BehaviorNCT04496258
Investigating the Neural Systems That Support the Beneficial Effects of Positive Emotion on Stress Regulation
A study testing Positive Emotion Induction and Neutral Emotion Induction in people with Behavior, run by University of Denver at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Behavior
- What is being tested?
- Positive Emotion Induction and Neutral Emotion Induction
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 99 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Oct 2021to 14 Apr 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Community members ages 18-55
- Fluent in English
- Without present psychotic symptoms
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Denver, Frontier Hall
Denver, Colorado, 80208
About this study
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.
Read the 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.
- Conditions
- Behavior
- Being tested
- Positive Emotion Induction, Neutral Emotion Induction
- Keywords
- cognition, reappraisal
- Medical subject headings
- Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Positive Emotion InductionBehavioural
Participants are expected to have a positive emotional response to the more positive beach scene.
Neutral Emotion InductionBehavioural
Participants are expected to have a neutral emotional response to the neutral office scene.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Neutral Emotion Induction |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Pre-reappraisalTask
Secondary outcomes (10)
Debriefing of Instructions
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.
Measured: Post-reappraisal task
Task Difficulty
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.
Measured: Post-reappraisal task
Number of Participants With Full Task Compliance
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.
Measured: Immediately after the reappraisal task
Number of Participants Reviewed for Possible Prior Experience With the Reappraisal Task and/or Task Images
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.
Measured: Post-reappraisal task
DWECK-E (Theries of Emotion Scale)
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.
Measured: Post-reappraisal task
The Big Five Inventory-10 (BFI-1)
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.
Measured: Post-reappraisal task
Brief Resilience Scale
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.
Measured: Post-reappraisal task
Satisfaction With Life Scale
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.
Measured: Post-reappraisal task
The Igroup Presence Questionnaire (IPQ)
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.
Measured: Post-reappraisal task
Brief Cope
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.
Measured: Post-reappraisal task
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2020
- Study start5 Oct 2021
- Primary completion14 Apr 2022
- Study completion14 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for BehaviorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Denver
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Kateri McRae, University of Denver
- Investigators
- Kateri McRae, Ph.D., Principal investigator, University of Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04496258
- Sponsor's protocol ID
- 1606445
- Other IDs
- 2R15MH106928-02A1
- Status last verified
- Aug 2024
- First submitted
- 16 Jul 2020
- Last updated
- 27 Aug 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 37744975
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Neural Systems That Support the Beneficial Effects of Positive Emotion on Stress Regulation
- ClinicalTrials.gov ID
- NCT04496258
- Acronym / sponsor ID
- 1606445
- Conditions
- Behavior
- Keywords
- cognition, reappraisal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- University of DenverUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 5 Oct 2021 (actual)
- Primary completion
- 14 Apr 2022 (actual)
- Study completion
- 14 Apr 2022 (actual)
- First posted
- 3 Aug 2020 (actual)
- Results
- Posted 24 Jul 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Positive VR Scene | Experimental | Behavioral: Positive Emotion InductionParticipants 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. |
| Neutral VR Scene | Experimental | Behavioral: Neutral Emotion InductionParticipants 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. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Community members ages 18-55
- Fluent in English
- Without present psychotic symptoms
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Positive Emotion InductionParticipants are expected to have a positive emotional response to the more positive beach scene. | Behavioural | Positive VR Scene |
| Neutral Emotion InductionParticipants are expected to have a neutral emotional response to the neutral office scene. | Behavioural | Neutral VR Scene |
Primary outcome
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.
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.
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.
10 secondary outcomes
Debriefing of Instructions
Time frame: Post-reappraisal task
Task Difficulty
Time frame: Post-reappraisal task
Number of Participants With Full Task Compliance
Time frame: 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
DWECK-E (Theries of Emotion Scale)
Time frame: Post-reappraisal task
The Big Five Inventory-10 (BFI-1)
Time frame: Post-reappraisal task
Brief Resilience Scale
Time frame: Post-reappraisal task
Satisfaction With Life Scale
Time frame: Post-reappraisal task
The Igroup Presence Questionnaire (IPQ)
Time frame: Post-reappraisal task
Brief Cope
Time frame: Post-reappraisal task
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37744975Kako 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kateri McRae, Ph.D. principal investigator
University of Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Positive Emotion Induction and Neutral Emotion Induction in people with Behavior, run by University of Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Jul 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mood Ratings (Pos) (time frame: Baseline, and post-reappraisal task). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04496258, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2024.