Depressive SymptomsNCT04473599
Stay Well at Home: a Text-messaging Study Social Distancing
A study testing Uniform random message delivery, Reinforcement learning message delivery and Mood ratings only in people with Depressive Symptoms and Anxiety, run by University of California, Berkeley at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Depressive Symptoms, Anxiety, COVID-19
- What is being tested?
- Uniform random message delivery, Reinforcement learning message delivery and Mood ratings only
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Apr 2020to 10 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Over 18 years old
- Own a mobile phone
- Speak English or Spanish
Who cannot join
- Not owning a mobile phone
- Under 18 years old
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California Berkeley
Berkeley, California, 94709
About this study
Official title: Stay Well at Home: A Text-messaging Study to Improve Mood and Help Cope With Social Distancing
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.
Read the detailed description
The investigators will send participants supportive text-messages for a period of 2 months. These text-messages will include tips about behavioral activation and coping skills to deal with worries and stress. The investigators generated a message bank balanced such that 50% of all messages are related to behavioral activation (BA) and 50% messages involve different coping skills. Participants will receive one of these messages per day between 9:00 am and 6:00 pm. Participants will also receive a message asking them to rate their mood on a scale of 1-9 once a day 3 hours after the BA or coping message.
Participants will be randomized to:
- a uniform random messaging group (micro-randomized trial design).
- a reinforcement learning group with a learned decision mechanism for the timing and type of text-message. The algorithm learns from previous data (which messages were sent, what was the participants' mood) to maximize an increase in participants mood. No other data are collected from participants' phones.
The investigators will compare the effect of sending text-messages by a random schedule, and text-messaging chosen by the RL algorithm. This allows to both evaluate the effect of the individual intervention components over time within a micro-randomized trial design, and assess the added value of using RL to adapt the messaging scheme.
The investigators hypothesize that:
- Participant will show improvements in depression, anxiety symptoms and mood during the 60 day study.
- The participants in the group receiving reinforcement learning will have a greater improvement in depressive symptoms, anxiety and positive mood during the study than participants in the micro-randomized group.
- The investigators will find differential effects on mood ratings for the two categories of messages
- Conditions
- Depressive Symptoms, Anxiety, COVID-19
- Being tested
- Uniform random message delivery, Reinforcement learning message delivery, Mood ratings only
- Keywords
- Mobile health, Text-messaging, Covid-19, Mental health, Coping
- Medical subject headings
- Depression, Anxiety Disorders, COVID-19, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Uniform random message deliveryBehavioural
In this arm, the categories and timings of text-messages will be delivered to participants using a random schedule
Reinforcement learning message deliveryBehavioural
In this arm, the categories and timings of text-messages will be chosen by a reinforcement learning algorithm
Mood ratings onlyBehavioural
In this arm, participants will monitor their mood daily and receive feedback on that mood randomly
| Study group | Role | What they receive |
|---|---|---|
| Uniform Random | Active comparator | Participants 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. Receives: Behavioral: Uniform random message delivery |
| Reinforcement Learning | Experimental | In 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. Receives: Behavioral: Reinforcement learning message delivery |
| Mood ratings only | Active comparator | In this arm, participants will monitor their mood and receive random feedback based on mood responses. Receives: Behavioral: Mood ratings only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depression scores
Patient Health Questionnaire 9 item (PHQ-9). The PHQ-9 has scores from 0 to 27. Higher scores mean a worse outcome.
Measured: 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.
Measured: Change from baseline to 8 week follow-up
Secondary outcomes (1)
Self reported mood ratings
The self-reported mood rating 3 hours after receiving a message. The score is from 0-9. A higher mood rating indicates a better outcome.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2020
- Study start17 Apr 2020
- Primary completion25 Jul 2022
- Study completion10 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Depressive SymptomsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 1,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Berkeley
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Adrian Aguilera, PhD, Principal investigator, UC Berkeley
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04473599
- Sponsor's protocol ID
- 2020-04-13162
- Status last verified
- May 2023
- First submitted
- 13 Jul 2020
- Last updated
- 23 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlies the results reported in the articles will be made available to researchers on request after deidentification.
Publications
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.
PubMed 37146444Aguilera 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.
PubMed 34543230Figueroa 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.
PubMed 33370721
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stay Well at Home: A Text-messaging Study to Improve Mood and Help Cope With Social Distancing
- ClinicalTrials.gov ID
- NCT04473599
- Acronym / sponsor ID
- 2020-04-13162
- Conditions
- Depressive Symptoms, Anxiety, COVID-19
- Keywords
- Mobile health, Text-messaging, Covid-19, Mental health, Coping
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- University of California, BerkeleyUniversity, hospital or other
- Study start
- 17 Apr 2020 (actual)
- Primary completion
- 25 Jul 2022 (actual)
- Study completion
- 10 Jan 2023 (actual)
- First posted
- 16 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The investigators will send participants supportive text-messages for a period of 2 months. These text-messages will include tips about behavioral activation and coping skills to deal with worries and stress. The investigators generated a message bank balanced such that 50% of all messages are related to behavioral activation (BA) and 50% messages involve different coping skills. Participants will receive one of these messages per day between 9:00 am and 6:00 pm. Participants will also receive a message asking them to rate their mood on a scale of 1-9 once a day 3 hours after the BA or coping message.
Participants will be randomized to:
- a uniform random messaging group (micro-randomized trial design).
- a reinforcement learning group with a learned decision mechanism for the timing and type of text-message. The algorithm learns from previous data (which messages were sent, what was the participants' mood) to maximize an increase in participants mood. No other data are collected from participants' phones.
The investigators will compare the effect of sending text-messages by a random schedule, and text-messaging chosen by the RL algorithm. This allows to both evaluate the effect of the individual intervention components over time within a micro-randomized trial design, and assess the added value of using RL to adapt the messaging scheme.
The investigators hypothesize that:
- Participant will show improvements in depression, anxiety symptoms and mood during the 60 day study.
- The participants in the group receiving reinforcement learning will have a greater improvement in depressive symptoms, anxiety and positive mood during the study than participants in the micro-randomized group.
- The investigators will find differential effects on mood ratings for the two categories of messages
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Uniform Random | Active comparator | Behavioral: Uniform random message deliveryParticipants 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 | Experimental | Behavioral: Reinforcement learning message deliveryIn 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 comparator | Behavioral: Mood ratings onlyIn this arm, participants will monitor their mood and receive random feedback based on mood responses. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Over 18 years old
- Own a mobile phone
- Speak English or Spanish
Key exclusion criteria (2 listed)
- Not owning a mobile phone
- Under 18 years old
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Uniform random message deliveryIn this arm, the categories and timings of text-messages will be delivered to participants using a random schedule | Behavioural | Uniform Random |
| Reinforcement learning message deliveryIn this arm, the categories and timings of text-messages will be chosen by a reinforcement learning algorithm | Behavioural | Reinforcement Learning |
| Mood ratings onlyIn this arm, participants will monitor their mood daily and receive feedback on that mood randomly | Behavioural | Mood ratings only |
Primary outcome
Depression scores
Time frame: Change from baseline to 8 week follow-up
Patient Health Questionnaire 9 item (PHQ-9). The PHQ-9 has scores from 0 to 27. Higher scores mean a worse outcome.
Anxiety scores
Time frame: Change from baseline to 8 week follow-up
General Anxiety Disorder 7 item (GAD-7). The GAD-7 has scores from 0 to 21. Higher scores mean a worse outcome.
1 secondary outcome
Self reported mood ratings
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2023.
- Derived from this study: PubMed 37146444Haro-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.
- Derived from this study: PubMed 34543230Aguilera 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.
- Derived from this study: PubMed 33370721Figueroa 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.
- Individual participant dataSharing planned: Yes. Individual participant data that underlies the results reported in the articles will be made available to researchers on request after deidentification.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adrian Aguilera, PhD principal investigator
UC Berkeley
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Uniform random message delivery, Reinforcement learning message delivery and Mood ratings only in people with Depressive Symptoms and Anxiety, run by University of California, Berkeley at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Depression scores (time frame: Change from baseline to 8 week follow-up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04473599, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2023.