Clinical Trials Directory

Trials / Completed

CompletedNCT01262066

Effects of Lifeskills Workshop on BP in Hypertensive Employees

RCT of LifeSkills Workshop on BP in Hypertensive Employees

Status
Completed
Phase
Phase 2
Study type
Interventional
Enrollment
181 (actual)
Sponsor
National Heart, Lung, and Blood Institute (NHLBI) · NIH
Sex
All
Age
18 Years – 75 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALLifeskills Workshop InterventionIntervention participants attended 10 one-hour weekly group sessions. The content of the groups followed the LifeSkills Workshop manual and Video ( (Williams LifeSkills, Inc, Durham NC). The LifeSkills Workshop is a structured psycho-educational group intervention using workbooks and videotapes that draw on cognitive-behavioral techniques and stress reduction approaches.

Timeline

Start date
2002-09-01
Primary completion
2006-08-01
Completion
2006-08-01
First posted
2010-12-17
Last updated
2016-07-29

Source: ClinicalTrials.gov record NCT01262066. Inclusion in this directory is not an endorsement.