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. Author manuscript; available in PMC: 2023 Apr 1.
Published in final edited form as: Psychol Health Med. 2021 Jan 25;27(4):761–779. doi: 10.1080/13548506.2021.1874436

Women’s Participation in Stress Management Interventions for Chronic Heart Failure: A Meta-Analysis of Randomized Controlled Trials

Lori A J Scott-Sheldon a,b,c, Emily C Gathright a,b, Elena Salmoirago-Blother a,d,e, Wen-Chih Wu d,e,f,g
PMCID: PMC9671067  NIHMSID: NIHMS1664537  PMID: 33486993

Abstract

Stress management interventions (SMIs) can alleviate the psychosocial stress often experienced by women with heart failure. The purpose of this meta-analysis was to summarize women’s participation rates, and predictors of participation, in SMIs for the management of psychosocial distress in women with chronic HF. Studies were retrieved from bibliographic databases, reference sections of relevant papers, and research registries. Included studies (a) evaluated a SMI approach for the management of chronic HF, (b) sampled chronic HF patients, and (c) used a randomized controlled trial (RCT) design. Independent coders extracted the relevant data. Thirty-five RCTs met inclusion criteria (N = 3,649; mean age = 63.5±7.0 years). All studies sampled both men and women; the mean proportion of women who participated in the trials was 38.8% (95% confidence interval [CI]=34.5–43.4; I2 = 82.4, 95% CI=81.0–83.6). Women’s participation rates were higher in studies sampling more HF patients with hypertension (B = 1.01, SE = 0.45, P = .046) but fewer HF patients prescribed beta blockers (B = −1.10, SE = 0.33, P = .006), F (2,12) = 6.27, P = 0.014, adjusted R2 = 61%. SMIs may offer women a complementary or integrative approach to standard treatment to help manage the psychological distress associated with HF. Future research should explore the potential benefits of offering stress management approaches to women as part of comprehensive HF care.

Keywords: chronic heart failure, women, stress management interventions, meta-analysis

INTRODUCTION

Heart failure (HF) is a chronic condition affecting 26 million adults globally (Ponikowski et al., 2014). The global prevalence of HF is increasing worldwide but most notably in Asia where HF prevalence is 1.2 to 6.7% of the population (Ponikowski et al., 2014). HF affects 6.2 million U.S. adults (2.2% of the population) and is expected to increase 46% by 2030 (Virani et al., 2020). The increasing prevalence can be attributed to improvements in survival following a HF diagnosis but long-term prognosis for HF patients remains poor with high rates of hospitalization, hospital readmissions, and mortality (Dharmarajan & Rich, 2017). The burden on the healthcare system is substantial, costing the U.S. healthcare system an estimated $11 billion in 2014 (Jackson et al., 2018).

The prevalence of HF is similar among men and women and increases with age, but the clinical presentation, prognosis, and etiology of HF varies by sex (Levinsson et al., 2018). Women with HF tend to be diagnosed at an older age, present with multiple comorbidities (e.g., obesity, hypertension, chronic kidney disease), and report worse symptoms than men (Dewan, Rorth, Jhund, et al., 2019; Dewan, Rorth, Raparelli, et al., 2019; Pepine et al., 2020). Women with HF are also more likely than men to report greater psychological distress (e.g., depression, anxiety), increased fatigue, and lower quality of life (Chobufo et al., 2020; Lesman-Leegte et al., 2009; Piepenburg et al., 2019). Cardiovascular death, especially sudden death, however, is lower in women compared to men (Dewan, Rorth, Raparelli, et al., 2019; Pepine et al., 2020). Consequently, women tend to live longer with HF but experience greater symptom burden (Dewan, Rorth, Jhund, et al., 2019; Dewan, Rorth, Raparelli, et al., 2019). Therefore, secondary prevention efforts are necessary to improve outcomes especially among women with HF.

Cardiac rehabilitation (CR) programs offer supervised exercise programs integrated with education and counseling to promote the secondary prevention of HF. Participation in CR is associated with decreased morbidity and mortality (Morris & Chen, 2019). Compared to men, women’s participation in CR is associated with similar or greater improvements in mortality, cardiorespiratory fitness, psychological functions, and quality of life (Galati et al., 2018). Women, however, are less likely to be referred to CR and are also less likely to complete CR even when referred and enrolled relative to men (Colella et al., 2015; Oosenbrug et al., 2016).

Women are less likely to enroll in or complete CR due to multiple concerns, including concerns that aerobic exercise may place an undue strain on the heart, lack of motivation, and elevated depressive symptoms (Resurreccion et al., 2017). Stress management interventions (SMIs) provide stress management training with or without gentle physical exercise and stretching that may be an acceptable, complementary or integrative health (CIH) approach to help women not only manage the psychological distress but also the symptoms of, and treatment for, HF (Baum et al., 1995). Few exercise-based CR programs offer these additional interventions but prior reviews show the potential benefits of SMIs (e.g., cognitive-behavioral therapy, mindfulness, tai chi, yoga) as a CIH approach to CR to reduce psychological distress and increase quality of life among patients with cardiac disease (Blumenthal et al., 2016; Liu et al., 2018). Furthermore, emerging evidence shows that some SMIs such as tai chi and yoga can improve cardiorespiratory endurance among HF patients relative to controls (Gathright et al., 2020). Patient enrolled in CR who experience a reduction in psychosocial distress (e.g., depression) also had a lower mortality rate (Milani & Lavie, 2007; Milani et al., 2011).

Women represent 52% of patients living with HF but are often underrepresented in randomized controlled trials (RCTs) of recommended exercise-based CR for the management of chronic HF (Samayoa et al., 2014; Virani et al., 2020). SMIs can address the psychological and physical concerns that often prevent women from participating in CR but do women with HF participate in SMIs? To our knowledge, women’s participation rates in SMIs for chronic HF has not been documented. Therefore, the purpose of this meta-analysis was to investigate women’s participation rates in RCTs of SMIs for chronic HF and to assess possible predictors of women’s participation (i.e., patient characteristics such as age, race, HF stage, comorbidities, and medications, geographical location, and type of SMI).

METHODS

The Preferred Reported Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines were followed in the conduct and preparation of this meta-analysis (Moher et al., 2009). The PRISMA checklist can be found in the Electronic Supplemental Materials (Supplemental Table 1).

Eligibility Criteria

Published studies were included in the meta-analysis if the study (a) evaluated a SMI; (b) sampled chronic HF patients; and (c) used an RCT design. For this meta-analysis, SMIs were operationalized as interventions that included cognitive approaches (e.g., cognitive behavioral stress management, cognitive therapy, or coping skills interventions), relaxation techniques (e.g., mindfulness meditation, biofeedback, progressive muscle relaxation), and exercise-based practices (e.g., tai chi, yoga). Interventions that included aerobic exercise training were excluded because these interventions are provided as part of standard CR.

Information Sources and Search Strategy

Studies were identified using four information sources: (1) electronic bibliographic database (PubMed, PsycINFO, Embase, ProQuest Dissertations & Theses Global, CINAHL, Cochrane Library, ERIC, Global Health, SocIndex, and Web of Science) searches were conducted using a Boolean search string [((“complementary and alternative medicine”) OR (autogenic training) OR (biofeedback) OR (“cognitive restructuring”) OR (“cognitive behavioral stress management”) OR (“deep breathing”) OR (“emotional freedom technique”) OR (guided imagery) OR (“mindfulness-based stress reduction”) OR (mindfulness) OR (meditation) OR (“problem-solving training”) OR (“progressive muscle relaxation”) OR (“relaxation techniques”) OR (self-disclosure) OR (self-hypnosis) OR (tai chi) OR (“transcendental meditation”) OR (yoga) OR (“stress management”)) AND (“heart failure” OR (heart failure))] with no language or geographical restrictions applied; (2) reviewing reference sections of relevant manuscripts; (3) review of electronic tables of contents of related journals; and (4) electronic searches of online databases of funded research (e.g., NIH RePORTER) and clinical trials (ClinicalTrials.gov). Database searches were conducted in August 2017 and repeated annually with the last search conducted in April 2020 to ensure the inclusion of all records published through March 2020.

Study Selection

All records retrieved from the electronic bibliographic database searches were initially screened for inclusion based on title and abstract. The full-text manuscripts of potentially relevant records were retrieved and reviewed for inclusion by the study authors and verified by the PI (LAJSS). If the research was reported in multiple records, the records were linked in the database and represented as a single unit. The record reporting the most complete data was selected as the primary study, additional study records were considered relevant supplemental materials. Relevant research identified from reference sections, journals, and databases of funded research and clinical trials were cross-referenced with the electronic bibliographic database records and were added to the database as additional records as needed.

Data Extraction

Two raters independently coded study information, sample and intervention characteristics, and methodological features of the studies using a coding form with predefined codes. The quality of the studies was assessed using a 17-item methodological quality (MQ) rating form adapted from published checklists (Downs & Black, 1998; Fowkes & Fulton, 1991; Miller et al., 1995); the total possible score is 25 with higher values indicating stronger study quality. Coding discrepancies were reviewed, discussed, and resolved. The interrater reliability was high with 91% agreement between coders for the categorical variables (mean Cohen’s κ = 0.79) and the mean inter-class correlation coefficient for the continuous variables was 0.92 (median = 1.00).

Statistical Analyses

The proportion of women included in each sample (calculated based on the number of women who consented to participate in the study divided by the total number of participants in the sample) was used as the effect size (ES) estimate. Consistent with meta-analytic recommendations, the observed proportions were then converted to logits and used in the analyses (Lipsey & Wilson, 2001). The mean logit and the corresponding 95% confidence intervals (CIs) were calculated using a random-effects model with the between-study variance estimated using restricted maximum likelihood (Lipsey & Wilson, 2001). Results of the analyses (using logits) were converted back to proportions (and corresponding CIs) for ease of interpretation of study findings. The distribution of the ESs surrounding the mean logit ES was assessed using the homogeneity statistic, Q; a significant Q indicates a lack of homogeneity and an inference of heterogeneity. To assess heterogeneity, the I2 index and its corresponding 95% CIs were calculated consistent with a random-effects model (Higgins & Thompson, 2002; Huedo-Medina et al., 2006).

To explain variability in the proportion of women included in the samples, moderator analyses were conducted using meta-regression (following random-effects assumptions with a Knapp-Hartung adjustment) with weights equivalent to the inverse of the variance for the mean logit ESs (Hedges, 1994; Lipsey & Wilson, 2001) These analyses examined a priori selected predictors of women’s participation in SMIs. Patient characteristics (age, race, HF stage, comorbidities, medications), geographical location, and type of SMI (cognitive, relaxation, and exercise-based) were examined as potential moderators of women’s participation. Meta-regression was also used to assess the impact of methodological quality on the proportion of women included in the samples.

Publication bias was assessed by visually inspecting the funnel plot and conducting statistical tests (i.e., Egger’s regression test, Begg’s rank correlation test) (Begg & Mazumdar, 1994; Egger et al., 1997; Sterne & Egger, 2001) Trim-and-fill methods were used to statistically detect and adjust for the possibility of missing studies (Duval & Tweedie, 2000) All statistical analyses were conducted in Stata 16 (LLC, 2020)

RESULTS

Study, Sample, and Intervention Characteristics

Comprehensive searches revealed 1,933 unique studies; 35 RCTs met inclusion criteria (see Figure 1 for details). Characteristics of the included RCTs are provided in Table 1. Studies were published between 1997 and 2019 with data collection occurring between 1992 and 2018 (mean lag time = 4.11 years, SD = 2.30; range = 1–9 years). The studies were conducted in the United States (43%), China (31%), Sweden (6%), Brazil (3%), Germany (3%), India (3%), Iran (3%), Philippines (3%), Taiwan (3%), and England (3%). Financial support was reported in 20 (57%) of the studies; 15 studies (43%) did not report receiving research funding.

Figure 1.

Figure 1.

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Search and Selection Procedures. Note. A discrepancy in the total number of studies providing supplemental information is due to the inclusion of Pullen(Pullen et al., 2008) as both a primary study and a linked pilot study for Pullen.(Pullen et al., 2010) HF, heart failure; SM, stress management; CR, cardiac rehabilitation.

Table 1.

Study and Sample Characteristics of the 34 Randomized Controlled Trials Included in the Meta-Analysis.

Citation Location Data Year N % F Age % NW % NYHA Class LVEF I/C % HTN % Beta-Blockers Intervention Control
I II III IV
Aghamohammadi (2019) Iran 2019 90 44 69 NR 0 NR NR 0 NR NR NR SM HE
Barrow (2007) England 2004 69 18 68 NR 0 NR NR 0 NR 0 NR Tai Chi UC
Bose (2016) Sweden 2011 103 31 71 NR 0 84 16 0 NR 58 98 CET UC
Cajanding (2016) Philippines 2013 123 33 56 NR 12 43 40 5 NR 37 NR CBT UC
Chang (2005) * USA 2000 63 1 67 16 0 51 49 0 31/30 NR 76 RR UC
Curiati (2005) Brazil 2000 19 74 75 NR 84 16 0 0 57/72 95 84 Meditation HE
Dekker (2012) USA 2009 42 45 66 10 0 19 74 7 41/38 88 86 CBT UC
Freedland (2015) USA 2010 158 46 56 37 NR NR 42 0 40/38 72 92 CBT HE
Gary (2010) * USA 2004 36 58 66 28 0 43 57 0 NR 81 NR CBT UC
Hagglund (2018) Sweden 2010 45 22 75 NR 0 NR NR 0 NR NR NR Tai Chi UC
Huang (2016) Taiwan 2008 60 33 60 100 NR NR NR NR 49/41 NR NR BFAR UC
Jayadevappa (2007) USA 2003 31 61 64 100 0 NR NR 0 27 NR NR TM HE
Krishna (2014) India 2011 130 30 50 NR 29 71 0 0 39/40 79 78 Yoga UC
Kristen (2010) Germany 2003 17 35 60 NR 0 82 18 0 29/31 NR 100 Acupuncture Placebo
Li (2012) China 2010 40 53 67 100 0 0 NR NR NR NR NR Acupuncture UC
Li (2003) China 2010 40 53 67 100 0 0 NR NR NR 20 NR Acupuncture UC
Moser (1997) USA 1992 43 38 55 NR 0 0 NR NR 22/21 NR NR BFAR AC
Pen (2016) China 2013 61 43 67 100 0 NR NR 0 32/33 NR NR Tai Chi UC
Powell (2010) USA 2001 902 47 64 40 0 68 32 0 NR 75 71 SMC HE
Pullen (2008) USA 2006 19 53 51 82 37 26 37 0 28/23 89 95 Yoga UC
Pullen (2010) USA 2008 40 43 54 98 28 40 33 0 31/27 95 97 Yoga UC
Redwine (2019) USA 2010 48 10 65 40 NR NR NR NR 46 NR NR Tai Chi UC
Sang (2015a) China 2013 60 42 66 100 0 NR NR 0 35/37 NR NR Tai Chi UC
Sang (2015b) China 2013 100 43 71 100 0 NR NR 0 36/37 0 NR Tai Chi UC
Seo (2016) USA 2011 73 31 66 0 0 51 46 3 35/39 NR 89 DBR HE
Sherwood (2017) USA 2009 199 27 58 0 0 NR NR 0 32/28 74 97 CST HE
Swanson (2009) USA 2007 35 21 55 20 NR NR NR 0 30/29 7 100 Biofeedback Placebo
Wang (2018) China 2016 60 43 69 100 0 38 62 0 NR NR 8 MBSR UC
Wang (2014) China 2009 142 58 62 NR 8 62 17 13 NR 59 NR Biofeedback UC
Yao (2010) China 2008 150 41 52 100 0 100 0 0 31/30 16 48 Tai Chi UC
Yeh (2011) USA 2002 30 37 64 43 17 50 27 7 28/30 70 90 Tai Chi HE
Yeh (2004) USA 2005 100 36 67 14 20 63 17 0 24/22 67 86 Tai Chi UC
Yu (2007) * Hong Kong 2002 121 50 75 100 4 56 38 3 NR 68 22 PMRT HE
Zhao (2019) China 2017 86 45 61 100 0 46 37 17 41/43 NR NR MBCT UC
Zhao (2018) China 2015 148 49 70 100 NR NR NR NR NR NR NR MBSR HE
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*

Sample participating in a non-SMI was excluded: Chang et al. (2005) (Education, n = 32); Gary et al. (2010) (Exercise, n = 20; Exercise/CBT, n = 18); Yu et al. (2007) (Exercise Training, n = 32).

NW, nonwhite; NYHA, New York Heart Association; LVEF, left ventricular ejection fraction; I/C, intervention/control; HTN, hypertension; AC. Attention Control; BFAR, Biofeedback-Assisted Relaxation; CBT, Cognitive Behavioral Therapy; CET, Coping Effectiveness Training; CST, Coping Skills Training; DBR, Diaphragmatic Breathing Retraining; EDUC, Education; HE, Health Education; MBSR, Mindfulness-Based Stress Reduction; MBCT, Mindfulness-Based Cognitive Therapy; PMRT, Progression Muscle Relaxation Therapy; RR, Relaxation Response; SM, Self-Management; SMC, Self-Management Counseling; TM, Transcendental Meditation; UC, Usual Care; NR, Not Reported.

The samples included a total of 3,649 patients who consented to participate in the studies and 3,402 participants were included in the studies’ analyses. All studies recruited patients from clinical settings and included both women and men in the samples. The mean age of the participants was 63.5±7.0 years. In addition, 18 studies reported the age range of the study sample; ages ranged from 18 and 94 years with 67% of the study samples including participants ≥80 years of age. Race of the samples was fully or partially reported in most studies (26 out of 35); 69±36% (range = 6 to 100%) of participants were nonwhite. Less than half of the studies (17 out of 35) assessed baseline depressive symptoms using validated measures (e.g., Beck’s Depression Inventory (Beck et al., 1996), Hamilton Depression Rating Scale (Hamilton, 1960), Hospital Anxiety and Depression Scale(Zigmond & Snaith, 1983)); three studies recruited patients with elevated depressive symptoms (Dekker et al., 2012; Freedland et al., 2015; Gary et al., 2010)

Participants’ clinical characteristics were incompletely described in most studies. Thirty-three studies reported full or partial data on New York Heart Association Classification (NYHA) with 45% of the studies sampling patients classified as NYHA Class II or III. In the studies reporting NYHA Class of the study samples, 11±24% (k = 30) of patients were Class I, 46±28% (k = 22) were Class II, 30±21% (k = 21) were Class III, and 2±4% (k = 30) were Class IV. Twenty-one studies characterized patients’ cardiac functioning using left ventricular ejection fraction (LVEF). The average LVEF was 33±8% (range = 22–46; k = 13); with 35±8% (range = 22–57; k = 20) and 34±11% (range = 21–72; k = 20) for the intervention and control groups, respectively. Comorbidities were common among patients, with 57±32% (k = 20) reporting hypertension, 31±10% (k = 15) reporting diabetes, and 32±9% (k = 10) reporting coronary heart disease. Nineteen studies provided full or partial information on patients’ pharmacotherapy: 79±27% beta-blockers (k = 18), 66±24% angiotensin-converting enzyme inhibitors (k = 18), 69±27% diuretics (k = 15), 53±25% antiplatelets (k = 6), and 63±10% statins (k = 6).

SMIs included tai chi (k = 9), cognitive-behavioral therapy approaches (k = 6), biofeedback (4), yoga (k = 3), acupuncture (k = 3), self-management education/counseling (k = 2), mindfulness-based stress reduction (k = 2), mindfulness-based cognitive therapy (k = 1), progressive muscle relaxation therapy (k = 1), diaphragmatic breathing (k = 1), meditation (k = 1), relaxation, (k = 1), and transcendental meditation (k = 1). Control groups consisted of usual care (k = 22), health-related education/advice (k = 10), placebo (k = 2), and no treatment (assessment only, k = 1).

Prevalence and Predictors of Women’s Participation in SMIs

The mean proportion of women who participated in the trials was 38.8% (95% CI=34.9–43.4; I2 = 82.4, 95% CI=81.0–83.6; k = 35; Figure 2). Participation rates did not differ based on age, race, NYHA class, LVEF, comorbidities (i.e., diabetes), geographical location, or type of SMI (Table 2). The proportion of women participants was higher in studies sampling HF patients with hypertension (p =.021) and lower in studies sampling HF patients prescribed with beta-blockers (p = .081). A multiple meta-regression test showed that hypertension and beta-blockers predicted women’s participation in RCTs of SMIs. The model was significant (F [2, 12] = 6.27, p = .014, I2 residual = 62.5%) and accounted for 61% (adjusted R2) of the between-study variance in the mean proportion of women who participated with limited variance remaining (τ2 = .064). Adjusting for multiple testing using the permutation test (20000 permutations) showed that the proportion of women participating in SMIs was associated with lower beta-blocker use (adjusted p-value = .007) but not hypertension (adjusted p-value = .079).

Figure 2.

Figure 2.

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Forest Plot of the Effect Sizes (and 95% Confidence Intervals) of Women’s Participation Rates in SMIs. Note. Proportions were converted to logits and used in all analyses.

Table 2.

Predictors of Women’s Participation in Randomized Controlled Trials of SMIs for Heart Failure*

k Coefficient SE p-value
Sample Characteristics
Age, mean (SD) 35 .009 .017 .585
Nonwhite, % 26 .559 .363 .137
NYHA Class, %
 I 30 −.043 .530 .935
 II 22 −.349 .504 .497
 III 21 .884 .595 .154
 IV 30 1.364 2.840 .635
LVEF, mean (SD) 22 .012 .018 .526
Medications, %
 Beta-blockers 18 −.905 .486 .081
 ACE-inhibitors 18 −.557 .640 .397
 Diuretics 15 −.078 .7567 .919
 Statins 6 −2.821 1.595 .152
 Antiplatelet 6 .059 .930 .952
Comorbidities, %
 Hypertension 20 .938 .372 .021
 Diabetes 15 −.149 1.419 .918
 CHD 10 −1.670 2.272 .483
Study Characteristics
United States
 Yes 15 −.116 .234 .622
 No (Ref) 20
Type of SMI
 Cognitive 7 .273 .301 .371
 Relaxation 16 .321 .259 .224
 Exercise-based (Ref) 12
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k, number of studies; SE, standard error; NYHA, New York Heart Association; LVEF, left ventricular ejection fraction; ACE, angiotensin converting enzyme; CHD, coronary heart disease; SMI, stress management intervention; Ref, reference category.

*

Unstandardized regression coefficients and the standard errors from each moderator test are presented. Continuous variables (age, non-white, NYHA class, LVEF, medications, and comorbidities) were mean centered; categorical variables were dummy coded (United States: 1 = yes, 0 = no; type of SMI: 1 = Cognitive, 2 = Relaxation, 3 = Exercise-Based). SMIs were categorized as cognitive (e.g., cognitive behavioral therapy, coping skills training), relaxation (e.g., mindfulness-based stress reduction, progressive muscle relaxation), or exercise-based (e.g., tai chi, yoga). Bold variables are significant at the p<.10 level.

The methodological quality of the studies was moderate to high (mean = 70±9%; range = 52–88%); study quality was not associated with women’s participation rate (β = −1.34, SE = 1.12, p = .232). Visual inspection of the funnel plot did not reveal any asymmetries that would indicate publication bias (see Supplemental Figure 1); statistical tests revealed discrepant results (Egger: bias coefficient = −2.23, SE = 0.76, P =.003; Begg: Δx-y = −131.00, z = 1.85, P = 0.065) but trim-and-fill methods indicated that no studies were omitted (estimated ES = 38.8%, 95% CI = 34.5–43.4%).

DISCUSSION

The current study shows that 38.8% of women participated in RCTs of SMIs which is substantially higher than the 19–30% of women who participated in meta-analyses of exercise-based CR for patients with HF (Lewinter et al., 2015; Taylor et al., 2019). Our findings suggest that offering stress management training may be an important consideration for women with HF. Psychosocial stress (e.g., depression, anxiety) has a profound impact on cardiovascular health,(Das & O’Keefe, 2008) and women with HF are more likely to experience higher levels of depressive symptoms, greater anxiety, and worse quality of life compared to men (Moser et al., 2010; Riedinger et al., 2001; Rutledge et al., 2006). While counseling to reduce stress is a recommended component for all patients enrolled in exercise-based CR, stress management training (e.g., cognitive-behavioral stress management, progressive muscle relaxation, meditation, yoga) is not routinely included as a component of traditional CR programs. CR may be an ideal setting to implement stress management training given the improved psychosocial and clinical benefits of enhanced CR + stress management training compared to standard exercise-based CR alone (Blumenthal et al., 2016).

Women’s participation in SMIs was higher in studies sampling women with hypertension and lower in studies enrolling participants using beta blockers. These findings are consistent with the large body of research showing significant sex-differences in the clinical presentation and treatment of HF. Comorbid cardiovascular-related conditions, except for hypertension, are less likely to be diagnosed in women with HF compared to men (Dewan, Rorth, Jhund, et al., 2019). Hypertension is more common among older adults (≥65 years of age) (Ahmad & Oparil, 2017), and women tend to develop HF at an older age, which may explain the sex differences in rates of hypertension among women and men with HF (Bozkurt & Khalaf, 2017). Consistent with these sex-disparities, our moderator analyses showed that samples with higher proportions of hypertensive patients significantly predicted higher rates of women’s participation. In our analyses, age was not a significant predictor of women’s participation, but this may have been a result of a restricted range of ages given that inclusion criteria reported in many of the individual studies restricted participation to patients within a specified age range. Similar to the differences in clinical presentation, women are undertreated relative to men with HF (Dewan, Rorth, Jhund, et al., 2019; Levinsson et al., 2018). Beta blocker therapy tends to be delayed or reduced in women with HF (Baumhakel et al., 2009) even though the efficacy of beta blockers is similar in both women and men.(Kotecha et al., 2016) Furthermore, most studies sampled HF patients with reduced ejection fraction (i.e., patients with LVEF ≤40%) for which beta-blockers are first-line pharmacological therapy. Understanding these sex differences in the clinical presentation and treatment of HF will be important in developing appropriate stress management approaches for women.

The proportion of women enrolled in RCTs of SMIs for HF in the current meta-analysis differ markedly from the proportion of women in the general population of HF patients (38.8% vs. 51.6%). Furthermore, none of the included studies targeted women or reported using strategies to increase women’s participation in the trials. Women are often underrepresented in HF clinical trials (Tahhan et al., 2018), and receive suboptimal HF treatment compared with men (Dewan, Rorth, Jhund, et al., 2019). Future RCTs should enroll a representative sample of the HF population to more completely understand the benefits of SMIs for all HF patients. This could be accomplished by not only specifying inclusion criteria that required equal numbers of women to be enrolled in the trial but also by developing targeted recruitment strategies, educating physicians and other healthcare workers who may refer patients to these trials about the value of stress management, and offering flexible hours, days, and delivery methods for SMIs.

Limitations

There are several limitations of the current meta-analysis that must be considered when interpreting our findings. First, by specifying that the included studies be published RCTs of SMIs for HF, our findings may not be representative of all SMIs for HF. It is well-known that that studies with significant findings are more likely to be published than studies with non-significant findings (i.e., publication bias) and it is also possible that the samples included in published studies may be systematically different from that of unpublished studies. Only published RCTs of SMIs for HF were included as a measure to increase the quality of the included studies and to obtain more reliable results. Second, our findings indicated significant between-study heterogeneity among the 35 included studies with an I2 of 82%. Meta-regression tests were conducted to identify possible sources of heterogeneity, but heterogeneity was only moderately reduced in the final model (I2 = 63%) suggesting at least some between-study heterogeneity could not be explained by the selected moderators. Finally, our moderator tests were limited by the number or completeness of studies reporting on predictors of interest (e.g., race/ethnicity, HF status, comorbidities, medications). More complete reporting of patient demographic and health characteristics is needed for all RCTs of SMIs for HF.

Conclusion

The current study shows that 38.8% of women participated in RCTs of SMIs which is higher than the 19–30% reported in recent meta-analyses of exercise-based CR for patients with HF (Lewinter et al., 2015; Taylor et al., 2019). Future research should explore the potential benefits of offering stress management training to women as part of comprehensive HF care to minimize sex-related gaps in engagement in care.

Supplementary Material

Supplementary Material

Acknowledgements:

We are grateful to the Systematic Review and Meta-Analysis Research Methods (SMART) Team, especially Julie DeCosta, Marissa L. Donahue, Melissa M. Feulner, and Brittany L. Balletto, for their assistance with data collection.

DECLARATIONS

Funding. This work was supported by the National Center for Complementary and Integrative Health of the National Institutes of Health under award number 5R01AT008815 to Lori A. J. Scott-Sheldon, PhD. Emily C. Gathright, PhD was supported by 1K23AG061214 from the National Institute on Aging. Elena Salmoirago-Blotcher is supported by grant 5R01HL149672 from the National Heart, Lung and Blood Institute. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.

Footnotes

Disclosure. The authors declare that they have no conflicts of interest.

Availability of data and material. This data used in this meta-analytic review were extracted from published randomized controlled trials of stress management interventions for heart failure patients. The database used to conduct the analyses is available upon request to the first author.

Code availability. The commands used to conduct the meta-analysis are available in Stata 16.0.

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