Skip to content

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04473599
Enrollment
1000
Registered
2020-07-16
Start date
2020-04-17
Completion date
2023-01-10
Last updated
2023-05-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety, COVID-19, Depressive Symptoms

Keywords

Mobile health, Text-messaging, Covid-19, Mental health, Coping

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.

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: 1. a uniform random messaging group (micro-randomized trial design). 2. 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

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

BEHAVIORALMood ratings only

In this arm, participants will monitor their mood daily and receive feedback on that mood randomly

Sponsors

University of California, Berkeley
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)

Masking description

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.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Over 18 years old * Own a mobile phone * Speak English or Spanish

Exclusion criteria

* Not owning a mobile phone * Under 18 years old

Design outcomes

Primary

MeasureTime frameDescription
Depression scoresChange from baseline to 8 week follow-upPatient Health Questionnaire 9 item (PHQ-9). The PHQ-9 has scores from 0 to 27. Higher scores mean a worse outcome.
Anxiety scoresChange from baseline to 8 week follow-upGeneral Anxiety Disorder 7 item (GAD-7). The GAD-7 has scores from 0 to 21. Higher scores mean a worse outcome.

Secondary

MeasureTime frameDescription
Self reported mood ratings8 weeksThe self-reported mood rating 3 hours after receiving a message. The score is from 0-9. A higher mood rating indicates a better outcome.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 17, 2026