Clinical trial NCT06334887: esTOCma, an App Used by Teachers: an RCT
Official title: A RCT of a Mobile App (esTOCma) to Improve Mental Health Literacy, Stigmatizing Attitudes Related to OCD, and Confidence in Dealing With Students With OCD in Teachers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obsessive-Compulsive Disorder
Keywords: obsessive-compulsive disorder
adolescence
mobile app
mental health literacy
teachers
Lead sponsor: University of Valencia
Sponsor class: OTHER
Collaborators: name: Ministry of Science and Innovation, Spain
First posted: 2024-03-28
Enrollment: 168
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A parallel randomized controlled trial (RCT) with two arms: experimental group (use of esTOCma) and control group (untreated) will be carried out.

As participants enroll in the study, those that meet the inclusion criteria will be randomized into experimental or control group and into contamination or aggressive vignette (see Outcome Measures). Everyone will complete the baseline measures (T1). Then, those assigned to experimental group will use the app esTOCma until they finish it (they will be given a 10-days deadline), whereas control group will do nothing for 10 days. After that, all the participants will complete again the assessment instruments (T2).
Primary purpose: PREVENTION

Brief summary: The aim of the present study is to assess the efficacy of a mobile application called esTOCma in promoting mental health literacy, reducing stigmatizing attitudes related to the Obsessive-Compulsive Disorder (OCD) and improving teachers' confidence in dealing with students that might have OCD. A parallel, randomized controlled trial with two conditions (experimental and control group) will be carried out in a sample of teachers that work in primary and secondary education. Pre-post changes will be assessed. Experimental group will use the app until they finish it (within a set period of 10 days), whereas control group will do nothing for 10 days. Primarily, it is expected that after the use of the app, participants will show an improvement in OCD-related literacy, stigmatizing attitudes, desired social distance and their comfort, confidence and perceived ability in teaching and handling students with OCD. Secondarily, the investigators hypothesize that experimental group might show a reduction in obsessive-compulsive symptoms.

Detailed description: Adolescence is a critical stage that is associated with a high vulnerability to developing obsessive-compulsive disorder (OCD). Schools are part of the natural developmental context of adolescents, and teachers are involved in their education and personal development. In this sense, teachers play an essential role in the early detection and referral of students with possible obsessional symptoms and will also have to deal with the management of this symptomatology in the classroom. Moreover, teachers often have low knowledge of mental health problems and lack strategies for handling mental symptomatology in the classroom.

esTOCma is a mobile health (mHealth) application that has been developed to promote mental health literacy and reduce stigmatizing attitudes associated with OCD. Previous studies have shown that it is a tool with great potential in terms of intervention on stigma and OCD literacy in the general population. Thus, it could be of great interest to use this app in the field of education, and especially in non-university education since adolescents, a highly vulnerable collective to the development of OCD, spend much of their time in the classroom, and often seek help from school staff.

Eligibility criteria: Inclusion Criteria:

* Being a practising teacher in non-university education.
* Working in the education field as a guidance counsellor, language teacher or therapeutic pedagogue.

Exclusion Criteria:

* Working in a field other than those mentioned above.
* Having less than 18 years old.

Primary outcomes:
measure: Change in general OCD literacy
timeFrame: Through app completion (an estimation of 10 days).
measure: Change in OCD literacy associated with a vignette
timeFrame: Through app completion (an estimation of 10 days).
measure: Change in stigmatizing attitudes related to OCD associated with a vignette
timeFrame: Through app completion (an estimation of 10 days).
measure: Change in comfort in addressing OCD
timeFrame: Through app completion (an estimation of 10 days).
measure: Change in desired social distance
timeFrame: Through app completion (an estimation of 10 days).
Secondary outcomes:
measure: Change in obsessive-compulsive symptoms
timeFrame: Through app completion (an estimation of 10 days).
Other outcomes:
Locations:
city: Valencia
country: Spain
facility: University of Valencia/ Universitat de València
Study officials:
affiliation: University of Valencia
name: Gemma García-Soriano
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chaves A, Arnaez S, Castilla D, Roncero M, Garcia-Soriano G. Enhancing mental health literacy in obsessive-compulsive disorder and reducing stigma via smartphone: A randomized controlled trial protocol. Internet Interv. 2022 Jul 13;29:100560. doi: 10.1016/j.invent.2022.100560. eCollection 2022 Sep.
citation: Garcia-Soriano G, Arnaez S, Chaves A, Del Valle G, Roncero M, Moritz S. Can an app increase health literacy and reduce the stigma associated with obsessive-compulsive disorder? A crossover randomized controlled trial. J Affect Disord. 2024 Apr 1;350:636-647. doi: 10.1016/j.jad.2024.01.168. Epub 2024 Jan 20.