StressNCT02660307
A Stress Reduction Program for Companies
A study testing PROGRESS group in people with Stress, run by Centro de estudos em Atenção Plena.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Stress
- What is being tested?
- PROGRESS group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- No sites listed yet
- Study dates
- Feb 2014to Sep 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- workers with stress complaints aging from 18 to 60 years. They also had to have at least 8 years of education.
Who cannot join
- 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.
About this study
Official title: A Randomized Controlled Trial With a Follow-up Evaluation of a Stress Reduction Program for Companies - PROGRESS
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).
Read the 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).
- Conditions
- Stress
- Being tested
- PROGRESS group
- Keywords
- stress, work, employees, mindfulness, depression, anxiety
- Medical subject headings
- Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PROGRESS groupOther
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: PROGRESS group |
What is being measured
The primary outcome is the main question the study is designed to answer.
changes in subjective symptoms of stress
questionnaire for stress symptoms via 37 somatic symptoms and 19 psychological symptoms.
Measured: baseline, 8 weeks and 16 weeks
Secondary outcomes (5)
changes in subjective depression symptoms
questionnaire for depression symptoms, 21 items describing depression symptoms, each item in a scale from 0 to 3.
Measured: 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.
Measured: 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
Measured: 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
Measured: baseline, 8 weeks and 16 weeks
changes in psychiatric symptoms
questionnaire for psychiatric symptoms with 20 questions about mental health
Measured: baseline, 8 weeks and 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2016 (estimated)
- Study startFeb 2014
- Primary completionJun 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centro de estudos em Atenção Plena
- Sponsor type
- University, hospital or other
- Collaborators
- SESI (Serviço Social da Indústria)
- Responsible party
- Principal investigator, Stephen William Little Me, Centro de estudos em Atenção Plena
- Investigators
- stephen Little Me, Principal investigator, Centro de estudos em Atenção Plena
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02660307
- Sponsor's protocol ID
- PROGRESS
- Status last verified
- May 2018
- First submitted
- 22 Dec 2015
- Last updated
- 16 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Publications
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.
PubMed 29867646
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial With a Follow-up Evaluation of a Stress Reduction Program for Companies - PROGRESS
- ClinicalTrials.gov ID
- NCT02660307
- Acronym / sponsor ID
- PROGRESS
- Conditions
- Stress
- Keywords
- stress, work, employees, mindfulness, depression, anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Centro de estudos em Atenção PlenaUniversity, hospital or other
- Collaborators
- SESI (Serviço Social da Indústria)
- Study start
- Feb 2014
- Primary completion
- Jun 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 21 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PROGRESS group | Experimental | Other: PROGRESS groupthis 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. |
| control group | Other | Other: PROGRESS groupthis 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- workers with stress complaints aging from 18 to 60 years. They also had to have at least 8 years of education.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PROGRESS group | Other | PROGRESS group, control group |
Primary outcome
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.
5 secondary outcomes
changes in subjective depression symptoms
Time frame: baseline, 8 weeks and 16 weeks
changes in anxiety symptoms
Time frame: baseline, 8 weeks and 16 weeks
changes in speed of perception and visual and motor response
Time frame: baseline, 8 weeks and 16 weeks
changes in Mindful Awareness and attention
Time frame: baseline, 8 weeks and 16 weeks
changes in psychiatric symptoms
Time frame: baseline, 8 weeks and 16 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2018.
- Derived from this study: PubMed 29867646Lacerda 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.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
stephen Little Me principal investigator
Centro de estudos em Atenção Plena
Questions about this trial
What is this clinical trial studying?
A study testing PROGRESS group in people with Stress, run by Centro de estudos em Atenção Plena.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 May 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
changes in subjective symptoms of stress (time frame: baseline, 8 weeks and 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02660307, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2018.