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OpenTrials
Completed

NCT Number: NCT02660307

A Stress Reduction Program for Companies

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).

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

PROGRESS group

Other

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Centro de estudos em Atenção Plena

Other

Collaborators

  • SESI (Serviço Social da Indústria)

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Jan 21, 2016
Registry last updated
May 16, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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