Corrigendum Supports Therapeutic Contribution of Acupoint Tapping to EFTs' Observed Effects: Response to Spielmans (2021).

ABSTRACT: We published a meta-analysis of studies that examined the various components of an evidence-based therapy called emotional freedom techniques (EFTs). EFT uses elements of conventional therapies such as exposure and cognitive processing but includes the unique ingredient of acupoint stimulation using fingertip tapping. Six studies were identified, and three of these met the quality control criteria of the American Psychological Association's Division 12 Task Force for Empirically Validated Therapies. Meta-analysis found that the acupoint component of EFT was not an inert ingredient or inactive placebo but made an active contribution to the therapeutic effects noted in a research literature that now numbers over 100 clinical trials of EFT. Subsequent to publication, errors in the original analysis were identified, primarily incorrect standard deviations. A new analysis was performed by an independent statistician and found slightly greater effects than the original investigation. The results were published as a corrigendum, which was subsequently challenged by Spielmans. Here we examine the critiques of the corrigendum and original article. We find that although they may be of academic interest, they are irrelevant to the central research question of whether the acupoint component of EFT is inert or active. We reaffirm that the evidence clearly validates the contribution made by acupoint tapping to EFT's observed clinical effects.

Mindfulness-based stress reduction for breast cancer survivors (MBSR(BC)): evaluating mediators of psychological and physical outcomes in a large randomized controlled trial.

MBSR(BC) is known to have a positive impact on psychological and physical symptoms among breast cancer survivors (BCS). The cognitive mechanisms of "how" MBSR(BC) works was addressed in a recent study that found that there was strong consistent evidence that reduced emotional reactivity is a mediator and moderate consistent evidence that mindfulness, rumination, and worry were mediators. The purpose of this study, as part of a larger R01 trial, was to test whether positive effects achieved from the MBSR(BC) program were mediated through changes in increased mindfulness, decreased fear of breast cancer recurrence, and perceived stress. Female BCS > 21 years diagnosed with Stage 0-III breast cancer were randomly assigned to a 6-week MBSR(BC) or a Usual Care (UC)regimen. Potential mediators of 6- and 12-week outcomes were identified by analysis of covariance (ANCOVA), followed by formal mediational analyses of main effects of MBSR(BC) on 6- and 12-week outcomes, including percentage of total effects explained. Among 322 BCS (167 MBSR(BC) and 155 UC), fear of recurrence and perceived stress, but not mindfulness, mediated reductions in anxiety and fatigue at weeks 6 and 12, partially supporting our hypothesis of cognitive mechanisms of MBSR(BC). TRIAL REGISTRATION: Registration Number: NCT01177124 http://www.ClinicalTrials.gov.

Corrigendum to: Is Tapping on Acupuncture Points an Active Ingredient in Emotional Freedom Techniques: A Systematic Review and Meta-Analysis of Comparative Studies.

We published a meta-analysis of component trials of emotional freedom techniques (EFT) in this journal. EFT is an evidence-based method, validated in over 100 clinical trials, that uses fingertip tapping on acupressure points in conjunction with techniques from exposure and cognitive therapy. The meta-analysis examined six studies in which an active control, such as diaphragmatic breathing or sham acupoints, was used in place of tapping on actual acupoints. The purpose of the meta-analysis was to determine whether tapping was an inert or an active ingredient in EFTs observed treatment effects. Subsequent to publication, errors in the statistical analysis were identified, primarily incorrect standard deviation values, and our methodological approach was questioned by others. We therefore had the meta-analysis rerun by an independent senior statistician who compared pre- to follow-up results to determine the sustained effects of treatment. The cumulative fixed effects Hedge's g-value was found to be 0.73 (95% confidence interval = 0.42-1.04, p < 0.0001). The corresponding random effects Hedge's g-value is 0.74 (95% confidence interval = 0.34-1.13, p < 0.0001). We also reviewed and clarified our methodology. In conclusion, despite computational errors in our original publication, the present revised analysis supports the original conclusion that the acupressure component of the EFT protocol is an active ingredient that contributes to the method's favorable health effects.

Feasibility and acceptability of a self-managed exercise to rhythmic music intervention for ICU survivors.

BACKGROUND: Post-ICU rehabilitation is a challenging clinical issue for patients discharged from an Intensive Care Unit ("ICU survivors"). Our exercise to rhythmic music intervention was designed to allow ICU survivors to self-manage their exercise by following a personalized, recorded exercise playlist. AIM: Our study reports the feasibility and acceptability of an innovative music intervention among ICU survivors enrolled in a randomized controlled pilot study. METHODS: ICU survivors, admitted in ICU for at least 5 days and cognitively intact, were randomly assigned to an exercise to rhythmic music group (n = 10) or an active control group (n = 10). Participants in the music group were taught to self-manage exercise by listening to a recorded playlist of instructions and music-facilitated movements tailored to their musical preference and exercise ability. Participants in the control group were provided a brochure with exercise instructions. After 5 days or at hospital discharge, participants completed an 8-item acceptability questionnaire and were interviewed. Content analysis was conducted. RESULTS: 18 Participants were included for final analysis. Participants were 61.8 ± 14.7 years old, predominantly male (66.7%), and Caucasian (55.6%). Results demonstrated feasibility, as the study team was able to meet the enrollment goal of 5-6 participants per month. Three themes related to general, physical, and psychosocial benefits were identified. Based on positive feedback, the exercise to rhythmic music intervention was deemed acceptable. CONCLUSION: The exercise to rhythmic music intervention was feasible and acceptable, suggesting that clinical trials with larger sample sizes should investigate the effects of the intervention on outcomes among ICU survivors.

Adverse Childhood Experiences (ACEs) and Headaches Among Children: A Cross-Sectional Analysis.

OBJECTIVES: This cross-sectional study examined the association between adverse childhood experiences (ACEs) and history of frequent headaches (including migraine) among children 3-17 years old using data from the 2016 and 2017 U.S. National Survey of Children's Health (NSCH). BACKGROUND: ACEs include abuse (physical, emotional, or sexual), parental divorce, death, mental illness, or addiction, and are linked to higher morbidity and mortality in adulthood. A relationship between ACEs and headaches exists among adults, but studies examining the relationship among children are lacking. To our knowledge, no studies have examined the link among children using NSCH data. METHODS: The NSCH is a nationally representative survey of U.S. children's physical and emotional well-being aimed at understanding their health needs. Parental-reported information was collected on child history of headaches and 9 ACEs for the selected child. The survey collected information on 71,881 children in 2016 and 2017 out of which 61,565 were eligible for the study (age ≥3 years and not missing data on history headaches). Children with missing values for headache, ACEs, or covariates (n = 58,958) were excluded from the final analysis. We used multivariable logistic regression with survey weighting and adjusted for demographics and comorbidities (anxiety, depression, epilepsy, and brain injury) to examine the association between ACEs and headaches overall and stratified by gender. We further assessed the independent relationship between each ACE and headaches. RESULTS: In the current study, out of 61,656 children, 26,884 (48.6%) experienced at least 1 ACE and 3426 (6.5%) experienced 4+ ACEs. Overall, compared with children with no ACEs, the adjusted odds of headache were 1.34 times higher among children with 1 reported ACE (95% CI: 1.07, 1.68), 2.15 times higher among children with 2 ACEs (95% CI: 1.66, 2.80), 1.89 times higher among children with 3 ACEs (95% CI: 1.40, 2.53), and 3.40 times higher among children with 4+ ACEs (95% CI: 2.61, 4.43). Females with 3 and 4+ ACEs were somewhat more likely to report headaches compared to males with the same number of ACEs. Individually, no ACE was independently associated with history of headaches except for difficulty due to family's income (aOR = 2.46, 95% CI: 1.98, 3.06). CONCLUSION: Experiencing one or more ACEs vs none was associated with higher risk of headaches in children, and difficulty due to family's income was the only ACE independently associated with headaches. Our findings support results of other studies on ACEs and headache in young adults and suggest that adverse ACE-related health outcomes begin earlier than previously recognized. Additionally, struggling due to low income may represent a constellation of chronic stressors that independently contribute to poor health outcomes in childhood as compared to other individual ACEs. Future research should examine the importance of specific ACE clusters and stressors during childhood.

Accelerated Resolution Therapy: Randomized Controlled Trial of a Complicated Grief Intervention.

BACKGROUND AND OBJECTIVES: Complicated grief (CG) is severe, prolonged (>12 months) grieving. Complicated grief disproportionately affects older adults and is associated with negative physical/psychological effects. Although treatment options exist, those which do are time-intensive. We report on a randomized clinical trial (RCT) which examined whether accelerated resolution therapy (ART), a novel mind-body therapy, is effective in treating CG, post-traumatic stress disorder (PTSD), and depression among hospice informal caregivers. RESEARCH DESIGN AND METHODS: Prospective 2 group, wait-listed RCT. All participants were scheduled to receive 4 ART sessions. INCLUSION: ≥60 years, inventory of CG >25, and PTSD checklist for Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition >33 or Psychiatric Diagnostic Screen Questionnaire PTSD subscale >5. EXCLUSION: Major psychiatric disorder, other current psychotherapy treatment. Depression was measured by the Center for Epidemiologic Studies Depression. RESULTS: Mean (standard deviation [SD]) age of 54 participants was 68.7 (7.2) years, 85% female, and 93% white. Participants assigned to ART reported significantly greater mean (SD) CG reduction (-22.8 [10.3]) versus Wait-list participants (-4.3 [6.0]). Within-participant effect sizes (ESs) for change from baseline to 8-week post-treatment were CG (ES = 1.96 (95% confidence interval [CI]: 1.45-2.47; P < .0001), PTSD (ES = 2.40 [95% CI: 1.79-3.00]; P < .0001), depression (ES = 1.63 [95% CI: 1.18-2.08; P < .0001). Treatment effects did not substantially differ by baseline symptom levels. DISCUSSION AND IMPLICATIONS: Results suggests that ART presents an effective and less time-intensive intervention for CG in older adults. However, it should undergo further effectiveness testing in a larger, more diverse clinical trial with a focus on determining physiological or behavioral mechanisms of action.

A Mobile and Web-Based Self-Directed Complementary and Integrative Health Program for Veterans and Their Partners (Mission Reconnect): Protocol for a Mixed-Methods Randomized Controlled Trial.

BACKGROUND: Complementary and integrative health (CIH) is a viable solution to PTSD and chronic pain. Many veterans believe CIH can be performed only by licensed professionals in a health care setting. Health information technology can bring effective CIH to veterans and their partners. OBJECTIVE: This paper describes the rationale, design, and methods of the Mission Reconnect protocol to deliver mobile and Web-based complementary and integrative health programs to veterans and their partners (eg, spouse, significant other, caregiver, or family member). METHODS: This three-site, 4-year mixed-methods randomized controlled trial uses a wait-list control to determine the effects of mobile and Web-based CIH programs for veterans and their partners, or dyads. The study will use two arms (ie, treatment intervention arm and wait-list control arm) in a clinical sample of veterans with comorbid pain and posttraumatic stress disorder, and their partners. The study will evaluate the effectiveness and perceived value of the Mission Reconnect program in relation to physical and psychological symptoms, global health, and social outcomes. RESULTS: Funding for the study began in November 2018, and we are currently in the process of recruitment screening and data randomization for the study. Primary data collection will begin in May 2019 and continue through May 2021. Projected participants per site will be 76 partners/dyads, for a total of 456 study participants. Anticipated study results will be published in November 2022. CONCLUSIONS: This work highlights innovative delivery of CIH to veterans and their partners for treatment of posttraumatic stress disorder and chronic pain. TRIAL REGISTRATION: ClinicalTrials.gov NCT03593772; https://clinicaltrials.gov/ct2/show/NCT03593772 (Archived by WebCite at http://www.webcitation.org/77Q2giwtw). INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/13666.

Brazilian Jiu Jitsu Training for US Service Members and Veterans with Symptoms of PTSD.

INTRODUCTION: The United States has been actively involved in major armed conflicts over the last 15 years. As a result, a significant proportion of active duty service personnel and returning veterans have endured combat, putting them at risk for developing post-traumatic stress disorder (PTSD), a disabling disorder that may occur after exposure to a traumatic event. Current therapies often require long-term, time-intensive and costly commitment from the patient and have variable degrees of success. There remains an ongoing need for better therapies, including complementary medicine approaches that can effectively reduce PTSD symptoms. While anecdotal evidence suggests that routine practice of Brazilian Jiu Jitsu (BJJ) can reduce symptoms of PTSD, there have been no formal studies to address this. MATERIALS AND METHODS: This study was approved by the University of South Florida Institutional Review Board (#PRO00019430). Male US active duty service members and veterans from the Tampa area participated in a 5-month (40 sessions) BJJ training program. Before beginning and again midway through and upon completion of training the participants completed several validated self-report measures that addressed symptoms of PTSD and other co-morbid conditions. Effect size and 95% confidence intervals were determined using a within-person single-group pretest-posttest design. RESULTS: Study participants demonstrated clinically meaningful improvements in their PTSD symptoms as well as decreased symptoms of major depressive disorder, generalized anxiety and decreased alcohol use; effect sizes varied from 0.80 to 1.85. CONCLUSIONS: The results from this first-of-kind pilot study suggest that including BJJ as a complementary treatment to standard therapy for PTSD may be of value. It will be necessary to validate these promising results with a larger subject cohort and a more rigorous experimental design before routinely recommending this complementary therapy.

Translational genomic research: the role of genetic polymorphisms in MBSR program among breast cancer survivors (MBSR[BC]).

Genetic variations of breast cancer survivors (BCS) may contribute to level of residual symptoms, such as depression, stress, fatigue, and cognitive impairment. The objective of this study was to investigate whether particular single-nucleotide polymorphisms (SNPs) moderated symptom improvement resulting from the Mindfulness-Based Stress Reduction for Breast Cancer (MBSR[BC]) program. An overarching goal of personalized medicine is to identify individuals as risk for disease and tailor interventions based on genetic profiles of patients with diseases including cancer. BCS were recruited from Moffitt Cancer Center and University of South Florida's Breast Health Program and were randomized to either the 6-week MBSR(BC) program (n = 92) or Usual Care (n = 93). Measures of symptoms, demographic, and clinical history data were attained at baseline, 6 weeks, and 12 weeks. A total of 10 SNPs from eight genes known to be related to these symptoms were studied using genomic DNA extracted from blood. Our results were examined for effect sizes, consistency, and statistical significance (p < .05). Three SNPs (rs4680 in COMT, rs6314 in HTR2A, and rs429358 in APOE) emerged as having the strongest (though relatively weak) and most consistent effects in moderating the impact of the MBSR program on symptom outcomes. Although effects were generally weak, with only one effect withstanding multiple comparisons correction for statistical significance, this translational behavioral research may help start the identification of genetic profiles that moderate the impact of MBSR(BC). The ultimate goal of this study is the development of personalized treatment programs tailored to the genetic profile of each patient.

Clinical, Empirical, and Theoretical Rationale for Selection of Accelerated Resolution Therapy for Treatment of Post-traumatic Stress Disorder in VA and DoD Facilities.

INTRODUCTION: Post-traumatic stress disorder (PTSD) is a chronic, disabling psychiatric disorder prevalent among U.S. service members and veterans. First-line treatments for PTSD endorsed in the 2017 Veterans Affairs (VA)/Department of Defense (DoD) Clinical Practice Guideline for PTSD emphasize individual, manualized trauma-focused psychotherapies that have a primary component of exposure and/or cognitive restructuring. These include prolonged exposure (PE) therapy, cognitive processing therapy (CPT), eye movement desensitization and reprocessing (EMDR), and others. Accelerated resolution therapy (ART) is an emerging trauma-focused therapy not specifically referenced in the guideline, but one that is consistent with the recommendations and is derived directly from EMDR. One randomized clinical trial and multiple observational studies have suggested that ART can be delivered in an average of just four treatment sessions. This commentary reviews the clinical, empirical, and theoretical rationale for use of ART as a potential first-line PTSD treatment modality in VA and DoD facilities. MATERIALS AND METHODS: The clinical protocol of ART is summarized into discrete procedural steps. The theoretical rationale as to how ART may help clients process traumatic memories and resolve symptoms of PTSD is also discussed, including how repeated sets of smooth pursuit horizontal eye movements may facilitate a relaxation response and assist with processing emotionally intrusive memories. Herein, we review primary treatment results from four published studies of ART, including mean symptom score reductions on the 17-item PCL (PTSD checklist) after treatment with ART, along with effect sizes and percentage of treatment responders. Finally, the ART protocol is compared directly against specific recommended elements of trauma-focused therapy described in the VA/DoD Clinical Practice Guideline. RESULTS: The four published studies of ART reviewed (n = 291) included adult civilians and service members/veterans; the mean age was 42.3 ± 12.3 yr and 28.9% were female. Among 237 treatment completers (81.4% of the combined cohort), the mean number of ART sessions received was 3.9 ± 1.1. Across the four studies, mean treatment-related reductions in PCL scores ranged from 15.6 ± 13.2 to 25.6 ± 11.3, with a pooled mean reduction on the PCL of 20.6 ± 15.0. Effect sizes were large and ranged from 1.18 to 2.26 (p< 0.0005) across studies, with a pooled effect size of 1.38 (95% confidence interval: 1.20-1.56, p < 0.0001). Using the clinical cutpoint of >10-point reduction on the PCL instrument, clinically significant change (response) ranged from 63.8% to 100.0% across the four studies, with a pooled treatment response rate of 74.7%. Results were nominally attenuated when conservatively assuming no treatment response for non-completers. CONCLUSION: The ART protocol contains the core therapeutic elements and aligns closely with the current VA/DoD Clinical Practice Guideline. It has a plausible theoretical rationale and an evolving empirical research base that includes four studies with peer-reviewed publications, one of which was a randomized controlled trial. These features, along with the brevity of the treatment protocol, no requirement for narration, and high provider satisfaction rates, provide a rationale for the potential use of ART as a first-line PTSD treatment modality for active duty and veteran military personnel.

Feasibility of the mobile mindfulness-based stress reduction for breast cancer (mMBSR(BC)) program for symptom improvement among breast cancer survivors.

OBJECTIVE: The purpose of this pilot study was to test the feasibility of delivering the mobile mindfulness-based stress reduction for breast cancer (mMBSR(BC)) program using an iPad and to evaluate its impact on symptom improvement. METHODS: A single group, pre-posttest design was implemented among female stages 0-III breast cancer survivors (BCS) who completed treatment. Data were collected at baseline and week 6 on measures of psychological and physical symptoms and quality of life. The mMBSR(BC) program is a standardized, stress-reducing intervention that combines sitting and walking meditation, body scan, and yoga and is designed to deliver weekly 2-hour sessions for 6 weeks using an iPad. RESULTS: The mean age of the 15 enrolled BCS was 57 years; one participant was non-Hispanic black, and 14 were non-Hispanic white. Of the 13 who completed the study, there were significant improvements from baseline to 6 weeks post-mMBSR(BC) in psychological and physical symptoms of depression, state anxiety, stress, fear of recurrence, sleep quality, fatigue, and quality of life (P's < .05). Effect sizes for improvements of multiple symptoms ranged from medium to large. CONCLUSIONS: These results provide preliminary support that the mMBSR(BC) program may be feasible and acceptable, showing a clinical impact on decreasing psychological and physical symptoms. This mobile-based program offers a delivery of a standardized MBSR(BC) intervention to BCS that is convenient for their own schedule while decreasing symptom burden in the survivorship phase after treatment for breast cancer.

A Randomized Controlled Trial of the Effects of Mindfulness-Based Stress Reduction (MBSR[BC]) on Levels of Inflammatory Biomarkers Among Recovering Breast Cancer Survivors.

PURPOSE: The purpose of this substudy of a large randomized controlled trial was to evaluate the efficacy of the Mindfulness-Based Stress Reduction (Breast Cancer) (MBSR[BC]) program compared to usual care (UC) in normalizing blood levels of pro-inflammatory cytokines among breast cancer survivors (BCS). METHOD: A total of 322 BCS were randomized to either a 6-week MBSR(BC) program or a UC. At baseline and 6 and 12 weeks, 10 ml of venous blood and demographic and clinical data were collected and/or updated. Plasma cytokines (interleukin [IL]-1ß, IL-6, IL-10, tumor necrosis factor [TNF] α, transforming growth factor [TGF] ß1, soluble tumor necrosis factor receptor [sTNFR] 1) were assayed. Linear mixed models were used to assess cytokine levels across three time points (baseline and 6 and 12 weeks) by group (MBSR[BC] vs. UC). RESULTS: Of the six measured cytokines, three were nondetectable at rates greater than 50% (IL-10, IL-1ß, TGF-ß1) and, because of overall low prevalence, were not analyzed further. For the remaining cytokines (TNFα, IL-6, sTNFR1), results showed that TNFα and IL-6 increased during the follow-up period (between 6 and 12 weeks) rather than during the MBSR(BC) training period (between baseline and 6 weeks), while sTNFR1 levels did not change significantly across the 12-week period. CONCLUSIONS: Study results suggest that MBSR(BC) affects cytokine levels in BCS, mainly with increases in TNFα and IL-6. The data further suggest that B-cell modulation may be a part of immune recovery during breast cancer management and that increases in TNFα and IL-6 may be markers for MBSR(BC)-related recovery.

Mindfulness-Based Stress Reduction in Post-treatment Breast Cancer Patients: Immediate and Sustained Effects Across Multiple Symptom Clusters.

CONTEXT: Breast cancer survivors (BCS) face adverse physical and psychological symptoms, often co-occurring. Biologic and psychological factors may link symptoms within clusters, distinguishable by prevalence and/or severity. Few studies have examined the effects of behavioral interventions or treatment of symptom clusters. OBJECTIVES: The aim of this study was to identify symptom clusters among post-treatment BCS and determine symptom cluster improvement following the Mindfulness-Based Stress Reduction for Breast Cancer (MBSR(BC)) program. METHODS: Three hundred twenty-two Stage 0-III post-treatment BCS were randomly assigned to either a six-week MBSR(BC) program or usual care. Psychological (depression, anxiety, stress, and fear of recurrence), physical (fatigue, pain, sleep, and drowsiness), and cognitive symptoms and quality of life were assessed at baseline, six, and 12 weeks, along with demographic and clinical history data at baseline. A three-step analytic process included the error-accounting models of factor analysis and structural equation modeling. RESULTS: Four symptom clusters emerged at baseline: pain, psychological, fatigue, and cognitive. From baseline to six weeks, the model demonstrated evidence of MBSR(BC) effectiveness in both the psychological (anxiety, depression, perceived stress and QOL, emotional well-being) (P = 0.007) and fatigue (fatigue, sleep, and drowsiness) (P < 0.001) clusters. Results between six and 12 weeks showed sustained effects, but further improvement was not observed. CONCLUSION: Our results provide clinical effectiveness evidence that MBSR(BC) works to improve symptom clusters, particularly for psychological and fatigue symptom clusters, with the greatest improvement occurring during the six-week program with sustained effects for several weeks after MBSR(BC) training. TRIAL REGISTRATION: Name and URL of Registry: ClinicalTrials.gov. Registration number: NCT01177124.

Evaluation of brief treatment of symptoms of psychological trauma among veterans residing in a homeless shelter by use of Accelerated Resolution Therapy.

BACKGROUND: Posttraumatic stress disorder (PTSD) is prevalent in both homeless and nonhomeless veterans. PURPOSE: To examine unique characteristics of being homeless that may influence PTSD treatment completion and clinical success. METHODS: Twenty-three veterans who were homeless and residing in a homeless shelter, along with 94 veterans from the community, were enrolled to receive one to five sessions of Accelerated Resolution Therapy (ART), an emerging trauma-focused therapy for symptoms of PTSD. Rates of treatment completion with ART and acute and 6-month change in symptoms of PTSD were compared in an observational (nonrandomized) manner by housing status. FINDINGS: Compared to veterans recruited from the community, veterans residing in the homeless shelter were older and presented with more extensive psychopathology yet had less combat exposure while being more likely to have experienced sexual assault. Rates of treatment completion were 52.2% (12 of 23) among homeless veterans compared to 81.9% (77 of 94) among veterans from the community (p = .005). Among treatment completers, both groups received an average of four sessions of ART. Reduction of symptoms of PTSD was substantial and nonsignificantly greater among homeless veterans vs. those treated from the community (p = .14), as were comorbidity reductions in depression, anxiety, sleep quality, pain, and improved quality of life. Results at 6-month posttreatment follow-up were similar. CONCLUSIONS: Although limited by small sample size and a nonrandomized design, ART appears to be an effective, brief treatment for symptoms of PTSD among veterans residing in a homeless shelter. However, development of effective strategies to maximize treatment completion among homeless veterans is needed.

Examination of Broad Symptom Improvement Resulting From Mindfulness-Based Stress Reduction in Breast Cancer Survivors: A Randomized Controlled Trial.

PURPOSE: The purpose of this randomized trial was to evaluate the efficacy of the Mindfulness-Based Stress Reduction for Breast Cancer (MBSR[BC]) program in improving psychological and physical symptoms and quality of life among breast cancer survivors (BCSs) who completed treatment. Outcomes were assessed immediately after 6 weeks of MBSR(BC) training and 6 weeks later to test efficacy over an extended timeframe. PATIENTS AND METHODS: A total of 322 BCSs were randomly assigned to either a 6-week MBSR(BC) program (n = 155) or a usual care group (n = 167). Psychological (depression, anxiety, stress, and fear of recurrence) and physical symptoms (fatigue and pain) and quality of life (as related to health) were assessed at baseline and at 6 and 12 weeks. Linear mixed models were used to assess MBSR(BC) effects over time, and participant characteristics at baseline were also tested as moderators of MBSR(BC) effects. RESULTS: Results demonstrated extended improvement for the MBSR(BC) group compared with usual care in both psychological symptoms of anxiety, fear of recurrence overall, and fear of recurrence problems and physical symptoms of fatigue severity and fatigue interference (P < .01). Overall effect sizes were largest for fear of recurrence problems (d = 0.35) and fatigue severity (d = 0.27). Moderation effects showed BCSs with the highest levels of stress at baseline experienced the greatest benefit from MBSR(BC). CONCLUSION: The MBSR(BC) program significantly improved a broad range of symptoms among BCSs up to 6 weeks after MBSR(BC) training, with generally small to moderate overall effect sizes.

A Cost-Effective Mindfulness Stress Reduction Program: A Randomized Control Trial for Breast Cancer Survivors.

Many breast cancer survivors continue to experience residual symptoms including anxiety, cognitive impairment, depression, fatigue, and pain. In this study, the cost-effectiveness of a Mindfulness-Based Stress Reduction intervention for breast cancer survivors was examined. The cost of the program was assessed from the societal perspective, accounting for both direct medical and patient opportunity costs. The cost per quality-adjusted life year was relatively low compared to the cost-utility findings of other published breast cancer interventions. The program appears to provide for significantly improved health-related quality of life at a comparativelv low cost.

Moderating Effects of Genetic Polymorphisms on Improvements in Cognitive Impairment in Breast Cancer Survivors Participating in a 6-Week Mindfulness-Based Stress Reduction Program.

Breast cancer (BC) survivors often report cognitive impairment, which may be influenced by single-nucleotide polymorphisms (SNPs). The purpose of this study was to test whether particular SNPs were associated with changes in cognitive function in BC survivors and whether these polymorphisms moderated cognitive improvement resulting from the Mindfulness-Based Stress Reduction for Breast Cancer (MBSR[BC]) program. BC survivors recruited from Moffitt Cancer Center and the University of South Florida's Breast Health Program, who had completed adjuvant radiation and/or chemotherapy treatment, were randomized to either the 6-week MBSR(BC) program (n = 37) or usual care (UC; n = 35) group. Measures of cognitive function and demographic and clinical history data were attained at baseline and at 6 and 12 weeks. A total of 10 SNPs from eight genes known to be related to cognitive function were analyzed using blood samples. Results showed that SNPs in four genes (ankyrin repeat and kinase domain containing 1 [ANKK1], apolipoprotein E [APOE], methylenetetrahydrofolate reductase [MTHFR], and solute carrier family 6 member 4 [SLC6A4]) were associated with cognitive impairment. Further, rs1800497 in ANKK1 was significantly associated with improvements in cognitive impairment in response to MBSR(BC). These results may help to identify individuals who would be better served by MBSR(BC) or other interventions.

The effects of mindfulness-based stress reduction on objective and subjective sleep parameters in women with breast cancer: a randomized controlled trial.

OBJECTIVE: The purpose of this study was to investigate the effects of mindfulness-based stress reduction for breast cancer survivors (MBSR(BC)) on multiple measures of objective and subjective sleep parameters among breast cancer survivors (BCS). METHODS: Data were collected using a two-armed randomized controlled design among BCS enrolled in either a 6-week MBSR(BC) program or a usual care (UC) group with a 12-week follow-up. The present analysis is a subset of the larger parent trial (ClinicalTrials.gov Identifier: NCT01177124). Seventy-nine BCS participants (mean age 57 years), stages 0-III, were randomly assigned to either the formal (in-class) 6-week MBSR(BC) program or UC. Subjective sleep parameters (SSP) (i.e., sleep diaries and the Pittsburgh Sleep Quality Index (PSQI)) and objective sleep parameters (OSP) (i.e., actigraphy) were measured at baseline, 6 weeks, and 12 weeks after completing the MBSR(BC) or UC program. RESULTS: Results showed indications of a positive effect of MBSR(BC) on OSP at 12 weeks on sleep efficiency (78.2% MBSR(BC) group versus 74.6% UC group, p = 0.04), percent of sleep time (81.0% MBSR(BC) group versus 77.4% UC group, p = 0.02), and less number waking bouts (93.5 in MBSR(BC) group versus 118.6 in the UC group, p < 0.01). Small nonsignificant improvements were found in SSP in the MBSR(BC) group from baseline to 6 weeks (PSQI total score, p = 0.09). No significant relationship was observed between minutes of MBSR(BC) practice and SSP or OSP. CONCLUSIONS: These data suggest that MBSR(BC) may be an efficacious treatment to improve objective and subjective sleep parameters in BCS.

Influence of mindfulness-based stress reduction (MBSR) on telomerase activity in women with breast cancer (BC).

Mindfulness-based stress reduction (MBSR) reduces symptoms of depression, anxiety, and fear of recurrence among breast cancer (BC) survivors. However, the effects of MBSR (BC) on telomere length (TL) and telomerase activity (TA), known markers of cellular aging, psychological stress, and disease risk, are not known. This randomized, wait-listed, controlled study, nested within a larger trial, investigated the effects of MBSR (BC) on TL and TA. BC patients (142) with Stages 0-III cancer who had completed adjuvant treatment with radiation and/or chemotherapy at least 2 weeks prior to enrollment and within 2 years of completion of treatment with lumpectomy and/or mastectomy were randomly assigned to either a 6-week MBSR for BC program or a usual care. Assessments of TA and TL were obtained along with psychological measurements at baseline, 6 weeks, and 12 weeks after completing the MBSR(BC) program. The mean age of 142 participants was 55.3 years; 72% were non-Hispanic White; 78% had Stage I or II cancer; and 36% received both chemotherapy and radiation. In analyses adjusted for baseline TA and psychological status, TA increased steadily over 12 weeks in the MBSR(BC) group (approximately 17%) compared to essentially no increase in the control group (approximately 3%, p < .01). In contrast, no between-group difference was observed for TL (p = .92). These results provide preliminary evidence that MBSR(BC) increases TA in peripheral blood mononuclear cells from BC patients and have implications for understanding how MBSR(BC) may extend cell longevity at the cellular level.

Baseline immune biomarkers as predictors of MBSR(BC) treatment success in off-treatment breast cancer patients.

Researchers focused on patient-centered medicine are increasingly trying to identify baseline factors that predict treatment success. Because the quantity and function of lymphocyte subsets change during stress, we hypothesized that these subsets would serve as stress markers and therefore predict which breast cancer patients would benefit most from mindfulness-based stress reduction (MBSR)-facilitated stress relief. The purpose of this study was to assess whether baseline biomarker levels predicted symptom improvement following an MBSR intervention for breast cancer survivors (MBSR[BC]). This randomized controlled trial involved 41 patients assigned to either an MBSR(BC) intervention group or a no-treatment control group. Biomarkers were assessed at baseline, and symptom change was assessed 6 weeks later. Biomarkers included common lymphocyte subsets in the peripheral blood as well as the ability of T cells to become activated and secrete cytokines in response to stimulation with mitogens. Spearman correlations were used to identify univariate relationships between baseline biomarkers and 6-week improvement of symptoms. Next, backward elimination regression models were used to identify the strongest predictors from the univariate analyses. Multiple baseline biomarkers were significantly positively related to 6-week symptom improvement. The regression models identified B-lymphocytes and interferon-γ as the strongest predictors of gastrointestinal improvement (p < .01), +CD4+CD8 as the strongest predictor of cognitive/psychological (CP) improvement (p = .02), and lymphocytes and interleukin (IL)-4 as the strongest predictors of fatigue improvement (p < .01). These results provide preliminary evidence of the potential to use baseline biomarkers as predictors to identify the patients likely to benefit from this intervention.