NCT05949840

Brief Summary

Expressive writing and motivational interviewing are well-known approaches to help patients handle stressful life events. While these methods are often applied by human counselors, it is less well understood if an automated approach can encourage behavior changes in patients. This study presents an automated writing system and evaluates its impact on individual behavior related to the COVID-19 pandemic. The investigators developed a rule-based dialogue system for "Expressive Interviewing" to elicit writing from participants on the subject of how COVID-19 has impacted their lives. In May-June 2021, the investigators randomly assigned online participants (N=151) to the Expressive Interviewing task and a control condition. The investigators examined their behavior with a survey before the intervention, immediately after, and two weeks after. In aggregate, task participants experienced a significant decrease in stress in the short-term (\~23% decrease, p \< 0.001) and no significant changes in longer-term outcomes compared to the control group. Within the task, participants showed different outcomes based on their writing. Participants who wrote with more anxiety-related words showed a greater short-term decrease in stress (R=-0.264, p\<0.001), and those who wrote with more positive emotion words reported a more meaningful experience (R=0.243, p=0.001). For longer-term effects, participants who wrote with more lexical diversity underwent an increase in social activity (R=0.266, p\<0.001). Expressive Interviewing can generally help with mental health in the short term but not longer-term, and participants' writing choices may make a difference in outcomes. While there were no significant long-term effects observed, the positive short term effect points to potential future directions with a series of Expressive Interviewing interventions for longer-term effects.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
151

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 24, 2021

Completed
14 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 7, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 7, 2021

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

June 26, 2023

Completed
22 days until next milestone

First Posted

Study publicly available on registry

July 18, 2023

Completed
Last Updated

July 18, 2023

Status Verified

July 1, 2023

Enrollment Period

14 days

First QC Date

June 26, 2023

Last Update Submit

July 9, 2023

Conditions

Outcome Measures

Primary Outcomes (4)

  • Stress (short-term)

    Short-term change in stress, self-assessed before and after intervention. Participants answered the question "How stressed are you feeling right now?" with a 1-7 point scale, where higher means more stress. Stress variable was assessed for change after the intervention.

    20 minutes

  • Mental health (long-term)

    Long-term change in stress, anxiety, and other mental health behaviors, before and after study. Participants answered 5 questions related to mental health, such as "Over the last two weeks, how often have you been bothered by the following problems? - Not being able to stop or control worrying" with a 1-7 point scale indicating number of days per week that the mental health condition affected them. Higher scores indicate negative outcome. HMental health condition was assessed for change after the intervention/control.

    2 weeks

  • Social behavior (long-term)

    Long-term change in socialization, before and after study. Participants answered 6 questions related to social behavior, such as "In the last week, on how many days did you do the following in the presence of people who were not fully vaccinated or with unknown vaccination status: - Have a face-to-face meeting with someone outside your home" with a 1-7 point scale indicating number of days per week that they participated in the social behavior. Higher scores indicate positive outcome. Social behavior was assessed for change after the intervention/control.

    2 weeks

  • Awareness of COVID-19

    Long-term change in awareness of COVID-19 problems, before and after study. Participants answered 12 questions related to COVID awareness, such as "In the last week, on how many days did you - Talk to people about COVID-19 and/or vaccinations" with a 1-7 point scale indicating number of days per week that they exhibited such behavior. Higher scores indicate negative outcome. COVID awareness was assessed for change after the intervention/control.

    2 weeks

Study Arms (2)

Expressive Interviewing + Survey

EXPERIMENTAL

Intervention with Expressive Interviewing computer system. Participants spent roughly 10-15 minutes each in conversation with an automated computer chat system. Participants answered a survey about mental health and social outcomes immediately before the intervention and two weeks after the intervention.

Other: Expressive Interviewing

Survey Only

NO INTERVENTION

No intervention. Participants answered a survey about mental health and social outcomes at time of recruitment and two weeks afterward.

Interventions

Automated computer system designed to engage participants in discussion about challenges faced during the COVID-19 pandemic.

Expressive Interviewing + Survey

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Using Prolific platform as crowd worker
  • Living in United States

You may not qualify if:

  • Participating in another condition of the same study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Related Publications (1)

  • Stewart I, Welch C, An L, Resnicow K, Pennebaker J, Mihalcea R. Expressive Interviewing Agents to Support Health-Related Behavior Change: Randomized Controlled Study of COVID-19 Behaviors. JMIR Form Res. 2023 Aug 1;7:e40277. doi: 10.2196/40277.

MeSH Terms

Conditions

Stress, Psychological

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
Participants were recruited online, and were anonymized to the researchers.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Computer Science

Study Record Dates

First Submitted

June 26, 2023

First Posted

July 18, 2023

Study Start

May 24, 2021

Primary Completion

June 7, 2021

Study Completion

June 7, 2021

Last Updated

July 18, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

No sharing of individual participant data due to privacy concerns.

Locations