Stress, PsychologicalPST on stressNCT04016883
Effect of Problem-solving Therapy Offered Through a Web Platform on Levels of Stress
A study testing Problem Solving Therapy offered through a web platform and Conventional web platform in people with Stress, Psychological and Behavior, run by Universidad Peruana Cayetano Heredia at 1 site in Peru.
Trial summary
Work-related stress is a problem due to its repercussions on workers' health and productivity, which is why workplace interventions are required to reduce stress levels through coping techniques. Read more about this study
- Who is it for?
- Ages 25 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Stress, Psychological, Behavior, Occupational Stress
- What is being tested?
- Problem Solving Therapy offered through a web platform and Conventional web platform
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 sitePeru
- Study dates
- 20 Dec 2019to 28 Sep 2020
- 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 25 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Workers between 25 to 50 years of age poor conditions to be able to develop a therapy through a web platform.
- Workers with self-perceived stress scale and work stress with scores considered as stress.
- Working time ≥ one year.
- With signed informed consent.
- Workers with access to a computer connected to the internet during their working hours.
- Workers with ranges on the stress scale up to 2 standard deviations above the average.
Who cannot join
- Workers are taking anti-anxiety drugs and antidepressants, who scheduled their vacations during the follow-up period.
- People who for any physical or mental disability cannot use the web platform
- Workers with ranges on the stress scale for above three standard deviations above the average.
Trial locations and contacts
1 site in 1 country.
Peru1 site, 1 recruiting
- Recruiting
Universidad Peruana Cayetano Heredia
Lima, 07056
Katherine Arapa, Research, +51944203312, katherine.arapa.a@upch.pe
About this study
Official title: Effect of Problem-solving Therapy Offered Through a Web Platform on Levels of Perceived Stress by Administrative Workers: A Controlled Randomized Trial
Work-related stress is a problem due to its repercussions on workers' health and productivity, which is why workplace interventions are required to reduce stress levels through coping techniques. One of the interventions in mental health to reduce levels of work stress are those based on the Internet and mobile applications, with proven effectiveness. Among the interventions are cognitive-behavioral therapies and within these the Problem Solving Therapy (PST).
Therefore, there is a need to study the effect of Problem Solving Therapy offered through a web platform on the levels of self-perceived stress. However, there have been no studies on mental health interventions such as the TSP for the reduction of stress levels in office workers. For this reason, the objective of the study is to determine, through a randomized cluster trial, the effectiveness of problem-solving therapy offered through a web platform on self-perceived stress levels. Two scales will measure the levels of stress; one for self-perceived stress and another for work-related stress. Workers who have a high score on both scales will be enrolled. The establishments assigned to the intervention will receive the TSP distributed in 4 sessions. The establishments in the control group would have access to a web page with information on stress management. Immediately after having finished the last session, self-perceived stress levels will be evaluated. One month later a new measurement will be made to evaluate the persistence of the effect.
Read the detailed description
The objective of the study is to determine, through a randomized cluster trial, the effectiveness of problem-solving therapy offered through a web platform on self-perceived stress levels.
Overall objective Evaluate the effect of Problem Solving Therapy offered through a web platform, on the self-perceived stress level of administrative workers.
Specific objectives
- Develop and validate a web platform with problem-solving therapy.
- Determine the cut-off point of self-perceived stress measurement scales.
- Evaluate the factors associated with stress in office workers.
- Compare the levels of Perceived stress scale (PSS) before and after the use of a web platform with educational material in Problem Solving Therapy (PST).
- Compare the effect of a conventional platform versus the Problem Solving Therapy offered through a web platform on self-perceived stress levels.
- Compare the levels of occupational stress (OSS) before and after the use of a web platform with educational material in Problem Solving Therapy (PST).
- Compare the effect of Problem Solving Therapy offered through a web platform versus a conventional web platform on work stress levels (WSS).
- Evaluate the correlation between the perceived stress scale and the occupational stress scale (OSS).
- Being tested
- Problem Solving Therapy offered through a web platform, Conventional web platform
- Medical subject headings
- Stress, Psychological, Behavior, Occupational Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Problem Solving Therapy offered through a web platformOther
Problem Solving Therapy offered through a web platform. There will be four sessions, during the first four weeks of treatment, and subsequent sessions are dedicated to refining problem-solving skills. Participants set treatment goals; different ways to reach goals are discussed and evaluated; action plans are created, and its effectiveness is evaluated to achieve the objectives. Participants are expected to implement plans and apply the problem-solving model to additional problems between sessions. In the last two sessions, participants create a relapse prevention plan using the problem-solving therapy model.
Conventional web platformOther
The conventional web platform, which will contain the general content on stress coping techniques.
| Study group | Role | What they receive |
|---|---|---|
| Conventional web platform | Sham comparator | Participants asked to review the web platform for 4 weeks. Receives: Other: Conventional web platform |
| Problem Solving Therapy offered through a web platform | Experimental | 4 sessions with cognitive behavioral therapy, offered through a web platform. Each session will be offered per week. Receives: Other: Problem Solving Therapy offered through a web platform |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Self-perceived stress scale score
Perceived Stress Scale (PSS) It's formed by 14 items that measure the degree to which, during the last month, people have felt upset or worried or, on the contrary, have felt confident in their ability to control their personal problems. Scale scores between 0-56, with higher scores indicating greater stress perceived. Use a five-way Likert response format with a range of 0 "Never") to 4 ("Very often"). The cut point for determinate stress is 20.9 points (14 + 1 SD (6.9)) for hispanics. [ L. Harris Pol]
Measured: 0 and 5 weeks
Secondary outcomes (1)
Change in Occupational stress scale
Change in Occupational stress scale. This instrument has as author ILO-WHO. The questions are 25 with 7 alternatives such as answers ranging from the score from 1 to 7, of as follows.
[1= if the condition 'Never' is a source of stress. 2 = if the condition 'Rarely' is a source of stress. 3 = if the condition 'Occasionally' is a source of stress 4 = if the condition 'Sometimes' is a source of stress. 5 = if the condition 'Frequently' is a source of stress 6 = if the condition "specifically" is a source of stress. 7 = if the "Always" condition is a source of stress.] The scale determinate the cut point for stress in 120 for Peruvian population. (Suaréz A. 2013)
Measured: 0 and 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2019
- Study start20 Dec 2019
- Primary completion28 Apr 2020
- Study completion28 Sep 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Stress, PsychologicalStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study is a randomized controlled trial of parallel type (2 arms, with a ratio of 1: 1, and with a block size of 5), which consists of the following phases where necessary changes in the methods are described after to start the trial:
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Peruana Cayetano Heredia
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Principal investigator, Katherine Linda Arapa Apaza, Universidad Peruana Cayetano Heredia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04016883
- Sponsor's protocol ID
- 103876
- Acronym
- PST on stress
- Status last verified
- Jun 2020
- First submitted
- 8 Jul 2019
- Last updated
- 9 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No individual participant data will be shared
Publications
Heber E, Ebert DD, Lehr D, Nobis S, Berking M, Riper H. Efficacy and cost-effectiveness of a web-based and mobile stress-management intervention for employees: design of a randomized controlled trial. BMC Public Health. 2013 Jul 15;13:655. doi: 10.1186/1471-2458-13-655.
PubMed 23855376Heber E, Lehr D, Ebert DD, Berking M, Riper H. Web-Based and Mobile Stress Management Intervention for Employees: A Randomized Controlled Trial. J Med Internet Res. 2016 Jan 27;18(1):e21. doi: 10.2196/jmir.5112.
PubMed 26818683
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Problem-solving Therapy Offered Through a Web Platform on Levels of Perceived Stress by Administrative Workers: A Controlled Randomized Trial
- ClinicalTrials.gov ID
- NCT04016883
- Acronym / sponsor ID
- PST on stress / 103876
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Universidad Peruana Cayetano HerediaUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- 20 Dec 2019 (actual)
- Primary completion
- 28 Apr 2020 (actual)
- Study completion
- 28 Sep 2020 (estimated)
- First posted
- 12 Jul 2019 (actual)
- 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.
Work-related stress is a problem due to its repercussions on workers' health and productivity, which is why workplace interventions are required to reduce stress levels through coping techniques. One of the interventions in mental health to reduce levels of work stress are those based on the Internet and mobile applications, with proven effectiveness. Among the interventions are cognitive-behavioral therapies and within these the Problem Solving Therapy (PST).
Therefore, there is a need to study the effect of Problem Solving Therapy offered through a web platform on the levels of self-perceived stress. However, there have been no studies on mental health interventions such as the TSP for the reduction of stress levels in office workers. For this reason, the objective of the study is to determine, through a randomized cluster trial, the effectiveness of problem-solving therapy offered through a web platform on self-perceived stress levels. Two scales will measure the levels of stress; one for self-perceived stress and another for work-related stress. Workers who have a high score on both scales will be enrolled. The establishments assigned to the intervention will receive the TSP distributed in 4 sessions. The establishments in the control group would have access to a web page with information on stress management. Immediately after having finished the last session, self-perceived stress levels will be evaluated. One month later a new measurement will be made to evaluate the persistence of the effect.
Detailed description
The objective of the study is to determine, through a randomized cluster trial, the effectiveness of problem-solving therapy offered through a web platform on self-perceived stress levels.
Overall objective Evaluate the effect of Problem Solving Therapy offered through a web platform, on the self-perceived stress level of administrative workers.
Specific objectives
- Develop and validate a web platform with problem-solving therapy.
- Determine the cut-off point of self-perceived stress measurement scales.
- Evaluate the factors associated with stress in office workers.
- Compare the levels of Perceived stress scale (PSS) before and after the use of a web platform with educational material in Problem Solving Therapy (PST).
- Compare the effect of a conventional platform versus the Problem Solving Therapy offered through a web platform on self-perceived stress levels.
- Compare the levels of occupational stress (OSS) before and after the use of a web platform with educational material in Problem Solving Therapy (PST).
- Compare the effect of Problem Solving Therapy offered through a web platform versus a conventional web platform on work stress levels (WSS).
- Evaluate the correlation between the perceived stress scale and the occupational stress scale (OSS).
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- The study is a randomized controlled trial of parallel type (2 arms, with a ratio of 1: 1, and with a block size of 5), which consists of the following phases where necessary changes in the methods are described after to start the trial:
| Arm | Type | Receives |
|---|---|---|
| Conventional web platform | Sham comparator | Other: Conventional web platformParticipants asked to review the web platform for 4 weeks. |
| Problem Solving Therapy offered through a web platform | Experimental | Other: Problem Solving Therapy offered through a web platform4 sessions with cognitive behavioral therapy, offered through a web platform. Each session will be offered per week. |
Who may qualify
- Ages
- 25 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Workers between 25 to 50 years of age poor conditions to be able to develop a therapy through a web platform.
- Workers with self-perceived stress scale and work stress with scores considered as stress.
- Working time ≥ one year.
- With signed informed consent.
- Workers with access to a computer connected to the internet during their working hours.
Key exclusion criteria (3 listed)
- Workers are taking anti-anxiety drugs and antidepressants, who scheduled their vacations during the follow-up period.
- People who for any physical or mental disability cannot use the web platform
- Workers with ranges on the stress scale for above three standard deviations above the average.
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 |
|---|---|---|
| Problem Solving Therapy offered through a web platformProblem Solving Therapy offered through a web platform. There will be four sessions, during the first four weeks of treatment, and subsequent sessions are dedicated to refining problem-solving skills. Participants set treatment goals; different ways to reach goals are discussed and evaluated; action plans are created, and its effectiveness is evaluated to achieve the objectives. Participants are expected to implement plans and apply the problem-solving model to additional problems between sessions. In the last two sessions, participants create a relapse prevention plan using the problem-solving therapy model. | Other | Problem Solving Therapy offered through a web platform |
| Conventional web platformThe conventional web platform, which will contain the general content on stress coping techniques. | Other | Conventional web platform |
Primary outcome
Change in Self-perceived stress scale score
Time frame: 0 and 5 weeks
Perceived Stress Scale (PSS) It's formed by 14 items that measure the degree to which, during the last month, people have felt upset or worried or, on the contrary, have felt confident in their ability to control their personal problems. Scale scores between 0-56, with higher scores indicating greater stress perceived. Use a five-way Likert response format with a range of 0 "Never") to 4 ("Very often"). The cut point for determinate stress is 20.9 points (14 + 1 SD (6.9)) for hispanics. [ L. Harris Pol]
1 secondary outcome
Change in Occupational stress scale
Time frame: 0 and 5 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2020.
- Background: PubMed 23855376Heber E, Ebert DD, Lehr D, Nobis S, Berking M, Riper H. Efficacy and cost-effectiveness of a web-based and mobile stress-management intervention for employees: design of a randomized controlled trial. BMC Public Health. 2013 Jul 15;13:655. doi: 10.1186/1471-2458-13-655.
- Results publication: PubMed 26818683Heber E, Lehr D, Ebert DD, Berking M, Riper H. Web-Based and Mobile Stress Management Intervention for Employees: A Randomized Controlled Trial. J Med Internet Res. 2016 Jan 27;18(1):e21. doi: 10.2196/jmir.5112.
- Individual participant dataSharing planned: No. No individual participant data will be shared
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Problem Solving Therapy offered through a web platform and Conventional web platform in people with Stress, Psychological and Behavior, run by Universidad Peruana Cayetano Heredia at 1 site in Peru.
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 6 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 9 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Peru. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Cesar Carcamo, MD (997350773, cesar.carcamo@upch.pe), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Self-perceived stress scale score (time frame: 0 and 5 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 NCT04016883, which also lists 2 linked publications.
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 9 Jun 2020.