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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.

ABSTRACT: 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.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.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.clinicaltrials.gov/ (NCT01909102).

SUBMITTER: Spatola CA

PROVIDER: S-EPMC3936953 | biostudies-literature | 2014 Feb

REPOSITORIES: biostudies-literature

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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.

Spatola Chiara A M CA Manzoni Gian Mauro GM Castelnuovo Gianluca G Malfatto Gabriella G Facchini Mario M Goodwin Christina L CL Baruffi Matteo M Molinari Enrico E

Health and quality of life outcomes 20140219

<h4>Background</h4>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, ...[more]

PMID: 24552555

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Project description:INTRODUCTION:Functional somatic syndromes (FSS) are common in adolescents, characterised by severe disability and reduced quality of life. Behavioural treatments such as acceptance and commitment therapy (ACT) has shown promising results in children and adolescents with FSS, but has focused on specific syndromes such as functional pain. The current study will compare the efficacy of group-based ACT with that of enhanced usual care (EUC) in adolescents with a range of FSS operationalised by the unifying construct of multiorgan bodily distress syndrome (BDS). METHODS AND ANALYSIS:A total of 120 adolescents aged 15-19 and diagnosed with multiorgan BDS, of at least 12?months duration, will be assessed and randomised to either: (1) EUC: a manualised consultation with a child and adolescent psychiatrist and individualised treatment plan or (2) manualised ACT-based group therapy plus EUC. The ACT programme consists of 9 modules (ie, 27?hours) and 1 follow-up meeting (3?hours). The primary outcome is physical health, assessed by an Short Form Health Survey (SF-36) aggregate score 12?months after randomisation. Secondary outcomes include self-reported symptom severity, symptom interference, depression and anxiety, illness worry, perceived stress and global improvement; as well as objective physical activity and bodily stress response measured by heart rate variability, hair cortisol and inflammatory biomarkers. Process measures are illness perception, illness-related behaviour and psychological flexibility. ETHICS AND DISSEMINATION:The study is conducted in accordance with Helsinki Declaration II. Approval has been obtained from the Science Ethics Committee of the Central Denmark Region and the Danish Data Protection. The results will be sought to be published according to the CONSORT statement in peer-reviewed journals. DISCUSSION:This is one of the first larger randomised clinical trials evaluating the effect of a group-based intervention for adolescents with a range of severe FSS. TRIAL REGISTRATION NUMBER:NCT02346071; Pre-results.

Project description:Background: Evidence on factors associated with guideline-directed secondary prevention medication (GDPM) after percutaneous coronary intervention (PCI) and its effect on the prognosis of patients with coronary artery disease (CAD) is lacking in China. Aims: To ascertain predictors of GDPM in real-world clinical practice and to assess the effect of GDPM on clinical outcomes. Design: A retrospective cohort study. Methods: Consecutive patients admitted to Fuwai Hospital between January 2013 and December 2013 were recruited. GDPM comprised aspirin, clopidogrel, statins, β-blockers, and angiotensin-converting enzyme inhibitors/angiotensin Ⅱ receptor blockers. The primary outcome was five-year major adverse cardiovascular event (MACE) (cardiac death, myocardial infarction [MI] and unplanned revascularization). Multivariable logistic regression was used to identify predictors of prescribing GDPM. Multivariable Cox regression was used to examine the relationship between GDPM and clinical outcomes. Results: 10,067 patients were followed up for a median of 5.0 years (interquartile range: 4.3–5.2), 45.1% were prescribed with GDPM. Presenting with ST-segment elevation MI (adjusted OR = 3.252 [2.832–3.736]), prior MI (adjusted OR = 2.174 [1.948–2.425]), more stents implanted (adjusted OR = 1.063 [1.022–1.106]), overweight (adjusted OR = 1.136 [1.038–1.243]), obesity (adjusted OR = 1.274 [1.100–1.476]), diabetes (adjusted OR = 1.225 [1.115–1.344]), and hypertension (adjusted OR = 3.556 [3.196–3.956]) predicted the prescription of GDPM. Advanced age (adjusted OR = 0.556 [0.379–0.816]) was associated with lower prescription rate of GDPM. Patients with GDPM had lower rate of 5-year MACE (adjusted HR = 0.889 [0.808–0.978]) relative to those without GDPM. Conclusions: Despite the benefit of GDPM in improving the prognosis of CAD patients undergoing PCI, gaps still exist in GDPM prescription in real-world clinical practice. Our study determined target populations for physicians to strive to promote the application of GDPM.

Project description:BackgroundDepression is a leading cause of disability worldwide. African American adults, compared to White adults, are half as likely to be screened for depression in primary care settings. Disparities in depression screening contribute to poor clinical outcomes, as African Americans with depression are more disabled and sicker longer compared to Whites. African American churches are trusted settings that provide access to supports for depression. Indeed, in the first study of its kind, the investigators found that 20% of adults in African American churches screened positive for depression using the Patient Health Questionnaire-9 (PHQ-9). However, no subjects with a positive screen (PHQ-9 ≥ 10) accepted a treatment referral when offered by research personnel. Community Health Workers, who are trusted paraprofessionals from the target community, may bridge the gap between depression screening and treatment. The investigators have trained and certified 112 Community Health Workers from 45 African American churches in New York City to deliver an evidence-based intervention called Screening, Brief Intervention, and Referral to Treatment (SBIRT). Thus, the aim of the current study is to test the impact of Community Health Worker-delivered depression screening in Black churches on engagement with clinical services.MethodsUsing a hybrid type 1 effectiveness-implementation design, we propose a 2-arm, mixed-methods cluster randomized controlled trial. Church study sites will be randomized to either SBIRT (intervention arm) or referral as usual (usual care arm). This trial will be conducted with 600 church members across 30 churches (300 intervention; 300 usual care). Our primary outcome is treatment engagement, defined as attending a depression-related clinical visit. Secondary outcomes will be changes in Mental Health-Related Quality of Life and depressive symptoms at 3 and 6 months post-screening. Lastly, we will conduct a concurrent, mixed-methods (qualitative-quantitative) process evaluation to assess contextual facilitators and barriers of screening and referral.DiscussionThis is the first randomized trial of a church-placed, community health worker-delivered intervention for depression in African American populations. This study may provide a novel and effective approach to increasing depression identification and treatment linkage in economically disadvantaged populations with high depression rates.Trial registrationClinicalTrials.gov NCT04524767 . Registered on 21 August 2020.

Project description:BackgroundFor patients with coronary heart diseases a substantial part of secondary prevention is delivered in primary care. Along with the growing importance of prevention, health-related quality of life (HRQoL) is an indicator of patient-centered care that has gained increased attention. Different approaches for reorganization in primary care have been associated with improvements in HRQoL. However, these are often results of complex interventions. Evidence on aspects concerning usual primary care that actually have an impact on HRQoL remains scarce. Therefore, this observational study aimed to identify factors which are associated with HRQoL in usual primary care at practice and patient-level.MethodsThis observational study was conducted in eight European countries. We were able to match data from survey instruments for 3505 patients with coronary heart disease (CHD) in 228 practices. A multilevel analysis was performed to identify associations of EQ-5D scores at patient and practice-level.ResultsAfter dropping patients with missing information, our cohort consisted of 2656 patients. In this sample, 30.5% were female and the mean age was 67.5 years (SD 10.1). The final model included a total set of 14 potential explanatory variables. At practice-level no variable was associated with EQ-5D. At patient-level, lower education (r =?-0.0381, p<0.0001), female gender (r =?-0.0543, p<0.0001) and a higher number of other conditions (r =?-0.0340, p<0.0001), had a strong negative effect on HRQoL. Strong positive associations with HRQoL were found for a good medication adherence (Morisky) (r = 0.0195, p<0.0001) and more positive evaluations of physicians' clinical behavior (r = 0.0282, p = 0.002). In terms of HRQoL no differences between single-handed and group practices exist.ConclusionThe results of our study suggest that a better patient-physician relationship rather than organization of CHD care is associated with higher HRQOL in the primary care setting. The results may imply that interventions to improve HRQoL require a strong patient-centered approach.

Project description:ObjectiveOverall, the literature on the effectiveness of psychological treatments in general and those for fibromyalgia in particular has been dominated by research designs that focus on large groups and explore changes on average, so the treatment impact at the individual level remains unclear. In this quasi-experimental, replicated single-case design, we will test the feasibility and effectiveness of a brief acceptance and committed therapy intervention using ecological momentary assessment supported by technology.MethodsThe sample comprised 7 patients (3 in the individual condition and 4 in the group condition) who received a brief, 5-week psychological treatment. Patient evolution was assessed one week prior to treatment onset and during the whole study with a smartphone app. Because ecological momentary assessment and the use of an app are not frequent practices in routine care, we also evaluated the feasibility of this assessment methodology (i.e., compliance with the app). Change was investigated with a nonoverlap of all pairs index. Outcomes were pain interference with sleep and social activities, fatigue, sadness, and pain intensity.ResultsPatient change was not uniform across outcomes. Four patients (two in each condition) showed relatively moderate levels of change (approximately 60% nonoverlap in several outcomes). The remaining patients showed more modest improvements which affected a reduced number of outcomes. Based on nonoverlapping indices, there was no clear evidence in favor of any treatment format.ConclusionsAn alternative design to large-scale trials, one that focuses on the individual change, exists and it can be implemented in pain research. The use of technology (e.g., smartphones) simplifies such designs by facilitating ecological momentary assessment. Based on our findings showing that changes were not homogeneous across patients or outcomes, more single-case designs and patient-centered analyses (e.g., responder and moderation analyses) are required.

Project description:Mobile phone apps offer a promising medium to deliver psychological interventions. A mobile app based on Acceptance and Commitment Therapy (ACT) was developed and studied in a randomized controlled trial (RCT).To study usage metrics of a mobile ACT intervention and dose-response relationship between usage and improvement in psychological flexibility.An RCT was conducted to investigate the effectiveness of different lifestyle interventions for overweight people with psychological stress. This paper presents a secondary analysis of the group that received an 8-week mobile ACT intervention. Most of the analyzed 74 participants were female (n=64, 86%). Their median age was 49.6 (interquartile range, IQR 45.4-55.3) years and their mean level of psychological flexibility, measured with the Acceptance and Action Questionnaire II, was 20.4 (95% confidence interval 18.3-22.5). Several usage metrics describing the intensity of use, usage of content, and ways of use were calculated. Linear regression analyses were performed to study the dose-response relationship between usage and the change in psychological flexibility and to identify the usage metrics with strongest association with improvement. Binary logistic regression analyses were further used to assess the role of usage metrics between those who showed improvement in psychological flexibility and those who did not. In addition, associations between usage and baseline participant characteristics were studied.The median number of usage sessions was 21 (IQR 11.8-35), the number of usage days was 15 (IQR 9.0-24), and the number of usage weeks was 7.0 (IQR 4.0-8.0). The participants used the mobile app for a median duration of 4.7 (IQR 3.2-7.2) hours and performed a median of 63 (IQR 46-98) exercises. There was a dose-response relationship between usage and the change in psychological flexibility. The strongest associations with psychological flexibility (results adjusted with gender, age, and baseline psychological variables) were found for lower usage of Self as context related exercises (B=0.22, P=.001) and higher intensity of use, described by the number of usage sessions (B=-0.10, P=.01), usage days (B=-0.17, P=.008), and usage weeks (B=-0.73, P=.02), the number of exercises performed (B=-0.02, P=.03), and the total duration of use (B=-0.30, P=.04). Also, higher usage of Acceptance related exercises (B=-0.18, P=.04) was associated with improvement. Active usage was associated with female gender, older age, and not owning a smart mobile phone before the study.The results indicated that active usage of a mobile ACT intervention was associated with improved psychological flexibility. Usage metrics describing intensity of use as well as two metrics related to the usage of content were found to be most strongly associated with improvement.ClinicalTrials.gov NCT01738256; https://clinicaltrials.gov/ct2/show/NCT01738256 (Archived by WebCite at http://www.webcitation.org/6iTePjPLL).

Project description:Psychological interventions have a long history of successful treatment of patients suffering from mental health and certain medical conditions. At the same time, psychotherapy research has revealed key areas of growth for optimizing patient care. These include identifying novel treatment delivery methods that increase treatment adherence, developing new strategies to more effectively address the ever-growing population of patients with comorbid conditions, and elucidating the mechanisms by which effective treatments work in order to further refine their design. Acceptance and commitment therapy (ACT) is an empirically supported psychotherapy that offers promise for patients suffering from a wide range of mental and physical conditions, while addressing these gaps and challenges in the field. ACT rests on the fundamental premise that pain, grief, disappointment, illness, and anxiety are inevitable features of human life, with the therapeutic goal of helping individuals productively adapt to these types of challenges by developing greater psychological flexibility rather than engaging in counterproductive attempts to eliminate or suppress undesirable experiences. This is achieved through committed pursuit of valued life areas and directions, even in the face of the natural desire to escape or avoid painful and troubling experiences, emotions, and thoughts. ACT is transdiagnostic (applies to more than one condition), process-focused, and flexibly delivered. In a relatively short period of time, ACT has been effectively implemented across a broad range of therapeutic settings, including mental health, primary care, and specialty medical clinics. ACT has also been delivered in a variety of formats, including 1-day group workshops, online and smartphone applications, and telehealth. Focus on how best to package and deliver treatment to meet the unique needs of different patient populations helps to ensure treatment adherence and has fostered successful application of ACT for patients in everyday clinical settings.

Dataset Information

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.

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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.

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