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

COVID-19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04473599
• Other study ID #: 2020-04-13162
• Status: Completed
• Phase: N/A
• Start date: April 17, 2020
• Est. completion date: January 10, 2023

Study information

• Verified date: May 2023
• Source: University of California, Berkeley
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1000
• Est. completion date: January 10, 2023
• Est. primary completion date: July 25, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• COVID-19
• Depression
• Depressive Symptoms

Intervention

Behavioral:
• Uniform random message delivery
In this arm, the categories and timings of text-messages will be delivered to participants using a random schedule
• Reinforcement learning message delivery
In this arm, the categories and timings of text-messages will be chosen by a reinforcement learning algorithm
• Mood ratings only
In this arm, participants will monitor their mood daily and receive feedback on that mood randomly

Locations

Country	Name	City	State
United States	University of California Berkeley	Berkeley	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Berkeley

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Depression scores	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
Primary	Anxiety scores	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	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.	8 weeks