Obsessive-Compulsive DisorderESTOCMANCT04777292
ESTOCMA: Mental Health Application for Enhancing Mental Health Literacy About Obsessive-compulsive Disorder
A study testing Use of a mobile health application until app completion in people with Obsessive-Compulsive Disorder, run by University of Valencia at 1 site in Spain.
Trial summary
The aim of the study is to analyze the efficacy of a mobile health application (app) designed to increase mental health literacy, help seeking attitudes and reduce stigma associated with obsessive-compulsive disorder. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Obsessive-Compulsive Disorder
- What is being tested?
- Use of a mobile health application until app completion
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 228 participants
- Where
- 1 siteSpain
- Study dates
- 21 Dec 2021to 30 Jul 2022
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- having 18 years old or more
- mobile phone
Who cannot join
- having an obsessive-compulsive disorder diagnosis or suspictious of having OCD
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Controlled Trial of a Mobile Health Application for Enhancing Mental Health Literacy About Obsessive-compulsive Disorder and Reduce Stigmatizing Attitudes in Community (ESTOCMA)
The aim of the study is to analyze the efficacy of a mobile health application (app) designed to increase mental health literacy, help seeking attitudes and reduce stigma associated with obsessive-compulsive disorder. A randomized controlled trial with crossover design will be carried out in non-clinical population to assess pre-post changes in levels mental health literacy, help seeking attitudes and stigma through app completion (an estimation of 10 days). Moreover, the stability of the changes will be tested at 3 months. Participants from community will be randomly assigned to one of two conditions: undertaking immediate-use or delayed use. We hypothesized that after using the app, participants will have a greater knowledge about obsessive-compulsive disorder, will be more prone to ask for help in case of showing OCD symptoms, and will show lower stigma attitudes and social distance.
Read the detailed description
Stigmatizing attitudes are a problem associated to mental disorders. In obsessive-compulsive disorder (OCD) stigma has been associated to shame, guilty and delay asking for help. The aim of the study is to analyze the efficacy of a mobile health application (app) designed to increase mental health literacy, help seeking attitudes and reduce stigma associated with obsessive-compulsive disorder. The app has been named esTOCma. It consists in a game in which participants are asked to fight against the OCD stigma monster through ten missions. Participants have to liberate 10 characters who are prisoners of EsTOCma monster. A randomized controlled trial with crossover design will be carried out in non-clinical population to assess pre-post changes in levels mental health literacy, help seeking attitudes and stigma through app completion. Participants from community will be randomly assigned to one of two conditions: undertaking immediate-use (experimental group) or delayed-use (wait list control group) of the intervention through the esTOCma mobile app. Participants will be randomized through the app either to the experimental or control group. Then, within each group, participants will be randomized to one of six vignettes describing different obsessive-compulsive contents, and will be asked to complete baseline questionnaires (T0). Participants in the experimental group will be allowed to start using the app immediately after completing T0 and until completing the game (approximately 10 days). Immediately after finishing the app they will be asked to complete the post intervention assessment (T1), and then, 10 days after they will be asked to complete a follow up (T2). Participants in the control group will work as a waiting list comparison, in this sense, after completing the baseline assessment (T0), they will not be allowed to use the app. Then, days after completing the baseline questionnaires will be asked to complete again the baseline assessment (T1), and then, they will be allowed to begin the game until completing it. After, they will be asked to complete the post intervention assessment (T2). All participants will be asked to complete again the questionnaires 3 months after the post intervention assessment.
- Conditions
- Obsessive-Compulsive Disorder
- Being tested
- Use of a mobile health application until app completion
- Keywords
- mental health literacy, randomized controlled trial, obsessive-compulsive disorder, stigma, seeking help
- Medical subject headings
- Obsessive-Compulsive Disorder, Social Stigma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Use of a mobile health application until app completionDevice
Also called Use of esTOCma app
Participants are asked to use esTOCma app approximately during 10 days, until app completion. This app has been designed to increase knowledge about obsessive-compulsive disorder (OCD), help seeking attitudes, and reduce stigmatizing attitudes. It consists in a game in which participants are asked to fight against the OCD stigma monster through ten missions. Participants have to liberate 10 characters who are prisoners of EsTOCma monster.
| Study group | Role | What they receive |
|---|---|---|
| Immediate-use | Experimental | Immediate use of esTOCma mobile app. Participants will use the mobile application immediately after the baseline assessment (T0) during approximately 10 days or until app completion. Receives: Device: Use of a mobile health application until app completion |
| Delayed use | Active comparator | Delayed use of esTOCma mobile app. Participants will start using the app 10 days after the first assessment (T0), and immediately after the T1 assessment. Receives: Device: Use of a mobile health application until app completion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in mental health literacy about obsessive-compulsive disorder
Score change in mental health literacy (MHL) from baseline to app completion. MHL will be assessed through a self-report questionnaire developed ad hoc to assess general OCD knowledge and OCD identification. It is composed by 8 items with different alternatives. Correct answers will be computed. Higher score indicates higher number of correct answers, that is, higher OCD knowledge and identification.
Measured: Through app completion, an average 10 days, and at 3 months follow-up
Change in stigmatizing attitudes associated with obsessive-compulsive disorder
Score change in stigma from baseline to app completion. Stigma will be assessed by the Spanish Mental Illness Stigma Attribution Questionnaire. It is composed by 27 items and a Likert scale from 1 to 9. Higher scores indicate higher stigmatizing attitudes.
Measured: Through app completion, an average 10 days, and at 3 months follow-up.
Change in social distance associated with obsessive-compulsive disorder
Score change in social distance from baseline to app completion. Social distance will be measured through a self-report questionnaire: Social Distance Scale, 7 items, Likert scale from 0 to 3. Higher scores, higher social distance.
Measured: Through app completion, an average 10 days, and at 3 months follow-up.
Change in help-seeking attitudes associated with obsessive-compulsive symptoms
Score change in attitudes toward seeking help from baseline to app completion. It will be assessed with a self-report questionnaire assessing intention of seeking from formal/ informal sources of help: the General Help Seeking Questionnaire. It is composed by 7 items with a Likert scale from 1 to 7. Higher scores indicate higher intentions of asking for help except in item 7 (reversed score).
Measured: Through app completion, an average 10 days, and at 3 months follow-up.
Change in Obsessive-Compulsive symptoms
Score change on distress caused by obsessive-compulsive symptoms from baseline to app completion.. It will be assessed with the Obsessive-Compulsive Inventory-Revised. It is an 18-item self-report questionnaire, rated on a 4-point scale ranging from 1 ("not at all") to 4 ("extremely") that provides a total score (ranging from 0 to 72) and scores on six subscales: washing, checking, ordering, obsessing, hoarding and neutralizing. The total score will be used.
Measured: Through app completion, an average 10 days, and at 3 months follow-up
Secondary outcomes (1)
Change in Self-esteem
Score change in self-esteem from baseline to app completion. It will be assessed with the Single-Item Self-esteem Scale, a single item to measure self-esteem (i.e., I have high self-esteem) on a 5-point Likert Scale ranging from 1 ("not very true of me") to 5 ("very true of me"). The scale has strong convergent validity with the Rosenberg Self-Esteem Scale and showed similar predictive validity.
Measured: Through app completion, an average 10 days, and at 3 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2021
- Study start21 Dec 2021
- Primary completion30 Apr 2022
- Study completion30 Jul 2022
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
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 228 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Valencia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gemma García-Soriano, University of Valencia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04777292
- Sponsor's protocol ID
- 29401
- Other IDs
- RTI2018-098349-B-I00
- Acronym
- ESTOCMA
- Status last verified
- Nov 2022
- First submitted
- 23 Feb 2021
- Last updated
- 4 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 4 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of a Mobile Health Application for Enhancing Mental Health Literacy About Obsessive-compulsive Disorder and Reduce Stigmatizing Attitudes in Community (ESTOCMA)
- ClinicalTrials.gov ID
- NCT04777292
- Acronym / sponsor ID
- ESTOCMA / 29401
- Conditions
- Obsessive-Compulsive Disorder
- Keywords
- mental health literacy, randomized controlled trial, obsessive-compulsive disorder, stigma, seeking help
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 228 participants (actual)
- Lead sponsor
- University of ValenciaUniversity, hospital or other
- Study start
- 21 Dec 2021 (actual)
- Primary completion
- 30 Apr 2022 (actual)
- Study completion
- 30 Jul 2022 (actual)
- First posted
- 2 Mar 2021 (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 study is to analyze the efficacy of a mobile health application (app) designed to increase mental health literacy, help seeking attitudes and reduce stigma associated with obsessive-compulsive disorder. A randomized controlled trial with crossover design will be carried out in non-clinical population to assess pre-post changes in levels mental health literacy, help seeking attitudes and stigma through app completion (an estimation of 10 days). Moreover, the stability of the changes will be tested at 3 months. Participants from community will be randomly assigned to one of two conditions: undertaking immediate-use or delayed use. We hypothesized that after using the app, participants will have a greater knowledge about obsessive-compulsive disorder, will be more prone to ask for help in case of showing OCD symptoms, and will show lower stigma attitudes and social distance.
Detailed description
Stigmatizing attitudes are a problem associated to mental disorders. In obsessive-compulsive disorder (OCD) stigma has been associated to shame, guilty and delay asking for help. The aim of the study is to analyze the efficacy of a mobile health application (app) designed to increase mental health literacy, help seeking attitudes and reduce stigma associated with obsessive-compulsive disorder. The app has been named esTOCma. It consists in a game in which participants are asked to fight against the OCD stigma monster through ten missions. Participants have to liberate 10 characters who are prisoners of EsTOCma monster. A randomized controlled trial with crossover design will be carried out in non-clinical population to assess pre-post changes in levels mental health literacy, help seeking attitudes and stigma through app completion. Participants from community will be randomly assigned to one of two conditions: undertaking immediate-use (experimental group) or delayed-use (wait list control group) of the intervention through the esTOCma mobile app. Participants will be randomized through the app either to the experimental or control group. Then, within each group, participants will be randomized to one of six vignettes describing different obsessive-compulsive contents, and will be asked to complete baseline questionnaires (T0). Participants in the experimental group will be allowed to start using the app immediately after completing T0 and until completing the game (approximately 10 days). Immediately after finishing the app they will be asked to complete the post intervention assessment (T1), and then, 10 days after they will be asked to complete a follow up (T2). Participants in the control group will work as a waiting list comparison, in this sense, after completing the baseline assessment (T0), they will not be allowed to use the app. Then, days after completing the baseline questionnaires will be asked to complete again the baseline assessment (T1), and then, they will be allowed to begin the game until completing it. After, they will be asked to complete the post intervention assessment (T2). All participants will be asked to complete again the questionnaires 3 months after the post intervention assessment.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immediate-use | Experimental | Device: Use of a mobile health application until app completionImmediate use of esTOCma mobile app. Participants will use the mobile application immediately after the baseline assessment (T0) during approximately 10 days or until app completion. |
| Delayed use | Active comparator | Device: Use of a mobile health application until app completionDelayed use of esTOCma mobile app. Participants will start using the app 10 days after the first assessment (T0), and immediately after the T1 assessment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- having 18 years old or more
- mobile phone
Key exclusion criteria (1 listed)
- having an obsessive-compulsive disorder diagnosis or suspictious of having OCD
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 a mobile health application until app completionAlso: Use of esTOCma appParticipants are asked to use esTOCma app approximately during 10 days, until app completion. This app has been designed to increase knowledge about obsessive-compulsive disorder (OCD), help seeking attitudes, and reduce stigmatizing attitudes. It consists in a game in which participants are asked to fight against the OCD stigma monster through ten missions. Participants have to liberate 10 characters who are prisoners of EsTOCma monster. | Device | Delayed use, Immediate-use |
Primary outcome
Change in mental health literacy about obsessive-compulsive disorder
Time frame: Through app completion, an average 10 days, and at 3 months follow-up
Score change in mental health literacy (MHL) from baseline to app completion. MHL will be assessed through a self-report questionnaire developed ad hoc to assess general OCD knowledge and OCD identification. It is composed by 8 items with different alternatives. Correct answers will be computed. Higher score indicates higher number of correct answers, that is, higher OCD knowledge and identification.
Change in stigmatizing attitudes associated with obsessive-compulsive disorder
Time frame: Through app completion, an average 10 days, and at 3 months follow-up.
Score change in stigma from baseline to app completion. Stigma will be assessed by the Spanish Mental Illness Stigma Attribution Questionnaire. It is composed by 27 items and a Likert scale from 1 to 9. Higher scores indicate higher stigmatizing attitudes.
Change in social distance associated with obsessive-compulsive disorder
Time frame: Through app completion, an average 10 days, and at 3 months follow-up.
Score change in social distance from baseline to app completion. Social distance will be measured through a self-report questionnaire: Social Distance Scale, 7 items, Likert scale from 0 to 3. Higher scores, higher social distance.
Change in help-seeking attitudes associated with obsessive-compulsive symptoms
Time frame: Through app completion, an average 10 days, and at 3 months follow-up.
Score change in attitudes toward seeking help from baseline to app completion. It will be assessed with a self-report questionnaire assessing intention of seeking from formal/ informal sources of help: the General Help Seeking Questionnaire. It is composed by 7 items with a Likert scale from 1 to 7. Higher scores indicate higher intentions of asking for help except in item 7 (reversed score).
Change in Obsessive-Compulsive symptoms
Time frame: Through app completion, an average 10 days, and at 3 months follow-up
Score change on distress caused by obsessive-compulsive symptoms from baseline to app completion.. It will be assessed with the Obsessive-Compulsive Inventory-Revised. It is an 18-item self-report questionnaire, rated on a 4-point scale ranging from 1 ("not at all") to 4 ("extremely") that provides a total score (ranging from 0 to 72) and scores on six subscales: washing, checking, ordering, obsessing, hoarding and neutralizing. The total score will be used.
1 secondary outcome
Change in Self-esteem
Time frame: Through app completion, an average 10 days, and at 3 months follow-up
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 4 Nov 2022.
- 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.
- Derived from this study: 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: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 a mobile health application until app completion 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 1 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 4 Nov 2022. 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 mental health literacy about obsessive-compulsive disorder (time frame: Through app completion, an average 10 days, and at 3 months follow-up). The study lists 5 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 NCT04777292, 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 4 Nov 2022.