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

NCT ID: NCT04016883

Last Updated: 2020-06-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-20

Study Completion Date

2020-09-28

Brief Summary

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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

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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).

Conditions

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Stress, Psychological Behavior Occupational Stress Mental Health Wellness 1

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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:
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Investigators
double-blind masking

Study Groups

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Conventional web platform

Participants asked to review the web platform for 4 weeks.

Group Type SHAM_COMPARATOR

Conventional web platform

Intervention Type OTHER

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

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.

Group Type EXPERIMENTAL

Problem Solving Therapy offered through a web platform

Intervention Type 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.

Interventions

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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.

Intervention Type OTHER

Conventional web platform

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

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

25 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institutes of Health (NIH)

NIH

Sponsor Role collaborator

Universidad Peruana Cayetano Heredia

OTHER

Sponsor Role lead

Responsible Party

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Katherine Linda Arapa Apaza

Researcher

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Universidad Peruana Cayetano Heredia

Lima, , Peru

Site Status RECRUITING

Countries

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Peru

Central Contacts

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Cesar Carcamo, MD

Role: CONTACT

997350773

Facility Contacts

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Katherine Arapa, Research

Role: primary

+51944203312

References

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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.

Reference Type BACKGROUND
PMID: 23855376 (View on PubMed)

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.

Reference Type RESULT
PMID: 26818683 (View on PubMed)

Other Identifiers

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103876

Identifier Type: -

Identifier Source: org_study_id

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