NCT03889301

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2018

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

March 20, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 26, 2019

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 27, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 27, 2020

Completed
Last Updated

November 6, 2020

Status Verified

November 1, 2020

Enrollment Period

1.5 years

First QC Date

March 20, 2019

Last Update Submit

November 4, 2020

Conditions

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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

Study Arms (2)

E-E Video

EXPERIMENTAL

Watch E-E video that incorporates health and educational messages

Behavioral: E-E Video

Discussion

ACTIVE COMPARATOR

Structured discussion about depression and anxiety

Behavioral: Discussion

Interventions

E-E VideoBEHAVIORAL

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.

E-E Video
DiscussionBEHAVIORAL

Structured psychoeducation and pamphlet about anxiety and depression.

Discussion

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Spanish-speaking

You may not qualify if:

  • Screen positive for suicidality or psychosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Community Health Alliance

Reno, Nevada, 89502, United States

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants will be assigned to experimental or control group.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 20, 2019

First Posted

March 26, 2019

Study Start

November 1, 2018

Primary Completion

April 27, 2020

Study Completion

April 27, 2020

Last Updated

November 6, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share

Locations