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Completed

NCT Number: NCT04473599

Stay Well at Home: a Text-messaging Study 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.

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Key information

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Uniform random message delivery

Behavioral

In this arm, the categories and timings of text-messages will be delivered to participants using a random schedule

Reinforcement learning message delivery

Behavioral

In this arm, the categories and timings of text-messages will be chosen by a reinforcement learning algorithm

Mood ratings only

Behavioral

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

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. Self reported mood ratings

    Time frame: 8 weeks

    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.

Sponsors and collaborators

Lead sponsor

University of California, Berkeley

Other

Registry information

Official study title

Stay Well at Home: A Text-messaging Study to Improve Mood and Help Cope With Social Distancing

Important dates

Study start
2020
Primary completion
2022
Study completion
2023
First posted
Jul 16, 2020
Registry last updated
May 23, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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