Depression, AnxietyNCT04862624
Media Project and Health Study - Spanish Version
A study testing Catalina Story-Based Web-App in people with Depression, Anxiety, run by University of California, Los Angeles at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 21 to 50 years, women only
- Conditions the study is for
- Depression, Anxiety
- What is being tested?
- Catalina Story-Based Web-App
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Nov 2020to 12 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- currently getting treatment for depression or anxiety
- suicidal ideation identified at screening
Trial locations and contacts
1 site in 1 country.
United States1 site
UCLA School of Nursing
Los Angeles, California, 90095-6919
About this study
Official title: 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.
- Conditions
- Depression, Anxiety
- Being tested
- Catalina Story-Based Web-App, Attention Control Web-App
- Medical subject headings
- Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Catalina Story-Based Web-AppBehavioural
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-AppBehavioural
Latinas in the attention control group will view non-story based media that is informational.
| Study group | Role | What they receive |
|---|---|---|
| Story-based media | Experimental | Participants will receive a link to our story-based media with Latina characters. Receives: 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. Receives: Behavioral: Attention Control Web-App |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline and 6 weeks
Secondary outcomes (4)
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.
Measured: Baseline and 6 weeks.
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.
Measured: Baseline and 6 weeks.
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
Measured: Baseline and 6 weeks.
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.
Measured: Baseline and 6 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2021
- Study start16 Nov 2020
- Primary completion20 Nov 2021
- Study completion12 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depression, AnxietyStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, MarySue Heilemann, PhD, RN, FAAN, University of California, Los Angeles
- Investigators
- MarySue V Heilemann, PhD, RN, Principal investigator, UCLA School of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04862624
- Sponsor's protocol ID
- IRB#19-002046
- Status last verified
- May 2022
- First submitted
- 23 Apr 2021
- Last updated
- 10 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of the Spanish Version of the "Catalina" Intervention Media Project and Health Study
- ClinicalTrials.gov ID
- NCT04862624
- Acronym / sponsor ID
- IRB#19-002046
- Conditions
- Depression, Anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Study start
- 16 Nov 2020 (actual)
- Primary completion
- 20 Nov 2021 (actual)
- Study completion
- 12 Dec 2021 (actual)
- First posted
- 28 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Story-based media | Experimental | Behavioral: Catalina Story-Based Web-AppParticipants will receive a link to our story-based media with Latina characters. |
| Attention control media | Active comparator | Behavioral: Attention Control Web-AppParticipants will receive a link to non-story based media that is informational and does not involve story characters. |
Who may qualify
- Ages
- 21 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- currently getting treatment for depression or anxiety
- suicidal ideation identified at screening
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Catalina Story-Based Web-AppLatinas 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. | Behavioural | Story-based media |
| Attention Control Web-AppLatinas in the attention control group will view non-story based media that is informational. | Behavioural | Attention control media |
Primary outcome
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).
4 secondary outcomes
Change attitudes towards seeking psychological services.
Time frame: Baseline and 6 weeks.
Change in attitudes in mental help seeking.
Time frame: Baseline and 6 weeks.
Change in Anxiety
Time frame: Baseline and 6 weeks.
Change in Depression
Time frame: Baseline and 6 weeks.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
MarySue V Heilemann, PhD, RN principal investigator
UCLA School of Nursing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Catalina Story-Based Web-App in people with Depression, Anxiety, run by University of California, Los Angeles at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in help seeking intention and action (time frame: Baseline and 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2022.