Clinical trial NCT04016883: Effect of Problem-solving Therapy Offered Through a Web Platform on Levels of 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stress, Psychological
Behavior
Occupational Stress
Mental Health Wellness 1
Lead sponsor: Universidad Peruana Cayetano Heredia
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2019-07-12
Enrollment: 100
Sex: ALL
Minimum age (years): 25
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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:
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Change in Self-perceived stress scale score
timeFrame: 0 and 5 weeks
Secondary outcomes:
measure: Change in Occupational stress scale
timeFrame: 0 and 5 weeks
Other outcomes:
Locations:
city: Lima
country: Peru
facility: Universidad Peruana Cayetano Heredia
Study officials:
References:
citation: 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.
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.