Anxiety DepressionNCT03889301
¡Yo no Estoy Loc@! Improving Treatment Engagement for Latinos Using an E-E Video
A study testing E-E Video and Discussion in people with Anxiety Depression, run by University of Nevada, Reno at 1 site in United States.
Trial summary
The underutilization of behavioral health services for mood and anxiety disorders by Latinos is a public health concern warranting intervention development. Perceived stigma associated with the pursuit of behavioral health services disproportionately restricts mental healthcare in Latinos. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anxiety Depression
- What is being tested?
- E-E Video and Discussion
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2018to 27 Apr 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
- Spanish-speaking
Who cannot join
- Screen positive for suicidality or psychosis
Trial locations and contacts
1 site in 1 country.
About this study
The underutilization of behavioral health services for mood and anxiety disorders by Latinos is a public health concern warranting intervention development. Perceived stigma associated with the pursuit of behavioral health services disproportionately restricts mental healthcare in Latinos. The current study empirically tests an intervention aimed at improving perceptions of behavioral health services for mood and anxiety disorders, ultimately improving Latinos' mental health through access to treatment. The experimental intervention is based on the Entertainment-Education (E-E) model, a popular media campaign that incorporates health and educational messages in an entertaining, story-telling narrative. The E-E model incorporates characters who have characteristics, beliefs, attitudes, and behaviors that are similar to those of the targeted audience to maximize social validity. Using data gathered in focus groups with Latinos a 3-minute E-E video (in Spanish) that aims to reduce stigma towards mental illness and behavioral health services was developed. Sixty adult Latinos pursuing care at a Federally Qualified Health Center, who screen positive for anxiety and/or depression will be invited to participate in the study. Participants will be administered a structured demographic interview and measures that assess stigma and attitudes towards mental health and behavioral health services and then randomized to the E-E video or control (structured discussion about depression and anxiety) condition. Participants will then complete the study measures and be invited to attend a Cognitive Behavior Therapy (CBT) group for depression or anxiety. Consumer satisfaction will also be evaluated.
- Conditions
- Anxiety Depression
- Being tested
- E-E Video, Discussion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
E-E VideoBehavioural
The E-E video was developed by the research team and chronicles the story of Ana who while enjoying coffee with two family members, shares her challenges with depression and her successful outcome with therapy. The video utilizes the genre of the telenovela which creates an entertaining environment where the audience is captivated by the content and absorbs the messages portrayed.
DiscussionBehavioural
Structured psychoeducation and pamphlet about anxiety and depression.
| Study group | Role | What they receive |
|---|---|---|
| E-E Video | Experimental | Watch E-E video that incorporates health and educational messages Receives: Behavioral: E-E Video |
| Discussion | Active comparator | Structured discussion about depression and anxiety Receives: Behavioral: Discussion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in score on Generalized Anxiety Stigma Scale (GASS)
The GASS is a twenty-item scale used to measure stigma associated with anxiety disorders and was developed by Griffiths et al, (2004). It consists of two subscales, which measure two different types of stigma: personal and perceived. Responses to each item are measured on a five-point scale ranging from strongly disagree (0) to strongly agree (4). Scores on each subscale can range from 0 to 40. Higher scores indicate higher levels of stigma against generalized anxiety. A Spanish-language version of the measure is being tested for validity and reliability (Benuto \& Gonzalez, In Progress).
Measured: immediately before and immediately after intervention
Change in score on Depression Stigma Scale (DSS)
The DSS is an eighteen-item scale used to measure stigma associated with depression and was developed by Griffiths et al, (2004). It consists of two subscales, which measure two different types of stigma: personal and perceived. Responses to each item are measured on a five-point scale ranging from strongly disagree (0) to strongly agree (4).Scores on each subscale can range from 0 to 36. Higher scores indicate higher levels of stigma against depression. A Spanish-language version of the measure is being tested for validity and reliability (Benuto \& Gonzalez, In Progress).
Measured: immediately before and immediately after intervention
Change in score on Attitudes Towards Seeking Professional Help Scale (ATSPH)
The ATSPH is a 20-item item measure that is intended to reflect an individual's attitude toward professional behavioral health treatment. It is a modified version of the Attitudes Towards Seeking Professional Psychological Help Scale (Fisher \& Turner, 1970). Responses to each item are measured on a four-point scale ranging from disagree (0) to agree (3). Items (including some that are reverse-scored) are summed; total scores can range from 0 to 30. Higher scores indicate more positive attitudes toward seeking treatment. A Spanish-language version of the measure is being tested for validity and reliability among a sample of Spanish-speaking individuals (Benuto \& Gonzalez, In Progress).
Measured: immediately before and immediately after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2019
- Study start1 Nov 2018
- Primary completion27 Apr 2020
- Study completion27 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anxiety DepressionStudies of the same condition, open and under way.
- 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
- Participants will be assigned to experimental or control group.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nevada, Reno
- Sponsor type
- University, hospital or other
- Collaborators
- University of Nevada, Las Vegas
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03889301
- Sponsor's protocol ID
- 1228113-1
- Status last verified
- Nov 2020
- First submitted
- 20 Mar 2019
- Last updated
- 6 Nov 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 6 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ¡Yo no Estoy Loc@! Improving Treatment Engagement for Latinos Using an E-E Video
- ClinicalTrials.gov ID
- NCT03889301
- Acronym / sponsor ID
- 1228113-1
- Conditions
- Anxiety Depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- University of Nevada, RenoUniversity, hospital or other
- Collaborators
- University of Nevada, Las Vegas
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- 27 Apr 2020 (actual)
- Study completion
- 27 Apr 2020 (actual)
- First posted
- 26 Mar 2019 (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 underutilization of behavioral health services for mood and anxiety disorders by Latinos is a public health concern warranting intervention development. Perceived stigma associated with the pursuit of behavioral health services disproportionately restricts mental healthcare in Latinos. The current study empirically tests an intervention aimed at improving perceptions of behavioral health services for mood and anxiety disorders, ultimately improving Latinos' mental health through access to treatment. The experimental intervention is based on the Entertainment-Education (E-E) model, a popular media campaign that incorporates health and educational messages in an entertaining, story-telling narrative. The E-E model incorporates characters who have characteristics, beliefs, attitudes, and behaviors that are similar to those of the targeted audience to maximize social validity. Using data gathered in focus groups with Latinos a 3-minute E-E video (in Spanish) that aims to reduce stigma towards mental illness and behavioral health services was developed. Sixty adult Latinos pursuing care at a Federally Qualified Health Center, who screen positive for anxiety and/or depression will be invited to participate in the study. Participants will be administered a structured demographic interview and measures that assess stigma and attitudes towards mental health and behavioral health services and then randomized to the E-E video or control (structured discussion about depression and anxiety) condition. Participants will then complete the study measures and be invited to attend a Cognitive Behavior Therapy (CBT) group for depression or anxiety. Consumer satisfaction will also be evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Participants will be assigned to experimental or control group.
| Arm | Type | Receives |
|---|---|---|
| E-E Video | Experimental | Behavioral: E-E VideoWatch E-E video that incorporates health and educational messages |
| Discussion | Active comparator | Behavioral: DiscussionStructured discussion about depression and anxiety |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Spanish-speaking
Key exclusion criteria (1 listed)
- Screen positive for suicidality or psychosis
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 |
|---|---|---|
| E-E VideoThe E-E video was developed by the research team and chronicles the story of Ana who while enjoying coffee with two family members, shares her challenges with depression and her successful outcome with therapy. The video utilizes the genre of the telenovela which creates an entertaining environment where the audience is captivated by the content and absorbs the messages portrayed. | Behavioural | E-E Video |
| DiscussionStructured psychoeducation and pamphlet about anxiety and depression. | Behavioural | Discussion |
Primary outcome
Change in score on Generalized Anxiety Stigma Scale (GASS)
Time frame: immediately before and immediately after intervention
The GASS is a twenty-item scale used to measure stigma associated with anxiety disorders and was developed by Griffiths et al, (2004). It consists of two subscales, which measure two different types of stigma: personal and perceived. Responses to each item are measured on a five-point scale ranging from strongly disagree (0) to strongly agree (4). Scores on each subscale can range from 0 to 40. Higher scores indicate higher levels of stigma against generalized anxiety. A Spanish-language version of the measure is being tested for validity and reliability (Benuto \& Gonzalez, In Progress).
Change in score on Depression Stigma Scale (DSS)
Time frame: immediately before and immediately after intervention
The DSS is an eighteen-item scale used to measure stigma associated with depression and was developed by Griffiths et al, (2004). It consists of two subscales, which measure two different types of stigma: personal and perceived. Responses to each item are measured on a five-point scale ranging from strongly disagree (0) to strongly agree (4).Scores on each subscale can range from 0 to 36. Higher scores indicate higher levels of stigma against depression. A Spanish-language version of the measure is being tested for validity and reliability (Benuto \& Gonzalez, In Progress).
Change in score on Attitudes Towards Seeking Professional Help Scale (ATSPH)
Time frame: immediately before and immediately after intervention
The ATSPH is a 20-item item measure that is intended to reflect an individual's attitude toward professional behavioral health treatment. It is a modified version of the Attitudes Towards Seeking Professional Psychological Help Scale (Fisher \& Turner, 1970). Responses to each item are measured on a four-point scale ranging from disagree (0) to agree (3). Items (including some that are reverse-scored) are summed; total scores can range from 0 to 30. Higher scores indicate more positive attitudes toward seeking treatment. A Spanish-language version of the measure is being tested for validity and reliability among a sample of Spanish-speaking individuals (Benuto \& Gonzalez, In Progress).
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 6 Nov 2020.
- Individual participant dataSharing planned: No
Related trials for Anxiety Depression
Recruiting
Unified Protocol in Penitentiary Facilities
Depression Disorders, Anxiety
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
Not yet recruitingObservational study
Functional Impact of Psychological Symptoms in Patients With Superior Semicircular Canal Dehiscence Syndrome (SSCD): a National Cross-sectional Study
Superior Semicircular Canal Dehiscence
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
Recruiting
Cultural Adaptation of an Online Parenting Intervention to Reduce the Risk of Depression and Anxiety in Adolescents
Risk of Depression and Anxiety
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 E-E Video and Discussion in people with Anxiety Depression, run by University of Nevada, Reno 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 1 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 6 Nov 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?
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 score on Generalized Anxiety Stigma Scale (GASS) (time frame: immediately before and immediately after intervention). The study lists 3 primary outcomes in all. 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 6 Nov 2020.