Stay Well at Home: a Text-messaging Study Social Distancing
Stay Well at Home: A Text-messaging Study to Improve Mood and Help Cope With Social Distancing
1 other identifier
interventional
1,000
1 country
1
Brief Summary
The investigators have developed supportive text-messages in English and Spanish to help people cope with the stress and anxiety of COVID-19 social distancing. The purpose of this study is to examine if automated text-messages will improve depression and anxiety symptoms and enhance positive mood. Additionally, the investigators will compare the effectiveness of sending messages on a random schedule (using a micro-randomized trial design) or sent by a reinforcement learning policy on overall change in depression and anxiety symptoms and daily mood during the 8-week study.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2020
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 17, 2020
CompletedFirst Submitted
Initial submission to the registry
July 13, 2020
CompletedFirst Posted
Study publicly available on registry
July 16, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 25, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
January 10, 2023
CompletedMay 23, 2023
May 1, 2023
2.3 years
July 13, 2020
May 19, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Depression scores
Patient Health Questionnaire 9 item (PHQ-9). The PHQ-9 has scores from 0 to 27. Higher scores mean a worse outcome.
Change from baseline to 8 week follow-up
Anxiety scores
General Anxiety Disorder 7 item (GAD-7). The GAD-7 has scores from 0 to 21. Higher scores mean a worse outcome.
Change from baseline to 8 week follow-up
Secondary Outcomes (1)
Self reported mood ratings
8 weeks
Study Arms (3)
Uniform Random
ACTIVE COMPARATORParticipants will receive supportive text-messages for a period of 2 months. These text-messages have two categories: behavioral activation (BA) and coping skills. In this arm, participants will receive one of these types of messages daily on a random schedule in random time periods throughout the day.
Reinforcement Learning
EXPERIMENTALIn this arm we will test a reinforcement learning (RL) algorithm with a learned decision mechanism for the timing and type of text-messages. The algorithm learns from previous data (which messages were sent, what was the participants' mood) to maximize an increase in participants' mood.
Mood ratings only
ACTIVE COMPARATORIn this arm, participants will monitor their mood and receive random feedback based on mood responses.
Interventions
In this arm, the categories and timings of text-messages will be delivered to participants using a random schedule
In this arm, the categories and timings of text-messages will be chosen by a reinforcement learning algorithm
In this arm, participants will monitor their mood daily and receive feedback on that mood randomly
Eligibility Criteria
You may qualify if:
- Over 18 years old
- Own a mobile phone
- Speak English or Spanish
You may not qualify if:
- Not owning a mobile phone
- Under 18 years old
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of California Berkeley
Berkeley, California, 94709, United States
Related Publications (3)
Haro-Ramos AY, Rodriguez HP, Aguilera A. Effectiveness and implementation of a text messaging intervention to reduce depression and anxiety symptoms among Latinx and Non-Latinx white users during the COVID-19 pandemic. Behav Res Ther. 2023 Jun;165:104318. doi: 10.1016/j.brat.2023.104318. Epub 2023 Apr 16.
PMID: 37146444DERIVEDAguilera A, Hernandez-Ramos R, Haro-Ramos AY, Boone CE, Luo TC, Xu J, Chakraborty B, Karr C, Darrow S, Figueroa CA. A Text Messaging Intervention (StayWell at Home) to Counteract Depression and Anxiety During COVID-19 Social Distancing: Pre-Post Study. JMIR Ment Health. 2021 Nov 1;8(11):e25298. doi: 10.2196/25298.
PMID: 34543230DERIVEDFigueroa CA, Hernandez-Ramos R, Boone CE, Gomez-Pathak L, Yip V, Luo T, Sierra V, Xu J, Chakraborty B, Darrow S, Aguilera A. A Text Messaging Intervention for Coping With Social Distancing During COVID-19 (StayWell at Home): Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2021 Jan 14;10(1):e23592. doi: 10.2196/23592.
PMID: 33370721DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Adrian Aguilera, PhD
UC Berkeley
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Masking Details
- Participants are randomized to receive messages according to a random schedule (within a mico-randomized trial), delivered via a reinforcement learning policy or a control with mood ratings only.
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 13, 2020
First Posted
July 16, 2020
Study Start
April 17, 2020
Primary Completion
July 25, 2022
Study Completion
January 10, 2023
Last Updated
May 23, 2023
Record last verified: 2023-05
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ANALYTIC CODE
- Time Frame
- After publication of the data, no end date
- Access Criteria
- Anyone with a methodologically sound proposal.
Individual participant data that underlies the results reported in the articles will be made available to researchers on request after deidentification.