A Stress Reduction Program for Companies

Study Overview
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Brief Summary
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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).

Detailed Description
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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).

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

Conditions
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Stress

Intervention / Treatment
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* Other: PROGRESS group


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PROGRESS group<br>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<br> <br> |
| Other: control group<br>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<br> <br> |

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stress, work, employees, mindfulness, depression, anxiety