Clinical trial NCT04473599: Stay Well at Home: a Text-messaging Study Social Distancing
Official title: Stay Well at Home: A Text-messaging Study to Improve Mood and Help Cope With Social Distancing
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depressive Symptoms
Anxiety
COVID-19
Keywords: Mobile health
Text-messaging
Covid-19
Mental health
Coping
Lead sponsor: University of California, Berkeley
Sponsor class: OTHER
First posted: 2020-07-16
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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

Eligibility criteria: 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

Primary outcomes:
measure: Depression scores
timeFrame: Change from baseline to 8 week follow-up
measure: Anxiety scores
timeFrame: Change from baseline to 8 week follow-up
Secondary outcomes:
measure: Self reported mood ratings
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Berkeley
country: United States
facility: University of California Berkeley
state: California
Study officials:
affiliation: UC Berkeley
name: Adrian Aguilera, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Aguilera A, Hernandez-Ramos R, Haro-Ramos AY, Boone CE, Luo TC, Xu J, Chakraborty B, Karr C, Darrow S, Figueroa CA. A Text Messaging Intervention (StayWell at Home) to Counteract Depression and Anxiety During COVID-19 Social Distancing: Pre-Post Study. JMIR Ment Health. 2021 Nov 1;8(11):e25298. doi: 10.2196/25298.
citation: Figueroa CA, Hernandez-Ramos R, Boone CE, Gomez-Pathak L, Yip V, Luo T, Sierra V, Xu J, Chakraborty B, Darrow S, Aguilera A. A Text Messaging Intervention for Coping With Social Distancing During COVID-19 (StayWell at Home): Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2021 Jan 14;10(1):e23592. doi: 10.2196/23592.