Clinical trial NCT02660307: A Stress Reduction Program for Companies
Official title: A Randomized Controlled Trial With a Follow-up Evaluation of a Stress Reduction Program for Companies - PROGRESS
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress
Keywords: stress
work
employees
mindfulness
depression
anxiety
Lead sponsor: Centro de estudos em Atenção Plena
Sponsor class: OTHER
Collaborators: name: SESI (Serviço Social da Indústria)
First posted: 2016-01-21
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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).

Eligibility 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.

Primary outcomes:
measure: changes in subjective symptoms of stress
timeFrame: baseline, 8 weeks and 16 weeks
Secondary outcomes:
measure: changes in subjective depression symptoms
timeFrame: baseline, 8 weeks and 16 weeks
measure: changes in anxiety symptoms
timeFrame: baseline, 8 weeks and 16 weeks
measure: changes in speed of perception and visual and motor response
timeFrame: baseline, 8 weeks and 16 weeks
measure: changes in Mindful Awareness and attention
timeFrame: baseline, 8 weeks and 16 weeks
measure: changes in psychiatric symptoms
timeFrame: baseline, 8 weeks and 16 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Centro de estudos em Atenção Plena
name: stephen Little Me
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.