Trial Outcomes & Findings for Intervention Trial to Reduce Mental Health Disparities in Latina Immigrant Women (NCT NCT03545282)

NCT ID: NCT03545282

Last Updated: 2024-05-24

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

226 participants

Primary outcome timeframe

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.

Results posted on

2024-05-24

Participant Flow

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.

Unit of analysis: Site

Participant milestones

Participant milestones
Measure
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.
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.
Overall Study
STARTED
111 1
115 1
Overall Study
Attended at Least One Session
103 1
85 1
Overall Study
Attended 50% of Sessions
88 1
65 1
Overall Study
Attended 75% of Intervention Sessions
56 1
57 1
Overall Study
Follow-up, 2 Months After Baseline
99 1
100 1
Overall Study
Follow-up, 4 Months After Baseline
94 1
103 1
Overall Study
COMPLETED
94 1
103 1
Overall Study
NOT COMPLETED
17 0
12 0

Reasons for withdrawal

Reasons for withdrawal
Measure
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.
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.
Overall Study
Lost to Follow-up
15
10
Overall Study
Withdrawal by Subject
2
2

Baseline Characteristics

Intervention Trial to Reduce Mental Health Disparities in Latina Immigrant Women

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
ALMA Intervention Group
n=111 Participants
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.
ALMA Delayed Intervention Control Group
n=115 Participants
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.
Total
n=226 Participants
Total of all reporting groups
Age, Categorical
<=18 years
0 Participants
n=93 Participants
0 Participants
n=4 Participants
0 Participants
n=27 Participants
Age, Categorical
Between 18 and 65 years
107 Participants
n=93 Participants
113 Participants
n=4 Participants
220 Participants
n=27 Participants
Age, Categorical
>=65 years
4 Participants
n=93 Participants
2 Participants
n=4 Participants
6 Participants
n=27 Participants
Age, Continuous
41.23 years
STANDARD_DEVIATION 1.04 • n=93 Participants
39.09 years
STANDARD_DEVIATION 0.03 • n=4 Participants
40.14 years
STANDARD_DEVIATION 0.70 • n=27 Participants
Sex: Female, Male
Female
111 Participants
n=93 Participants
115 Participants
n=4 Participants
226 Participants
n=27 Participants
Sex: Female, Male
Male
0 Participants
n=93 Participants
0 Participants
n=4 Participants
0 Participants
n=27 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
111 Participants
n=93 Participants
115 Participants
n=4 Participants
226 Participants
n=27 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
0 Participants
n=93 Participants
0 Participants
n=4 Participants
0 Participants
n=27 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=93 Participants
0 Participants
n=4 Participants
0 Participants
n=27 Participants
Region of Enrollment
Mexico
96 Participants
n=93 Participants
89 Participants
n=4 Participants
185 Participants
n=27 Participants
Region of Enrollment
El Salvador
6 Participants
n=93 Participants
5 Participants
n=4 Participants
11 Participants
n=27 Participants
Region of Enrollment
Colombia
1 Participants
n=93 Participants
3 Participants
n=4 Participants
4 Participants
n=27 Participants
Region of Enrollment
Venezuela
1 Participants
n=93 Participants
1 Participants
n=4 Participants
2 Participants
n=27 Participants
Region of Enrollment
Ecuador
1 Participants
n=93 Participants
0 Participants
n=4 Participants
1 Participants
n=27 Participants
Region of Enrollment
Peru
1 Participants
n=93 Participants
0 Participants
n=4 Participants
1 Participants
n=27 Participants
Region of Enrollment
Guatemala
5 Participants
n=93 Participants
10 Participants
n=4 Participants
15 Participants
n=27 Participants
Region of Enrollment
Argentina
0 Participants
n=93 Participants
1 Participants
n=4 Participants
1 Participants
n=27 Participants
Region of Enrollment
United States
0 Participants
n=93 Participants
2 Participants
n=4 Participants
2 Participants
n=27 Participants
Region of Enrollment
Chile
0 Participants
n=93 Participants
1 Participants
n=4 Participants
1 Participants
n=27 Participants
Region of Enrollment
Honduras
0 Participants
n=93 Participants
2 Participants
n=4 Participants
2 Participants
n=27 Participants
Region of Enrollment
Bolivia
0 Participants
n=93 Participants
1 Participants
n=4 Participants
1 Participants
n=27 Participants
Education, categorical
High school degree or higher
67 Participants
n=93 Participants
83 Participants
n=4 Participants
150 Participants
n=27 Participants
Education, categorical
Less than high school degree
44 Participants
n=93 Participants
32 Participants
n=4 Participants
76 Participants
n=27 Participants
Immigration status, categorical
Current visa/ permission
24 Participants
n=93 Participants
37 Participants
n=4 Participants
61 Participants
n=27 Participants
Immigration status, categorical
Entry and/or stay without permission
73 Participants
n=93 Participants
59 Participants
n=4 Participants
132 Participants
n=27 Participants
Immigration status, categorical
Preferred not to answer
14 Participants
n=93 Participants
19 Participants
n=4 Participants
33 Participants
n=27 Participants
Anxiety symptoms, continuous
6.67 units on a scale
STANDARD_DEVIATION 0.40 • n=93 Participants
7.06 units on a scale
STANDARD_DEVIATION 0.40 • n=4 Participants
6.87 units on a scale
STANDARD_DEVIATION 0.30 • n=27 Participants
Anxiety symptoms, categorical
None (0-4)
39 Participants
n=93 Participants
37 Participants
n=4 Participants
76 Participants
n=27 Participants
Anxiety symptoms, categorical
Mild (5-9)
46 Participants
n=93 Participants
46 Participants
n=4 Participants
92 Participants
n=27 Participants
Anxiety symptoms, categorical
Moderate (10-14)
19 Participants
n=93 Participants
21 Participants
n=4 Participants
40 Participants
n=27 Participants
Anxiety symptoms, categorical
Severe (15-21)
7 Participants
n=93 Participants
11 Participants
n=4 Participants
18 Participants
n=27 Participants
Depressive symptoms, continuous
7.06 units on a scale
STANDARD_DEVIATION 0.50 • n=93 Participants
6.66 units on a scale
STANDARD_DEVIATION 0.40 • n=4 Participants
6.86 units on a scale
STANDARD_DEVIATION 0.30 • n=27 Participants
Depressive symptoms, categorical
None (0-4)
42 Participants
n=93 Participants
47 Participants
n=4 Participants
89 Participants
n=27 Participants
Depressive symptoms, categorical
Mild (5-9)
41 Participants
n=93 Participants
39 Participants
n=4 Participants
80 Participants
n=27 Participants
Depressive symptoms, categorical
Moderate (10-14)
15 Participants
n=93 Participants
20 Participants
n=4 Participants
35 Participants
n=27 Participants
Depressive symptoms, categorical
Moderate to Severe (15-27)
13 Participants
n=93 Participants
9 Participants
n=4 Participants
22 Participants
n=27 Participants

PRIMARY outcome

Timeframe: 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.

Population: 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.

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.

Outcome measures

Outcome measures
Measure
ALMA Intervention Group
n=111 Participants
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.
ALMA Delayed Intervention Control Group
n=115 Participants
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.
Depressive Symptoms
Baseline
7.01 score on a scale
Interval 6.1 to 7.92
6.61 score on a scale
Interval 5.76 to 7.47
Depressive Symptoms
Two-month follow-up
4.96 score on a scale
Interval 4.06 to 5.87
6.39 score on a scale
Interval 5.32 to 7.45
Depressive Symptoms
Four-month follow-up
5.19 score on a scale
Interval 4.2 to 6.18
6.31 score on a scale
Interval 5.27 to 7.36

PRIMARY outcome

Timeframe: 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.

Population: 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.

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.

Outcome measures

Outcome measures
Measure
ALMA Intervention Group
n=111 Participants
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.
ALMA Delayed Intervention Control Group
n=115 Participants
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.
Anxiety Symptoms
Baseline
6.71 score on a scale
Interval 5.83 to 7.6
7.02 score on a scale
Interval 6.17 to 7.86
Anxiety Symptoms
Two-month follow-up
4.09 score on a scale
Interval 3.34 to 4.84
5.56 score on a scale
Interval 4.67 to 6.46
Anxiety Symptoms
Four-month follow-up
4.30 score on a scale
Interval 3.48 to 5.12
5.35 score on a scale
Interval 4.43 to 6.27

SECONDARY outcome

Timeframe: 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.

Population: 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.

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.

Outcome measures

Outcome measures
Measure
ALMA Intervention Group
n=111 Participants
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.
ALMA Delayed Intervention Control Group
n=115 Participants
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.
Stress
Baseline
6.36 score on a scale
Standard Deviation 0.30
6.27 score on a scale
Standard Deviation 0.27
Stress
Two month follow-up
5.20 score on a scale
Standard Deviation 0.25
5.65 score on a scale
Standard Deviation 0.29
Stress
Four month follow-up
5.19 score on a scale
Standard Deviation 0.33
5.73 score on a scale
Standard Deviation 0.31

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Population: 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.

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).

Outcome measures

Outcome measures
Measure
ALMA Intervention Group
n=97 Participants
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.
ALMA Delayed Intervention Control Group
n=76 Participants
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.
Program Satisfaction
Would recommend program
4.95 score on a scale
Standard Deviation 0.02
4.80 score on a scale
Standard Deviation 0.05
Program Satisfaction
Program was relevant
4.84 score on a scale
Standard Deviation 0.05
4.78 score on a scale
Standard Deviation 0.05
Program Satisfaction
Enjoyed ALMA program
4.92 score on a scale
Standard Deviation 0.03
4.71 score on a scale
Standard Deviation 0.06
Program Satisfaction
The program helped improve my mental health
4.82 score on a scale
Standard Deviation 0.04
4.63 score on a scale
Standard Deviation 0.08

Adverse Events

ALMA Intervention Group

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

ALMA Delayed Intervention Control Group

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

India Ornelas

University of Washington

Phone: 206-685-8887

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place