Effect of Problem-solving Therapy Offered Through a Web Platform on Levels of Stress

Stress, Psychological Clinical Trial

— PST on stress  

Official title:

Effect of Problem-solving Therapy Offered Through a Web Platform on Levels of Perceived Stress by Administrative Workers: A Controlled Randomized Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04016883
• Other study ID #: 103876
• Status: Recruiting
• Phase: N/A
• Start date: December 20, 2019
• Est. completion date: September 28, 2020

Study information

• Verified date: June 2020
• Source: Universidad Peruana Cayetano Heredia
• Contact: Cesar Carcamo, MD
• Phone: 997350773
• Email: cesar.carcamo[@]upch.pe
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: September 28, 2020
• Est. primary completion date: April 28, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 25 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Behavior
• Mental Health Wellness 1
• Occupational Stress
• Stress, Psychological

Intervention

Other:
• Problem Solving Therapy offered through a web platform
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 platform
The conventional web platform, which will contain the general content on stress coping techniques.

Locations

Country	Name	City	State
Peru	Universidad Peruana Cayetano Heredia	Lima

Sponsors (2)

Lead Sponsor	Collaborator
Universidad Peruana Cayetano Heredia	National Institutes of Health (NIH)

Country where clinical trial is conducted

Peru, 

References & Publications (2)

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. — View Citation

Heber 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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]	0 and 5 weeks
Secondary	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)	0 and 5 weeks