Anxiety, Depression, Stress
Conditions
Keywords
Mental Health, Minority Health, Latina
Brief 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. 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 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.
Interventions
BEHAVIORALAmigas 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.
Sponsors
National Institute on Minority Health and Health Disparities (NIMHD)
University of Washington
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Investigator, Outcomes Assessor)
Masking description
The investigators and outcomes assessor will not have knowledge of the interventions assigned to individual participants.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 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.
Exclusion criteria
* Participant screened for high levels of depressive symptoms (as indicated by a score of 20 or higher on the PHQ-9) which indicates severe symptoms. Participants with scores above 20 were referred to the licensed mental health counselor on the study team. If these women are not already receiving mental health treatment, they will be referred to mental health providers offering low-cost services in Spanish. The counselor will discuss participation in the program with the potential participants and make the final determination about their ability to participate based on the care they are currently receiving and the severity of their symptoms.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Depressive Symptoms | 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. | 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. |
| Anxiety Symptoms | 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. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Stress | 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. | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Program Satisfaction | 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. | 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). |
Countries
United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 111 |
| 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. | 115 |
| Total | 226 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 15 | 10 |
| Overall Study | Withdrawal by Subject | 2 | 2 |
Baseline characteristics
| Characteristic | ALMA Delayed Intervention Control Group | Total | ALMA Intervention Group |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 2 Participants | 6 Participants | 4 Participants |
| Age, Categorical Between 18 and 65 years | 113 Participants | 220 Participants | 107 Participants |
| Age, Continuous | 39.09 years STANDARD_DEVIATION 0.03 | 40.14 years STANDARD_DEVIATION 0.7 | 41.23 years STANDARD_DEVIATION 1.04 |
| Anxiety symptoms, categorical Mild (5-9) | 46 Participants | 92 Participants | 46 Participants |
| Anxiety symptoms, categorical Moderate (10-14) | 21 Participants | 40 Participants | 19 Participants |
| Anxiety symptoms, categorical None (0-4) | 37 Participants | 76 Participants | 39 Participants |
| Anxiety symptoms, categorical Severe (15-21) | 11 Participants | 18 Participants | 7 Participants |
| Anxiety symptoms, continuous | 7.06 units on a scale STANDARD_DEVIATION 0.4 | 6.87 units on a scale STANDARD_DEVIATION 0.3 | 6.67 units on a scale STANDARD_DEVIATION 0.4 |
| Depressive symptoms, categorical Mild (5-9) | 39 Participants | 80 Participants | 41 Participants |
| Depressive symptoms, categorical Moderate (10-14) | 20 Participants | 35 Participants | 15 Participants |
| Depressive symptoms, categorical Moderate to Severe (15-27) | 9 Participants | 22 Participants | 13 Participants |
| Depressive symptoms, categorical None (0-4) | 47 Participants | 89 Participants | 42 Participants |
| Depressive symptoms, continuous | 6.66 units on a scale STANDARD_DEVIATION 0.4 | 6.86 units on a scale STANDARD_DEVIATION 0.3 | 7.06 units on a scale STANDARD_DEVIATION 0.5 |
| Education, categorical High school degree or higher | 83 Participants | 150 Participants | 67 Participants |
| Education, categorical Less than high school degree | 32 Participants | 76 Participants | 44 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 115 Participants | 226 Participants | 111 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Immigration status, categorical Current visa/ permission | 37 Participants | 61 Participants | 24 Participants |
| Immigration status, categorical Entry and/or stay without permission | 59 Participants | 132 Participants | 73 Participants |
| Immigration status, categorical Preferred not to answer | 19 Participants | 33 Participants | 14 Participants |
| Region of Enrollment Argentina | 1 Participants | 1 Participants | 0 Participants |
| Region of Enrollment Bolivia | 1 Participants | 1 Participants | 0 Participants |
| Region of Enrollment Chile | 1 Participants | 1 Participants | 0 Participants |
| Region of Enrollment Colombia | 3 Participants | 4 Participants | 1 Participants |
| Region of Enrollment Ecuador | 0 Participants | 1 Participants | 1 Participants |
| Region of Enrollment El Salvador | 5 Participants | 11 Participants | 6 Participants |
| Region of Enrollment Guatemala | 10 Participants | 15 Participants | 5 Participants |
| Region of Enrollment Honduras | 2 Participants | 2 Participants | 0 Participants |
| Region of Enrollment Mexico | 89 Participants | 185 Participants | 96 Participants |
| Region of Enrollment Peru | 0 Participants | 1 Participants | 1 Participants |
| Region of Enrollment United States | 2 Participants | 2 Participants | 0 Participants |
| Region of Enrollment Venezuela | 1 Participants | 2 Participants | 1 Participants |
| Sex: Female, Male Female | 115 Participants | 226 Participants | 111 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 111 | 0 / 115 |
| other Total, other adverse events | 0 / 111 | 0 / 115 |
| serious Total, serious adverse events | 0 / 111 | 0 / 115 |
Outcome results
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.
Time frame: 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.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| ALMA Intervention Group | Anxiety Symptoms | Baseline | 6.71 score on a scale |
| ALMA Intervention Group | Anxiety Symptoms | Two-month follow-up | 4.09 score on a scale |
| ALMA Intervention Group | Anxiety Symptoms | Four-month follow-up | 4.30 score on a scale |
| ALMA Delayed Intervention Control Group | Anxiety Symptoms | Baseline | 7.02 score on a scale |
| ALMA Delayed Intervention Control Group | Anxiety Symptoms | Two-month follow-up | 5.56 score on a scale |
| ALMA Delayed Intervention Control Group | Anxiety Symptoms | Four-month follow-up | 5.35 score on a scale |
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.
Time frame: 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.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| ALMA Intervention Group | Depressive Symptoms | Baseline | 7.01 score on a scale |
| ALMA Intervention Group | Depressive Symptoms | Two-month follow-up | 4.96 score on a scale |
| ALMA Intervention Group | Depressive Symptoms | Four-month follow-up | 5.19 score on a scale |
| ALMA Delayed Intervention Control Group | Depressive Symptoms | Baseline | 6.61 score on a scale |
| ALMA Delayed Intervention Control Group | Depressive Symptoms | Two-month follow-up | 6.39 score on a scale |
| ALMA Delayed Intervention Control Group | Depressive Symptoms | Four-month follow-up | 6.31 score on a scale |
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ALMA Intervention Group | Stress | Baseline | 6.36 score on a scale | Standard Deviation 0.3 |
| ALMA Intervention Group | Stress | Two month follow-up | 5.20 score on a scale | Standard Deviation 0.25 |
| ALMA Intervention Group | Stress | Four month follow-up | 5.19 score on a scale | Standard Deviation 0.33 |
| ALMA Delayed Intervention Control Group | Stress | Baseline | 6.27 score on a scale | Standard Deviation 0.27 |
| ALMA Delayed Intervention Control Group | Stress | Two month follow-up | 5.65 score on a scale | Standard Deviation 0.29 |
| ALMA Delayed Intervention Control Group | Stress | Four month follow-up | 5.73 score on a scale | Standard Deviation 0.31 |
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).
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ALMA Intervention Group | Program Satisfaction | Would recommend program | 4.95 score on a scale | Standard Deviation 0.02 |
| ALMA Intervention Group | Program Satisfaction | Program was relevant | 4.84 score on a scale | Standard Deviation 0.05 |
| ALMA Intervention Group | Program Satisfaction | Enjoyed ALMA program | 4.92 score on a scale | Standard Deviation 0.03 |
| ALMA Intervention Group | Program Satisfaction | The program helped improve my mental health | 4.82 score on a scale | Standard Deviation 0.04 |
| ALMA Delayed Intervention Control Group | Program Satisfaction | The program helped improve my mental health | 4.63 score on a scale | Standard Deviation 0.08 |
| ALMA Delayed Intervention Control Group | Program Satisfaction | Would recommend program | 4.80 score on a scale | Standard Deviation 0.05 |
| ALMA Delayed Intervention Control Group | Program Satisfaction | Enjoyed ALMA program | 4.71 score on a scale | Standard Deviation 0.06 |
| ALMA Delayed Intervention Control Group | Program Satisfaction | Program was relevant | 4.78 score on a scale | Standard Deviation 0.05 |