StressNCT03749278
Latina Friends Motivating the Soul (ALMA)
A study testing Latina Friends Motivating the Soul (ALMA) in people with Stress and Depression, run by University of Washington at 2 sites in United States.
Trial summary
Latina immigrant women are particularly vulnerable to depression and anxiety due to the social and economic stressors they face, including high levels of poverty, low levels of education, family obligations, exposure to violence, and limited access to community resources. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Stress, Depression, Anxiety
- What is being tested?
- Latina Friends Motivating the Soul (ALMA)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 2 sitesUnited States
- Study dates
- 26 Sep 2018to 31 May 2022
- 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 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- To be eligible for study participation, participants must be at least 18 years of age, female, speak Spanish, must self-identify as Latina, and have been born outside of the United States
Who cannot join
- The investigators will screen for and exclude women who currently have high levels of depressive symptoms (as indicated by a score of 20 or higher on the PHQ-9). If women excluded from the study are not already receiving mental health treatment, the will be referred to mental health providers offering low-cost services in Spanish.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Casa Latina
Seattle, Washington, 98144
El Centro de la Raza
Seattle, Washington, 98144
About this study
Official title: Latina Friends Motivating the Soul (ALMA): A Delayed Intervention Control Trial of Program to Reduce Mental Health Disparities in Latina Immigrant Women
Latina immigrant women are particularly vulnerable to depression and anxiety due to the social and economic stressors they face, including high levels of poverty, low levels of education, family obligations, exposure to violence, and limited access to community resources. ALMA aims to prevent and reduce depression and anxiety among Latina immigrant women. Women attend 8 weekly sessions in a group format to teach and encourage women to use coping strategies to reduce depression and anxiety. The intervention aims to increase participants' social ties and the social support they receive from other Latina immigrant women. The program also helps decrease the stigma associated with mental health and connects women to mental health services when needed.
Read the detailed description
The proposed study aims to test the efficacy of the Latina Friends Motivating the Soul (ALMA) intervention in a delayed intervention control trial. ALMA is an 8-week program offered in a group format to teach women new coping strategies and enhance their social ties and social support to prevent and reduce their depression and anxiety. Aim 2 is to determine the efficacy of the ALMA intervention to reduce depressive and anxiety symptoms using a delayed intervention control study design. The investigators will recruit women from community-based organizations serving Latino immigrants to participate in the program, which will be offered in community settings. The investigators will assess process outcomes of recruitment, retention, fidelity, and participant satisfaction through observations and in-depth interviews with participants. The investigators will assess the efficacy of the intervention by comparing changes in women's depressive and anxiety symptoms in the intervention and attention control groups at four time points (baseline, 3-month follow-up, 6-month follow-up, and 9-month follow-up). Aim 3 is to assess the potential impact of the intervention on both individual (stigma, stress, coping strategies) and interpersonal (social support, social ties) factors, and whether the impact of the intervention is mediated by these factors. The research team includes investigators in psychology, medicine, social work and public health, as well as community-based organizations serving Latina immigrants. The study uses rigorous methods to test an innovative program that integrates both culturally relevant and evidenced-based strategies to address significant mental health disparities in a high-risk and underserved population. Findings will help inform future research and practice. Given the growth of the Latino population, identifying interventions that reduce mental health disparities among Mexican immigrant women can have a significant public health impact.
- Conditions
- Stress, Depression, Anxiety
- Being tested
- Latina Friends Motivating the Soul (ALMA)
- Keywords
- Mental Health, Minority Health, Latina
- Medical subject headings
- Depression, Anxiety Disorders, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Latina Friends Motivating the Soul (ALMA)Behavioural
In a series of 8 weekly sessions, the program uses a group format to teach and encourage women to use coping strategies to reduce depression and anxiety. Over the course of the eight ALMA sessions, 25 women are (1) engaged in activities to identify coping strategies they are currently using and encouraged to continue to use them; (2) introduced to new coping strategies (e.g. mindfulness techniques, increased social ties and social support); and, (3) provided resources for seeking additional help if needed
| Study group | Role | What they receive |
|---|---|---|
| ALMA Intervention Group | Experimental | Latina Friends Motivating the Soul (ALMA). This group receives the intervention after baseline assessment. Receives: Behavioral: Latina Friends Motivating the Soul (ALMA) |
| ALMA Delayed Intervention Control Group | Active comparator | Latina Friends Motivating the Soul (ALMA). This group receives the intervention six months after the baseline assessment (after the post-intervention, and 3 month assessments have been completed). Receives: Behavioral: Latina Friends Motivating the Soul (ALMA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depressive Symptoms
Frequency of depressive symptoms as measured by the Patient Health Questionnaire 9 (PHQ-9) in the last two weeks. The PHQ-9 is a multipurpose instrument for screening, diagnosing, monitoring and measuring the severity of depression. Scores range from 0 to 27. In general, a total of 10 or above is suggestive of the presence of depression. Depression Severity: 0-4 none, 5-9 mild, 10-14 moderate, 15-19 moderately severe, 20-27 severe.
Measured: Change measure (baseline, 4 months, 6 months, 9 months)
Anxiety Symptoms
Frequency of anxiety symptoms as measured by the General Anxiety Disorders 7 (GAD_\&) in the last two weeks. Generalized Anxiety Disorder 7 (GAD-7) is a self-reported questionnaire for screening and severity measuring of generalized anxiety disorder (GAD). Scores range from 0 to 21. Scores ≥10. Anxiety Severity: 1-4 minimal symptoms, 5-9 mild symptoms, 10-14 moderate symptoms, 15-21 severe symptoms
Measured: Change measure (baseline, 4 months, 6 months, 9 months)
Secondary outcomes (1)
Stress
Frequency of perceived stress in the last month. The Perceived Stress Scale (PSS) is a classic stress assessment instrument. Individual scores on the PSS can range from 0 to 40 with higher scores indicating higher perceived stress. Scores ranging from 0-13 would be considered low stress. Scores ranging from 14-26 would be considered moderate stress. Scores ranging from 27-40 would be considered high perceived stress.
Measured: Change measure (baseline, 4 months, 6 months, 9 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2018
- Study start26 Sep 2018
- Primary completion1 Jan 2022
- Study completion31 May 2022 (estimated)
Why it stopped: This record was a placeholder created before trial was conducted. Trial is now described in NCT03545282.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for StressStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Responsible party
- Principal investigator, India Ornelas, University of Washington
- Investigators
- India J Ornelas, PhD, MPH, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03749278
- Sponsor's protocol ID
- STUDY00005476
- Other IDs
- R01MD012230
- Status last verified
- May 2023
- First submitted
- 13 Nov 2018
- Last updated
- 10 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Miranda MM, Rao D, Price C, Gudino J, Perez G, Maurer S, Nelson AK, Perez-Solorio SA, Ornelas IJ. Amigas Latinas Motivando el Alma: Participant Perspectives on an In-Person and Online Implementation of an Intervention to Promote Mental Health in Latina Immigrant Women. Community Ment Health J. 2024 Jul;60(5):908-918. doi: 10.1007/s10597-024-01244-z. Epub 2024 Mar 2.
PubMed 38430288Ornelas IJ, Perez G, Maurer S, Gonzalez S, Childs V, Price C, Nelson AK, Perez Solorio SA, Tran A, Rao D. Amigas Latinas Motivando el Alma: In-Person and Online Delivery of an Intervention to Promote Mental Health Among Latina Immigrant Women. J Integr Complement Med. 2022 Oct;28(10):821-829. doi: 10.1089/jicm.2022.0491. Epub 2022 Jun 20.
PubMed 35723668
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Latina Friends Motivating the Soul (ALMA): A Delayed Intervention Control Trial of Program to Reduce Mental Health Disparities in Latina Immigrant Women
- ClinicalTrials.gov ID
- NCT03749278
- Acronym / sponsor ID
- STUDY00005476
- Conditions
- Stress, Depression, Anxiety
- Keywords
- Mental Health, Minority Health, Latina
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: This record was a placeholder created before trial was conducted. Trial is now described in NCT03545282.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Study start
- 26 Sep 2018 (actual)
- Primary completion
- 1 Jan 2022 (actual)
- Study completion
- 31 May 2022 (estimated)
- First posted
- 21 Nov 2018 (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.
Latina immigrant women are particularly vulnerable to depression and anxiety due to the social and economic stressors they face, including high levels of poverty, low levels of education, family obligations, exposure to violence, and limited access to community resources. ALMA aims to prevent and reduce depression and anxiety among Latina immigrant women. Women attend 8 weekly sessions in a group format to teach and encourage women to use coping strategies to reduce depression and anxiety. The intervention aims to increase participants' social ties and the social support they receive from other Latina immigrant women. The program also helps decrease the stigma associated with mental health and connects women to mental health services when needed.
Detailed description
The proposed study aims to test the efficacy of the Latina Friends Motivating the Soul (ALMA) intervention in a delayed intervention control trial. ALMA is an 8-week program offered in a group format to teach women new coping strategies and enhance their social ties and social support to prevent and reduce their depression and anxiety. Aim 2 is to determine the efficacy of the ALMA intervention to reduce depressive and anxiety symptoms using a delayed intervention control study design. The investigators will recruit women from community-based organizations serving Latino immigrants to participate in the program, which will be offered in community settings. The investigators will assess process outcomes of recruitment, retention, fidelity, and participant satisfaction through observations and in-depth interviews with participants. The investigators will assess the efficacy of the intervention by comparing changes in women's depressive and anxiety symptoms in the intervention and attention control groups at four time points (baseline, 3-month follow-up, 6-month follow-up, and 9-month follow-up). Aim 3 is to assess the potential impact of the intervention on both individual (stigma, stress, coping strategies) and interpersonal (social support, social ties) factors, and whether the impact of the intervention is mediated by these factors. The research team includes investigators in psychology, medicine, social work and public health, as well as community-based organizations serving Latina immigrants. The study uses rigorous methods to test an innovative program that integrates both culturally relevant and evidenced-based strategies to address significant mental health disparities in a high-risk and underserved population. Findings will help inform future research and practice. Given the growth of the Latino population, identifying interventions that reduce mental health disparities among Mexican immigrant women can have a significant public health impact.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ALMA Intervention Group | Experimental | Behavioral: Latina Friends Motivating the Soul (ALMA)Latina Friends Motivating the Soul (ALMA). This group receives the intervention after baseline assessment. |
| ALMA Delayed Intervention Control Group | Active comparator | Behavioral: Latina Friends Motivating the Soul (ALMA)Latina Friends Motivating the Soul (ALMA). This group receives the intervention six months after the baseline assessment (after the post-intervention, and 3 month assessments have been completed). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- To be eligible for study participation, participants must be at least 18 years of age, female, speak Spanish, must self-identify as Latina, and have been born outside of the United States
Key exclusion criteria (1 listed)
- The investigators will screen for and exclude women who currently have high levels of depressive symptoms (as indicated by a score of 20 or higher on the PHQ-9). If women excluded from the study are not already receiving mental health treatment, the will be referred to mental health providers offering low-cost services in Spanish.
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 |
|---|---|---|
| Latina Friends Motivating the Soul (ALMA)In a series of 8 weekly sessions, the program uses a group format to teach and encourage women to use coping strategies to reduce depression and anxiety. Over the course of the eight ALMA sessions, 25 women are (1) engaged in activities to identify coping strategies they are currently using and encouraged to continue to use them; (2) introduced to new coping strategies (e.g. mindfulness techniques, increased social ties and social support); and, (3) provided resources for seeking additional help if needed | Behavioural | ALMA Delayed Intervention Control Group, ALMA Intervention Group |
Primary outcome
Depressive Symptoms
Time frame: Change measure (baseline, 4 months, 6 months, 9 months)
Frequency of depressive symptoms as measured by the Patient Health Questionnaire 9 (PHQ-9) in the last two weeks. The PHQ-9 is a multipurpose instrument for screening, diagnosing, monitoring and measuring the severity of depression. Scores range from 0 to 27. In general, a total of 10 or above is suggestive of the presence of depression. Depression Severity: 0-4 none, 5-9 mild, 10-14 moderate, 15-19 moderately severe, 20-27 severe.
Anxiety Symptoms
Time frame: Change measure (baseline, 4 months, 6 months, 9 months)
Frequency of anxiety symptoms as measured by the General Anxiety Disorders 7 (GAD_\&) in the last two weeks. Generalized Anxiety Disorder 7 (GAD-7) is a self-reported questionnaire for screening and severity measuring of generalized anxiety disorder (GAD). Scores range from 0 to 21. Scores ≥10. Anxiety Severity: 1-4 minimal symptoms, 5-9 mild symptoms, 10-14 moderate symptoms, 15-21 severe symptoms
1 secondary outcome
Stress
Time frame: Change measure (baseline, 4 months, 6 months, 9 months)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2023.
- Derived from this study: PubMed 38430288Miranda MM, Rao D, Price C, Gudino J, Perez G, Maurer S, Nelson AK, Perez-Solorio SA, Ornelas IJ. Amigas Latinas Motivando el Alma: Participant Perspectives on an In-Person and Online Implementation of an Intervention to Promote Mental Health in Latina Immigrant Women. Community Ment Health J. 2024 Jul;60(5):908-918. doi: 10.1007/s10597-024-01244-z. Epub 2024 Mar 2.
- Derived from this study: PubMed 35723668Ornelas IJ, Perez G, Maurer S, Gonzalez S, Childs V, Price C, Nelson AK, Perez Solorio SA, Tran A, Rao D. Amigas Latinas Motivando el Alma: In-Person and Online Delivery of an Intervention to Promote Mental Health Among Latina Immigrant Women. J Integr Complement Med. 2022 Oct;28(10):821-829. doi: 10.1089/jicm.2022.0491. Epub 2022 Jun 20.
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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.
India J Ornelas, PhD, MPH principal investigator
University of Washington
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Latina Friends Motivating the Soul (ALMA) in people with Stress and Depression, run by University of Washington at 2 sites 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 1 inclusion and 1 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: withdrawn, as of the sponsor's last update on 10 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 was withdrawn before enrolling participants, so there are no results.
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?
Depressive Symptoms (time frame: Change measure (baseline, 4 months, 6 months, 9 months)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03749278, which also lists 2 linked publications.
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 2023.