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Clinical Trials/NCT01262066
NCT01262066
Completed
Phase 2

RCT of LifeSkills Workshop on BP in Hypertensive Employees

National Heart, Lung, and Blood Institute (NHLBI)0 sites181 target enrollmentSeptember 2002
ConditionsHypertension

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Hypertension
Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Enrollment
181
Primary Endpoint
change in mean office BP, covarying hostility and hostility x time (stratification variable)
Status
Completed
Last Updated
9 years ago

Overview

Brief Summary

A number of psychosocial risk factors have been strongly related to a range of health problems (chief among them CVD). Clinical research has shown that behavioral interventions have enormous promise to ameliorate the psychosocial distress, the health-damaging effects and the costs associated with these risk factors. However, few such programs have been implemented in a large-scale way. Corporations are increasingly interested in providing such services for their employees, but they have encountered difficulties in knowing which programs are most effective. Until these programs are developed as products that can be tested and shown to produce consistent benefits, dissemination of these beneficial programs will be hindered. Taken together, these findings make a strong case that the development of a standardized, protocol-driven behavioral intervention package that can be delivered in a wide range of corporate settings presents a remarkable commercial opportunity. The overall goal of this SBIR Fast-Track-funded project is to gain empirical evidence in a RCT that documents the effectiveness of the Williams LifeSkills Workshop (a protocol driven 6-session workshop) in reducing BP, psychosocial risk factors, and promoting positive health outcomes in a cost effective manner in a corporate setting. This empirical support, tested in a setting independent of the program developers and by an experienced research team, will then be used to help market the product in the corporate wellness marketplace. It is hypothesized that participants (employees in an urban medical center) in the LifeSkills intervention will experience greater reductions in blood pressure and improvements in measures of psychosocial well-being than those receiving usual medical care and given educational materials on reducing BP.

Registry
clinicaltrials.gov
Start Date
September 2002
End Date
August 2006
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • Adults age 18-75
  • Employees of Columbia University Medical Center
  • BP \>= 140/90 on 2 occasions (average of 3 readings each time)

Exclusion Criteria

  • Pregnancy
  • End-stage Renal disease
  • BP \> 165/110 (average over 3 readings)

Outcomes

Primary Outcomes

change in mean office BP, covarying hostility and hostility x time (stratification variable)

Time Frame: 2 months after end of treatment

The change in the mean office BP (evaluated automatically by BP-Tru device) from baseline to follow-up. Hostility, evaluated by Cook-Medley questionnaire (Barefoot scoring) was a stratification variable and thus was used as a covariate in the analysis

Secondary Outcomes

  • Changes in mean office BP, controlling for baseline medications and medication changes during trial(baseline to follow-up 2 months after end of intervention)

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