esTOCma, an App Used by Teachers: an RCT

Obsessive-Compulsive Disorder Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06334887
• Other study ID #: PID2021-124409OB-I00_O3
• Status: Recruiting
• Phase: N/A
• Start date: February 26, 2024
• Est. completion date: May 31, 2024

Study information

• Verified date: March 2024
• Source: University of Valencia
• Contact: Gemma García-Soriano
• Phone: +34 963983389
• Email: gemma.garcia[@]uv.es
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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 (primary and secondary 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: May 31, 2024
• Est. primary completion date: May 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

• Being a practising teacher in Primary or Secondary 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.

Related Conditions & MeSH terms

• Obsessive-Compulsive Disorder

Intervention

Device:
• Use of esTOCma
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.

Locations

Country	Name	City	State
Spain	University of Valencia/ Universitat de València	Valencia

Sponsors (2)

Lead Sponsor	Collaborator
University of Valencia	Ministry of Science and Innovation

Country where clinical trial is conducted

Spain, 

References & 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).
Primary	Change in OCD literacy associated with a vignette	Score change in mental health literacy associated with a vignette assesses by: An ad hoc questionnaire with 2 items: an open-ended question that inquires about what the participants thinks is happening to the person described in the vignette; and a Likert question "To what extent do you feel capable of helping a student like N?" with a 5-point scale (from 1 "Slightly/Not at all confident" to 5 "Extremely/Very confident". Each item will the reviewed individually.; Questionnaire developed by Whitley & Gooderham (2016) composed by 6 items. The 3 items corresponding to Teacher Efficacy, Teacher Expectations and Problem Severity will be used. 4-point Likert scale ranging from 1"Least/Lowest" to 4 "Most/Highest". The total score and each item will be taken into account.; 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 aggressive content.	Through app completion (an estimation of 10 days).
Primary	Change in stigmatizing attitudes related to OCD associated with a vignette	Score change in stigma associated with a vignette measured by: Attribution Questionnaire (AQ-9; González-Sanguino, et al., 2019) is a self-report measure. 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 and two subscales (Severe Mental Illness-related Stereotypes and Anxiety-relevant Stereotypes). 11 items will be used in this study. A total score (sum of all the items) is interpreted, as well as each subscale.	Through app completion (an estimation of 10 days).
Primary	Change in comfort in addressing OCD	Score change in the comfort in dealing with people with OCD will be measured by Comfort Questionnaire (Kutcher et al., 2016). It is a self-report instrument with two parts. Part A assesses the sense of comfort in talking to, identifying and advising students with OCD, and part B appraises the referrals, that is, whether participants have identified and advised a student or acquaintance who might have OCD, or if they have sought help for themselves. Part A has a Likert scale ranging from 1 "Completely disagree" to 5 "Completely agree" so the total score will be obtained by adding up and averaging these items. And in part B they have to answer Yes or No, therefore each item will be reviewed individually in terms of percentages.	Through app completion (an estimation of 10 days).
Primary	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). 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).
Secondary	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.	Through app completion (an estimation of 10 days).

External Links

•   Blog about the app esTOCma