Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Media Project and Health Study - Spanish Version

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04862624
Recruitment Status : Recruiting
First Posted : April 28, 2021
Last Update Posted : April 28, 2021
Sponsor:
Information provided by (Responsible Party):
MarySue Heilemann, PhD, RN, FAAN, University of California, Los Angeles

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief 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.

Condition or disease Intervention/treatment Phase
Depression, Anxiety Behavioral: Catalina Story-Based Web-App Behavioral: Attention Control Web-App Not Applicable

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Other
Official Title: Efficacy of the Spanish Version of the "Catalina" Intervention Media Project and Health Study
Actual Study Start Date : November 16, 2020
Estimated Primary Completion Date : December 1, 2021
Estimated Study Completion Date : December 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Story-based media
Participants will receive a link to our story-based media with Latina characters.
 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.
Active Comparator: Attention control media
Participants will receive a link to non-story based media that is informational and does not involve story characters.
 Behavioral: Attention Control Web-App
Latinas in the attention control group will view non-story based media that is informational.


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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

  4. 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.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   21 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Yes, this is determined by self report.
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04862624


Contacts
Layout table for location contacts
Contact: Marianne Gutierrez, MS, RN 310-795-1674 mgutierrez7430@gmail.com

Locations
Layout table for location information
United States, California
UCLA School of Nursing Recruiting
Los Angeles, California, United States, 90095-6919
Contact: MarySue V Heilemann, PhD, RN    310-382-0242    mheilema@ucla.edu   
Sponsors and Collaborators
University of California, Los Angeles
Investigators
Layout table for investigator information
Principal Investigator: MarySue V Heilemann, PhD, RN UCLA School of Nursing
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: MarySue Heilemann, PhD, RN, FAAN, Associate Professor, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT04862624    
Other Study ID Numbers: IRB#19-002046
First Posted: April 28, 2021    Key Record Dates
Last Update Posted: April 28, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Depression
Behavioral Symptoms