- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06334887
esTOCma, an App Used by Teachers: an RCT
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 Overview
Status
Conditions
Intervention / Treatment
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 (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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Gemma García-Soriano
- Phone Number: +34 963983389
- Email: gemma.garcia@uv.es
Study Locations
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Valencia, Spain, 46010
- Recruiting
- University of Valencia/ Universitat de València
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Contact:
- Gemma Garcia-Soriano, PhD
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Use of esTOCma
Experimental group will use esTOCma until they finish it (within a preestablished 10-days period).
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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. |
No Intervention: Control group
Control group will do nothing for 10 days.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in general OCD literacy
Time Frame: Through app completion (an estimation of 10 days).
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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.
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Through app completion (an estimation of 10 days).
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Change in comfort in addressing OCD
Time Frame: Through app completion (an estimation of 10 days).
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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.
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Through app completion (an estimation of 10 days).
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Change in OCD literacy associated with a vignette
Time Frame: Through app completion (an estimation of 10 days).
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Score change in mental health literacy associated with a vignette assesses by:
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).
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Change in stigmatizing attitudes related to OCD associated with a vignette
Time Frame: Through app completion (an estimation of 10 days).
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Score change in stigma associated with a vignette measured by:
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Through app completion (an estimation of 10 days).
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Change in desired social distance
Time Frame: Through app completion (an estimation of 10 days).
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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).
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in obsessive-compulsive symptoms
Time Frame: Through app completion (an estimation of 10 days).
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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.
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Through app completion (an estimation of 10 days).
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Gemma García-Soriano, University of Valencia
Publications and helpful links
General 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.
- 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.
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PID2021-124409OB-I00_O3
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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