Obsessive-Compulsive DisorderNCT06334887
esTOCma, an App Used by Teachers: an RCT
A study testing Use of esTOCma in people with Obsessive-Compulsive Disorder, run by University of Valencia at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Obsessive-Compulsive Disorder
- What is being tested?
- Use of esTOCma
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 175 participants
- Where
- 1 siteSpain
- Study dates
- 26 Feb 2024to 30 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Being a practising teacher in non-university education.
- Working in the education field as a guidance counsellor, language teacher or therapeutic pedagogue.
Who cannot join
- Working in a field other than those mentioned above.
- Having less than 18 years old.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Obsessive-Compulsive Disorder
- Being tested
- Use of esTOCma
- Keywords
- obsessive-compulsive disorder, adolescence, mobile app, mental health literacy, teachers
- Medical subject headings
- Obsessive-Compulsive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Use of esTOCmaDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Use of esTOCma | Experimental | Experimental group will use esTOCma until they finish it (within a preestablished 10-days period). Receives: Device: Use of esTOCma |
| Control group | No intervention | Control group will do nothing for 10 days. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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:
- 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.
- 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.
Measured: 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.
Measured: 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.
Measured: Through app completion (an estimation of 10 days).
Secondary outcomes (1)
Change in obsessive-compulsive symptoms
Score change in OCD symptoms will be measured by Obsessive-Compulsive Inventory - Revised. The reduced 4-item version (OCI-4; Abramovich et al., 2021) that assesses four dimensions of OCD (washing, checking, ordering, obsessing) will be used. It has a 5-point Likert scale ranging from 0 "Not at all" to 4 "Very much". The items will be added.
Measured: Through app completion (an estimation of 10 days).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2024
- Study start26 Feb 2024
- Primary completion30 Jun 2024
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Obsessive-Compulsive DisorderStudies of the same condition, open and under way.
- More trials run by University of ValenciaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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).
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 175 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Valencia
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Science and Innovation, Spain
- Responsible party
- Principal investigator, Gemma García-Soriano, University of Valencia
- Investigators
- Gemma García-Soriano, Principal investigator, University of Valencia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06334887
- Sponsor's protocol ID
- PID2021-124409OB-I00_O3
- Status last verified
- Dec 2025
- First submitted
- 21 Mar 2024
- Last updated
- 30 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Share all IPD that underlie results in a publication.
Publications
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.
PubMed 35874968Garcia-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.
PubMed 38253133
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06334887
- Acronym / sponsor ID
- PID2021-124409OB-I00_O3
- Conditions
- Obsessive-Compulsive Disorder
- Keywords
- obsessive-compulsive disorder, adolescence, mobile app, mental health literacy, teachers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 175 participants (actual)
- Lead sponsor
- University of ValenciaUniversity, hospital or other
- Collaborators
- Ministry of Science and Innovation, Spain
- Study start
- 26 Feb 2024 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 28 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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).
| Arm | Type | Receives |
|---|---|---|
| Use of esTOCma | Experimental | Device: Use of esTOCmaExperimental group will use esTOCma until they finish it (within a preestablished 10-days period). |
| Control group | No intervention | –Control group will do nothing for 10 days. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Being a practising teacher in non-university education.
- Working in the education field as a guidance counsellor, language teacher or therapeutic pedagogue.
Key exclusion criteria (2 listed)
- Working in a field other than those mentioned above.
- Having less than 18 years old.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Use of esTOCmaParticipants 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. | Device | Use of esTOCma |
Primary outcome
Change in general OCD literacy
Time frame: Through app completion (an estimation of 10 days).
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.
Change in stigmatizing attitudes related to OCD
Time frame: Through app completion (an estimation of 10 days).
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.
Change in desired social distance
Time frame: Through app completion (an estimation of 10 days).
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.
Change in percieved confidence when addressing students with OCD
Time frame: Through app completion (an estimation of 10 days).
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.
1 secondary outcome
Change in obsessive-compulsive symptoms
Time frame: Through app completion (an estimation of 10 days).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2025.
- Background: PubMed 35874968Chaves 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.
- Background: PubMed 38253133Garcia-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.
- Individual participant dataSharing planned: Yes. Share all IPD that underlie results in a publication.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gemma García-Soriano principal investigator
University of Valencia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Use of esTOCma in people with Obsessive-Compulsive Disorder, run by University of Valencia at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in general OCD literacy (time frame: Through app completion (an estimation of 10 days).). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06334887, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Dec 2025; AzTrials last refreshed its copy on 6 Nov 2026.