Ignite Creation Date:
2025-12-25 @ 12:20 AM
Ignite Modification Date:
2025-12-25 @ 10:24 PM
Study NCT ID:
NCT04496258
Status:
COMPLETED
Last Update Posted:
2024-08-27
First Post:
2020-07-16
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Investigating the Neural Systems That Support the Beneficial Effects of Positive Emotion on Stress Regulation
Sponsor:
University of Denver
Organization:
Study Overview
Official Title:
Investigating the Neural Systems That Support the Beneficial Effects of Positive Emotion on Stress Regulation
Status:
COMPLETED
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
For this study, community participants visited the PI's psychophysiology lab for a single experimental session. In this study, participants completed a brief mood measure, followed by a task training in which a research assistant described and gave examples of cognitive reappraisal in response to negative images. Participants were then randomly assigned to positive or neutral emotion induction conditions, delivered by virtual reality. Then, participants completed an event-related, picture-based cognitive reappraisal task for 23 minutes. Following the task, participants once again responded to a mood measure, completed post-task questionnaires (individual difference measures) and answered a series of questions regarding the task they completed, including difficulty of regulation, or any images that were personally relevant.
The investigators predicted that the positive emotion induction would result in powerful effects on self-reported emotion, which may or may not interact with the cognitive reappraisal condition.
The investigators predicted that the positive emotion induction would result in powerful effects on self-reported emotion, which may or may not interact with the cognitive reappraisal condition.
Detailed Description:
For the studies, participants were recruited via paper and electronic flyers on campus and in the surrounding communities. Interested participants were screened via phone, email and/or web form to assess eligibility according to criteria listed elsewhere. If participants qualified, they were be invited to complete a single laboratory session in the PI's lab.
Once arriving at the laboratory, participants completed the consent process, in which a research assistant trained in ethical principles regarding human subjects research answered any questions about the consent form and verbally reinforced the key rights of the participants outlined there. Once both parties were satisfied, the consent form was signed.
Participants sat with a trained research assistant/experimenter who gave an overview of the entire session, and then began training for the cognitive reappraisal task. The training took 10-15 minutes. During the training, the experimenter offered several possible reappraisals of negative images and allowed the participants to offer their own as well, providing encouragement and feedback. During this training, the experimenter also went over the method of responding (using the VR equipment). Participants were reminded during training that they may stop the experiment at any point if the pictures are too upsetting.
Immediately following task training, participants will made a general mood rating using the mDES. Then, they were randomly assigned to a positive or neutral mood induction, to be delivered via the VR headset for three minutes. Participants were encouraged to explore the VR environment, which was either a positive (beach scene) or neutral (office scene). The VR environment was implemented using a headset with integrated audio. After the VR exploration, participants made a rating of their current positive and negative affect in the VR environment. Then, participants completed the reappraisal task in the VR environment. The task took approximately 23 minutes.
Finally, participants completed post-task individual difference measures.
Once arriving at the laboratory, participants completed the consent process, in which a research assistant trained in ethical principles regarding human subjects research answered any questions about the consent form and verbally reinforced the key rights of the participants outlined there. Once both parties were satisfied, the consent form was signed.
Participants sat with a trained research assistant/experimenter who gave an overview of the entire session, and then began training for the cognitive reappraisal task. The training took 10-15 minutes. During the training, the experimenter offered several possible reappraisals of negative images and allowed the participants to offer their own as well, providing encouragement and feedback. During this training, the experimenter also went over the method of responding (using the VR equipment). Participants were reminded during training that they may stop the experiment at any point if the pictures are too upsetting.
Immediately following task training, participants will made a general mood rating using the mDES. Then, they were randomly assigned to a positive or neutral mood induction, to be delivered via the VR headset for three minutes. Participants were encouraged to explore the VR environment, which was either a positive (beach scene) or neutral (office scene). The VR environment was implemented using a headset with integrated audio. After the VR exploration, participants made a rating of their current positive and negative affect in the VR environment. Then, participants completed the reappraisal task in the VR environment. The task took approximately 23 minutes.
Finally, participants completed post-task individual difference measures.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2R15MH106928-02A1 | NIH | None | https://reporter.nih.gov/quic… | View |