A Stress Reduction Program for Companies

A Randomized Controlled Trial With a Follow-up Evaluation of a Stress Reduction Program for Companies - PROGRESS

This protocol proposes a well-being program based in stress reduction program for employees of a company.

objectives: To evaluate the effects of a stress reduction program with a specific orientation for workers and taught to them within their companies.

Methods: Participants with stress complaints were recruited and randomized into two groups: group 1 (G1) received the intervention while group 2 (G2) did not. Both groups were evaluated before the intervention (time 1 - T1); again after the eight weeks of the program for G1 (time 2 - T2); and then at the end of a second eight-week period during which G2 received the intervention and G1 was simply instructed to maintain the practice they had learned without further instruction (time 3- T3).

Study Overview

• Status: Completed
• Conditions: Stress
• Intervention / Treatment: Other: PROGRESS group

Detailed Description

Disorders resulting from chronic stress are some of the main causes of absenteeism and reduced productivity in companies. A number of successful stress management programs are based on the principle of mindfulness and may help individuals to relieve stress symptoms and to improve well-being and pro-social behavior. The objective of this study was to evaluate the feasibility and efficacy of a weekly one-hour stress reduction program adapted for companies and if the possible benefits would be sustained 8 weeks after the end of the program. Participants with stress complaints were recruited in two companies and they were randomized into two groups: in the first period of the study, group 1 (G1) N=23 received the intervention while group 2 (G2) N=18 did not. Both groups were evaluated before the intervention (time 1 - T1); again after the eight weeks of the program for G1 (time 2 - T2); and then at the end of a second eight-week period during which G2 received the intervention and G1 was simply instructed to maintain the practice they had learned without further instruction (time 3- T3).

• Study Type: Interventional
• Enrollment (Actual): 41
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• workers with stress complaints aging from 18 to 60 years. They also had to have at least 8 years of education.

Exclusion Criteria:

• participants with a history of psychiatric or neurological disorders or who were under psychological or psychiatric treatment during the period of the study, or with a history of substance abuse, with the exception of tobacco.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PROGRESS group; this group received the intervention based in meditation in the first 8 weeks. They were instructed to practice at least 5 times a week for up to half an hour a day. During the second 8 week period this group were left to manage their practice on their own.	Other: PROGRESS group
Other: control group; this group received no intervention in the first 8 weeks. During the second 8 week period, this group received the same intervention based in meditation that received PROGRESS group.	Other: PROGRESS group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
changes in subjective symptoms of stress	questionnaire for stress symptoms via 37 somatic symptoms and 19 psychological symptoms.	baseline, 8 weeks and 16 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
changes in subjective depression symptoms	questionnaire for depression symptoms, 21 items describing depression symptoms, each item in a scale from 0 to 3.	baseline, 8 weeks and 16 weeks
changes in anxiety symptoms	questionnaire for anxiety symptoms, 21 items describing anxiety symptom, each item in a scale from 0 to 3.	baseline, 8 weeks and 16 weeks
changes in speed of perception and visual and motor response	this test is the association of numbers and symbols lasting 2 minutes. This variable measure is a neuropsychological test and the data presentation are in total scores	baseline, 8 weeks and 16 weeks
changes in Mindful Awareness and attention	in a scale from 1 to 6 the participant classifies how frequently or infrequently he/she becomes aware or mindful by contemplating the 15 described daily conditions provided	baseline, 8 weeks and 16 weeks
changes in psychiatric symptoms	questionnaire for psychiatric symptoms with 20 questions about mental health	baseline, 8 weeks and 16 weeks

Collaborators and Investigators

• Sponsor: Centro de estudos em Atenção Plena
• Collaborators: SESI (Serviço Social da Indústria)
• Investigators: Principal Investigator: stephen Little Me, Centro de estudos em Atenção Plena

Publications and helpful links

General Publications

• Lacerda SS, Little SW, Kozasa EH. A Stress Reduction Program Adapted for the Work Environment: A Randomized Controlled Trial With a Follow-Up. Front Psychol. 2018 May 9;9:668. doi: 10.3389/fpsyg.2018.00668. eCollection 2018.

Study record dates

Study Major Dates

• Study Start: February 1, 2014
• Primary Completion (Actual): June 1, 2014
• Study Completion (Actual): September 1, 2014

Study Registration Dates

• First Submitted: December 22, 2015
• First Submitted That Met QC Criteria: January 16, 2016
• First Posted (Estimate): January 21, 2016

Study Record Updates

• Last Update Posted (Actual): May 16, 2018
• Last Update Submitted That Met QC Criteria: May 11, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Keywords: depression; anxiety; mindfulness; stress; work; employees
• Other Study ID Numbers: PROGRESS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES