<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03749278</url>
  </required_header>
  <id_info>
    <org_study_id>STUDY00005476</org_study_id>
    <secondary_id>R01MD012230</secondary_id>
    <nct_id>NCT03749278</nct_id>
  </id_info>
  <brief_title>Latina Friends Motivating the Soul (ALMA)</brief_title>
  <official_title>Latina Friends Motivating the Soul (ALMA): A Delayed Intervention Control Trial of Program to Reduce Mental Health Disparities in Latina Immigrant Women</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Washington</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute on Minority Health and Health Disparities (NIMHD)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Washington</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Latina immigrant women are particularly vulnerable to depression and anxiety due to the&#xD;
      social and economic stressors they face, including high levels of poverty, low levels of&#xD;
      education, family obligations, exposure to violence, and limited access to community&#xD;
      resources. ALMA aims to prevent and reduce depression and anxiety among Latina immigrant&#xD;
      women. Women attend 8 weekly sessions in a group format to teach and encourage women to use&#xD;
      coping strategies to reduce depression and anxiety. The intervention aims to increase&#xD;
      participants' social ties and the social support they receive from other Latina immigrant&#xD;
      women. The program also helps decrease the stigma associated with mental health and connects&#xD;
      women to mental health services when needed.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The proposed study aims to test the efficacy of the Latina Friends Motivating the Soul (ALMA)&#xD;
      intervention in a delayed intervention control trial. ALMA is an 8-week program offered in a&#xD;
      group format to teach women new coping strategies and enhance their social ties and social&#xD;
      support to prevent and reduce their depression and anxiety. Aim 2 is to determine the&#xD;
      efficacy of the ALMA intervention to reduce depressive and anxiety symptoms using a delayed&#xD;
      intervention control study design. The investigators will recruit women from community-based&#xD;
      organizations serving Latino immigrants to participate in the program, which will be offered&#xD;
      in community settings. The investigators will assess process outcomes of recruitment,&#xD;
      retention, fidelity, and participant satisfaction through observations and in-depth&#xD;
      interviews with participants. The investigators will assess the efficacy of the intervention&#xD;
      by comparing changes in women's depressive and anxiety symptoms in the intervention and&#xD;
      attention control groups at four time points (baseline, 3-month follow-up, 6-month follow-up,&#xD;
      and 9-month follow-up). Aim 3 is to assess the potential impact of the intervention on both&#xD;
      individual (stigma, stress, coping strategies) and interpersonal (social support, social&#xD;
      ties) factors, and whether the impact of the intervention is mediated by these factors. The&#xD;
      research team includes investigators in psychology, medicine, social work and public health,&#xD;
      as well as community-based organizations serving Latina immigrants. The study uses rigorous&#xD;
      methods to test an innovative program that integrates both culturally relevant and&#xD;
      evidenced-based strategies to address significant mental health disparities in a high-risk&#xD;
      and underserved population. Findings will help inform future research and practice. Given the&#xD;
      growth of the Latino population, identifying interventions that reduce mental health&#xD;
      disparities among Mexican immigrant women can have a significant public health impact.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    This record was a placeholder created before trial was conducted. Trial is now described in&#xD;
    NCT03545282.&#xD;
  </why_stopped>
  <start_date type="Actual">September 26, 2018</start_date>
  <completion_date type="Anticipated">May 31, 2022</completion_date>
  <primary_completion_date type="Actual">January 1, 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Double (Investigator, Outcomes Assessor)</masking>
    <masking_description>The investigator and outcomes assessor will not have knowledge of the intervention assigned to individual participants</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Depressive Symptoms</measure>
    <time_frame>Change measure (baseline, 4 months, 6 months, 9 months)</time_frame>
    <description>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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Anxiety Symptoms</measure>
    <time_frame>Change measure (baseline, 4 months, 6 months, 9 months)</time_frame>
    <description>Frequency of anxiety symptoms as measured by the General Anxiety Disorders 7 (GAD_&amp;) 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</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Stress</measure>
    <time_frame>Change measure (baseline, 4 months, 6 months, 9 months)</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Stress</condition>
  <condition>Depression</condition>
  <condition>Anxiety</condition>
  <arm_group>
    <arm_group_label>ALMA Intervention Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Latina Friends Motivating the Soul (ALMA). This group receives the intervention after baseline assessment.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ALMA Delayed Intervention Control Group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>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).</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Latina Friends Motivating the Soul (ALMA)</intervention_name>
    <description>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</description>
    <arm_group_label>ALMA Delayed Intervention Control Group</arm_group_label>
    <arm_group_label>ALMA Intervention Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  To be eligible for study participation, participants must be at least 18 years of age,&#xD;
             female, speak Spanish, must self-identify as Latina, and have been born outside of the&#xD;
             United States&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  The investigators will screen for and exclude women who currently have high levels of&#xD;
             depressive symptoms (as indicated by a score of 20 or higher on the PHQ-9). If women&#xD;
             excluded from the study are not already receiving mental health treatment, the will be&#xD;
             referred to mental health providers offering low-cost services in Spanish.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>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.</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>India J Ornelas, PhD, MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Washington</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Casa Latina</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98144</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>El Centro de la Raza</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98144</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>November 13, 2018</study_first_submitted>
  <study_first_submitted_qc>November 19, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 21, 2018</study_first_posted>
  <last_update_submitted>May 8, 2023</last_update_submitted>
  <last_update_submitted_qc>May 8, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 10, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Washington</investigator_affiliation>
    <investigator_full_name>India Ornelas</investigator_full_name>
    <investigator_title>Associate Professor, School of Public Health</investigator_title>
  </responsible_party>
  <keyword>Mental Health</keyword>
  <keyword>Minority Health</keyword>
  <keyword>Latina</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Depression</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03749278
org study id: STUDY00005476
secondary id: R01MD012230
nct id: NCT03749278
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
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 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.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Double (Investigator, Outcomes Assessor)
masking description: The investigator and outcomes assessor will not have knowledge of the intervention assigned to individual participants
measure: Depressive Symptoms
time frame: Change measure (baseline, 4 months, 6 months, 9 months)
description: 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.
measure: Anxiety Symptoms
time frame: Change measure (baseline, 4 months, 6 months, 9 months)
description: 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
measure: Stress
time frame: Change measure (baseline, 4 months, 6 months, 9 months)
description: 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.
arm group label: ALMA Intervention Group
arm group type: Experimental
description: Latina Friends Motivating the Soul (ALMA). This group receives the intervention after baseline assessment.
arm group label: ALMA Delayed Intervention Control Group
arm group type: Active Comparator
description: 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).
intervention type: Behavioral
intervention name: Latina Friends Motivating the Soul (ALMA)
description: 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
arm group label: ALMA Delayed Intervention Control Group
arm group label: ALMA Intervention Group
criteria: 
gender: Female
gender based: Yes
gender description: 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.
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: India J Ornelas, PhD, MPH
role: Principal Investigator
affiliation: University of Washington
facility: 
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Washington
investigator full name: India Ornelas
investigator title: Associate Professor, School of Public Health
mesh term: Depression