Effects of Lifeskills Workshop on BP in Hypertensive Employees

Phase 2

Completed

• Conditions: Hypertension
• Interventions: Behavioral: Lifeskills Workshop Intervention

• Registration Number: NCT01262066
• Lead Sponsor: National Heart, Lung, and Blood Institute (NHLBI)

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-09
• Primary Completion: 2006-08
• Study Completion: 2006-08
• Status Verified: 2010-11
• Study First Submitted: 2010-12-15
• Study First Submitted QC: 2010-12-15
• Study First Posted: 2010-12-17
• Last Update Submitted: 2016-07-28
• Last Update Posted: 2016-07-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 181

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LifeSkills workshop intervention	Lifeskills Workshop Intervention	Participants attended 10 1-hr weekly 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.

Primary Outcome Measures

Name	Time	Method
change in mean office BP, covarying hostility and hostility x time (stratification variable)	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 Outcome Measures

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