A Stress Reduction Program for Companies

Stress Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02660307
• Other study ID #: PROGRESS
• Status: Completed
• Phase: N/A
• Start date: February 2014
• Est. completion date: September 2014

Study information

• Verified date: May 2018
• Source: Centro de estudos em Atenção Plena
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: September 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Stress

Intervention

Other:
• PROGRESS group

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Centro de estudos em Atenção Plena	SESI (Serviço Social da Indústria)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	changes in psychiatric symptoms	questionnaire for psychiatric symptoms with 20 questions about mental health	baseline, 8 weeks and 16 weeks