NCT04496258

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
99

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2021

Shorter than P25 for not_applicable

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

First Submitted

Initial submission to the registry

July 16, 2020

Completed
18 days until next milestone

First Posted

Study publicly available on registry

August 3, 2020

Completed
1.2 years until next milestone

Study Start

First participant enrolled

October 5, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 14, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 14, 2022

Completed
2.3 years until next milestone

Results Posted

Study results publicly available

July 24, 2024

Completed
Last Updated

August 27, 2024

Status Verified

August 1, 2024

Enrollment Period

6 months

First QC Date

July 16, 2020

Results QC Date

July 5, 2023

Last Update Submit

August 5, 2024

Conditions

Keywords

cognitionreappraisal

Outcome Measures

Primary Outcomes (3)

  • Mood Ratings (Pos)

    Before putting on the VR headset and at the end of the experiment, participants used the modified Differential Emotions Scale (mDES; Fredrickson, 2013; Izard, 1977) to rate their current mood. We defined the mDES as a mood measure because it was intended to measure participants' current mood absent of a stimulus intended to evoke an emotional response (Rosenberg,1998). The mDES consists of 20 questions and is comprised of two sub-scales for positive and negative emotions with 10 questions for each subscale respectively. Scales are comprised of averaging all positive scores together and all negative scores together. In our study, participants were asked to rate their current experience of all 20 emotions on a five-point Likert Scale (1 - not at all to 5 - Extremely). Minimum socre = 1, maximum score = 5. Higher scores indicate higher levels of positive/negative mood.

    Baseline, and post-reappraisal task

  • Means of Self-reported Emotion Ratings

    The mean of each negative and positive emotion score were calculated post-reappraisal task. Higher scores indicate higher positive and negative emotions. The scale for both positive and negative was 1 - 9 where 1 was not positive at all/not negative at all and 9 was very positive/very negative. The minimum score was 1 and the maximum score was 9.

    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.

  • Mood Induction Ratings

    After the VR induced mood induction, and prior to starting the reappraisal task participants rated their positive and negative emotions on a 1-9 scale, where 1 is not at all and 9 is extremely.

    Pre-reappraisalTask

Secondary Outcomes (10)

  • Debriefing of Instructions

    Post-reappraisal task

  • Task Difficulty

    Post-reappraisal task

  • Number of Participants With Full Task Compliance

    Immediately after the reappraisal task

  • Number of Participants Reviewed for Possible Prior Experience With the Reappraisal Task and/or Task Images

    Post-reappraisal task

  • DWECK-E (Theries of Emotion Scale)

    Post-reappraisal task

  • +5 more secondary outcomes

Other Outcomes (2)

  • Depression Trait Differences

    Post-reappraisal task

  • Emotional Regulation Trait Differences

    Baseline

Study Arms (2)

Positive VR Scene

EXPERIMENTAL

Participants will explore a virtual reality (VR) environment of a beach scene. Participants will be randomly assigned (between subjects) to beach or office scene. VR will be presented on an Occulus Rift device.

Behavioral: Positive Emotion Induction

Neutral VR Scene

EXPERIMENTAL

Participants will explore a virtual reality (VR) environment of a neutral office scene. Participants will be randomly assigned (between subjects) to beach or office scene. VR will be presented on an Occulus Rift device.

Behavioral: Neutral Emotion Induction

Interventions

Participants are expected to have a positive emotional response to the more positive beach scene.

Positive VR Scene

Participants are expected to have a neutral emotional response to the neutral office scene.

Neutral VR Scene

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Denver, Frontier Hall

Denver, Colorado, 80208, United States

Location

Related Publications (1)

  • Kako N, Waugh CE, McRae K. The Future of Immersive Mood Induction in Affective Science: Using Virtual Reality to Test Effects of Mood Context on Task Performance. Affect Sci. 2023 Sep 12;4(3):570-579. doi: 10.1007/s42761-023-00213-1. eCollection 2023 Sep.

MeSH Terms

Conditions

Behavior

Results Point of Contact

Title
Kateri McRae
Organization
University of Denver

Study Officials

  • Kateri McRae, Ph.D.

    University of Denver

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

July 16, 2020

First Posted

August 3, 2020

Study Start

October 5, 2021

Primary Completion

April 14, 2022

Study Completion

April 14, 2022

Last Updated

August 27, 2024

Results First Posted

July 24, 2024

Record last verified: 2024-08

Locations