Jeffery C JC Albanese Ariana M AM Campbell Kirsti A KA Celano Christopher M CM Millstein Rachel A RA Mastromauro Carol A CA Healy Brian C BC Chung Wei-Jean WJ Januzzi James L JL Collins Linda M LM Park Elyse R ER

Clinical trials (London, England) 20170112 2

<h4>Background</h4>Positive psychological constructs, such as optimism, are associated with greater participation in cardiac health behaviors and improved cardiac outcomes. Positive psychology interventions, which target psychological well-being, may represent a promising approach to improving health behaviors in high-risk cardiac patients. However, no study has assessed whether a positive psychology intervention can promote physical activity following an acute coronary syndrome.<h4>Objective</h ...[more]

PMID: 28079394

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Project description:OBJECTIVE:Despite the clear benefits of physical activity and related behaviors on prognosis, most patients experiencing an acute coronary syndrome (ACS) remain nonadherent to these behaviors. Deficits in positive psychological constructs (e.g., optimism) are linked to reduced participation in health behaviors, supporting the potential utility of a positive psychology (PP)-based intervention in post-ACS patients. Accordingly, we aimed to identify optimal components of a PP-based intervention to promote post-ACS physical activity. METHODS:As part of a multiphase optimization strategy, we completed a randomized factorial trial with eight conditions in 128 post-ACS patients to efficiently identify best-performing intervention components. All participants received a PP-based intervention, with conditions varying in duration (presence/absence of booster sessions), intensity (weekly/daily PP exercises), and content (PP alone or combined with motivational interviewing), allowing three concurrent comparisons within the trial. The study aims included assessments of the overall feasibility, acceptability, and impact of the intervention, along with the primary aim of determining which components were associated with objectively measured physical activity and self-reported health behavior adherence at 16 weeks, assessed using longitudinal models. RESULTS:The intervention was well accepted and associated with substantial improvements in behavioral and psychological outcomes. Booster sessions were associated with greater activity to a nearly significant degree (? = 8.58, 95% confidence interval = -0.49-17.65, effect size difference = .43, p = .064), motivational interviewing was associated with overall adherence (? = 0.95, 95% confidence interval = 0.02-1.87, effect size difference = .39, p = .044), and weekly exercise completion was generally superior to daily. CONCLUSIONS:These findings will enable optimization of the PP-based intervention in preparation for a well-powered controlled trial. CLINICAL TRIAL REGISTRATION:Clinicaltrials.gov, NCT02754895.

Project description:Cerebral ischemia and reperfusion initiate cellular events in brain that lead to neurological disability. Investigating these cellular events provides ample targets for developing new treatments. Despite considerable work, no such therapy has translated into successful stroke treatment. Among other issues-such as incomplete mechanistic knowledge and faulty clinical trial design-a key contributor to prior translational failures may be insufficient scientific rigor during preclinical assessment: nonblinded outcome assessment; missing randomization; inappropriate sample sizes; and preclinical assessments in young male animals that ignore relevant biological variables, such as age, sex, and relevant comorbid diseases. Promising results are rarely replicated in multiple laboratories. We sought to address some of these issues with rigorous assessment of candidate treatments across 6 independent research laboratories. The Stroke Preclinical Assessment Network (SPAN) implements state-of-the-art experimental design to test the hypothesis that rigorous preclinical assessment can successfully reduce or eliminate common sources of bias in choosing treatments for evaluation in clinical studies. SPAN is a randomized, placebo-controlled, blinded, multilaboratory trial using a multi-arm multi-stage protocol to select one or more putative stroke treatments with an implied high likelihood of success in human clinical stroke trials. The first stage of SPAN implemented procedural standardization and experimental rigor. All participating research laboratories performed middle cerebral artery occlusion surgery adhering to a common protocol and rapidly enrolled 913 mice in the first of 4 planned stages with excellent protocol adherence, remarkable data completion and low rates of subject loss. SPAN stage 1 successfully implemented treatment masking, randomization, prerandomization inclusion/exclusion criteria, and blinded assessment to exclude bias. Our data suggest that a large, multilaboratory, preclinical assessment effort to reduce known sources of bias is feasible and practical. Subsequent SPAN stages will evaluate candidate treatments for potential success in future stroke clinical trials using aged animals and animals with comorbid conditions.

Project description:BackgroundBehavioral interventions are often complex, operate at multiple levels, across settings, and employ a range of behavior change techniques. Collecting and reporting key indicators of initial trial and intervention feasibility is essential to decisions for progressing to larger-scale trials. The extent of reporting on feasibility indicators and how this may have changed over time is unknown. The aims of this study were to (1) conduct a historical scoping review of the reporting of feasibility indicators in behavioral pilot/feasibility studies related to obesity published through 2020, and (2) describe trends in the amount and type of feasibility indicators reported in studies published across three time periods: 1982-2006, 2011-2013, and 2018-2020.MethodsA search of online databases (PubMed, Embase, EBSCOhost, Web of Science) for health behavior pilot/feasibility studies related to obesity published up to 12/31/2020 was conducted and a random sample of 600 studies, 200 from each of the three timepoints (1982-2006, 2011-2013, and 2018-2020), was included in this review. The presence/absence of feasibility indicators, including recruitment, retention, participant acceptability, attendance, compliance, and fidelity, were identified/coded for each study. Univariate logistic regression models were employed to assess changes in the reporting of feasibility indicators across time.ResultsA total of 16,365 unique articles were identified of which 6873 of these were reviewed to arrive at the final sample of 600 studies. For the total sample, 428 (71.3%) studies provided recruitment information, 595 (99.2%) provided retention information, 219 (36.5%) reported quantitative acceptability outcomes, 157 (26.2%) reported qualitative acceptability outcomes, 199 (33.2%) reported attendance, 187 (31.2%) reported participant compliance, 23 (3.8%) reported cost information, and 85 (14.2%) reported treatment fidelity outcomes. When compared to the Early Group (1982-2006), studies in the Late Group (2018-2020) were more likely to report recruitment information (OR=1.60, 95%CI 1.03-2.49), acceptability-related quantitative (OR=2.68, 95%CI 1.76-4.08) and qualitative (OR=2.32, 95%CI 1.48-3.65) outcomes, compliance outcomes (OR=2.29, 95%CI 1.49-3.52), and fidelity outcomes (OR=2.13, 95%CI 1.21, 3.77).ConclusionThe reporting of feasibility indicators within behavioral pilot/feasibility studies has improved across time, but key aspects of feasibility, such as fidelity, are still not reported in the majority of studies. Given the importance of behavioral intervention pilot/feasibility studies in the translational science spectrum, there is a need for improving the reporting of feasibility indicators.

Project description:Purpose:Early adulthood represents one period of increased risk for the emergence of a serious mental illness. The college campus provides a unique opportunity to assess and monitor individuals in this at-risk age group. However, there are no validated early detection programs that are widely implemented on college campuses. In an effort to address this gap, we designed and tested an early detection and prevention program tailored to college students. A transdiagnostic approach was employed because of evidence for shared risk factors across major mental illnesses. Design:Single arm, prospective study evaluating outcomes following a 4-week intervention. Method:Three in-person mental health screenings were conducted on the campus of one university. Undergraduate students with at least mildly elevated, self-reported levels of depressive or subclinical psychotic symptoms, who were not receiving treatment for these symptoms, were invited to participate in a 4-session workshop focused on increasing self- and other- awareness and emotion regulation using established mindfulness, self-compassion, and mentalization principles and experiential exercises. Symptoms, resilience-promoting capacities, and aspects of social functioning were assessed pre- and post- intervention. Results:416 students were screened and a total of 63 students participated in the workshop. 91% attended at least 3 of the 4 sessions. The majority of participants found the workshop interesting and useful and would recommend it to a friend. Significant pre-to-post reductions in symptoms (depression, anxiety, and subclinical psychotic symptoms, ps < 0.004) and improvements in resilience-promoting capacities (self-compassion and self-efficacy, ps < 0.006) and indices of social functioning (social motivation, activity, and a measure of comfort with the physical presence of others, ps < 0.04) were observed. Moreover, the significant increases in resilience-promoting capacities correlated with the reductions in affective symptoms (ps < 0.03). Conclusions:These findings suggest that an on-campus mental health screening and early intervention program is feasible, acceptable, and may be associated with improvements in resilience-related capacities and symptom reductions in young adults with non-impairing, subclinical symptoms of psychopathology. Follow-up work will determine whether this program can improve both shorter and longer-term mental health and functional outcomes in this at-risk population.

Dataset Information

The Positive Emotions after Acute Coronary Events behavioral health intervention: Design, rationale, and preliminary feasibility of a factorial design study.

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The Positive Emotions after Acute Coronary Events behavioral health intervention: Design, rationale, and preliminary feasibility of a factorial design study.

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