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

Primary Purpose

Depressive Symptoms, Anxiety, COVID-19

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Uniform random message delivery
Reinforcement learning message delivery
Mood ratings only
Sponsored by
University of California, Berkeley
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Depressive Symptoms focused on measuring Mobile health, Text-messaging, Covid-19, Mental health, Coping

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of California Berkeley

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Active Comparator

Arm Label

Uniform Random

Reinforcement Learning

Mood ratings only

Arm Description

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.

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.

In this arm, participants will monitor their mood and receive random feedback based on mood responses.

Outcomes

Primary Outcome Measures

Depression scores
Patient Health Questionnaire 9 item (PHQ-9). The PHQ-9 has scores from 0 to 27. Higher scores mean a worse outcome.
Anxiety scores
General Anxiety Disorder 7 item (GAD-7). The GAD-7 has scores from 0 to 21. Higher scores mean a worse outcome.

Secondary Outcome Measures

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.

Full Information

First Posted
July 13, 2020
Last Updated
May 19, 2023
Sponsor
University of California, Berkeley
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1. Study Identification

Unique Protocol Identification Number
NCT04473599
Brief Title
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

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
April 17, 2020 (Actual)
Primary Completion Date
July 25, 2022 (Actual)
Study Completion Date
January 10, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, Berkeley

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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: 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depressive Symptoms, Anxiety, COVID-19
Keywords
Mobile health, Text-messaging, Covid-19, Mental health, Coping

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Masking Description
Participants are randomized to receive messages according to a random schedule (within a mico-randomized trial), delivered via a reinforcement learning policy or a control with mood ratings only.
Allocation
Randomized
Enrollment
1000 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Uniform Random
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Reinforcement Learning
Arm Type
Experimental
Arm Description
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.
Arm Title
Mood ratings only
Arm Type
Active Comparator
Arm Description
In this arm, participants will monitor their mood and receive random feedback based on mood responses.
Intervention Type
Behavioral
Intervention Name(s)
Uniform random message delivery
Intervention Description
In this arm, the categories and timings of text-messages will be delivered to participants using a random schedule
Intervention Type
Behavioral
Intervention Name(s)
Reinforcement learning message delivery
Intervention Description
In this arm, the categories and timings of text-messages will be chosen by a reinforcement learning algorithm
Intervention Type
Behavioral
Intervention Name(s)
Mood ratings only
Intervention Description
In this arm, participants will monitor their mood daily and receive feedback on that mood randomly
Primary Outcome Measure Information:
Title
Depression scores
Description
Patient Health Questionnaire 9 item (PHQ-9). The PHQ-9 has scores from 0 to 27. Higher scores mean a worse outcome.
Time Frame
Change from baseline to 8 week follow-up
Title
Anxiety scores
Description
General Anxiety Disorder 7 item (GAD-7). The GAD-7 has scores from 0 to 21. Higher scores mean a worse outcome.
Time Frame
Change from baseline to 8 week follow-up
Secondary Outcome Measure Information:
Title
Self reported mood ratings
Description
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.
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adrian Aguilera, PhD
Organizational Affiliation
UC Berkeley
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California Berkeley
City
Berkeley
State/Province
California
ZIP/Postal Code
94709
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
Citations:
PubMed Identifier
34543230
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.
Results Reference
derived
PubMed Identifier
33370721
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.
Results Reference
derived

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

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