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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04862624
Other study ID # IRB#19-002046
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 16, 2020
Est. completion date December 12, 2021

Study information

Verified date May 2022
Source University of California, Los Angeles
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

We seek to test the efficacy of the Spanish version of the "Catalina" web-app intervention compared to an attention control web-app in reducing symptoms of depression and/or anxiety and motivate women to take action to get help.


Recruitment information / eligibility

Status Completed
Enrollment 56
Est. completion date December 12, 2021
Est. primary completion date November 20, 2021
Accepts healthy volunteers No
Gender Female
Age group 21 Years to 50 Years
Eligibility Inclusion Criteria: - self identifies as Latina - scores 10 or more on Patient Health Questionnaire-8 (PHQ-8) or General Anxiety Disorder (GAD)-7 - can read, write, and speak Spanish - has access to the internet Exclusion Criteria: - currently getting treatment for depression or anxiety - suicidal ideation identified at screening

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Catalina Story-Based Web-App
Latinas in the experimental group will view a story-based web-app featuring a character named "Catalina" and psycho-therapeutic modules to motivate them to take action and get help for their symptoms of depression and/or anxiety.
Attention Control Web-App
Latinas in the attention control group will view non-story based media that is informational.

Locations

Country Name City State
United States UCLA School of Nursing Los Angeles California

Sponsors (1)

Lead Sponsor Collaborator
University of California, Los Angeles

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change from baseline in help seeking intention and action Change from baseline in help seeking intentions will be assessed by the number of participants who expressed interest in, expressed intentions to take action, or reported actually taking help-seeking action (used a resource, called a clinic, made an appointment with a mental health professional, signed up for a support group, or actually attended a group or 1:1 mental health session). Baseline and 6 weeks
Secondary Change attitudes towards seeking psychological services. Change in individuals' attitudes with respect to seeking psychological services will be assessed with the Inventory of Attitudes toward Seeking Mental Health Services (IASMAS). It is a 24 item scale that measures psychological openness to seeking mental health services, help seeking propensity (ability and motivation to seek help), and indifference to stigma (a person's lack of concern of what others might think of their attitude toward seeking professional help). Total scores range from 0 to 96, and higher scores indicate more positive attitudes. Baseline and 6 weeks.
Secondary Change in attitudes in mental help seeking. Change in attitudes about seeking help from a mental health professional will be assessed with the Mental Help Seeking Attitudes Scale (MHSAS) which is a 9-item instrument designed to measure respondents' overall evaluation (unfavorable vs. favorable) of their seeking help from a mental health professional if they found themselves to be dealing with a mental health concern. Total scale scores range from 0 to 63, and higher scores indicate more positive attitudes toward seeking help. Baseline and 6 weeks.
Secondary Change in Anxiety Change in Anxiety will be assessed by the General Anxiety Disorder 7 (GAD7) which is a self-report screening and severity measure for generalized anxiety disorder. The seven items correspond to symptoms of anxiety and are summed for a range from 0-21; a score of 10-14 indicates moderate anxiety and scores at or above 15 indicate severe anxiety Baseline and 6 weeks.
Secondary Change in Depression Change in Depression will be assessed by the Patient Health Questionnaire-8 (PHQ-8) which is a self-report assessment of depression. It has been established as a valid diagnostic and severity measure. The eight items correspond to symptom-based diagnostic criteria in Diagnostic and Statistical Manual (DSM)-IV and are summed for a range from 0-24; a score of 10-14 indicates moderate depression and scores at or above 15 indicate severe depression. Baseline and 6 weeks.
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