A Stress Reduction Program for Companies

NCT02660307 | Completed DMC

• 1 other identifier: PROGRESS
• Study Type: interventional
• Target: 41
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Stress

Keywords

stress; work; employees; mindfulness; depression; anxiety

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• changes in subjective depression symptoms

  baseline, 8 weeks and 16 weeks

• changes in anxiety symptoms

  baseline, 8 weeks and 16 weeks

• changes in speed of perception and visual and motor response

  baseline, 8 weeks and 16 weeks

• changes in Mindful Awareness and attention

  baseline, 8 weeks and 16 weeks

• changes in psychiatric symptoms

  baseline, 8 weeks and 16 weeks

Study Arms (2)

PROGRESS group

EXPERIMENTAL

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

OTHER

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

Interventions

PROGRESS group OTHER

PROGRESS group; control group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• workers with stress complaints aging from 18 to 60 years. They also had to have at least 8 years of education.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centro de estudos em Atenção Plena: lead
• SESI (Serviço Social da Indústria): collaborator

Related Publications (1)

• 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.

  PMID: 29867646 DERIVED

MeSH Terms

Conditions

Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders

Study Officials

• stephen Little Me

  Centro de estudos em Atenção Plena

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 22, 2015
• First Posted: January 21, 2016
• Study Start: February 1, 2014
• Primary Completion: June 1, 2014
• Study Completion: September 1, 2014
• Last Updated: May 16, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will share