Jennifer P. Friedberg

A Pilot Study Measuring the Impact of Yoga on the Trait of Mindfulness

BACKGROUND The current study examined whether yoga would increase levels of mindfulness in a healthy population. METHOD Forty-six participants were randomly assigned to an 8-week yoga intervention group or a wait-list control group. Mindfulness was assessed pre and post yoga, using the Freiburg Mindfulness Inventory (FMI). RESULTS Results indicate that the yoga group experienced a significant increase in Overall mindfulness, and in three mindfulness subscales; Attention to the present moment, Accepting and open attitudes toward experience, and Insightful understanding (p < .01). The control group experienced a significant increase in overall mindfulness (p < .02) and insightful understanding (p < .01). Findings suggest that a yoga intervention may be a viable method for increasing levels of trait mindfulness in a healthy population, potentially implicating yoga as a preventive method for the later development of negative emotional mood states (i.e. anxiety and depression). The control group also experienced moderate elevations of mindfulness at the second assessment.

Usefulness of a run-in period to reduce drop-outs in a randomized controlled trial of a behavioral intervention

OBJECTIVES We evaluated the usefulness of a simple run-in period to reduce drop-outs in a behavioral intervention to improve blood pressure (BP). In a pilot study where a run-in period was not used, we had a 25% drop-out rate. METHODS A prospective evaluation was performed in the context of a blinded 3-arm randomized trial. Participants are eligible if they have uncontrolled BP on 2 consecutive visits. Potential participants are approached during a routine visit, informed, consented and enrolled. After a 1-month run-in period during which all participants receive a phone call to: i) verify phone availability, ii) get basic information on treatment, and iii) confirm the baseline visit, participants return for a baseline visit. They are then randomized to one of the three treatment arms: usual care, non-tailored counseling, or tailored counseling. Participants make return visits at 3, 6 and 12 months. RESULTS Of the 1275 potential participants who received detailed study information, 301 consented to participate, of whom 226 were enrolled. During the run-in period, 73 withdrew consent and 153 participants were randomized; 7 subsequently dropped out. There were no differences (p>.1) between the 73 cancelled and the 153 randomized patients. There were fewer drop-outs than in the pilot study (5% vs. 25%, p<.0001). CONCLUSIONS The run-in period reduces the number of drop-outs after randomization and improves statistical power. In order to retain external validity, it is important to compare participants who remain in the study and those that cancel, and incorporate that in generalizing from the study.

Relationship Between Forgiveness and Psychological and Physiological Indices in Cardiac Patients

BackgroundResearch suggests that forgiveness is associated with better psychological and physical health and in particular cardiovascular functioning. Despite these findings, most forgiveness studies involve healthy participants.PurposeThe current study assessed the psychological and physiological correlates of forgiveness in individuals with coronary artery disease (CAD).MethodSelf-reported forgiveness, perceived stress, anxiety, and depression, and physiological data, including triglycerides, total cholesterol, high- (HDL) and low-density lipoprotein (LDL) cholesterol, were obtained from 85 hospitalized CAD patients.ResultsHigher levels of forgiveness were associated with lower levels of anxiety (p < 0.05), depression (p < 0.01), and perceived stress (p < 0.005) as well as lower total cholesterol to HDL and LDL to HDL ratios (both at p < 0.05) after controlling for age and gender. The psychological indices did not mediate the relationship between forgiveness and cholesterol ratios.ConclusionsResults suggest that the psychological correlates of forgiveness are similar in cardiac patients and healthy individuals. Further, among cardiac patients, forgiveness may be associated with reduced risk for future cardiovascular events.

Effectiveness of a Tailored Behavioral Intervention to Improve Hypertension Control Primary Outcomes of a Randomized Controlled Trial

&NA;Blood pressure (BP) control rates are suboptimal. We evaluated the effectiveness of 2 behavioral interventions to improve BP control via a 3-arm, randomized controlled trial of 533 adults with repeated uncontrolled BP, despite antihypertensive drug treatment for ≥6 months. The interventions were a tailored stage-matched intervention (SMI) or a nontailored health education intervention (HEI) of 6 monthly calls targeting diet, exercise, and medication. Control was usual care (UC). There were no baseline group differences. Baseline BP control was 42.6%, 40.6%, and 44.6% in SMI, HEI, and UC (P=0.74), respectively; systolic BP (with SEs) was 136 (0.89), 137 (1.33), and 137 (0.96) mm Hg. Six-month control was 64.6% (SMI), 54.3% (HEI), and 45.8% (UC) (P values for pairwise comparisons versus UC, 0.001 [SMI] and 0.108 [HEI]). At 6 months, systolic BP (SE) was 131.2 (1.05), 131.8 (0.99), and 134.7 (1.02) for SMI, HEI, and UC, respectively (P values for pairwise comparisons versus UC, 0.009 for SMI and 0.047 for HEI). SMI led to lower systolic BP and better BP control than UC. SMI constitutes a new, potent approach to assist patients with uncontrolled hypertension to reach BP goals. Clinical Trial Registration—URL: http://www.clinicaltrials.gov. Unique identifier: NCT00286754.Blood pressure (BP) control rates are suboptimal. We evaluated the effectiveness of 2 behavioral interventions to improve BP control via a 3-arm, randomized controlled trial of 533 adults with repeated uncontrolled BP, despite antihypertensive drug treatment for ≥6 months. The interventions were a tailored stage-matched intervention (SMI) or a nontailored health education intervention (HEI) of 6 monthly calls targeting diet, exercise, and medication. Control was usual care (UC). There were no baseline group differences. Baseline BP control was 42.6%, 40.6%, and 44.6% in SMI, HEI, and UC ( P =0.74), respectively; systolic BP (with SEs) was 136 (0.89), 137 (1.33), and 137 (0.96) mm Hg. Six-month control was 64.6% (SMI), 54.3% (HEI), and 45.8% (UC) ( P values for pairwise comparisons versus UC, 0.001 [SMI] and 0.108 [HEI]). At 6 months, systolic BP (SE) was 131.2 (1.05), 131.8 (0.99), and 134.7 (1.02) for SMI, HEI, and UC, respectively ( P values for pairwise comparisons versus UC, 0.009 for SMI and 0.047 for HEI). SMI led to lower systolic BP and better BP control than UC. SMI constitutes a new, potent approach to assist patients with uncontrolled hypertension to reach BP goals. Clinical Trial Registration— URL: . Unique identifier: [NCT00286754][1]. # Novelty and Significance {#article-title-36} [1]: /lookup/external-ref?link_type=CLINTRIALGOV&access_num=NCT00286754&atom=%2Fhypertensionaha%2F65%2F2%2F440.atom

Challenges and recommendations for blinding in behavioral interventions illustrated using a case study of a behavioral intervention to lower blood pressure

OBJECTIVE To describe the challenges to blinding in behavioral interventions, specifically those for asymptomatic medical conditions, where the intervention is through counseling, and to provide recommendations for achieving blinding in behavioral randomized controlled trials (RCTs). METHODS This paper reviews the challenges of preserving blinding in behavioral RCTs with a focus on interventions for asymptomatic medical conditions. This is illustrated using a case study of an ongoing behavioral intervention to improve hypertension control. RESULTS In contrast to easily keeping study investigators and participants masked to treatment assignment through the use of identical pills or sham treatments, the need to have differing levels of blinding among study personnel and participants in randomized behavioral intervention trials is presented. Recommendations for achieving this are provided. CONCLUSIONS Despite the challenges inherent in behavioral interventions, it is possible to achieve differing levels of blinding across study personnel and participants to minimize bias and generate valid data in RCTs that test interventions for asymptomatic medical conditions such as hypertension. Modifications may be needed for RCTs in symptomatic medical conditions. PRACTICE IMPLICATIONS Researchers designing behavioral RCTs should be aware of the challenges to blinding all staff and study participants, and plan to have procedures in place to standardize outcome data collection and intervention delivery without compromising the varying levels of blinding. The challenges and recommendations described may need modifications in behavioral intervention studies for symptomatic conditions.

Forgiveness and Health in Patient Populations

While many recent studies have examined the relationship between forgiveness and health in healthy populations, there is growing emphasis on studying this link in medical patient populations. This chapter will discuss the association between forgiveness and both mental and physical health in patients with medical illnesses, with a particular focus on those with cardiovascular disease, chronic pain, traumatic brain injury, spinal cord injury, stroke, HIV/AIDS, cancer, and terminal illness. The few forgiveness interventions that have been studied in medical patients will also be discussed. In this burgeoning line of research, more research is needed to examine the relationship between forgiveness and objectively measured physiological markers of illness, using longitudinal rather than cross-sectional study designs, and testing the impact of forgiveness interventions on such physiological parameters. Forgiveness of self, other, and by God must also be considered when examining forgiveness in patients with medical illness.

The Effects of Indirect Exposure to September 11th–Related Trauma on Cardiovascular Reactivity

Direct and indirect exposure to trauma is related to cardiovascular reactivity to stress, which is a marker for the future development of cardiovascular disease. The current study compared the effects of indirect exposure and no exposure (assessed via self-reports) to the 9/11 terrorist attacks on cardiovascular reactivity among a sample of 31 New Yorkers. Cardiovascular responses, measured every 2 minutes during baseline, a semistructured interview in which they relived a personally relevant aspect of the terrorist attack, and recovery periods revealed that the indirect exposure group had significantly higher diastolic blood pressure levels at baseline (p < .01), task (p < .05), and recovery (p < .05) than the no exposure group. No differences in trauma symptoms were observed between the two groups. Results suggest that indirect exposure to a traumatic event may have an impact on physiological responses to stress.

Effectiveness of a Tailored Behavioral Intervention to Improve Hypertension Control

&NA;Blood pressure (BP) control rates are suboptimal. We evaluated the effectiveness of 2 behavioral interventions to improve BP control via a 3-arm, randomized controlled trial of 533 adults with repeated uncontrolled BP, despite antihypertensive drug treatment for ≥6 months. The interventions were a tailored stage-matched intervention (SMI) or a nontailored health education intervention (HEI) of 6 monthly calls targeting diet, exercise, and medication. Control was usual care (UC). There were no baseline group differences. Baseline BP control was 42.6%, 40.6%, and 44.6% in SMI, HEI, and UC (P=0.74), respectively; systolic BP (with SEs) was 136 (0.89), 137 (1.33), and 137 (0.96) mm Hg. Six-month control was 64.6% (SMI), 54.3% (HEI), and 45.8% (UC) (P values for pairwise comparisons versus UC, 0.001 [SMI] and 0.108 [HEI]). At 6 months, systolic BP (SE) was 131.2 (1.05), 131.8 (0.99), and 134.7 (1.02) for SMI, HEI, and UC, respectively (P values for pairwise comparisons versus UC, 0.009 for SMI and 0.047 for HEI). SMI led to lower systolic BP and better BP control than UC. SMI constitutes a new, potent approach to assist patients with uncontrolled hypertension to reach BP goals. Clinical Trial Registration—URL: http://www.clinicaltrials.gov. Unique identifier: NCT00286754.Blood pressure (BP) control rates are suboptimal. We evaluated the effectiveness of 2 behavioral interventions to improve BP control via a 3-arm, randomized controlled trial of 533 adults with repeated uncontrolled BP, despite antihypertensive drug treatment for ≥6 months. The interventions were a tailored stage-matched intervention (SMI) or a nontailored health education intervention (HEI) of 6 monthly calls targeting diet, exercise, and medication. Control was usual care (UC). There were no baseline group differences. Baseline BP control was 42.6%, 40.6%, and 44.6% in SMI, HEI, and UC ( P =0.74), respectively; systolic BP (with SEs) was 136 (0.89), 137 (1.33), and 137 (0.96) mm Hg. Six-month control was 64.6% (SMI), 54.3% (HEI), and 45.8% (UC) ( P values for pairwise comparisons versus UC, 0.001 [SMI] and 0.108 [HEI]). At 6 months, systolic BP (SE) was 131.2 (1.05), 131.8 (0.99), and 134.7 (1.02) for SMI, HEI, and UC, respectively ( P values for pairwise comparisons versus UC, 0.009 for SMI and 0.047 for HEI). SMI led to lower systolic BP and better BP control than UC. SMI constitutes a new, potent approach to assist patients with uncontrolled hypertension to reach BP goals. Clinical Trial Registration— URL: . Unique identifier: [NCT00286754][1]. # Novelty and Significance {#article-title-36} [1]: /lookup/external-ref?link_type=CLINTRIALGOV&access_num=NCT00286754&atom=%2Fhypertensionaha%2F65%2F2%2F440.atom

Effectiveness of a Tailored Behavioral Intervention to Improve Hypertension ControlNovelty and Significance

&NA;Blood pressure (BP) control rates are suboptimal. We evaluated the effectiveness of 2 behavioral interventions to improve BP control via a 3-arm, randomized controlled trial of 533 adults with repeated uncontrolled BP, despite antihypertensive drug treatment for ≥6 months. The interventions were a tailored stage-matched intervention (SMI) or a nontailored health education intervention (HEI) of 6 monthly calls targeting diet, exercise, and medication. Control was usual care (UC). There were no baseline group differences. Baseline BP control was 42.6%, 40.6%, and 44.6% in SMI, HEI, and UC (P=0.74), respectively; systolic BP (with SEs) was 136 (0.89), 137 (1.33), and 137 (0.96) mm Hg. Six-month control was 64.6% (SMI), 54.3% (HEI), and 45.8% (UC) (P values for pairwise comparisons versus UC, 0.001 [SMI] and 0.108 [HEI]). At 6 months, systolic BP (SE) was 131.2 (1.05), 131.8 (0.99), and 134.7 (1.02) for SMI, HEI, and UC, respectively (P values for pairwise comparisons versus UC, 0.009 for SMI and 0.047 for HEI). SMI led to lower systolic BP and better BP control than UC. SMI constitutes a new, potent approach to assist patients with uncontrolled hypertension to reach BP goals. Clinical Trial Registration—URL: http://www.clinicaltrials.gov. Unique identifier: NCT00286754.Blood pressure (BP) control rates are suboptimal. We evaluated the effectiveness of 2 behavioral interventions to improve BP control via a 3-arm, randomized controlled trial of 533 adults with repeated uncontrolled BP, despite antihypertensive drug treatment for ≥6 months. The interventions were a tailored stage-matched intervention (SMI) or a nontailored health education intervention (HEI) of 6 monthly calls targeting diet, exercise, and medication. Control was usual care (UC). There were no baseline group differences. Baseline BP control was 42.6%, 40.6%, and 44.6% in SMI, HEI, and UC ( P =0.74), respectively; systolic BP (with SEs) was 136 (0.89), 137 (1.33), and 137 (0.96) mm Hg. Six-month control was 64.6% (SMI), 54.3% (HEI), and 45.8% (UC) ( P values for pairwise comparisons versus UC, 0.001 [SMI] and 0.108 [HEI]). At 6 months, systolic BP (SE) was 131.2 (1.05), 131.8 (0.99), and 134.7 (1.02) for SMI, HEI, and UC, respectively ( P values for pairwise comparisons versus UC, 0.009 for SMI and 0.047 for HEI). SMI led to lower systolic BP and better BP control than UC. SMI constitutes a new, potent approach to assist patients with uncontrolled hypertension to reach BP goals. Clinical Trial Registration— URL: . Unique identifier: [NCT00286754][1]. # Novelty and Significance {#article-title-36} [1]: /lookup/external-ref?link_type=CLINTRIALGOV&access_num=NCT00286754&atom=%2Fhypertensionaha%2F65%2F2%2F440.atom

Effectiveness of a Tailored Behavioral Intervention to Improve Hypertension ControlNovelty and Significance: Primary Outcomes of a Randomized Controlled Trial

&NA;Blood pressure (BP) control rates are suboptimal. We evaluated the effectiveness of 2 behavioral interventions to improve BP control via a 3-arm, randomized controlled trial of 533 adults with repeated uncontrolled BP, despite antihypertensive drug treatment for ≥6 months. The interventions were a tailored stage-matched intervention (SMI) or a nontailored health education intervention (HEI) of 6 monthly calls targeting diet, exercise, and medication. Control was usual care (UC). There were no baseline group differences. Baseline BP control was 42.6%, 40.6%, and 44.6% in SMI, HEI, and UC (P=0.74), respectively; systolic BP (with SEs) was 136 (0.89), 137 (1.33), and 137 (0.96) mm Hg. Six-month control was 64.6% (SMI), 54.3% (HEI), and 45.8% (UC) (P values for pairwise comparisons versus UC, 0.001 [SMI] and 0.108 [HEI]). At 6 months, systolic BP (SE) was 131.2 (1.05), 131.8 (0.99), and 134.7 (1.02) for SMI, HEI, and UC, respectively (P values for pairwise comparisons versus UC, 0.009 for SMI and 0.047 for HEI). SMI led to lower systolic BP and better BP control than UC. SMI constitutes a new, potent approach to assist patients with uncontrolled hypertension to reach BP goals. Clinical Trial Registration—URL: http://www.clinicaltrials.gov. Unique identifier: NCT00286754.Blood pressure (BP) control rates are suboptimal. We evaluated the effectiveness of 2 behavioral interventions to improve BP control via a 3-arm, randomized controlled trial of 533 adults with repeated uncontrolled BP, despite antihypertensive drug treatment for ≥6 months. The interventions were a tailored stage-matched intervention (SMI) or a nontailored health education intervention (HEI) of 6 monthly calls targeting diet, exercise, and medication. Control was usual care (UC). There were no baseline group differences. Baseline BP control was 42.6%, 40.6%, and 44.6% in SMI, HEI, and UC ( P =0.74), respectively; systolic BP (with SEs) was 136 (0.89), 137 (1.33), and 137 (0.96) mm Hg. Six-month control was 64.6% (SMI), 54.3% (HEI), and 45.8% (UC) ( P values for pairwise comparisons versus UC, 0.001 [SMI] and 0.108 [HEI]). At 6 months, systolic BP (SE) was 131.2 (1.05), 131.8 (0.99), and 134.7 (1.02) for SMI, HEI, and UC, respectively ( P values for pairwise comparisons versus UC, 0.009 for SMI and 0.047 for HEI). SMI led to lower systolic BP and better BP control than UC. SMI constitutes a new, potent approach to assist patients with uncontrolled hypertension to reach BP goals. Clinical Trial Registration— URL: . Unique identifier: [NCT00286754][1]. # Novelty and Significance {#article-title-36} [1]: /lookup/external-ref?link_type=CLINTRIALGOV&access_num=NCT00286754&atom=%2Fhypertensionaha%2F65%2F2%2F440.atom