Stress management in the workplace for employees with hypertension: a randomized controlled trial.

While behavioral interventions can improve blood pressure (BP) in individuals with hypertension, getting such services to people who could benefit remains difficult. Workplace programs have potential as dissemination vehicles. The objective is to evaluate the effectiveness of a standardized stress management program delivered in groups at the workplace for reducing BP compared with enhanced usual care. This randomized controlled trial studied 92 urban medical center employees with hypertension randomized into two groups. The intervention was a 10-week group workshop on cognitive-behavioral coping skills. Enhanced usual care included self-help materials for BP reduction and physician referral. Intervention group participants' systolic BP (SBP) decreased 7.5 mm Hg over controls between baseline and follow-up, from 149.1 (95% CI: 146.0-152.1) to 140.0 (95% CI: 134.7-145.2), p < .001. The differential change between intervention and enhanced usual care groups (Group × Time interaction) was 7.5 mm Hg (t = -2.05; p = .04). Diastolic BP reductions were not significantly different. Scores on measures of emotional exhaustion and depressive rumination showed significant improvements and correlated with reductions in SBP. There was no significant change in the usual care group. A standardized worksite group intervention produced clinically meaningful reductions in SBP in participants with hypertension.

A 2-Year Holistic Health and Stress Intervention: Results of an RCT in Clergy.

INTRODUCTION: This study sought to determine the effect of a 2-year, multicomponent health intervention (Spirited Life) targeting metabolic syndrome and stress simultaneously. DESIGN: An RCT using a three-cohort multiple baseline design was conducted in 2010-2014. SETTING/PARTICIPANTS: Participants were United Methodist clergy in North Carolina, U.S., in 2010, invited based on occupational status. Of invited 1,745 clergy, 1,114 consented, provided baseline data, and were randomly assigned to immediate intervention (n=395), 1-year waitlist (n=283), or 2-year waitlist (n=436) cohorts for a 48-month trial duration. INTERVENTION: The 2-year intervention consisted of personal goal setting and encouragement to engage in monthly health coaching, an online weight loss intervention, a small grant, and three workshops delivering stress management and theological content supporting healthy behaviors. Participants were not blinded to intervention. MAIN OUTCOME MEASURES: Trial outcomes were metabolic syndrome (primary) and self-reported stress and depressive symptoms (secondary). Intervention effects were estimated in 2016 in an intention-to-treat framework using generalized estimating equations with adjustment for baseline level of the outcome and follow-up time points. Log-link Poisson generalized estimating equations with robust SEs was used to estimate prevalence ratios (PRs) for binary outcomes; mean differences were used for continuous/score outcomes. RESULTS: Baseline prevalence of metabolic syndrome was 50.9% and depression was 11.4%. The 12-month intervention effect showed a benefit for metabolic syndrome (PR=0.86, 95% CI=0.79, 0.94, p<0.001). This benefit was sustained at 24 months of intervention (PR=0.88; 95% CI=0.78, 1.00, p=0.04). There was no significant effect on depression or stress scores. CONCLUSIONS: The Spirited Life intervention improved metabolic syndrome prevalence in a population of U.S. Christian clergy and sustained improvements during 24 months of intervention. These findings offer support for long-duration behavior change interventions and population-level interventions that allow participants to set their own health goals. TRIAL REGISTRATION: This study is registered at www.clinicaltrials.gov NCT01564719.

Use of a randomized multiple baseline design: rationale and design of the spirited life holistic health intervention study.

Clergy suffer from high rates of obesity, chronic disease, and depression, and simultaneously underestimate the toll these take on their daily functioning. Health interventions are needed for clergy and may be tailored to their occupational context and theological beliefs. Few studies have sought to improve clergy health. No prior studies have utilized a randomized design. Spirited Life is a randomized, multiple baseline study that offered enrollment to nearly all United Methodist Church clergy in North Carolina in fall 2010. A total of 1114 clergy (response rate = 64%) enrolled. Using a multiple baseline design, we randomized participants to three cohorts. Each cohort began the health intervention in one of three consecutive years. The third cohort served as a randomized waitlist control cohort, allowing comparisons between the first and third cohorts. The two-year Spirited Life intervention consists of: 1) a theological underpinning for health stewardship based on incarnation, grace, and response and delivered during workshops; 2) the stress management program Williams LifeSkills; 3) Naturally Slim, an online weight loss program; 4) phone contact with a Wellness Advocate; and 5) $500 small grants for health goals. Metabolic syndrome is the primary endpoint. Stress and depressive severity are secondary endpoints. We measured each construct before, twice during, and at the end of the two-year intervention. Study outcomes, to be published after follow-up data are gathered, will provide evidence of the effectiveness of the combined intervention components of Spirited Life. If successful, the intervention may be considered for use with other clergy and faith populations.

IMPACT OF WILLIAMS LIFESKILLS® TRAINING ON ANGER, ANXIETY AND AMBULATORY BLOOD PRESSURE IN ADOLESCENTS.

BACKGROUND: The Williams LifeSkills® (WLS) anger and stress management workshop provides training in strategies to cope with stressful situations and build supportive relationships. PURPOSE: The purpose of this study was to determine the impact of school-based Williams LifeSkills training on anger, anxiety and blood pressure in adolescents. METHODS: 159 adolescents (mean age±SD=15.7±1.4 years) were randomized to WLS (n=86) or control (CTL, n=73) groups. The WLS group engaged in twelve 50-min WLS training sessions conducted by teachers at school. RESULTS: Anger-in and anxiety scores decreased and anger control scores increased in the WLS group across the six-month follow-up period compared to the CTL group (group x visit, ps<0.05). Daytime diastolic BP was lower across the follow-up in the WLS group (p=0.08). DBP was significantly lower across the follow-up period in the WLS group among those with higher SBP at baseline (p=0.04). CONCLUSION: These findings demonstrate beneficial impact of WLS upon self-reported anger-in, anger-control, anxiety levels and ambulatory DBP in the natural environment in healthy normotensive youth.

Adaptation and implementation of an evidence-based behavioral medicine program in diverse global settings: The Williams LifeSkills experience.

Epidemiological research has documented the health-damaging effects of psychosocial factors like hostility, depression, anxiety, job stress, social isolation and low socioeconomic status. Several studies suggest that behavioral interventions can reduce levels of these psychosocial factors. Herein we describe the translational process whereby the Williams LifeSkills® (WLS(®)) program and products for reducing psychosocial risk factors have been developed and tested in clinical trials in the U.S. and Canada and then adapted for other cultures and tested in clinical trials in other countries around the world. Evidence from published controlled and observational trials of WLS(®) products in the U.S. and elsewhere shows that persons receiving coping skills training using WLS(®) products have consistently reported reduced levels of psychosocial risk factors. In two controlled trials, one for caregivers of a relative with Alzheimer's Disease in the U.S. and one for coronary bypass surgery patients in Singapore, WLS(®) training also produced clinically significant blood pressure reductions. In conclusion, WLS(®) products have been shown in controlled and observational trials to produce reduced levels of both psychosocial and cardiovascular stress indices. Ongoing research has the potential to show that WLS(®) products can be an effective vehicle for the delivery of stress reduction and mental health services in developing countries.

Video-based coping skills to reduce health risk and improve psychological and physical well-being in Alzheimer's disease family caregivers.

OBJECTIVE: To determine whether video-based coping skills (VCS) training with telephone coaching reduces psychosocial and biological markers of distress in primary caregivers of a relative with Alzheimer's disease or related dementia (ADRD). METHODS: A controlled clinical trial was conducted with 116 ADRD caregivers who were assigned, alternately as they qualified for the study, to a Wait List control condition or the VCS training arm in which they viewed two modules/week of a version of the Williams LifeSkills Video adapted for ADRD family care contexts, did the exercises and homework for each module presented in an accompanying Workbook, and received one telephone coaching call per week for 5 weeks on each week's two modules. Questionnaire-assessed depressive symptoms, state and trait anger and anxiety, perceived stress, hostility, caregiver self-efficacy, salivary cortisol across the day and before and after a stress protocol, and blood pressure and heart rate during a stress protocol were assessed before VCS training, 7 weeks after training was completed, and at 3 months' and 6 months' follow-up. RESULTS: Compared with controls, participants who received VCS training plus telephone coaching showed significantly greater improvements in depressive symptoms, trait anxiety, perceived stress, and average systolic and diastolic blood pressures that were maintained over the 6-month follow-up period. CONCLUSIONS: VCS training augmented by telephone coaching reduced psychosocial and biological indicators of distress in ADRD caregivers. Future studies should determine the long-term benefits to mental and physical health from this intervention. TRIAL REGISTRATION: http://www.clinicaltrials.gov; #NCT00396825.

Worldwide stress: different problems, similar solutions? Cultural adaptation and evaluation of a standardized stress management program in Hungary.

BACKGROUND: Chronic stress is an important risk factor for morbidity and premature mortality at the individual and societal level. PURPOSE: Our aim was to describe the process of adapting and testing the effectiveness of a structured stress management skills training program in a culture different from the one in which it was first developed. METHOD: We translated an internationally used standardized behavioral intervention program into Hungarian and adapted it for use in a Hungarian cultural setting. We evaluated the changes in stress level and stress-related symptom scores among distressed voluntary participants on the basis of self-reported questionnaires completed before, immediately after, and 4 to 6 months after the 12-h intervention. The following measures were included: PSS-10, STAI-T, BDI-S, PHQ-15, and WBI-5. For statistical analyses, paired sample t test and Cohen's d value for effect size were used. RESULTS: In a sample of 107 distressed individuals, after the training, stress level, psychological and somatic symptoms decreased and well-being increased (p < 0.0001). These positive changes were maintained at follow-up in a subsample of 42 persons tested 4-6 months later. CONCLUSION: These results confirm the long-term positive effects of this standardized behavioral intervention in a different cultural context and in real-world settings, which encourages further dissemination of the program in various community settings.

Coping skills training to reduce psychosocial risk factors for medical disorders: a field trial evaluating effectiveness in multiple worksites.

OBJECTIVE: To determine whether a commercial coping skills training program shown to reduce psychosocial risk factors in randomized clinical trials of patients with coronary heart disease is also effective in achieving similar improvements among stressed workers in a real world corporate setting. METHODS: Conduct an observational trial to evaluate the impact of the Williams LifeSkills Workshop on depression, social support, anxiety, and hostility in a sample of 110 employees working at multiple U.S. sites of a client of Williams LifeSkills, Inc. RESULTS: All psychosocial risk factors showed highly significant improvements from pre- to post-training. Except for social support, these improvements were maintained at six months follow-up. CONCLUSIONS: These findings provide support for the effectiveness of the Williams LifeSkills Workshop by suggesting that its efficacy, as demonstrated in randomized clinical trials, generalizes to real world settings like the multiple U.S. work sites of a corporate client.

Psychosocial benefits of three formats of a standardized behavioral stress management program.

OBJECTIVE: Psychosocial factors are associated with increased morbidity and mortality in healthy and clinical populations. Behavioral interventions are needed to train the large number of people in the community setting who are affected by stressors to use coping skills that will reduce these risk factors. The aim of the current study was to evaluate the efficacy of three forms of delivery of a standardized, behavioral intervention-the Williams LifeSkills program-designed to reduce levels of psychosocial risk factors in nonclinical populations. METHODS: One hundred ninety-six participants screening positive for elevated psychosocial distress were randomized to either a waitlist control group or one of three intervention groups: the LifeSkills Workshop, the LifeSkills Video, or the LifeSkills Video and Workshop combined. Psychosocial risk factors were evaluated at baseline and at 10 days, 2 months, and 6 months after the training/wait period. RESULTS: At 10 days follow up, the workshop + video and video-only groups showed significant improvements over control subjects in trait anxiety and perceived stress. Moreover, the workshop + video group maintained benefit over control subjects throughout 6 months follow up in both of these measures, whereas the video-only group maintained benefit in trait anxiety. CONCLUSIONS: Because the psychosocial well-being of two of the treated groups improved over that of the control group, it appears that the Williams LifeSkills program accelerates and maintains a normal return to low distress after a stressful time. This is the first study to show that a commercially available, facilitator- or self-administered behavioral training product can have significant beneficial effects on psychosocial well-being in a healthy community sample.