Stay Well at Home: a Text-messaging Study Social Distancing

May 19, 2023 updated by: University of California, Berkeley

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

1000

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Berkeley, California, United States, 94709
        • University of California Berkeley

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Uniform Random
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.
Behavioral: Uniform random message delivery
In this arm, the categories and timings of text-messages will be delivered to participants using a random schedule
Experimental: Reinforcement Learning
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.
Behavioral: Reinforcement learning message delivery
In this arm, the categories and timings of text-messages will be chosen by a reinforcement learning algorithm
Active Comparator: Mood ratings only
In this arm, participants will monitor their mood and receive random feedback based on mood responses.
Behavioral: Mood ratings only
In this arm, participants will monitor their mood daily and receive feedback on that mood randomly

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Change from baseline to 8 week follow-up
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.
Change from baseline to 8 week follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, Berkeley

Investigators

  • Principal Investigator: Adrian Aguilera, PhD, UC Berkeley

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 17, 2020

Primary Completion (Actual)

July 25, 2022

Study Completion (Actual)

January 10, 2023

Study Registration Dates

First Submitted

July 13, 2020

First Submitted That Met QC Criteria

July 13, 2020

First Posted (Actual)

July 16, 2020

Study Record Updates

Last Update Posted (Actual)

May 23, 2023

Last Update Submitted That Met QC Criteria

May 19, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020-04-13162

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Individual participant data that underlies the results reported in the articles will be made available to researchers on request after deidentification.

IPD Sharing Time Frame

After publication of the data, no end date

IPD Sharing Access Criteria

Anyone with a methodologically sound proposal.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ANALYTIC_CODE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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