Investigating the Neural Systems That Support the Beneficial Effects of Positive Emotion on Stress Regulation

August 5, 2024 updated by: Kateri McRae, University of Denver

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
99

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • United States
    • Colorado
      • Denver, Colorado, United States, 80208
        • The University of Denver, Frontier Hall

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • None

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: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Positive VR Scene
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
Participants are expected to have a positive emotional response to the more positive beach scene.
Experimental: Neutral VR Scene
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
Participants are expected to have a neutral emotional response to the neutral office scene.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Mood Ratings (Pos)
Time Frame: Baseline, and post-reappraisal task
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
Time Frame: 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.
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
Time Frame: Pre-reappraisalTask
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Debriefing of Instructions
Time Frame: Post-reappraisal task
Following the VR task, participants were asked to report the task instructions in their own words. The first questions asked participants to reiterate the instructions they were given for the cognitive reappraisal task (for example: "What were you instructed to do during the 'LOOK' trials?") This is a fill in the blank question and there are no right or wrong answers. All participants' responses are viewed to ensure understanding of the task instruction. There are no scores to report for this measure. Rather this, outcome serves more as a comprehension check than an actual analysis of interest.
Post-reappraisal task
Task Difficulty
Time Frame: Post-reappraisal task
The next batch of questions asked the participants questions about the difficulty of the task. The questions asked were: "How difficult was it to follow the 'LOOK' instruction?" And: "How difficult was it to follow the 'DECREASE' instruction?" Participants will be rating the level of difficulty on a scale of 1 to 7 with 1 being "not difficult at all" to 7 being "very difficult". There are no right or wrong answers to this question. The range of scores is 1-7.
Post-reappraisal task
DWECK-E (Theries of Emotion Scale)
Time Frame: Post-reappraisal task
The theories of emotion scale was developed for use by Maya Tamir, Oliver P. John, Sanjay Srivastava, and James J. Gross in 2007, based on Carol Dweck's Implicit Theories of Intelligence scale (Dweck, 1999). It's used to measure beliefs about the malleable nature of emotion on a scale of 1 (strong disagree) to 5 (strongly agree) where higher scores indicate stronger agreement with the belief. There are 4 items, 2 of which are reverse coded. Scores are taken by averaging the response items. The minimum score is 1 and the maximum range is 5.
Post-reappraisal task
The Big Five Inventory-10 (BFI-1)
Time Frame: Post-reappraisal task
A 10 item self-report scale that is designed to measure the big five personality traits (extraversion, agreeableness, conscientiousness, neuroticism, and openness) on a scale of 1-5 where higher values indicate higher indication of the personality trait. Certain individual items are reversed scored on this measure. The subscales in our data were calculated using averages to produce a score. The possible range for each subscale reported included a minimum value of 1 and a maximum value of 5.
Post-reappraisal task
Brief Resilience Scale
Time Frame: Post-reappraisal task
The BRS is a self-report measure that assesses the ability to bounce back or recover from stress on a 1-5 scale. Higher scores indicate higher levels of resilience.
Post-reappraisal task
Satisfaction With Life Scale
Time Frame: Post-reappraisal task
A 5-item scale designed to measure global cognitive judgments of one's life satisfaction (not a measure of either positive or negative affect). Participants indicate how much they agree or disagree with each of the 5 items using a 7-point scale that ranges from 7 strongly agree to 1 strongly disagree. Higher scores indicate higher levels of satisfaction. The scale is summed to produce a score, and the possible range of scores is 5-35.
Post-reappraisal task
The Igroup Presence Questionnaire (IPQ)
Time Frame: Post-reappraisal task
The Igroup Presence Questionnaire (IPQ) is a self-report scale for measuring the sense of presence experienced in a virtual environment (VE). It contains three subscales that assess aspects of presence: spatial presence, involvement, and experience realism. Higher scores indicate higher sense of presence. Items were rated on a scale of 0 to 6 and items for each subscale are averaged to get each subscale core. The Range for all subscales are 0-6.
Post-reappraisal task
Brief Cope
Time Frame: Post-reappraisal task

The Brief-COPE is a 28 item self-report questionnaire designed to measure effective and ineffective ways to cope with a stressful life event. Sub-scales are reported. Higher scores indicate higher use of the coping strategy. he Brief COPE is comprised of 14 scales, each of which assesses the degree to which a respondent utilizes a specific coping strategy. The scales are: Active Coping, Planning, Positive Reframing, Acceptance, Humor, Religion, Using Emotional Support, Using Instrumental Support, Self-Distraction, Denial, Venting, Substance Use, Behavioral Disengagement, Self-Blame. Items are rated on a 4-point Likert scale, ranging from 1 - "I haven't been doing this at all" to 4 - "I've been doing this a lot." Each of the scales is comprised of 2 items; total scores on each scale range from 2 (minimum) to 8 (maximum).

Total scores for each sub scales are calculated by summing the items. There is no overall total score.
Post-reappraisal task
Number of Participants With Full Task Compliance
Time Frame: Immediately after the reappraisal task
Participants were asked about self-reported task compliance. For example, one question asked "What percentage of the time were you able to follow the "LOOK" instruction?" The participants were rating their self-compliance for each task from 0% (non-compliant) to 100% (fully compliant). There are no right or wrong answers to this question and these responses are more descriptive/exploratory. They are not used in any specific analyses. The number of participants analyzed below indicates the number of participants that were fully compliant across both conditions.
Immediately after the reappraisal task
Number of Participants Reviewed for Possible Prior Experience With the Reappraisal Task and/or Task Images
Time Frame: Post-reappraisal task
Participants were asked whether they have any experience with reappraisal or the specific images presented in the task. The first question asked "Have you ever been trained to change your emotions by changing the way you think (in therapy, or in another experiment, or anywhere else)?" Participants can choose "Yes" or "No" for this question. The participant will have to extrapolate if they have changed their emotions before using a fill in the blank. The next question asked"Have you ever seen any of these exact emotional images before?" If participants answered yes, they were once again asked to extrapolate which images they have seen and what emotional response was generated by these images using a fill in the blank option. These are descriptive and not used in any formal analyses. The number of participants analyzed below indicates the the number of participant responses we reviewed.
Post-reappraisal task

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Depression Trait Differences
Time Frame: Post-reappraisal task
The participants were given the Beck's Depression Inventory(BDI-II) which measures symptoms of depression and were used to examine any between-subjects trait differences. The BDI-II is a 21 self-report measure looking at symptoms of depression with ratings falling between 0 and 3 (0 being "not at all" and 3 would indicate experiencing these symptoms on a constant basis). There are no subscales. Higher scores indicate higher levels of depressive symptoms. Scores range from 0 - 63
Post-reappraisal task
Emotional Regulation Trait Differences
Time Frame: Baseline
The Emotion Regulation Questionnaire (ERQ) looks at methods of regulating emotions and will be used to examine any between-subjects trait differences. The ERQ is a 10-item self-report questionnaire assessing the use of two strategies to alter emotions: cognitive reappraisal and expressive suppression. The scale is rated on a 7-point Likert scale with 1 being "strongly disagree" and 7 being "strongly agree". Six items are categorized as using cognitive reappraisal while four of the items assess expressive suppression. Higher scores indicate higher use of the emotion regulation strategies. The scale scores were computed by taking the average of the items included in each sub scale. The possible range for each sub scale is 1-7
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Denver

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute of Mental Health (NIMH)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Kateri McRae, Ph.D., University of Denver

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 5, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 14, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 14, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 16, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 31, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 3, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 27, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 5, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 1606445
  • 2R15MH106928-02A1 (U.S. NIH Grant/Contract)

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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