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A Stress Reduction Program for Companies

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ClinicalTrials.gov Identifier: NCT02660307
Recruitment Status : Completed
First Posted : January 21, 2016
Last Update Posted : May 16, 2018
Sponsor:
Collaborator:
SESI (Serviço Social da Indústria)
Information provided by (Responsible Party):
Stephen William Little Me, Centro de estudos em Atenção Plena

Brief 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).


Condition or disease Intervention/treatment Phase
Stress Other: PROGRESS group Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 41 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial With a Follow-up Evaluation of a Stress Reduction Program for Companies - PROGRESS
Study Start Date : February 2014
Actual Primary Completion Date : June 2014
Actual Study Completion Date : September 2014

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
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



Primary Outcome Measures :
  1. changes in subjective symptoms of stress [ Time Frame: baseline, 8 weeks and 16 weeks ]
    questionnaire for stress symptoms via 37 somatic symptoms and 19 psychological symptoms.


Secondary Outcome Measures :
  1. changes in subjective depression symptoms [ Time Frame: baseline, 8 weeks and 16 weeks ]
    questionnaire for depression symptoms, 21 items describing depression symptoms, each item in a scale from 0 to 3.

  2. changes in anxiety symptoms [ Time Frame: baseline, 8 weeks and 16 weeks ]
    questionnaire for anxiety symptoms, 21 items describing anxiety symptom, each item in a scale from 0 to 3.

  3. changes in speed of perception and visual and motor response [ Time Frame: baseline, 8 weeks and 16 weeks ]
    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

  4. changes in Mindful Awareness and attention [ Time Frame: baseline, 8 weeks and 16 weeks ]
    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

  5. changes in psychiatric symptoms [ Time Frame: baseline, 8 weeks and 16 weeks ]
    questionnaire for psychiatric symptoms with 20 questions about mental health



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02660307


Sponsors and Collaborators
Centro de estudos em Atenção Plena
SESI (Serviço Social da Indústria)
Investigators
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Principal Investigator: stephen Little Me Centro de estudos em Atenção Plena
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Stephen William Little Me, Principal Investigator, Centro de estudos em Atenção Plena
ClinicalTrials.gov Identifier: NCT02660307    
Other Study ID Numbers: PROGRESS
First Posted: January 21, 2016    Key Record Dates
Last Update Posted: May 16, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Keywords provided by Stephen William Little Me, Centro de estudos em Atenção Plena:
stress
work
employees
mindfulness
depression
anxiety