Mental Health LiteracyNCT04319458
Testing Mediators and Moderators of a Fotonovela for Depression to Promote Help-seeking Behavior
A study testing Fotonovela in people with Mental Health Literacy, run by University of California, Los Angeles at 1 site in United States.
Trial summary
Although rates of depression are similar in Latinx populations compared to non-Latinx whites (NLW), there are significant disparities in service utilization. Mental health literacy - one's knowledge and attitudes about mental health and treatment-seeking - is a significant predictor of help-seeking behavior and likely… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mental Health Literacy
- What is being tested?
- Fotonovela
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 182 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2019to 30 Aug 2020
- 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
- 18 years or older
- fluent in English or Spanish
- mild, moderate, or severe levels of depression
- identify as Latinx or Hispanic
Who cannot join
- receipt of psychotherapy or pharmacotherapy for mental health problems in the last 6 months
- unable to read in English or Spanish
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California Los Angeles
Los Angeles, California, 90095
About this study
Official title: Entertainment Education for Depression in Latinx Adults: Testing Mediators and Moderators of a Culture-Centric Narrative Intervention to Promote Help-Seeking Behavior
Although rates of depression are similar in Latinx populations compared to non-Latinx whites (NLW), there are significant disparities in service utilization. Mental health literacy - one's knowledge and attitudes about mental health and treatment-seeking - is a significant predictor of help-seeking behavior and likely contributes to mental health disparities among Latinx. Understanding ways to improve mental health literacy in Latinx populations is important to reducing these disparities. Health literacy interventions that are engaging, dramatic, and culturally-relevant, such as fotonovelas (graphic novels designed to change health-related knowledge and attitudes), show promise in changing mental health literacy in Latinx populations. However, little is known about how these interventions work and for whom they are most effective. Furthermore, although there is some evidence that fotonovelas can change mental health attitudes and intent to seek treatment, their impact on help-seeking behavior is less understood. The purpose of this study is to examine 1) if narrative and cultural elements of a fotonovela for Latinx with depression (i.e., transportation, identification, and social proliferation) are important mediators in changing mental health attitudes and help-seeking behaviors and 2) if factors such as rurality, acculturation, depression severity and logistic barriers to treatment moderate these relationships.
Read the detailed description
Latinx adults with depression are a particularly vulnerable population; although Latinx exhibit similar rates of depression to other racial/ethnic groups, they are less likely to seek treatment, are more likely to drop out of treatment, and thus experience greater chronicity of depression. This health disparity is likely due to a complex network of factors, but mental health literacy is one important contributing factor. Latinx are more likely to exhibit lower mental health literacy (including misconceptions, stigma, knowledge of treatment, etc.), which contributes to lower rates of treatment-seeking. Understanding how to engage Latinx in depression treatment by overcoming health literacy barriers is important in reducing health disparities.
Entertainment-education interventions are those that use popular media to engage consumers and deliver health messages. These interventions hypothesized to be useful in targeting populations with health disparities in encouraging changes in health-related behavior through dramatic and culturally-relevant narrative elements. However, no study has tested these theorized mechanisms in helping to explain changes in health literacy and subsequent health behavior.
This study will test the impact of a graphic novel about depression specifically for Latinx adults with depressive symptoms on theorized mediators, including transportation (feeling emotionally engaged in the narrative), identification (cultural relevance of characters, their language, and their appearance), and social proliferation (sharing of health information and mutual reinforcement of health behaviors). Furthermore, this study will test if these mediators help explain changes in mental health literacy and subsequent health behavior. Lastly, this study will test moderators of changes in mental health literacy and behavior to determine for whom the fotonovela has the largest impact.
- Conditions
- Mental Health Literacy
- Being tested
- Fotonovela, Control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FotonovelaBehavioural
Secret Feelings/Sentimientos Secretos
ControlBehavioural
NIH Brochure: Depression: What You Need to Know
| Study group | Role | What they receive |
|---|---|---|
| Fotonovela | Experimental | Fotonovela mental health literacy intervention: Secret Feelings/Sentimientos Secretos Receives: Behavioral: Fotonovela |
| Control | Active comparator | Control mental health literacy intervention: NIH publication - Depression: What You Need to Know Receives: Behavioral: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Help-Seeking Behavior
The measure of help-seeking behavior is a checklist of behaviors that has been modified from the Service Assessment for Children and Adolescents. The measure assesses different sources of treatment, including psychiatrist, psychologist, social worker, spiritual advisors, ER visits, and traditional healers. Participants are asked if in the past 3 months, they have sought services from any of these professionals. Each item is binary (i.e., Yes or No). The total score will be calculated by summing the number of "yes" answers (i.e., the number of services used).
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2020
- Study start1 Mar 2019
- Primary completion30 Aug 2020 (estimated)
- Study completion30 Aug 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental Health LiteracyStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 182 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Louise Dixon De Silva, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04319458
- Sponsor's protocol ID
- 19-000112
- Status last verified
- Mar 2020
- First submitted
- 6 Sep 2019
- Last updated
- 25 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Entertainment Education for Depression in Latinx Adults: Testing Mediators and Moderators of a Culture-Centric Narrative Intervention to Promote Help-Seeking Behavior
- ClinicalTrials.gov ID
- NCT04319458
- Acronym / sponsor ID
- 19-000112
- Conditions
- Mental Health Literacy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 182 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 30 Aug 2020 (estimated)
- Study completion
- 30 Aug 2020 (estimated)
- First posted
- 24 Mar 2020 (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.
Although rates of depression are similar in Latinx populations compared to non-Latinx whites (NLW), there are significant disparities in service utilization. Mental health literacy - one's knowledge and attitudes about mental health and treatment-seeking - is a significant predictor of help-seeking behavior and likely contributes to mental health disparities among Latinx. Understanding ways to improve mental health literacy in Latinx populations is important to reducing these disparities. Health literacy interventions that are engaging, dramatic, and culturally-relevant, such as fotonovelas (graphic novels designed to change health-related knowledge and attitudes), show promise in changing mental health literacy in Latinx populations. However, little is known about how these interventions work and for whom they are most effective. Furthermore, although there is some evidence that fotonovelas can change mental health attitudes and intent to seek treatment, their impact on help-seeking behavior is less understood. The purpose of this study is to examine 1) if narrative and cultural elements of a fotonovela for Latinx with depression (i.e., transportation, identification, and social proliferation) are important mediators in changing mental health attitudes and help-seeking behaviors and 2) if factors such as rurality, acculturation, depression severity and logistic barriers to treatment moderate these relationships.
Detailed description
Latinx adults with depression are a particularly vulnerable population; although Latinx exhibit similar rates of depression to other racial/ethnic groups, they are less likely to seek treatment, are more likely to drop out of treatment, and thus experience greater chronicity of depression. This health disparity is likely due to a complex network of factors, but mental health literacy is one important contributing factor. Latinx are more likely to exhibit lower mental health literacy (including misconceptions, stigma, knowledge of treatment, etc.), which contributes to lower rates of treatment-seeking. Understanding how to engage Latinx in depression treatment by overcoming health literacy barriers is important in reducing health disparities.
Entertainment-education interventions are those that use popular media to engage consumers and deliver health messages. These interventions hypothesized to be useful in targeting populations with health disparities in encouraging changes in health-related behavior through dramatic and culturally-relevant narrative elements. However, no study has tested these theorized mechanisms in helping to explain changes in health literacy and subsequent health behavior.
This study will test the impact of a graphic novel about depression specifically for Latinx adults with depressive symptoms on theorized mediators, including transportation (feeling emotionally engaged in the narrative), identification (cultural relevance of characters, their language, and their appearance), and social proliferation (sharing of health information and mutual reinforcement of health behaviors). Furthermore, this study will test if these mediators help explain changes in mental health literacy and subsequent health behavior. Lastly, this study will test moderators of changes in mental health literacy and behavior to determine for whom the fotonovela has the largest impact.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fotonovela | Experimental | Behavioral: FotonovelaFotonovela mental health literacy intervention: Secret Feelings/Sentimientos Secretos |
| Control | Active comparator | Behavioral: ControlControl mental health literacy intervention: NIH publication - Depression: What You Need to Know |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 years or older
- fluent in English or Spanish
- mild, moderate, or severe levels of depression
- identify as Latinx or Hispanic
Key exclusion criteria (2 listed)
- receipt of psychotherapy or pharmacotherapy for mental health problems in the last 6 months
- unable to read in English or Spanish
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 |
|---|---|---|
| FotonovelaSecret Feelings/Sentimientos Secretos | Behavioural | Fotonovela |
| ControlNIH Brochure: Depression: What You Need to Know | Behavioural | Control |
Primary outcome
Help-Seeking Behavior
Time frame: 3 months
The measure of help-seeking behavior is a checklist of behaviors that has been modified from the Service Assessment for Children and Adolescents. The measure assesses different sources of treatment, including psychiatrist, psychologist, social worker, spiritual advisors, ER visits, and traditional healers. Participants are asked if in the past 3 months, they have sought services from any of these professionals. Each item is binary (i.e., Yes or No). The total score will be calculated by summing the number of "yes" answers (i.e., the number of services used).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2020.
- 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 Fotonovela in people with Mental Health Literacy, run by University of California, Los Angeles at 1 site in United States.
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: status not confirmed, as of the sponsor's last update on 25 Mar 2020. 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 United States. 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?
Results are not available in the source record.
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?
Help-Seeking Behavior (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Mar 2020.