NCT04862624

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
56

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2020

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 16, 2020

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

April 23, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 28, 2021

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 20, 2021

Completed
22 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 12, 2021

Completed
Last Updated

May 10, 2022

Status Verified

May 1, 2022

Enrollment Period

1 year

First QC Date

April 23, 2021

Last Update Submit

May 6, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Change attitudes towards seeking psychological services.

    Baseline and 6 weeks.

  • Change in attitudes in mental help seeking.

    Baseline and 6 weeks.

  • Change in Anxiety

    Baseline and 6 weeks.

  • Change in Depression

    Baseline and 6 weeks.

Study Arms (2)

Story-based media

EXPERIMENTAL

Participants will receive a link to our story-based media with Latina characters.

Behavioral: Catalina Story-Based Web-App

Attention control media

ACTIVE COMPARATOR

Participants will receive a link to non-story based media that is informational and does not involve story characters.

Behavioral: Attention Control Web-App

Interventions

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.

Story-based media

Latinas in the attention control group will view non-story based media that is informational.

Attention control media

Eligibility Criteria

Age21 Years - 50 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsYes, this is determined by self report.
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • currently getting treatment for depression or anxiety
  • suicidal ideation identified at screening

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UCLA School of Nursing

Los Angeles, California, 90095-6919, United States

Location

MeSH Terms

Conditions

DepressionAnxiety Disorders

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorMental Disorders

Study Officials

  • MarySue V Heilemann, PhD, RN

    UCLA School of Nursing

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

April 23, 2021

First Posted

April 28, 2021

Study Start

November 16, 2020

Primary Completion

November 20, 2021

Study Completion

December 12, 2021

Last Updated

May 10, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Locations