Effect of Problem-solving Therapy Offered Through a Web Platform on Levels of Stress (PST on stress)

June 5, 2020 updated by: Katherine Linda Arapa Apaza, Universidad Peruana Cayetano Heredia

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.

Study Overview

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 Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Lima, Peru, 07056
        • Recruiting
        • Universidad Peruana Cayetano Heredia
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Sham Comparator: Conventional web platform
Participants asked to review the web platform for 4 weeks.
The conventional web platform, which will contain the general content on stress coping techniques.
Experimental: Problem Solving Therapy offered through a web platform
4 sessions with cognitive behavioral therapy, offered through a web platform. Each session will be offered per week.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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]
0 and 5 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Occupational stress scale
Time Frame: 0 and 5 weeks

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)

0 and 5 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 20, 2019

Primary Completion (Actual)

April 28, 2020

Study Completion (Anticipated)

September 28, 2020

Study Registration Dates

First Submitted

July 8, 2019

First Submitted That Met QC Criteria

July 8, 2019

First Posted (Actual)

July 12, 2019

Study Record Updates

Last Update Posted (Actual)

June 9, 2020

Last Update Submitted That Met QC Criteria

June 5, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • 103876

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

No individual participant data will be shared

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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