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

National Institutes of Health (NIH) logo

National Institutes of Health (NIH)

Status and phase

Completed
Phase 2

Conditions

Hypertension

Treatments

Behavioral: Lifeskills Workshop Intervention

Study type

Interventional

Funder types

NIH

Identifiers

NCT01262066
Lifeskills BP study
R44HL067584 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment

181 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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)

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

181 participants in 2 patient groups

LifeSkills workshop intervention
Experimental group
Description:
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.
Treatment:
Behavioral: Lifeskills Workshop Intervention
Enhanced usual care
No Intervention group
Description:
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.

Trial contacts and locations

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Data sourced from clinicaltrials.gov

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