- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04862624
Media Project and Health Study - Spanish Version
May 6, 2022 updated by: MarySue Heilemann, PhD, RN, FAAN, University of California, Los Angeles
Efficacy of the Spanish Version of the "Catalina" Intervention Media Project and Health Study
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
56
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
-
-
California
-
Los Angeles, California, United States, 90095-6919
- UCLA School of Nursing
-
-
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
21 years to 50 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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 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: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Story-based media
Participants will receive a link to our story-based media with Latina characters.
|
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.
|
|
Active Comparator: Attention control media
Participants will receive a link to non-story based media that is informational and does not involve story characters.
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Latinas in the attention control group will view non-story based media that is informational.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change from baseline in help seeking intention and action
Time Frame: Baseline and 6 weeks
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change attitudes towards seeking psychological services.
Time Frame: Baseline and 6 weeks.
|
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.
|
|
Change in attitudes in mental help seeking.
Time Frame: Baseline and 6 weeks.
|
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.
|
|
Change in Anxiety
Time Frame: Baseline and 6 weeks.
|
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
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Baseline and 6 weeks.
|
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Change in Depression
Time Frame: Baseline and 6 weeks.
|
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.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: MarySue V Heilemann, PhD, RN, UCLA School of Nursing
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 16, 2020
Primary Completion (Actual)
November 20, 2021
Study Completion (Actual)
December 12, 2021
Study Registration Dates
First Submitted
April 23, 2021
First Submitted That Met QC Criteria
April 26, 2021
First Posted (Actual)
April 28, 2021
Study Record Updates
Last Update Posted (Actual)
May 10, 2022
Last Update Submitted That Met QC Criteria
May 6, 2022
Last Verified
May 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB#19-002046
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.
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