Mental Stress Clinical Trial
Official title:
Expressive Interviewing Agents to Support Health-Related Behavior Change: Randomized Controlled Study of COVID-19 Behaviors
NCT number | NCT05949840 |
Other study ID # | HUM00182586 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | May 24, 2021 |
Est. completion date | June 7, 2021 |
Verified date | July 2023 |
Source | University of Michigan |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 151 |
Est. completion date | June 7, 2021 |
Est. primary completion date | June 7, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | N/A and older |
Eligibility | Inclusion Criteria: - Using Prolific platform as crowd worker - Living in United States Exclusion Criteria: - Participating in another condition of the same study |
Country | Name | City | State |
---|---|---|---|
United States | University of Michigan | Ann Arbor | Michigan |
Lead Sponsor | Collaborator |
---|---|
University of Michigan | University of Texas at Austin |
United States,
Stewart I, Welch C, An L, Resnicow K, Pennebaker J, Mihalcea R. Expressive Interviewing Agents to Support Health-Related Behavior Change: A Study of COVID-19 Behaviors. JMIR Form Res. 2023 Mar 30. doi: 10.2196/40277. Online ahead of print. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 |
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