- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03889301
¡Yo no Estoy Loc@! Improving Treatment Engagement for Latinos Using an E-E Video
November 4, 2020 updated by: University of Nevada, Reno
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 Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
48
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Nevada
-
Reno, Nevada, United States, 89502
- Community Health Alliance
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Spanish-speaking
Exclusion Criteria:
- Screen positive for suicidality or psychosis
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: E-E Video
Watch E-E video that incorporates health and educational messages
|
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.
|
|
Active Comparator: Discussion
Structured discussion about depression and anxiety
|
Structured psychoeducation and pamphlet about anxiety and depression.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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).
|
immediately before and immediately after intervention
|
|
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).
|
immediately before and immediately after intervention
|
|
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).
|
immediately before and immediately after intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 1, 2018
Primary Completion (Actual)
April 27, 2020
Study Completion (Actual)
April 27, 2020
Study Registration Dates
First Submitted
March 20, 2019
First Submitted That Met QC Criteria
March 21, 2019
First Posted (Actual)
March 26, 2019
Study Record Updates
Last Update Posted (Actual)
November 6, 2020
Last Update Submitted That Met QC Criteria
November 4, 2020
Last Verified
November 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1228113-1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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.
Clinical Trials on Anxiety Depression
-
Sorlandet Hospital HFUniversity of Oslo; Karolinska Institutet; Australian Catholic University; Helse...RecruitingAnxiety | Anxiety Depression | Depression Anxiety Disorder | Depression - Major Depressive DisorderNorway
-
International Association Psychosomatics And Health...RecruitingAnxiety | Anxiety DepressionUkraine
-
Duke Kunshan UniversityNational Natural Science Foundation of China; Kunshan Hospital of Traditional... and other collaboratorsNot yet recruitingAnxiety DepressionChina
-
University of PatrasUniversity of Bologna; Modena Health Authority; 6th Hellenic Health DistrictNot yet recruitingAnxiety DepressionGreece, Italy
-
University of Wisconsin, MadisonNational Institute of Mental Health (NIMH)Recruiting
-
University of California, BerkeleyUniversity of California, San Francisco; University of California, IrvineRecruiting
-
Moon (Guangzhou) Biotechnology Co., Ltd.Not yet recruiting
-
Florida State UniversityNational Cancer Institute (NCI)Recruiting
-
University Rovira i VirgiliUniversitat de Girona; University Ramon LlullActive, not recruiting
-
Örebro University, SwedenUppsala University; Göteborg University; Sahlgrenska University HospitalCompletedDepression/Anxiety | DGBISweden
Clinical Trials on E-E Video
-
National University of MalaysiaRecruitingBreast Cancer | Breast Neoplasms | Depression, Anxiety | Distress, EmotionalMalaysia
-
Universiti Kebangsaan Malaysia Medical CentreNot yet recruitingCervical Cancer Screening
-
The Policy & Research GroupDepartment of Health and Human ServicesCompleted
-
European Institute of OncologyRecruitingBreast Surgery | Breast Cancer | Endoscopic Video-assisted Nipple-sparing MastectomyItaly
-
Columbia UniversityNational Multiple Sclerosis SocietyCompleted
-
American University of Beirut Medical CenterNational Institute on Drug Abuse (NIDA); National Institutes of Health (NIH)CompletedNicotine Dependence | Nicotine Vaping | Nicotine AddictionLebanon
-
University College CorkHealth Research Board, Ireland; Health Research Board - Trials Methodology...CompletedTesticular DiseasesIreland
-
University of Southern CaliforniaCompletedElectronic Cigarette Use | Cigarette Smoking | Cigarette Use, Electronic | VapingUnited States
-
McMaster UniversityCompleted
-
University of FloridaEunice Kennedy Shriver National Institute of Child Health and Human Development... and other collaboratorsCompletedCommunication Research | Attitude of Health Personnel | Trust | Attitude to Computers | Researcher-Subject RelationsUnited States