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

NCT04016883 | Unknown

• 1 other identifier: 103876
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Change in Occupational stress scale

  0 and 5 weeks

Study Arms (2)

Conventional web platform

SHAM COMPARATOR

Participants asked to review the web platform for 4 weeks.

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.

Other: Problem Solving Therapy offered through a web platform

Interventions

Problem Solving Therapy offered through a web platform OTHER

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.

Problem Solving Therapy offered through a web platform

Conventional web platform OTHER

The conventional web platform, which will contain the general content on stress coping techniques.

Conventional web platform

Eligibility Criteria

• Age: 25 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad Peruana Cayetano Heredia: lead
• National Institutes of Health (NIH): collaborator

Study Sites (1)

Universidad Peruana Cayetano Heredia

Lima, 07056, Peru

RECRUITING

Related 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.

  PMID: 23855376 BACKGROUND

• 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.

  PMID: 26818683 RESULT

MeSH Terms

Conditions

Stress, Psychological; Behavior; Occupational Stress

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Occupational Diseases

Central Study Contacts

Cesar Carcamo, MD

CONTACT

997350773; cesar.carcamo@upch.pe

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: double-blind masking
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher

Model Details: 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:

Study Record Dates

• First Submitted: July 8, 2019
• First Posted: July 12, 2019
• Study Start: December 20, 2019
• Primary Completion: April 28, 2020
• Study Completion: September 28, 2020
• Last Updated: June 9, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

PE (1)