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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03889301
Other study ID # 1228113-1
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 1, 2018
Est. completion date April 27, 2020

Study information

Verified date November 2020
Source University of Nevada, Reno
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


Recruitment information / eligibility

Status Completed
Enrollment 48
Est. completion date April 27, 2020
Est. primary completion date April 27, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Spanish-speaking Exclusion Criteria: - Screen positive for suicidality or psychosis

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
E-E Video
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.
Discussion
Structured psychoeducation and pamphlet about anxiety and depression.

Locations

Country Name City State
United States Community Health Alliance Reno Nevada

Sponsors (2)

Lead Sponsor Collaborator
University of Nevada, Reno University of Nevada, Las Vegas

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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). immediately before and immediately after intervention
Primary 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). immediately before and immediately after intervention
Primary 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). immediately before and immediately after intervention
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