Clinical Trials Directory

Trials / Completed

CompletedNCT04473599

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
Phase
N/A
Study type
Interventional
Enrollment
1,000 (actual)
Sponsor
University of California, Berkeley · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Accepted

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

Conditions

Interventions

TypeNameDescription
BEHAVIORALUniform random message deliveryIn this arm, the categories and timings of text-messages will be delivered to participants using a random schedule
BEHAVIORALReinforcement learning message deliveryIn this arm, the categories and timings of text-messages will be chosen by a reinforcement learning algorithm
BEHAVIORALMood ratings onlyIn this arm, participants will monitor their mood daily and receive feedback on that mood randomly

Timeline

Start date
2020-04-17
Primary completion
2022-07-25
Completion
2023-01-10
First posted
2020-07-16
Last updated
2023-05-23

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT04473599. Inclusion in this directory is not an endorsement.