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

Behavior Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04496258
• Other study ID #: 1606445
• Status: Completed
• Phase: N/A
• Start date: October 5, 2021
• Est. completion date: April 14, 2022

Study information

• Verified date: June 2022
• Source: University of Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

For this study, community participants will visit the PI's psychophysiology lab for a single experimental session. In this study, participants will complete pre-task questionnaires (trait measures), and a brief mood measure, followed by a task training in which a research assistant describes and gives examples of cognitive reappraisal in response to negative images. Participants are then randomly assigned to positive or neutral emotion induction conditions, to be delivered by virtual reality. Then, participants complete an event-related, picture-based cognitive reappraisal task for 30-45 minutes, during which skin conductance level will be collected. Following the task, participants will once again respond to a mood measure, and answer a series of questions regarding the task they have completed, including difficulty of regulation, or any images that were personally relevant.

The investigators predict that the positive emotion induction will result in powerful effects on self-reported emotion and skin conductance, which may or may not interact with the cognitive reappraisal condition.

Description:

For the studies, participants will be recruited via paper and electronic flyers on campus and in the surrounding communities. Interested participants will be screened via phone, email and/or web form to assess eligibility according to criteria listed elsewhere. Should participants qualify, they will be invited to complete a single laboratory session in the PI's psychophysiology lab.

Once arriving at the laboratory, participants will complete the consent process, in which a research assistant trained in ethical principles regarding human subjects research will answer any questions about the consent form and verbally reinforce the key rights of the participants outlined there. Once both parties are satisfied, consent forms will be signed.

Participants will sit with a trained research assistant/experimenter who will give an overview of the entire session, and then begin training for the cognitive reappraisal task. This training takes 10-15 minutes. During the training, the experimenter will offer several possible reappraisals of negative images and allow the participants to offer their own as well, providing encouragement and feedback. During this training, the experimenter will also go over the method of encouragement and feedback. During this training, the experimenter will also go over the method of responding (using the VR equipment). Participants will be reminded during training that they may stop the experiment at any point if the pictures are too upsetting.

Immediately following task training, participants will make a general mood rating using the PANAS. Then, they will be randomly assigned to a positive or neutral mood induction, to be delivered by 10 minutes exploring a positive (beach scene) or neutral (office scene) VR environment using a headset with integrated audio. After the VR exploration, participants will complete the reappraisal task. The task will take just under 20 minutes.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 96
• Est. completion date: April 14, 2022
• Est. primary completion date: April 14, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• Community members ages 18-55

• Fluent in English

• Without present psychotic symptoms

Exclusion Criteria:

• None

Related Conditions & MeSH terms

• Behavior

Intervention

Behavioral:
• Positive Emotion Induction
Participants are expected to have a positive emotional response to the more positive beach scene.
• Neutral Emotion Induction
Participants are expected to have a neutral emotional response to the neutral office scene.

Locations

Country	Name	City	State
United States	The University of Denver, Frontier Hall	Denver	Colorado

Sponsors (2)

Lead Sponsor	Collaborator
University of Denver	Wake Forest University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Depression trait differences	The participants will be given the Beck's Depression Inventory(BDI-II) which measures symptoms of depression and will be 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).	Baseline
Other	Emotional regulation trait differences	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.	Baseline
Primary	Self-reported emotion ratings	Participants will be rating their negative and positive emotions during the intervention. They will be asked "How positive do you feel?" and "How negative do you feel?" after each image and will answer on a scale of 1-9 with 1 being low ("I don't feel positive at all" or "I don't feel negative at all") to 9 ("I feel very positive" or "I feel very negative").	During the task intervention which will last 18 minutes
Primary	Means of self-reported emotion ratings	The mean of each negative and positive emotion score will be calculated post-intervention.	Immediately after the intervention
Primary	Skin conductance level	The researchers will place electrodes on the palm and will measure changes in conductance in response to negative/neutral images.	Immediately after the intervention
Secondary	Mood ratings	Pre- and post-task mood as measured by the Positive and Negative Affect Schedule (PANAS) will be taken before and after the intervention. The PANAS is a 20-question questionnaire rated on a scale of 1 to 5 (with 1 being "very slight or not at all" and 5 being "extremely"). Questions 1, 3, 5, 9, 10, 12, 14, 16, 17, and 19 represent the positive affect scale with scores ranging between 10 and 50 (the higher the score, the higher the levels of positive affect). Questions 2, 4, 6, 7, 8, 11, 13, 15,18, and 20 represent the negative affect scale with scores falling between 10 and 50 (lower scores represent lower levels of negative affect).	Pre-intervention and immediately after the intervention
Secondary	Debriefing of instructions	Following the VR task, participants will be asked to report the task instructions in their own words. The first questions will ask 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.	Immediately after the intervention
Secondary	Task difficulty	The next batch of questions will ask the participant questions about the difficulty of the task. An example question is "How difficult was it to follow the 'LOOK' 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".	Immediately after the intervention
Secondary	Task compliance	Participants will be asked about self-reported task compliance. For example, one question will ask "What percentage of the time were you able to follow the "LOOK" instruction?" The participants will be rating their self-compliance for each task from 0% (non-compliant) to 100% (fully compliant).	Immediately after the intervention
Secondary	Experience with task images	Participants will be asked whether they have any experience with reappraisal or the specific images presented in the task. The first question will ask "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 will ask "Have you ever seen any of these exact emotional images before?" The participant then once again will be asked to extrapolate which images they have seen and what emotional response was generated by these images using a fill in the blank option.	Immediately after the intervention