Effects of a brief intervention based on Acceptance and Commitment Therapy versus usual care for cardiac rehabilitation patients with coronary heart disease (ACTonHEART): a randomised controlled trial.

OBJECTIVES: The main objective of the study is to investigate the short-term efficacy of Acceptance and Commitment Therapy (ACT) on the simultaneous modification of biological indicators of risk and psychological well-being in patients with coronary heart disease attending cardiac rehabilitation (CR). DESIGN: This was a two-arm randomised controlled trial comparing a brief, manualised, ACT-based intervention with usual care (UC). SETTING: The study was conducted in an outpatient CR unit in Italy. Data collection took place from January 2016 to July 2017. PARTICIPANTS: Ninety-two patients were enrolled and randomised, following an unbalanced randomisation ratio of 2:1 to the ACT group (n=59) and the control group (n=33). Eighty-five patients completed the ACT (n=54) and the UC (n=31) interventions and were analysed. INTERVENTIONS: The control group received UC, a 6 weeks multidisciplinary outpatient CR programme, encompassing exercise training, educational counselling and medical examinations. The experimental group, in addition to UC, participated in the Acceptance and Commitment Therapy on HEART disease (ACTonHEART) intervention encompassing three group sessions based on ACT. OUTCOMES: The primary outcomes were Low Density Lipoproteins (LDL)cholesterol, resting systolic blood pressure, body mass index (BMI) and psychological well-being measured by the Psychological General Well-Being Index (PGWBI). Outcome measures were assessed at baseline and at the end of CR. RESULTS: Based on linear mixed models, no significant group × time interaction was observed for either the primary outcomes (ß, 95% CI: PGWBI =-1.13, -6.40 to -4.14; LDL cholesterol =-2.13, -11.02 to -6.76; systolic blood pressure =-0.50, -10.76 to -9.76; diastolic blood pressure =-2.73, -10.12 to -4.65; BMI =-0.16, -1.83 to -1.51, all p values >0.05) or the secondary outcomes (all p values >0.05). A significant time effect was found for the PGWBI total (beta=4.72; p=0.03). CONCLUSIONS: Although analyses revealed null findings, the results can inform the design of future ACT-based CR interventions and can help researchers to strike a balance between the idealised implementation of an ACT intervention and the structural limitations of existing CR programmes. TRIAL REGISTRATION NUMBER: NCT01909102.

The Impact of Depression and Exercise Self-Efficacy on Benefits of Pulmonary Rehabilitation in Veterans with COPD.

Pulmonary rehabilitation (PR) improves health-related quality of life (HRQoL) and exercise capacity. Little is known about the impact of depression symptoms and exercise self-efficacy on improvements in these key PR outcomes. This study examined the impact of baseline depression status and change in depression symptoms (Beck Depression Inventory-II [BDI-II] score) over the course of PR on change in HRQoL assessed by the Chronic Respiratory Disease Questionnaire-Self Reported (CRQ-SR) and exercise capacity as measured by the 6-Minute Walk Test (6MWT). We also examined whether baseline exercise self-efficacy moderated the association between baseline depression symptoms and change in these key PR outcomes. We studied 112 US veterans (aged 70.38 ± 8.49 years) with chronic obstructive pulmonary disease (COPD) who completed PR consisting of twice-weekly 2-hour classes for 18 sessions. Depressed (BDI-II >13) and nondepressed (BDI-II ≤13) patients at baseline demonstrated comparable and significant improvement in CRQ-SR total score, subscales, and 6MWT. Greater reduction in depression over the course of treatment was significantly associated with greater improvement in CRQ-SR total score and the following subscales: fatigue, mastery, and emotional function. Change in depression did not predict change in 6MWT distance. Baseline exercise self-efficacy moderated the association between baseline depression symptoms and change in CRQ-SR fatigue. Specifically, when baseline exercise self-efficacy was <30.4, greater baseline depression was associated with less improvement in CRQ-SR fatigue. When baseline self-efficacy was >152.0, greater baseline depression was associated with greater improvement in CRQ-SR fatigue. PR programs should address mood and confidence to exercise given their impact on key PR outcomes.

Predictors of Outpatient Pulmonary Rehabilitation Uptake, Adherence, Completion, and Treatment Response Among Male U.S. Veterans With Chronic Obstructive Pulmonary Disease.

OBJECTIVE: To examine predictors of uptake (never start), adherence (drop out), and completion of pulmonary rehabilitation (PR), as well as PR treatment response based on minimal clinically important difference (MCID) on the 6-minute walk test (6MWT) distance and Chronic Respiratory Questionnaire-Self-Report (CRQ-SR). DESIGN: Retrospective, cohort study. SETTING: Veterans Health Administration. PARTICIPANTS: U.S. veterans with chronic obstructive pulmonary disease (COPD) (N=253) referred to PR between 2010 and 2018. INTERVENTIONS: Outpatient PR program. MAIN OUTCOME MEASURES: Participants completed baseline (time 1) measures of depression (Beck Depression Inventory-II), health-related quality of life (CRQ-SR), self-efficacy (Exercise Self-Regulatory Efficacy Scale [Ex-SRES]), and COPD knowledge. Exercise capacity was assessed with the 6MWT. Participants who completed all 18 sessions of PR repeated assessments (time 2). Logistic regression models examined predictors of uptake, adherence, and completion of PR as well as treatment response based on MCID. RESULTS: Participants were referred to PR with 24.90% never starting, 28.90% dropping out, and 46.20% completing. No differences emerged between never starters and dropouts. Having a history of any cancer increased the likelihood of completing PR (vs never starting; odds ratio [OR], 3.18; P=.003). Greater CRQ-SR dyspnea score, indicating less dyspnea, was associated with increased likelihood of completing PR (OR, 1.12; P=.006). Past smoking compared with current smoking was associated with increased likelihood of completion (OR, 3.89; P≤.002). Those without a history of alcohol use disorder had increased likelihood of completing PR (OR, 2.23; P=.048). Greater baseline 6MWT distance was associated with lower likelihood of achieving MCID in 6MWT (OR, 0.99; P<.001). Greater Ex-SRES was associated with decreased likelihood of achieving 6MWT MCID (OR, 0.98; P=.023). CONCLUSIONS: Findings suggest that early psychoeducation on dyspnea management and smoking and alcohol cessation may increase completion of PR.

Fallen Between the Cracks: Protecting Research Staff From Participant-Perpetrated Harassment.

There has been a call to identify populations who are at-risk for harassment. At our institution, participant-perpetrated harassment led to the development of an institution-wide program called Cultivating Respect in Research Environments (CuRRE). In this article, we describe the proactive and multipronged approach used to promote and implement the CuRRE program. We describe a policy created to set guidelines and expectations for research participants and discuss the educational and skills-based trainings delivered to principal investigators and research staff members. Research staff members completed anonymous surveys before and after the training. Over half of the attendees reported having been harassed by a participant/patient. Attendees responded favorably to the training; they felt more confident and better equipped to address participant-perpetrated harassment at the conclusion of the training. Given the dearth of literature in this area, we offer our experiences to encourage others to address this issue within their own research environment and institution.

Cross-Lagged Relations Between Exercise Capacity and Psychological Distress During Cardiac Rehabilitation.

Background: Poorer mental health is associated with lower exercise capacity, above and beyond the effect of other cardiovascular risk factors. However, the directionality of this relationship remains unclear. Purpose: The main aim of the present study was to clarify, with a cross-lagged panel design, the relationship between psychological status and exercise capacity among patients in a cardiac rehabilitation (CR) program. Methods: A clinical sample of 212 CR patients completed exercise-capacity testing and measures of depression and anxiety (Hospital Anxiety and Depression Scale) pre-CR and post-CR. Demographic and clinical data, including BMI and smoking history, were also collected. Multivariate stepwise regression analysis was performed to identify the best predictors of exercise capacity at discharge. Structural equation modeling was utilized to quantify the cross-lagged effect between exercise capacity and psychological distress. Results: Multivariate regression analysis revealed that higher levels of psychological distress pre-CR are predictively associated with less improvement in exercise capacity post-CR, beyond the effects of age, sex, and baseline functional status. Results from structural equation modeling supported a 1-direction association, with psychological distress pre-CR predicting lower exercise capacity post-CR over and above autoregressive effects. Conclusions: Study results did not support the hypothesis of a bidirectional relationship between psychological distress and EC. High levels of psychological distress pre-CR appeared to be longitudinally associated with lower exercise capacity post-CR, but not vice versa. This finding highlights the importance of assessing and treating both anxiety and depression in the early phase of secondary prevention programs.

Lower Experiential Avoidance Is Associated With Psychological Well-being and Improved Cardiopulmonary Endurance Among Patients in Cardiac Rehabilitation.

PURPOSE: Patients with a diagnosis of cardiac disease are often asked to make significant lifestyle changes, but they may experience difficulty initiating and maintaining lifestyle changes, especially when engaging in experiential avoidance (EA), the tendency to push away unpleasant emotions and sensations. This study examined the relationship between EA, psychological functioning, cardiac-quality of life (cardiac-QOL), program adherence, and cardiopulmonary endurance among patients entering an outpatient cardiac rehabilitation (CR) program. METHODS: Patients completed study questionnaires pre-CR, including 2 measures of EA (general and cardiac-specific), and assessments of psychological functioning and cardiac-QOL. Adherence was calculated as the proportion of insurance-approved CR sessions attended. Thirty participants completed stress testing pre-CR and post-CR. RESULTS: Forty-seven patients completed the questionnaires. General EA was associated with greater depression (r = 0.73, P < .001), anxiety (r = 0.56, P < .001), and stress (r = 0.65, P < .001) and lower cardiac-QOL (r =-0.69, P < .001). In addition, when controlling for the influence of general EA, greater cardiac-specific EA was associated with depression ([INCREMENT]R = 0.05, P = .01), anxiety ([INCREMENT]R = 0.18, P < .001), and poorer cardiac-QOL ([INCREMENT]R = 0.04, P = .04). However, lower cardiac-specific EA predicted greater increases in cardiopulmonary endurance ((Equation is included in full-text article.)O2peak) during the CR program (b =-0.18, P = .002; [INCREMENT]adjusted R = 0.07). Experiential avoidance was not associated with adherence. CONCLUSIONS: Lower EA is associated with better psychological well-being among patients entering a CR program and with better exercise outcomes. Strategies for reducing EA may be important to consider in future clinical studies.

Development and initial validation of the Cardiovascular Disease Acceptance and Action Questionnaire (CVD-AAQ) in an Italian sample of cardiac patients.

Psychological inflexibility refers to the attempt to decrease internal distress even when doing so is inconsistent with life values, and has been identified as a potential barrier to making and maintaining health behavior changes that are consistent with a heart-healthy lifestyle. Disease- and behavior-specific measures of psychological inflexibility have been developed and utilized in treatment research. However, no specific measure has been created for patients with heart disease. Thus, the CardioVascular Disease Acceptance and Action Questionnaire (CVD-AAQ) was developed. The present study is aimed to evaluate the psychometric properties of the CVD-AAQ and to explore its association with measures of psychological adjustment and cardiovascular risk factors in an Italian sample of 275 cardiac patients. Exploratory factor analysis showed a structural one-factor solution with satisfactory internal consistency and test-retest reliability. The relation with other measures was in the expected direction with stronger correlations for the theoretically consistent variables, supporting convergent and divergent validity. CVD-AAQ scores were associated with general psychological inflexibility, anxiety and depression and inversely correlated with psychological well-being. Moreover, the results showed that CVD-AAQ scores are associated with two relevant risk factors for cardiac patients, namely low adherence to medication and being overweight. In sum, results suggest that the CVD-AAQ is a reliable and valid measure of heart disease-specific psychological inflexibility with interesting clinical applications for secondary prevention care.

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).

A pilot study examining the initial effectiveness of a brief acceptance-based behavior therapy for modifying diet and physical activity among cardiac patients.

Approximately 90% of cardiac events are attributable to a small number of modifiable behavioral risk factors that, if changed, can greatly decrease morbidity and mortality. However, few at-risk individuals make recommended behavioral changes, including those who receive formal interventions designed to facilitate healthy behavior. Given evidence for the potential of specific psychological factors inherent in acceptance-based behavior therapy (ABBT; that is, intolerance of discomfort, mindfulness, and values clarity) to impact health behavior change, the authors evaluated the feasibility and initial effectiveness of an ABBT pilot program designed to increase adherence to behavioral recommendations among cardiac patients. Participants (N = 16) were enrolled in four, 90-min group sessions focused on developing mindfulness and distress tolerance skills, and strengthening commitment to health-related behavior change. Participants reported high treatment satisfaction and comprehension and made positive changes in diet and physical activity. This was the first evaluation of an ABBT program aimed at increasing heart-healthy behaviors among cardiac patients.