esTOCma, an App Used by Teachers: an RCT

NCT06334887 | Completed

• 1 other identifier: PID2021-124409OB-I00_O3
• Study Type: interventional
• Target: 175
• Locations: 1 country
• Sites: 1

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.

Conditions

Obsessive-Compulsive Disorder

Keywords

obsessive-compulsive disorder; adolescence; mobile app; mental health literacy; teachers

Outcome Measures

Primary Outcomes (4)

• Change in general OCD literacy

  Score change in the knowledge and the attitudes towards obsessive-compulsive disorder measured by the OCD Knowledge Stigma Assessment Scale (OKSAS). It is a self-report ad hoc questionnaire with 24 items and a response scale ranging from 1 "Completely disagree" to 5 "Completely agree". The total score is the sum of the items and higher score indicate more knowledge about the disorder.

  Through app completion (an estimation of 10 days).

• Change in stigmatizing attitudes related to OCD

  Score change in stigma will be measured, in association with a vignette, by two questionnaires: 1. Attribution Questionnaire (AQ-9; Corrigan et al., 2015; Spanish version: Muñoz et al., 2015) is a self-report measure for social stigma. It has a Likert scale ranging from 1 = "Not at all" to 9 = "Very much". Investigators will not use the items corresponding to Coercion, Pity and Avoidance. The higher the score (total and per item), the higher the stigma. 2. OCD Stigma Measure (OSM; Ponzini et al., 2023) is a self-report measure composed by 16 items that assess OCD-related stereotypes. 11 items will be used in this study. A total score (sum of all the items) is interpreted. There will be two vignettes that will be randomly assigned. Both portray a student with OCD but one focuses on the contamination content, and the other on the aggression content.

  Through app completion (an estimation of 10 days).

• Change in desired social distance

  Score change in desired social distance will be measured by Reported and Intended Behaviour Scale (RIBS; Evans-Lacko et al., 2011; Spanish version: Sayols-Villanueva et al., 2015). It is a self-report measure with 8 items and it inquires about reported and intended behaviour among four different contexts: (1) living with, (2) working with, (3) living nearby and (4) continuing a relationship with someone with a mental health problem. Investigators will use the 4 items corresponding to intended behaviour subscale. Likert scale from 1 "Agree strongly" to 5 " Disagree strongly" and an additional "Don't know" response option. The total score is calculated by adding together the response values, and "Don't know" is coded as a neutral value (i.e. 3). This questionnaire will be used in association with a vignette.

  Through app completion (an estimation of 10 days).

• Change in percieved confidence when addressing students with OCD

  Score change in confidence when addressing students with OCD will be measured using items adapted and translated from previous studies (Jorm et al., 2010; Kutcher et al., 2016; Whitley \& Gooderham, 2016). Three dimensions are evaluated separately: Confidence in interacting, composed of three items with a Likert scale ranging from 1 "Completely disagree" to 5 "Completely agree". The total score will be obtained by summing the item responses. Confidence in helping, assessed with a single item ("To what extent do you feel capable of helping a student like N?") rated on a 5-point scale ranging from 1 "Slightly/Not at all confident" to 5 "Extremely/Very confident". Academic confidence, measured with two items rated on a 4-point Likert scale ranging from 1 ("Not at all capable/ Lower academic level") to 4 ("Very capable/Highest academic level"). A total score will be computed by summing both items.

  Through app completion (an estimation of 10 days).

Secondary Outcomes (1)

• Change in obsessive-compulsive symptoms

  Through app completion (an estimation of 10 days).

Study Arms (2)

Use of esTOCma

EXPERIMENTAL

Experimental group will use esTOCma until they finish it (within a preestablished 10-days period).

Device: Use of esTOCma

Control group

NO INTERVENTION

Control group will do nothing for 10 days.

Interventions

Use of esTOCma DEVICE

Participants of the experimental group will use the esTOCma mobile app until completion, within a set period of 10 days. EsTOCma is a a serious game with 10 missions where users have to free 10 characters who have been imprisoned by a monster called esTOCma, which metaphorically represents the stigma in OCD. With each mission, users will gain knowledge about OCD and free an imprisoned character until the tenth mission, when they will defeat the monster. This game has three modules: (1) Psychoeducation (missions 1-5), where general information about OCD, OCD treatments and where to seek help is provided; (2) Indirect Contact (missions 6 and 7), which consists of a series of audio-visual recordings in which OCD patients report their symptoms and the impact the disorder has had on their lives; and finally, (3) Cognitive Restructuring (missions 8-10), where common dysfunctional beliefs about OCD and OCD treatment are challenged.

Use of esTOCma

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Valencia: lead
• Ministry of Science and Innovation, Spain: collaborator

Study Sites (1)

University of Valencia/ Universitat de València

Valencia, 46010, Spain

Location

Related Publications (2)

• 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.

  PMID: 35874968 BACKGROUND

• 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.

  PMID: 38253133 BACKGROUND

Related Links

• Blog about the app esTOCma

MeSH Terms

Conditions

Obsessive-Compulsive Disorder

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Study Officials

• Gemma García-Soriano

  University of Valencia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD, associate professor

Model Details: 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).

Study Record Dates

• First Submitted: March 21, 2024
• First Posted: March 28, 2024
• Study Start: February 26, 2024
• Primary Completion: June 30, 2024
• Study Completion: June 30, 2024
• Last Updated: December 30, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Time Frame: It will be available for 3 months after the publication of the study.
• Access Criteria: Data will be available in a repository website: Zenodo.

Locations

ES (1)