Clinical trial NCT04496258: Investigating the Neural Systems That Support the Beneficial Effects of Positive Emotion on Stress Regulation
Official title: Investigating the Neural Systems That Support the Beneficial Effects of Positive Emotion on Stress Regulation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Behavior
Keywords: cognition
reappraisal
Lead sponsor: University of Denver
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2020-08-03
Enrollment: 99
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

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.

Eligibility criteria: Inclusion Criteria:

* Community members ages 18-55
* Fluent in English
* Without present psychotic symptoms

Exclusion Criteria:

* None

Primary outcomes:
measure: Mood Ratings (Pos)
timeFrame: Baseline, and post-reappraisal task
measure: Means of Self-reported Emotion Ratings
timeFrame: During the reappraisal task, individual ratings for each picture were taken immediately after viewing the image. The mean rating across all images was computed after the experiment was complete.
measure: Mood Induction Ratings
timeFrame: Pre-reappraisalTask
Secondary outcomes:
measure: Debriefing of Instructions
timeFrame: Post-reappraisal task
measure: Task Difficulty
timeFrame: Post-reappraisal task
measure: Number of Participants With Full Task Compliance
timeFrame: Immediately after the reappraisal task
measure: Number of Participants Reviewed for Possible Prior Experience With the Reappraisal Task and/or Task Images
timeFrame: Post-reappraisal task
measure: DWECK-E (Theries of Emotion Scale)
timeFrame: Post-reappraisal task
measure: The Big Five Inventory-10 (BFI-1)
timeFrame: Post-reappraisal task
measure: Brief Resilience Scale
timeFrame: Post-reappraisal task
measure: Satisfaction With Life Scale
timeFrame: Post-reappraisal task
measure: The Igroup Presence Questionnaire (IPQ)
timeFrame: Post-reappraisal task
measure: Brief Cope
timeFrame: Post-reappraisal task
Other outcomes:
measure: Depression Trait Differences
timeFrame: Post-reappraisal task
measure: Emotional Regulation Trait Differences
timeFrame: Baseline
Locations:
city: Denver
country: United States
facility: The University of Denver, Frontier Hall
state: Colorado
Study officials:
affiliation: University of Denver
name: Kateri McRae, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: