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| ID | Type | Description | Link |
|---|---|---|---|
| R01MD012230 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Minority Health and Health Disparities (NIMHD) | NIH |
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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.
The proposed study aims to test the efficacy of the Amigas Latinas Motivando el Alma (ALMA) intervention in a randomized 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 1 of the proposed study is to refine the ALMA intervention and study procedures, using information learned from focus groups and cognitive interviews with Mexican immigrant women. Aim 2 is to determine the efficacy of the ALMA intervention to reduce depressive and anxiety symptoms using a randomized control study design. We will recruit women from community-based organizations serving Latino immigrants to participate in the program, which will be offered in community settings. We will assess process outcomes of recruitment, retention, fidelity, and participant satisfaction through observations and in-depth interviews with participants. We 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 (pre-intervention, post-intervention, 6 months, 9 months). 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ALMA Intervention Group | Experimental | Amigas Latinas Motivando el Alma (ALMA). This group receives the intervention after baseline assessment. |
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| ALMA Delayed Intervention Control Group | Other | Amigas Latinas Motivando el Alma (ALMA). This group receives the intervention five months after the baseline assessment (after the post-intervention, and 3 month assessments have been completed). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Amigas Latinas Motivando el Alma (ALMA) | Behavioral | 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. Due to COVID-19 pandemic, the intervention was changed to online synchronous delivery via Zoom over 6 weekly sessions. |
| Measure | Description | Time Frame |
|---|---|---|
| Depressive Symptoms | Frequency of depressive symptoms as measured by the Patient Health Questionnaire 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. Higher scores indicate a worse outcome. | Baseline, 2 months after baseline (post-intervention for intervention group), 4 months after baseline, and 6 months after baseline. Outcomes reported at baseline, 2 and 4 months after baseline for both intervention and control groups. |
| Anxiety Symptoms | Frequency of anxiety symptoms as measured by the General Anxiety Disorders 7 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. Higher scores indicate a worse outcome. | Baseline, 2 months after baseline (post-intervention for intervention group), 4 months after baseline, and 6 months after baseline. Outcomes reported at baseline, 2 and 4 months after baseline for both intervention and control groups. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. Higher scores indicate worse outcomes. |
| Measure | Description | Time Frame |
|---|---|---|
| Program Satisfaction | Survey items that ask participant about their level of satisfaction with the program. Response options of 1 - 5, with 5 indicating highest satisfaction (better outcome). | Assessed in the intervention group at post-intervention follow-up, 2 months after baseline. In the control group, it was assessed post-intervention, 6 months after baseline. |
Inclusion Criteria:
Exclusion Criteria:
Men will not be included in the study. Participation is limited to this population because the research question addressed is relevant only to Latina women and the mental health concerns of this community.
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| Name | Affiliation | Role |
|---|---|---|
| India J Ornelas, PhD, MPH | University of Washington | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Casa Latina | Seattle | Washington | 98144 | United States | ||
| El Centro de la Raza |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35257311 | Background | Abarca GJ, Tornberg-Belanger SN, Ryan D, Price C, Rao D, Ornelas IJ. Understanding the Relationship Between Social Stressors, Trauma, and Somatic Symptoms Among Latina Immigrant Women. J Racial Ethn Health Disparities. 2023 Feb;10(1):387-394. doi: 10.1007/s40615-022-01230-9. Epub 2022 Mar 7. | |
| 34672827 | Background | Ornelas IJ, Tornberg-Belanger S, Balkus JE, Bravo P, Perez Solorio SA, Perez GE, Tran AN. Coping With COVID-19: The Impact of the Pandemic on Latina Immigrant Women's Mental Health and Well-being. Health Educ Behav. 2021 Dec;48(6):733-738. doi: 10.1177/10901981211050638. Epub 2021 Oct 21. |
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Participants were recruited from two community-based organizations serving Latino immigrants over four waves between September 2018 - February 2021. Bilingual study team members and community organization staff recruited participants by promoting the study to clients via flyers, PowerPoint presentations, social media announcements and word of mouth.
| ID | Title | Description |
|---|---|---|
| FG000 | ALMA Intervention Group | Amigas Latinas Motivando el Alma (ALMA). This group receives the intervention after baseline assessment. Amigas Latinas Motivando el Alma (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. Due to COVID-19 pandemic, the intervention was changed to online synchronous delivery via Zoom over 6 weekly sessions. |
| FG001 | ALMA Delayed Intervention Control Group | Amigas Latinas Motivando el Alma (ALMA). This group receives the intervention five months after the baseline assessment (after the post-intervention, and 3 month assessments have been completed). Amigas Latinas Motivando el Alma (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. Due to COVID-19 pandemic, the intervention was changed to online synchronous delivery via Zoom over 6 weekly sessions. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | ALMA Intervention Group | Amigas Latinas Motivando el Alma (ALMA). This group receives the intervention after baseline assessment. Amigas Latinas Motivando el Alma (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. Due to COVID-19 pandemic, the intervention was changed to online synchronous delivery via Zoom over 6 weekly sessions. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Depressive Symptoms | Frequency of depressive symptoms as measured by the Patient Health Questionnaire 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. Higher scores indicate a worse outcome. | In the intervention group: 12 participants were lost to follow-up at 2-month post-intervention time point, and 17 were not able to be contacted at the 4 month follow-up time point. In the control group: 15 participants were lost to follow-up at 2-month post intervention time point, and 12 were not able to be contacted at 4 month follow-up time point. Reasons were that they could not be contacted or declined to complete the survey. | Posted | Least Squares Mean | 95% Confidence Interval | score on a scale | Baseline, 2 months after baseline (post-intervention for intervention group), 4 months after baseline, and 6 months after baseline. Outcomes reported at baseline, 2 and 4 months after baseline for both intervention and control groups. |
Data on adverse events was collected through the final follow-up (9 months after baseline).
Does not differ.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | ALMA Intervention Group | Amigas Latinas Motivando el Alma (ALMA). This group receives the intervention after baseline assessment. Amigas Latinas Motivando el Alma (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. Due to COVID-19 pandemic, the intervention was changed to online synchronous delivery via Zoom over 6 weekly sessions. |
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Half of trial had to be conducted under COVID-19 protocol which changed intervention delivery and modes of data collection (phone instead of in-person).
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| India Ornelas | University of Washington | 206-685-8887 | iornelas@uw.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 8, 2022 | Nov 28, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003863 | Depression |
| D001008 | Anxiety Disorders |
| D000092862 | Psychological Well-Being |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D001523 | Mental Disorders |
| D010549 | Personal Satisfaction |
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The investigators and outcomes assessor will not have knowledge of the interventions assigned to individual participants.
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| Baseline, 2 months after baseline (post-intervention for intervention group), 4 months after baseline, and 6 months after baseline. Outcomes reported at baseline, 2 and 4 months after baseline for both intervention and control groups. |
| Seattle |
| Washington |
| 98144 |
| United States |
| 34371256 | Background | Ryan D, Tornberg-Belanger SN, Perez G, Maurer S, Price C, Rao D, Chan KCG, Ornelas IJ. Stress, social support and their relationship to depression and anxiety among Latina immigrant women. J Psychosom Res. 2021 Oct;149:110588. doi: 10.1016/j.jpsychores.2021.110588. Epub 2021 Jul 30. |
| 36809698 | Result | Ornelas IJ, Rao D, Price C, Chan G, Tran A, Aisenberg G, Perez G, Maurer S, Nelson AK. Promoting mental health in Latina immigrant women: Results from the Amigas Latinas Motivando el Alma intervention trial. Soc Sci Med. 2023 Mar;321:115776. doi: 10.1016/j.socscimed.2023.115776. Epub 2023 Feb 16. |
| 35723668 | Result | Ornelas 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. |
| BG001 | ALMA Delayed Intervention Control Group | Amigas Latinas Motivando el Alma (ALMA). This group receives the intervention five months after the baseline assessment (after the post-intervention, and 3 month assessments have been completed). Amigas Latinas Motivando el Alma (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. Due to COVID-19 pandemic, the intervention was changed to online synchronous delivery via Zoom over 6 weekly sessions. |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Education, categorical | Count of Participants | Participants |
|
| Immigration status, categorical | Count of Participants | Participants |
|
| Anxiety symptoms, continuous | range of 0 (minimum) to 21 (maximum) with higher scores indicating more frequent symptoms of anxiety | Mean | Standard Deviation | units on a scale |
|
| Anxiety symptoms, categorical | Count of Participants | Participants |
|
| Depressive symptoms, continuous | range of 0 (minimum) to 27 (maximum) with higher scores indicating more frequent symptoms of depression | Mean | Standard Deviation | units on a scale |
|
| Depressive symptoms, categorical | Count of Participants | Participants |
|
| ID | Title | Description |
|---|
| OG000 | ALMA Intervention Group | Amigas Latinas Motivando el Alma (ALMA). This group receives the intervention after baseline assessment. Amigas Latinas Motivando el Alma (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. Due to COVID-19 pandemic, the intervention was changed to online synchronous delivery via Zoom over 6 weekly sessions. |
| OG001 | ALMA Delayed Intervention Control Group | Amigas Latinas Motivando el Alma (ALMA). This group receives the intervention five months after the baseline assessment (after the post-intervention, and 3 month assessments have been completed). Amigas Latinas Motivando el Alma (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. Due to COVID-19 pandemic, the intervention was changed to online synchronous delivery via Zoom over 6 weekly sessions. |
|
|
| Primary | Anxiety Symptoms | Frequency of anxiety symptoms as measured by the General Anxiety Disorders 7 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. Higher scores indicate a worse outcome. | In the intervention group: 12 participants were lost to follow-up at 2-month post-intervention time point, and 17 were not able to be contacted at the 4 month follow-up time point. In the control group: 15 participants were lost to follow-up at 2-month post intervention time point, and 12 were not able to be contacted at 4 month follow-up time point. Reasons were that they could not be contacted or declined to complete the survey. | Posted | Least Squares Mean | 95% Confidence Interval | score on a scale | Baseline, 2 months after baseline (post-intervention for intervention group), 4 months after baseline, and 6 months after baseline. Outcomes reported at baseline, 2 and 4 months after baseline for both intervention and control groups. |
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| Secondary | 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. Higher scores indicate worse outcomes. | In the intervention group: 12 participants were lost to follow-up at 2-month post-intervention time point, and 17 were not able to be contacted at the 4 month follow-up time point. In the control group: 15 participants were lost to follow-up at 2-month post intervention time point, and 12 were not able to be contacted at 4 month follow-up time point. Reasons were that they could not be contacted or declined to complete the survey. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 2 months after baseline (post-intervention for intervention group), 4 months after baseline, and 6 months after baseline. Outcomes reported at baseline, 2 and 4 months after baseline for both intervention and control groups. |
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| Other Pre-specified | Program Satisfaction | Survey items that ask participant about their level of satisfaction with the program. Response options of 1 - 5, with 5 indicating highest satisfaction (better outcome). | In the intervention group: 14 participants were either lost to follow-up at two month time point or did not attend any sessions and therefore were not asked these questions. In the control group: 39 participants were either lost to follow-up at two month time point or did not attend any sessions and therefore were not asked the questions. | Posted | Mean | Standard Deviation | score on a scale | Assessed in the intervention group at post-intervention follow-up, 2 months after baseline. In the control group, it was assessed post-intervention, 6 months after baseline. |
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|
|
| 0 |
| 111 |
| 0 |
| 111 |
| 0 |
| 111 |
| EG001 | ALMA Delayed Intervention Control Group | Amigas Latinas Motivando el Alma (ALMA). This group receives the intervention five months after the baseline assessment (after the post-intervention, and 3 month assessments have been completed). Amigas Latinas Motivando el Alma (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. Due to COVID-19 pandemic, the intervention was changed to online synchronous delivery via Zoom over 6 weekly sessions. | 0 | 115 | 0 | 115 | 0 | 115 |
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| Two-month follow-up |
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| Four-month follow-up |
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| Two month follow-up |
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| Four month follow-up |
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| Enjoyed ALMA program |
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| The program helped improve my mental health |
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