- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05949840
Expressive Interviewing Agents to Support Health-Related Behavior Change
July 9, 2023 updated by: Rada Mihalcea, University of Michigan
Expressive Interviewing Agents to Support Health-Related Behavior Change: Randomized Controlled Study of COVID-19 Behaviors
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
151
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
-
-
Michigan
-
Ann Arbor, Michigan, United States, 48109
- University of Michigan
-
-
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
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Using Prolific platform as crowd worker
- Living in United States
Exclusion Criteria:
- Participating in another condition of the same study
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: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Expressive Interviewing + Survey
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.
|
Automated computer system designed to engage participants in discussion about challenges faced during the COVID-19 pandemic.
|
|
No Intervention: Survey Only
No intervention.
Participants answered a survey about mental health and social outcomes at time of recruitment and two weeks afterward.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Stress (short-term)
Time Frame: 20 minutes
|
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)
Time Frame: 2 weeks
|
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)
Time Frame: 2 weeks
|
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
Time Frame: 2 weeks
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
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.
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)
May 24, 2021
Primary Completion (Actual)
June 7, 2021
Study Completion (Actual)
June 7, 2021
Study Registration Dates
First Submitted
June 26, 2023
First Submitted That Met QC Criteria
July 9, 2023
First Posted (Actual)
July 18, 2023
Study Record Updates
Last Update Posted (Actual)
July 18, 2023
Last Update Submitted That Met QC Criteria
July 9, 2023
Last Verified
July 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HUM00182586
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
No sharing of individual participant data due to privacy concerns.
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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