Clinical trial NCT01262066: Effects of Lifeskills Workshop on BP in Hypertensive Employees
Official title: RCT of LifeSkills Workshop on BP in Hypertensive Employees
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hypertension
Keywords: hypertension
stress reduction
Lead sponsor: National Heart, Lung, and Blood Institute (NHLBI)
Sponsor class: NIH
First posted: 2010-12-17
Enrollment: 181
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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)

Primary outcomes:
measure: change in mean office BP, covarying hostility and hostility x time (stratification variable)
timeFrame: 2 months after end of treatment
Secondary outcomes:
measure: Changes in mean office BP, controlling for baseline medications and medication changes during trial
timeFrame: baseline to follow-up 2 months after end of intervention
Other outcomes:
Locations:
Study officials:
affiliation: Columbia University
name: Lynn P Clemow, PhD
role: PRINCIPAL_INVESTIGATOR
References: