BehaviorNCT04532242
Investigating the Neural Systems That Support the Reappraisal Tactics Leading to Positive Emotion
A study testing Cognitive reappraisal in people with Behavior, run by University of Denver at 1 site in United States.
Trial summary
Community participants will visit the neuroimaging facilities at CU Boulder for a single experimental session. In all studies, 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… 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?
- Cognitive reappraisal
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Jun 2023to 1 Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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.
Alyssa Asmar, B.A contact
United States1 site, 1 recruiting
- Recruiting
University of Denver
Denver, Colorado, 80208
Laurel Shurtleff, 303-871-3702, laurel.shurtleff@du.edu
About this study
Community participants will visit the neuroimaging facilities at CU Boulder for a single experimental session. In all studies, 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. Then, participants complete an event-related, picture-based cognitive reappraisal task for 30-45 minutes, during which whole-brain BOLD signal 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 researchers predict that the positive emotion induction will result in powerful effects on self-reported emotion which may or may not interact with the cognitive reappraisal condition. Participants will be trained to use reappraisal to increase positive emotion, and they will be asked to respond with the reappraisal tactic category that best fits the reappraisal they used for each image. The researchers predict greater use of future-focused tactics will be associated with greater reappraisal success, which in turn will result in greater recruitment of vmPFC and connectivity between vmPFC and other prefrontal regions.
Read the detailed description
For all 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 at the Intermountain Neuroimaging Facility at CU Boulder. Participants will be sent a copy of the consent form to read in advance of their visit, and to keep for their records.
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 then complete a mandatory day-of MRI eligibility form to ensure scanner compatibility has not changed since the initial screening (done by phone, email or webform). Females who are unable to indicate "no" to the question, "is it possible that you are pregnant?" will be asked to take a pregnancy test provided at the MR facility. Participants will change into MRI- compatible clothes or scrubs. 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 an external button box). 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, participants will be screened one final time for metal in or near their bodies at the door to the shielded MRI room, then be placed in the MRI scanner by a certified, full-time MRI technician. Participants will be reminded they can stop the experiment at any point if they are physically uncomfortable or become claustrophobic, and will be outfitted with a panic button to indicate that they wish to stop the experiment immediately once it has begun. After the initial structural and calibration scans, participants will complete the reappraisal task. The task will take 40-50 minutes (broken up into 4-5 separate functional runs in the scanner, with each run taking around 10 minutes).
- Conditions
- Behavior
- Being tested
- Cognitive reappraisal
- Keywords
- cognitive reappraisal, cognition
- Medical subject headings
- Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive reappraisalBehavioural
Participants will be trained to follow instructions to look/respond naturally or use cognitive reappraisal to reframe or reconsider a negative picture to decrease negative emotion.
| Study group | Role | What they receive |
|---|---|---|
| fMRI Participants | Experimental | Participants will be scanned in an fMRI session lasting approximately 45-50 minutes and will be shown negative images for which they will have to take on a cognitive reappraisal tactic. All participants will be taken through the scanner with the same reappraisal protocol for each participant. Receives: Behavioral: Cognitive reappraisal |
What is being measured
The primary outcome is the main question the study is designed to answer.
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").
Measured: During the task intervention which will last 50 minutes
Whole brain BOLD signal
Changes in blood oxygen dependent level (EPI sequences) from the whole brain collected in a 3T MRI scanner with a head-coil specifically for fMRI.
Measured: Immediately after the intervention
Secondary outcomes (4)
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).
Measured: Pre-intervention and immediately after the intervention
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".
Measured: Immediately after the intervention
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).
Measured: Immediately after intervention
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.
Measured: Immediately after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2020
- Study start22 Jun 2023
- Primary completion31 Aug 2023 (estimated)
- Study completion1 Nov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Denver
- Sponsor type
- University, hospital or other
- Collaborators
- Wake Forest University
- 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
- NCT04532242
- Sponsor's protocol ID
- 1606445-A
- Status last verified
- Jul 2023
- First submitted
- 25 Aug 2020
- Last updated
- 25 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Neural Systems That Support the Reappraisal Tactics Leading to Positive Emotion
- ClinicalTrials.gov ID
- NCT04532242
- Acronym / sponsor ID
- 1606445-A
- Conditions
- Behavior
- Keywords
- cognitive reappraisal, cognition
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of DenverUniversity, hospital or other
- Collaborators
- Wake Forest University
- Study start
- 22 Jun 2023 (actual)
- Primary completion
- 31 Aug 2023 (estimated)
- Study completion
- 1 Nov 2023 (estimated)
- First posted
- 31 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Community participants will visit the neuroimaging facilities at CU Boulder for a single experimental session. In all studies, 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. Then, participants complete an event-related, picture-based cognitive reappraisal task for 30-45 minutes, during which whole-brain BOLD signal 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 researchers predict that the positive emotion induction will result in powerful effects on self-reported emotion which may or may not interact with the cognitive reappraisal condition. Participants will be trained to use reappraisal to increase positive emotion, and they will be asked to respond with the reappraisal tactic category that best fits the reappraisal they used for each image. The researchers predict greater use of future-focused tactics will be associated with greater reappraisal success, which in turn will result in greater recruitment of vmPFC and connectivity between vmPFC and other prefrontal regions.
Detailed description
For all 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 at the Intermountain Neuroimaging Facility at CU Boulder. Participants will be sent a copy of the consent form to read in advance of their visit, and to keep for their records.
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 then complete a mandatory day-of MRI eligibility form to ensure scanner compatibility has not changed since the initial screening (done by phone, email or webform). Females who are unable to indicate "no" to the question, "is it possible that you are pregnant?" will be asked to take a pregnancy test provided at the MR facility. Participants will change into MRI- compatible clothes or scrubs. 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 an external button box). 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, participants will be screened one final time for metal in or near their bodies at the door to the shielded MRI room, then be placed in the MRI scanner by a certified, full-time MRI technician. Participants will be reminded they can stop the experiment at any point if they are physically uncomfortable or become claustrophobic, and will be outfitted with a panic button to indicate that they wish to stop the experiment immediately once it has begun. After the initial structural and calibration scans, participants will complete the reappraisal task. The task will take 40-50 minutes (broken up into 4-5 separate functional runs in the scanner, with each run taking around 10 minutes).
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| fMRI Participants | Experimental | Behavioral: Cognitive reappraisalParticipants will be scanned in an fMRI session lasting approximately 45-50 minutes and will be shown negative images for which they will have to take on a cognitive reappraisal tactic. All participants will be taken through the scanner with the same reappraisal protocol for each participant. |
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 |
|---|---|---|
| Cognitive reappraisalParticipants will be trained to follow instructions to look/respond naturally or use cognitive reappraisal to reframe or reconsider a negative picture to decrease negative emotion. | Behavioural | fMRI Participants |
Primary outcome
Self-reported emotion ratings
Time frame: During the task intervention which will last 50 minutes
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").
Whole brain BOLD signal
Time frame: Immediately after the intervention
Changes in blood oxygen dependent level (EPI sequences) from the whole brain collected in a 3T MRI scanner with a head-coil specifically for fMRI.
4 secondary outcomes
Mood ratings
Time frame: Pre-intervention and immediately after the intervention
Task difficulty
Time frame: Immediately after the intervention
Task compliance
Time frame: Immediately after intervention
Experience with task images
Time frame: Immediately after intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2023.
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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.
Alyssa Asmar, B.A contact
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 Cognitive reappraisal 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: status not confirmed, as of the sponsor's last update on 25 Jul 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kateri McRae, Ph.D. (303-871-3632, Kateri.McRae@du.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-reported emotion ratings (time frame: During the task intervention which will last 50 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Jul 2023.