Obsessive-Compulsive Disorder (OCD)esTOCma familyNCT06616350
Impact of EsTOCma on OCD Family Members
A study testing esTOCma: an app to fight stigma associated with OCD in people with Obsessive-Compulsive Disorder (OCD), run by University of Valencia at 1 site in Spain.
Trial summary
The goal of this clinical trial is to test the acceptability, feasibility, and effectiveness of esTOCma in families and relatives of individuals with obsessive-compulsive disorder (OCD). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obsessive-Compulsive Disorder (OCD)
- What is being tested?
- esTOCma: an app to fight stigma associated with OCD
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 211 participants
- Where
- 1 siteSpain
- Study dates
- 4 Apr 2022to 30 Sep 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- having signed the informed consent
- being over 18 years of age;
- having an Android or iOS mobile device with Internet access
- being a family member of a person diagnosed with OCD.
Who cannot join
- not completing one or more of the evaluation time points (pre- or post-intervention)
- not finishing the intervention (experimental group only)
Trial locations and contacts
1 site in 1 country.
About this study
The goal of this clinical trial is to test the acceptability, feasibility, and effectiveness of esTOCma in families and relatives of individuals with obsessive-compulsive disorder (OCD).
Specifically, a randomized controlled trial with two conditions (experimental and control) has been carried out in a sample of families and relatives of individuals with obsessive-compulsive disorder to assess pre-post-intervention changes. Researchers will compare experimental and control group to see if after using the app there is: lower stigma, higher knowledge and understanding about OCD, higher intention to seek help, and higher self-esteem and lower obsessive-compulsive symptoms. and there are no changes in the control group.
The experimental group received the intervention through the esTOCma app.
- Conditions
- Obsessive-Compulsive Disorder (OCD)
- Being tested
- esTOCma: an app to fight stigma associated with OCD
- Keywords
- stigma, obsessive-compulsive disorder, family, mental health literacy, esTOCma, app
- Medical subject headings
- Obsessive-Compulsive Disorder, Social Stigma, Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
esTOCma: an app to fight stigma associated with OCDDevice
The intervention consists of playing a serious game, called esTOCma, on a mobile phone. In the game, players must use their knowledge to battle the stigma monster of OCD, complete 10 missions, and release 10 individuals who have been afflicted by the esTOCma monster, a creature that feeds on false beliefs and misinformation in society.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Participants used the app esTOCma Receives: Device: esTOCma: an app to fight stigma associated with OCD |
| Control group | No intervention | Participants did nothing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change on mental health literacy about OCD
Score change on mental health literacy about OCD from baseline to after app completion in the experimental group, and no changes after 10 days in the control group. It will be assessed with the Mental Health Literacy Questionnaire (MHL) that was designed to assess level of knowledge about OCD, specifically the understanding of OCD and its treatment. Higher scores indicate higher knowledge.
Measured: through study completion, an average of 10 days
Change in social distance
Score change in social distance from baseline to after app completion (experimental group), or no changes on the control group after 10 days. It will be assessed with the Social Distance Scale (SDS) that employs a four-point Likert scale, ranging from 0 to 3, to assess an individual's willingness to interact with a person who has a mental disorder as depicted in the assigned OC vignette across seven different settings. Higher scores indicate a stronger desire for social distance.
Measured: through study completion, an average of 10 days
Change in stigma associated with OCD
Score change in stigma from baseline to app completion (estimation of 10 days) in the experimental group, and after 10 days in the control group. Stigma will be assessed by the Spanish version of the Attribution Questionnaire (AQ-27) that assesses public stigma related to a vignette. Respondents rate 27 items on a Likert-type scale from 1 to 9. Elevated scores indicate greater public stigma.
Measured: through study completion, an average of 10 days
Change in help-seeking intention
Score change in help-seeking intention General after the intervention in the experimental group, and after 10 days in the control group. It will be assessed with the Help-Seeking Questionnaire (GHSQ) that comprises 10 items assessing the intention to seek help from various sources in the event of experiencing symptoms similar to those described in the assigned OC vignette. Higher scores indicate a greater tendency to seek help.
Measured: through study completion, an average of 10 days
Secondary outcomes (2)
Change in obsessive-compulsive symptoms
Score change in obsessive-compulsive symptoms after the intervention (experimental group) or after 10 days (control group). It will be assessed with the Obsessive-Compulsive Inventory-Revised (OCI-R), an 18-item self-report questionnaire designed to assess the severity of OC symptoms. Higher scores indicate a greater degree of distress associated with OC symptoms.
Measured: through study completion, an average of 10 days
Change on self-esteem
Change on self-esteem is measured with the Single-Item Self-Esteem Scale, a single item that measures self-esteem, with higher scores reflecting greater self-esteem
Measured: through study completion, an average 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 posted27 Sep 2024
- Study start4 Apr 2022
- Primary completion30 Sep 2022
- Study completion30 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Obsessive-Compulsive Disorder (OCD)Studies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study is a two-arm randomized controlled trial with measurements taken at two time points: pre-intervention and post-intervention. Participants who met the inclusion criteria were automatically randomized within the app into either the experimental or control group using a 1:1 allocation ratio. The experimental group received the intervention through the esTOCma app, and completed the assessment questionnaires before and after the intervention. Participants in the control group did not receive the intervention and completed the assessment questionnaires again 10 days after the pre-assessment (post-intervention).
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 211 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
- Investigators
- Gemma García-Soriano, PhD, Principal investigator, Universitat de València
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06616350
- Sponsor's protocol ID
- 1276901_FAMILY
- Acronym
- esTOCma family
- Status last verified
- Sep 2024
- First submitted
- 19 Sep 2024
- Last updated
- 27 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD that underlie results in a publication
Publications
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.
PubMed 38253133
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of EsTOCma on OCD Family Members
- ClinicalTrials.gov ID
- NCT06616350
- Acronym / sponsor ID
- esTOCma family / 1276901_FAMILY
- Conditions
- Obsessive-Compulsive Disorder (OCD)
- Keywords
- stigma, obsessive-compulsive disorder, family, mental health literacy, esTOCma, app
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 211 participants (actual)
- Lead sponsor
- University of ValenciaUniversity, hospital or other
- Study start
- 4 Apr 2022 (actual)
- Primary completion
- 30 Sep 2022 (actual)
- Study completion
- 30 Sep 2022 (actual)
- First posted
- 27 Sep 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 goal of this clinical trial is to test the acceptability, feasibility, and effectiveness of esTOCma in families and relatives of individuals with obsessive-compulsive disorder (OCD).
Specifically, a randomized controlled trial with two conditions (experimental and control) has been carried out in a sample of families and relatives of individuals with obsessive-compulsive disorder to assess pre-post-intervention changes. Researchers will compare experimental and control group to see if after using the app there is: lower stigma, higher knowledge and understanding about OCD, higher intention to seek help, and higher self-esteem and lower obsessive-compulsive symptoms. and there are no changes in the control group.
The experimental group received the intervention through the esTOCma app.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- This study is a two-arm randomized controlled trial with measurements taken at two time points: pre-intervention and post-intervention. Participants who met the inclusion criteria were automatically randomized within the app into either the experimental or control group using a 1:1 allocation ratio. The experimental group received the intervention through the esTOCma app, and completed the assessment questionnaires before and after the intervention. Participants in the control group did not receive the intervention and completed the assessment questionnaires again 10 days after the pre-assessment (post-intervention).
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Device: esTOCma: an app to fight stigma associated with OCDParticipants used the app esTOCma |
| Control group | No intervention | –Participants did nothing |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- having signed the informed consent
- being over 18 years of age;
- having an Android or iOS mobile device with Internet access
- being a family member of a person diagnosed with OCD.
Key exclusion criteria (2 listed)
- not completing one or more of the evaluation time points (pre- or post-intervention)
- not finishing the intervention (experimental group only)
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 |
|---|---|---|
| esTOCma: an app to fight stigma associated with OCDThe intervention consists of playing a serious game, called esTOCma, on a mobile phone. In the game, players must use their knowledge to battle the stigma monster of OCD, complete 10 missions, and release 10 individuals who have been afflicted by the esTOCma monster, a creature that feeds on false beliefs and misinformation in society. | Device | Experimental group |
Primary outcome
Change on mental health literacy about OCD
Time frame: through study completion, an average of 10 days
Score change on mental health literacy about OCD from baseline to after app completion in the experimental group, and no changes after 10 days in the control group. It will be assessed with the Mental Health Literacy Questionnaire (MHL) that was designed to assess level of knowledge about OCD, specifically the understanding of OCD and its treatment. Higher scores indicate higher knowledge.
Change in social distance
Time frame: through study completion, an average of 10 days
Score change in social distance from baseline to after app completion (experimental group), or no changes on the control group after 10 days. It will be assessed with the Social Distance Scale (SDS) that employs a four-point Likert scale, ranging from 0 to 3, to assess an individual's willingness to interact with a person who has a mental disorder as depicted in the assigned OC vignette across seven different settings. Higher scores indicate a stronger desire for social distance.
Change in stigma associated with OCD
Time frame: through study completion, an average of 10 days
Score change in stigma from baseline to app completion (estimation of 10 days) in the experimental group, and after 10 days in the control group. Stigma will be assessed by the Spanish version of the Attribution Questionnaire (AQ-27) that assesses public stigma related to a vignette. Respondents rate 27 items on a Likert-type scale from 1 to 9. Elevated scores indicate greater public stigma.
Change in help-seeking intention
Time frame: through study completion, an average of 10 days
Score change in help-seeking intention General after the intervention in the experimental group, and after 10 days in the control group. It will be assessed with the Help-Seeking Questionnaire (GHSQ) that comprises 10 items assessing the intention to seek help from various sources in the event of experiencing symptoms similar to those described in the assigned OC vignette. Higher scores indicate a greater tendency to seek help.
2 secondary outcomes
Change in obsessive-compulsive symptoms
Time frame: through study completion, an average of 10 days
Change on self-esteem
Time frame: through study completion, an average 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 27 Sep 2024.
- 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.
- Link to download the app from Google PlayLink provided by the sponsor.
- Link to download the app for iOsLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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, PhD principal investigator
Universitat de València
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing esTOCma: an app to fight stigma associated with OCD in people with Obsessive-Compulsive Disorder (OCD), 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 4 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 27 Sep 2024. 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 on mental health literacy about OCD (time frame: through study completion, an average 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 NCT06616350, which also lists 1 linked publication.
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 27 Sep 2024.