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

Abstract

Objective:

This study evaluated the efficacy of a comprehensive stress management program in reducing perceived stress among women who reported moderate-to-high stress levels.

Methods:

A 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.

Results:

At 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).

Conclusion:

Despite 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.

Key words::

• Behavior modification
• Cognitive behavioral therapy
• Perceived Stress Scale (PSS)
• Stress management program
• Women

Transparency

Declaration of funding

This study was sponsored by Johnson & Johnson Consumer & Personal Products Worldwide, a division of Johnson & Johnson Consumer Companies, Inc.

Declaration of financial/other relationships

B.W., D.F., M.N. and M.A. have disclosed that they are employees of Johnson & Johnson Consumer Companies, Inc or business units of Johnson & Johnson Consumer Companies, Inc. K.L. and R.M. have disclosed that they are former employees of Johnson & Johnson Consumer Companies, Inc. who were involved with the study as employees of Johnson & Johnson Consumer Companies, Inc.

Acknowledgment

Statistical analysis was provided by DAaCRO GmbH & Co. KG, Diagnostic Assessment and Clinical Research Organization and Mei-Miau Wu, Johnson & Johnson Consumer Companies, Inc. Editorial support was provided by Devi Mukherjee, PhD and Majid Kerolous, PharmD, ICC Trio. Johnson & Johnson Consumer Personal Products Worldwide, a division of Johnson & Johnson Consumer Companies, Inc provided funding to DAaCRO GmbH & Co. KG, Diagnostic Assessment and Clinical Research Organization, and ICC Trio for their assistance. The authors also acknowledge all investigators, study centers and patients for their participation in this study.

These data were presented in part at the International Society of Psychoneuroendocrinology poster session in San Francisco, CA, USA, July 23–26, 2009.

Some peer reviewers receive honoraria from CMRO for their review work. The peer reviewers of this paper have disclosed that they have no relevant financial relationships.