Cuidándome: a self-management intervention for depression and anxiety among Latina immigrant women
| ISRCTN | ISRCTN16668518 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16668518 |
| Secondary identifying numbers | IRB00287200 |
- Submission date
- 20/12/2023
- Registration date
- 21/12/2023
- Last edited
- 09/01/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
The aim of this study is to examine the feasibility and acceptability of Cuidándome delivered virtually (via Zoom) to Latina immigrant survivors of adverse childhood experiences (ACEs) with depression and anxiety symptoms. Cuidándome is a 10-week, patient-centered, culturally appropriate, trauma-informed, group intervention delivered by a trained facilitator that promotes self-management of depression/anxiety symptoms through education and problem-solving training
Who can participate?
Latina immigrant women who were at least 18 years old, had experienced at least one ACE, and had at least mild symptoms of depression or anxiety
What does the study involve?
Participants are randomly allocated to Cuidándome or a comparison group delivered by trained facilitators. The researchers assess for changes in depression and anxiety symptoms as well as social problem-solving styles at baseline, post-intervention, and 3- and 6-month follow-up. Participants are expected to join group sessions via Zoom every week for 10 weeks, and complete surveys administered by a research assistant at baseline, and 3, 6, and 9 months post-intervention.
What are the possible benefits and risks of participating?
Participants in the intervention group had the opportunity to understand how ACEs may be impacting their personal lives and gained a better understanding of mental health conditions and how they may be managed. Those who participated in the control group learned about health behavior practices that may improve their well-being.
Because the education sessions were conducted in a group format, a potential but very unlikely risk was a breach of confidentiality; in addition, the nature of some questions – particularly to those who had experienced abuse – may have caused the participants to become upset or uncomfortable. Participants were also aware that participation was voluntary and that they could stop at any time.
Where is the study run from?
This study was conducted remotely from Baltimore, with participants in the Baltimore area participating from their homes.
When is the study starting and how long is it expected to run for?
September 2019 to March 2022
Who is funding the study?
Robert Wood Johnson Foundation (USA)
Who is the main contact?
Carmen Alvarez, alcarmen@upenn.edu
Contact information
Public, Scientific, Principal Investigator
418 Curie Blvd
Philadelphia
19104
United States of America
| Phone | +1 (0)2158980715 |
|---|---|
| alcarmen@upenn.edu |
Study information
| Study design | Randomized controlled study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Community |
| Study type | Other |
| Participant information sheet | Not available in web format, please use the contact details to request a participant information sheet |
| Scientific title | Feasibility and acceptability of the cuidándome telehealth intervention for self-management of depression and anxiety among Latina immigrant women: randomized controlled trial |
| Study objectives | It is hypothesized that compared to the comparison group, the intervention group would report lower depression and anxiety symptoms. |
| Ethics approval(s) |
Approved 13/05/2021, Johns Hopkins School of Medicine IRB (615 N Wolfe St, Baltimore, 21205, United States of America; +1 (0)443 927 1794; jpugh17@jhmi.edu), ref: IRB00287200 |
| Health condition(s) or problem(s) studied | Depression and anxiety symptoms |
| Intervention | 1:1 randomization is completed by REDCap. Randomization is stratified based on ACE score so that one group would not have more people with higher average ACEs than the other. Cuidándome (Intervention): a 10-week, patient-centered, culturally appropriate, trauma-informed, group intervention delivered by a trained facilitator that promotes self-management of depression/anxiety symptoms through education and problem-solving training Health education (Attention Control): 10, 1-hour weekly sessions on general health information (nutrition, exercise, bone health, etc). |
| Intervention type | Behavioural |
| Primary outcome measure | Depression symptoms measured using the Patient Health Questionnaire 8 (PHQ-8) at baseline and 3, 6, and 9 months post-intervention |
| Secondary outcome measures | Anxiety symptoms measured using the Generalized Anxiety Disorder (GAD-7) at baseline and 3, 6, and 9 months post-intervention |
| Overall study start date | 20/09/2019 |
| Completion date | 31/03/2022 |
Eligibility
| Participant type(s) | Population |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 75 Years |
| Sex | Female |
| Target number of participants | 50 |
| Total final enrolment | 47 |
| Key inclusion criteria | 1. Being ≥18 years 2. Foreign-born (or born on the island of Puerto Rico) 3. Self-identify as a Latina 4. Self-report of ≥1 ACE 5. Ability to understand and speak Spanish 6. Have a score of ≥5 on the Patient Health Questionnaire-8 (PHQ-8), an assessment for depression symptoms, or ≥5 on the Generalized Anxiety Disorder-7 (GAD-7), an assessment for anxiety symptoms |
| Key exclusion criteria | 1. Women currently enrolled in another study about mental health (to limit potential confounding or carryover effects) 2. Women who reported being pregnant |
| Date of first enrolment | 29/06/2021 |
| Date of final enrolment | 14/07/2021 |
Locations
Countries of recruitment
- United States of America
Study participating centre
5200 Eastern Ave
Baltimore
21224
United States of America
Sponsor information
Charity
50 College Road East
Princeton
08540
United States of America
| Website | http://www.rwjf.org/ |
|---|---|
"ROR" |
https://ror.org/02ymmdj85 |
Funders
Funder type
Charity
Private sector organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- RWJ Foundation, The Robert Wood Johnson Foundation, RWJF
- Location
- United States of America
Results and Publications
| Intention to publish date | 15/01/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Two publications have been accepted for publication and will be available in the Spring of 2024: one in Cultural Diversity & Ethnic Minority Psychology and JMIR Formative Research |
| IPD sharing plan | The data on which this study is based are not publicly available due to ethical considerations. Data are available on request for the corresponding author and with a data use agreement. All requests for participant-level data should be directed to Carmen Alvarez (alcarmen@upenn.edu). Only de-identified data will be shared after a data agreement has been established. Data will be available until 2025. The researchers do not have the participants' permission to publicly share their data. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 08/01/2024 | 09/01/2024 | Yes | No |
Editorial Notes
09/01/2024: Publication reference added.
21/12/2023: Study's existence confirmed by the Johns Hopkins School of Medicine IRB.
