• Curr Med Res Opin · Apr 2010

    Randomized Controlled Trial

    Efficacy of a comprehensive program for reducing stress in women: a prospective, randomized trial.

    • Benjamin Wiegand, Kathryn Luedtke, Diana Friscia, Mona Nair, Margaret Aleles, and Richard McCloskey.
    • Wellness & Prevention, Inc., a Johnson & Johnson Company, Ft. Washington, PA 19034, USA. bwiegan@its.jnj.com
    • Curr Med Res Opin. 2010 Apr 1; 26 (4): 991-1002.

    ObjectiveThis study evaluated the efficacy of a comprehensive stress management program in reducing perceived stress among women who reported moderate-to-high stress levels.MethodsA total of 562 highly motivated females, aged 25-45, with moderate to high stress levels, were enrolled in a 14-week study. Participants were randomized into one of three groups: Group 1 included Internet-based coaching focusing on behavior modification, daily use of proprietary olfactive-based personal care products, and periodic feedback reports; Group 2 consisted of only online coaching; and Group 3 had no active stress management program. Participants in the three groups filled out validated psychometric assessments at baseline and throughout the study period. Several outcomes including Perceived Stress Scale (PSS), Profile of Mood States (POMS), St Mary's Hospital Sleep Questionnaire (SMS), the Trier Inventory of Chronic Stress (TICS), Spielberger State-Trait Anxiety Inventory (STAI), Short-Form-36 (SF-36) and the Work Productivity and Activity Impairment (WPAI), were measured periodically to assess changes in subject-perceived stress, stress-related comorbidities, and sleep quality and to evaluate overall program efficacy. Ethical approval of protocols was conducted by the Allendale Investigational Review Board (AIRB). Voluntary informed consent was obtained from each subject.ResultsAt the end of the 14-week study period, subjects in Group 1 had statistically significant improvement in the PSS score vs. Group 3 (p < 0.01). There were statistically significant improvements in other efficacy outcomes such as POMS total mood disturbance, TICS work overload and social responsibility subscales, STAI and in the number of night awakenings, assessed by the SMS questionnaire (p < 0.05). Self-reported program efficacy was also significantly higher for Group 1 (p < 0.001).ConclusionDespite study limitations, including reduction of stress in Group 3, this study demonstrates that this comprehensive stress management program is effective in reducing stress among women with moderate to high stress levels.

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