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Effects of Lifeskills Workshop on BP in Hypertensive Employees (Lifeskills BP)

This study has been completed.
Sponsor:
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier:
NCT01262066
First received: December 15, 2010
Last updated: NA
Last verified: November 2010
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Hypertension
 Behavioral: Lifeskills Workshop Intervention
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: RCT of LifeSkills Workshop on BP in Hypertensive Employees

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

Primary Outcome Measures:
  • change in mean office BP, covarying hostility and hostility x time (stratification variable) [ Time Frame: 2 months after end of treatment ] [ Designated as safety issue: No ]
    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:
  • Changes in mean office BP, controlling for baseline medications and medication changes during trial [ Time Frame: baseline to follow-up 2 months after end of intervention ] [ Designated as safety issue: No ]

Enrollment: 181
Study Start Date: September 2002
Study Completion Date: August 2006
Primary Completion Date: August 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
 Behavioral: Lifeskills Workshop Intervention
Intervention 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.
No Intervention: Enhanced usual care
The Usual Care group received a self-help brochure on BP control developed by the National Heart, Lung, and Blood Institute (NHLBI). In addition, with the participants' permission, their BP readings were sent to their listed physicians, along with the 1-page JNC-7 express summary for the management of high BP.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01262066

Sponsors and Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
Principal Investigator: Lynn P Clemow, PhD Columbia University
  More Information

No publications provided

Responsible Party: Lynn Clemow, Ph.D., Williams LifeSkills, Inc.
ClinicalTrials.gov Identifier: NCT01262066     History of Changes
Other Study ID Numbers: Lifeskills BP study
Study First Received: December 15, 2010
Last Updated: December 15, 2010
Health Authority: United States: Federal Government

Keywords provided by National Heart, Lung, and Blood Institute (NHLBI):
hypertension
stress reduction

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 19, 2013