Effects of Lifeskills Workshop on BP in Hypertensive Employees (Lifeskills BP)
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|ClinicalTrials.gov Identifier: NCT01262066|
Recruitment Status : Completed
First Posted : December 17, 2010
Last Update Posted : July 29, 2016
|Condition or disease||Intervention/treatment||Phase|
|Hypertension||Behavioral: Lifeskills Workshop Intervention||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||181 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||RCT of LifeSkills Workshop on BP in Hypertensive Employees|
|Study Start Date :||September 2002|
|Actual Primary Completion Date :||August 2006|
|Actual Study Completion Date :||August 2006|
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.
- change in mean office BP, covarying hostility and hostility x time (stratification variable) [ Time Frame: 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
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01262066
|Principal Investigator:||Lynn P Clemow, PhD||Columbia University|